What is TIVDAK? TIVDAK is a prescription medicine used to treat adults with cervical cancer that has returned or has spread to other parts of the body, and who have received chemotherapy that did not work or is no longer working.

RESOURCES TO HELP YOU WHILE ON TREATMENT

Watch treatment guidance and tips from experienced specialists

There are several useful resources available to help you while on Tivdak

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Patient Brochure

An overview of Tivdak and what to expect from treatment

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Image sample from the first page of the Tivdak® (tisotumab vedotin-tftv) Caregiver Brochure

Caregiver Brochure

A resource providing guidance to caregivers about supporting their loved ones on Tivdak

Download English
Download Español
Image sample from the first page of the Tivdak® (tisotumab vedotin-tftv)Texts Brochure
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TivdakTexts Brochure

A guide to a text message support program designed to assist you throughout treatment

Download English
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Image sample from the first page of the Tivdak (tisotumab vedotin-tftv) Important Facts document

Important Facts

A short summary of key information about Tivdak

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Pfizer Oncology Together

Looking for support? We’ve got you covered

Pfizer Oncology Together™ logo

Pfizer Oncology Together understands that getting your prescribed Pfizer Oncology medicine is at the top of your to-do list. That’s why our dedicated team offers you available resources, personalized support, and connections to financial assistance, if needed, to help you work through the challenges of access and reimbursement.

From finding financial assistance options to addressing coverage concerns, Pfizer Oncology Together is here to support you every step of the way.

Get support that’s specific to you

Personalized patient support

If you’re prescribed a Pfizer Oncology medicine, you can get personalized support from a Field Reimbursement Director (FRD) at every step of your treatment. These experts are here to answer your questions and connect you with helpful resources and organizations.* Once you are signed up, an FRD will work with you directly.

Your Field Reimbursement Director can help you by:

  • Connecting eligible patients to available financial assistance options, no matter what insurance coverage they may have
  • Providing educational resources on insurance, financial literacy, benefits, and coverage
  • Linking you and your caregivers to a range of resources and advocacy groups that can offer practical and logistical support

*Some services are provided through third-party organizations that operate independently and are not controlled by Pfizer. Availability of services and eligibility requirements are determined solely by these organizations. Opt-in required.

Call 1-877-744-5675 to learn how to enroll in Pfizer Oncology Together

Visit the Website

Download the Brochure

TivdakTexts

Sign up for TivdakTexts

Ya disponible en español

Descargue el folleto

TivdakTexts is a free text message support program designed to assist you throughout treatment§

Some benefits of TivdakTexts include:

  • Calendar icon

    Infusion reminders

  • Droplet icon

    Eye drop reminders

  • Cell phone icon

    Inspirational messages

Cell phone showing a text message. The text message reads: Welcome to the Tivdak (tisotumab vedotin-tftv)Text program! With this program, you’ll receive important infusion and eye care reminders during your treatment with Tivdak (tisotumab vedotin-tftv) (tisotumab vedotin-tftv) for injection 40mg

To sign up for TivdakTexts, you can follow these steps:

  • Step 1

    On your mobile phone, text the word JOIN to 74277

  • Step 2

    When you get a message back from us, text back AGREE to confirm your participation in the support program

  • Step 3

    Then provide the following information:

    • Your first name so we can personalize messages
    • Your ZIP Code so we can set your time zone
    • The timing of your upcoming Tivdak infusion

§Message and data rates may apply. Check with your mobile service provider. Message frequency will be based on your selections. Text HELP for help with the program. Text STOP to stop receiving messages. See Terms of Use and Conditions. By initiating a text message, you agree to receive automated text messages from Pfizer. You can unsubscribe at any time. You represent that you are the subscriber of the number provided and 18 or older. You must notify Pfizer immediately if you relinquish the number provided. Consent is not required as a condition of purchasing any products or services.

Advocacy groups

Help is out there

When you have advanced cancer, it can be hard to know where to turn. There are a number of groups offering care and support throughout your experience.

These patient support groups are included as a reference for patients and caregivers. Their inclusion does not imply endorsement from the individual patient support groups listed.

Cancer Support Community logo

Cancer Support Community

A worldwide network committed to ensuring that no one faces cancer alone by providing navigation, support, and resources through face-to-face, telephone, and online programming.

cancersupportcommunity.org

Cervivor logo

Cervivor

A cervical cancer awareness and support community, a learning tool, an advocacy resource, and an online retreat for healing, connecting, and thriving.

cervivor.org

Family Reach logo

Family Reach

Family Reach delivers financial education, financial coaching, resource navigation, and emergency relief to patients and caregivers facing a cancer diagnosis.

familyreach.org

Foundation for Women’s Cancer logo

Foundation for Women’s Cancer

A foundation dedicated to increasing research, education, and awareness about gynecologic cancer risk, prevention, early detection, and optimal treatment.

foundationforwomenscancer.org

National Cervical Cancer Coalition, A program of the American Sexual Health Association logo

National Cervical Cancer Coalition

A grassroots organization that helps women, family members, and caregivers battle the personal issues related to cervical cancer and HPV, and advocates for cervical health in all women.

nccc-online.org

Triage Cancer logo

Triage Cancer

A nonprofit group that provides education on the practical and legal issues that may impact individuals diagnosed with cancer and their caregivers through free events, materials, and resources.

triagecancer.org

By clicking these links, you will be redirected to websites that are neither owned nor controlled by Pfizer or Genmab. Pfizer and Genmab are not responsible for the content or services of these sites.

Watch expert treatment TIPS & GUIDANCE

Click to watch Talking Tivdak (tisotumab vedotin-tftv) videos.
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What to expect DURING TREATMENT

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What to Expect

See the STUDY RESULTS

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Important Safety Information

What is the most important information I should know about TIVDAK?

Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems. Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or symptoms of eye problems.

Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with TIVDAK. Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems:

  • Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops 3 times a day for 3 days after each infusion
  • Use vasoconstrictor eye drops right before each infusion
  • Use lubricating eye drops throughout treatment and for 30 days after your last dose of TIVDAK

Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist.

What are the possible side effects of TIVDAK?

Serious side effects of TIVDAK may include:

Eye problems. See “What is the most important information I should know about TIVDAK?”

Nerve problems (peripheral neuropathy) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you have new or worsening numbness or tingling in your hands or feet or muscle weakness.

Bleeding problems (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider or get medical help right away if you have signs or symptoms of bleeding during treatment with TIVDAK, including blood in your stools or black stools (looks like tar), blood in your urine, cough up or vomit blood, unusual vaginal bleeding, or any unusual or heavy bleeding.

Lung problems. TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you have new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you have signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:

  • Skin reactions that look like rings (target lesions)
  • Rash or itching that continues to get worse
  • Blistering or peeling of the skin
  • Painful sores or ulcers in your mouth, nose, throat, or genital area
  • Fever or flu-like symptoms
  • Swollen lymph nodes

The most common side effects of TIVDAK include:

  • Decreased red blood cell counts
  • Numbness or tingling in your hands or feet
  • Eye problems (conjunctival disorders)
  • Nausea
  • Tiredness
  • Changes in liver function blood tests
  • Nosebleed
  • Hair loss (alopecia)
  • Bleeding (hemorrhage)

Your healthcare provider may decrease your dose of TIVDAK, temporarily stop, or completely stop treatment if you have side effects.

What should I tell my healthcare provider before receiving TIVDAK?

Tell your healthcare provider about all your medical conditions, including if you:

  • have a history of vision or eye problems
  • have numbness or tingling in your hands or feet
  • have bleeding problems
  • have liver problems
  • are pregnant or plan to become pregnant; TIVDAK can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TIVDAK

  • are breastfeeding (nursing) or plan to breastfeed. It is not known if TIVDAK passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of TIVDAK

    Females who can become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK
    • Use an effective method of birth control during your treatment and for at least 2 months after the last dose of TIVDAK

    Males with female partners who can become pregnant:

    • Use effective birth control during treatment and for 4 months after the last dose of TIVDAK

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TIVDAK with certain other medicines may cause side effects.

These are not all of the possible side effects of TIVDAK. Discuss side effects with your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information with Medication Guide about TIVDAK including an IMPORTANT WARNING.

What is TIVDAK?

TIVDAK is a prescription medicine used to treat adults with cervical cancer:

  • that has returned or has spread to other parts of the body, and
  • who have received chemotherapy that did not work or is no longer working.

Important Safety Information

What is the most important information I should know about TIVDAK?

Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems. Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or symptoms of eye problems.

Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with TIVDAK. Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems:

  • Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops 3 times a day for 3 days after each infusion
  • Use vasoconstrictor eye drops right before each infusion
  • Use lubricating eye drops throughout treatment and for 30 days after your last dose of TIVDAK

Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist.

What are the possible side effects of TIVDAK?

Serious side effects of TIVDAK may include:

Eye problems. See “What is the most important information I should know about TIVDAK?”

Nerve problems (peripheral neuropathy) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you have new or worsening numbness or tingling in your hands or feet or muscle weakness.

Bleeding problems (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider or get medical help right away if you have signs or symptoms of bleeding during treatment with TIVDAK, including blood in your stools or black stools (looks like tar), blood in your urine, cough up or vomit blood, unusual vaginal bleeding, or any unusual or heavy bleeding.

Lung problems. TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you have new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you have signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:

  • Skin reactions that look like rings (target lesions)
  • Rash or itching that continues to get worse
  • Blistering or peeling of the skin
  • Painful sores or ulcers in your mouth, nose, throat, or genital area
  • Fever or flu-like symptoms
  • Swollen lymph nodes

The most common side effects of TIVDAK include:

  • Decreased red blood cell counts
  • Numbness or tingling in your hands or feet
  • Eye problems (conjunctival disorders)
  • Nausea
  • Tiredness
  • Changes in liver function blood tests
  • Nosebleed
  • Hair loss (alopecia)
  • Bleeding (hemorrhage)

Your healthcare provider may decrease your dose of TIVDAK, temporarily stop, or completely stop treatment if you have side effects.

What should I tell my healthcare provider before receiving TIVDAK?

Tell your healthcare provider about all your medical conditions, including if you:

  • have a history of vision or eye problems
  • have numbness or tingling in your hands or feet
  • have bleeding problems
  • have liver problems
  • are pregnant or plan to become pregnant; TIVDAK can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TIVDAK

  • are breastfeeding (nursing) or plan to breastfeed. It is not known if TIVDAK passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of TIVDAK

    Females who can become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK
    • Use an effective method of birth control during your treatment and for at least 2 months after the last dose of TIVDAK

    Males with female partners who can become pregnant:

    • Use effective birth control during treatment and for 4 months after the last dose of TIVDAK

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TIVDAK with certain other medicines may cause side effects.

These are not all of the possible side effects of TIVDAK. Discuss side effects with your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information with Medication Guide about TIVDAK including an IMPORTANT WARNING.

What is TIVDAK?

TIVDAK is a prescription medicine used to treat adults with cervical cancer:

  • that has returned or has spread to other parts of the body, and
  • who have received chemotherapy that did not work or is no longer working.

See how Tivdak gave Alisha a chance to tell her story

Meet Alisha, an artist, hairdresser, and advanced cervical cancer patient.

a

  • ALISHA:

    I’m an artist. I’m a hairstylist and I own my own salon. I get a lot of happiness when someone feels good in their new haircut.

    Cutting hair and helping others has always felt like my purpose. It’s also important for me to find inspiration in life.

    I use my painting to escape and to be inspired. I’m in the moment, focused on what I’m creating.

    Drip painting is a way of painting that you pour paint straight onto the canvas. There’s just so many different ways to create something. No two paintings ever turn out exactly the same.

    I started painting to process everything going on in my life when I was diagnosed with cancer.

    When I was 30, my doctor found a tumor pressing up against my reproductive organs. I underwent some tests, including a Pap smear, and it showed I had cervical cancer.

    I received my initial treatment and, afterwards, my doctor said there was no more signs of cancer. For 22 years, I received regular scans and testing.

    One day I experienced unexplained bleeding, and I knew I needed to see my doctor. A biopsy showed that my cervical cancer was back.

    After that diagnosis, I was devastated. I was scared. I was scared of dying, I just really felt alone.

    After many rounds of chemotherapy, the treatment stopped working and I wasn’t sure what to do next.

    I started to get discouraged. It was so scary and so hard. I just needed something, an outlet, to leave it. I turned to my art to process the emotions I was feeling.

    It’s just so beautiful to create something and then, just, you don’t think about it. You don’t think about anything, no problems, no nothing. It’s just creating.

    The art is taking over. I let my emotions spill out onto the canvas. Immersing myself into my art allowed me to stay positive during this time.

    I knew I wasn’t ready to give up. I knew it was going to be a fight, but I made a choice to keep trying. That’s when my doctor recommended Tivdak.

    Narrator:

    TIVDAK (tisotumab vedotin-tftv) 40mg, for injection is a prescription medicine used to treat adults with cervical cancer that has returned or has spread to other parts of the body, and who have received chemotherapy that did not work or is no longer working.

    Alisha:

    My first reaction when I heard about TIVDAK was I had to do it.

    My doctor told me about the serious side effects of TIVDAK. I was concerned about the side effects, but I was also concerned about losing my fight with cancer. Giving up was not an option.

    After talking with my doctor, I learned about the steps that can help reduce the risk of eye problems. I felt more confident in my knowledge, and I decided to start treatment on TIVDAK.

    Narrator:

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss.

    Serious side effects of TIVDAK may include eye problems, nerve problems (peripheral neuropathy), bleeding problems (hemorrhage), lung problems, and severe skin reactions. TIVDAK can harm your unborn baby.

    These are not all the side effects of TIVDAK. Please see the end of this video for more details about side effects and visit TIVDAK.com/resources to review the Important Facts about TIVDAK including the IMPORTANT WARNING.

    Alisha:

    I visit an eye specialist before every infusion. After setting up a routine with my eye specialist, I feel good about the process.

    My treatment takes about 30 minutes. During that time, I like to sit back and listen to music.

    I had my first scan a few months after starting treatment. It showed that my cervical cancer was responding to treatment.

    I continue to go in for my infusions every three weeks. I experience some side effects, like nausea, dry, irritated eyes, but my doctor helped me manage them.

    There are additional side effects that you might experience on treatment. This is just my experience, everyone’s experience on TIVDAK is different.

    I’m so happy that I can continue finding my purpose by helping others.

    When cancer patients come into my salon, I love helping them feel confident with how they look.

    I now approach my art with a new energy. I’m able to keep trying new things for inspiration.

    I love discovering all the things I’m able to do through my art.

    VOICEOVER:

    What is TIVDAK?

    TIVDAK is a prescription medicine used to treat adults with cervical cancer:

    • that has returned or has spread to other parts of the body, and
    • who have received chemotherapy that did not work or is no longer working.

    Important Safety Information

    What is the most important information I should know about TIVDAK?

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems. Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or symptoms of eye problems.

    Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with TIVDAK. Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems:

    • Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops 3 times a day for 3 days after each infusion
    • Use vasoconstrictor eye drops right before each infusion
    • Use lubricating eye drops throughout treatment and for 30 days after your last dose of TIVDAK

    Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist.

    What are the possible side effects of TIVDAK?

    Serious side effects of TIVDAK may include:

    Eye problems. See “What is the most important information I should know about TIVDAK?”

    Nerve problems (peripheral neuropathy) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you have new or worsening numbness or tingling in your hands or feet or muscle weakness.

    Bleeding problems (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider or get medical help right away if you have signs or symptoms of bleeding during treatment with TIVDAK, including blood in your stools or black stools (looks like tar), blood in your urine, cough up or vomit blood, unusual vaginal bleeding, or any unusual or heavy bleeding.

    Lung problems. TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you have new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

    Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you have signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:

    • Skin reactions that look like rings (target lesions)
    • Rash or itching that continues to get worse
    • Blistering or peeling of the skin
    • Painful sores or ulcers in your mouth, nose, throat, or genital area
    • Fever or flu-like symptoms
    • Swollen lymph nodes

    The most common side effects of TIVDAK include:

    • Decreased red blood cell counts
    • Numbness or tingling in your hands or feet
    • Eye problems (conjunctival disorders)
    • Nausea
    • Tiredness
    • Changes in liver function blood tests
    • Nosebleed
    • Hair loss (alopecia)
    • Bleeding (hemorrhage)

    Your healthcare provider may decrease your dose of TIVDAK, temporarily stop, or completely stop treatment if you have side effects.

    What should I tell my healthcare provider before receiving TIVDAK?

    Tell your healthcare provider about all your medical conditions, including if you:

    • have a history of vision or eye problems
    • have numbness or tingling in your hands or feet
    • have bleeding problems
    • have liver problems
    • are pregnant or plan to become pregnant; TIVDAK can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TIVDAK
    • are breastfeeding (nursing) or plan to breastfeed. It is not known if TIVDAK passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of TIVDAK

    Females who can become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK
    • Use an effective method of birth control during your treatment and for at least 2 months after the last dose of TIVDAK

    Males with female partners who can become pregnant:

    • Use effective birth control during treatment and for 4 months after the last dose of TIVDAK

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TIVDAK with certain other medicines may cause side effects.

    These are not all of the possible side effects of TIVDAK. Discuss side effects with your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088.

    Please see the full Prescribing Information with Medication Guide about TIVDAK including an IMPORTANT WARNING at TIVDAK.com.

Is Tivdak Right for Me?

  • Dr. HODEIB:

    Hello, I’m Dr. Melissa Hodeib, a gynecologic oncologist. I specialize in treating patients with cervical cancer. And I wanted to talk to you about a treatment option. So, let’s talk about Tivdak.

    Narrator:

    TIVDAK is a prescription medicine used to treat adults with cervical cancer that has returned or has spread to other parts of the body, and who have had chemotherapy that did not work or is no longer working.

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    And remember to review Important Safety Information at the end of this video, which covers more information on eye problems.

    You should also read the Important Facts about Tivdak, including an IMPORTANT WARNING for eye problems, at tivdak.com.

    Dr. HODEIB:

    Now that we've covered that, let's talk about who Tivdak may be right for.

    When I'm thinking about Tivdak as a potential treatment for a patient, here are the questions that I consider: Have you been diagnosed with advanced cervical cancer? Or, do you have cervical cancer that has come back or spread after treatment? Have you already tried chemotherapy to treat your advanced cervical cancer? Did chemotherapy not work or stop working?

    If you answered yes to these questions, then Tivdak may be a treatment option for you.

    When it comes to advanced cervical cancer, Tivdak works differently and is not like traditional chemotherapy. Unlike some other medications for advanced cervical cancer, additional tests do not need to be performed on your tumor to check if Tivdak is right for you.

    Ask your doctor to see if Tivdak may be an option for you.

    Looking for more information?

    Check out the full Talking Tivdak video series to learn more.

    Keep watching for more Important Safety Information about Tivdak, including an important warning, and see the full Prescribing Information and Medication Guide at tivdak.com.

    Narrator:

    What is TIVDAK?

    TIVDAK is a prescription medicine used to treat adults with cervical cancer:

    • that has returned or has spread to other parts of the body, and
    • who have received chemotherapy that did not work or is no longer working.

    Important Safety Information

    What is the most important information I should know about TIVDAK?

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems. Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or symptoms of eye problems.

    Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with TIVDAK. Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems:

    • Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops 3 times a day for 3 days after each infusion
    • Use vasoconstrictor eye drops right before each infusion
    • Use lubricating eye drops throughout treatment and for 30 days after your last dose of TIVDAK

    Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist.

    What are the possible side effects of TIVDAK?

    Serious side effects of TIVDAK may include:

    Eye problems. See “What is the most important information I should know about TIVDAK?”

    Nerve problems (peripheral neuropathy) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you have new or worsening numbness or tingling in your hands or feet or muscle weakness.

    Bleeding problems (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider or get medical help right away if you have signs or symptoms of bleeding during treatment with TIVDAK, including blood in your stools or black stools (looks like tar), blood in your urine, cough up or vomit blood, unusual vaginal bleeding, or any unusual or heavy bleeding.

    Lung problems. TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you have new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

    Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you have signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:

    • Skin reactions that look like rings (target lesions)
    • Rash or itching that continues to get worse
    • Blistering or peeling of the skin
    • Painful sores or ulcers in your mouth, nose, throat, or genital area
    • Fever or flu-like symptoms
    • Swollen lymph nodes

    The most common side effects of TIVDAK include:

    • Decreased red blood cell counts
    • Numbness or tingling in your hands or feet
    • Eye problems (conjunctival disorders)
    • Nausea
    • Tiredness
    • Changes in liver function blood tests
    • Nosebleed
    • Hair loss (alopecia)
    • Bleeding (hemorrhage)

    Your healthcare provider may decrease your dose of TIVDAK, temporarily stop, or completely stop treatment if you have side effects.

    What should I tell my healthcare provider before receiving TIVDAK?

    Tell your healthcare provider about all your medical conditions, including if you:

    • have a history of vision or eye problems
    • have numbness or tingling in your hands or feet
    • have bleeding problems
    • have liver problems
    • are pregnant or plan to become pregnant; TIVDAK can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TIVDAK

    • are breastfeeding (nursing) or plan to breastfeed. It is not known if TIVDAK passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of TIVDAK

      Females who can become pregnant:

      • Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK
      • Use an effective method of birth control during your treatment and for at least 2 months after the last dose of TIVDAK

      Males with female partners who can become pregnant:

      • Use effective birth control during treatment and for 4 months after the last dose of TIVDAK

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TIVDAK with certain other medicines may cause side effects.

    These are not all of the possible side effects of TIVDAK. Discuss side effects with your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088.

    Please see the full Prescribing Information with Medication Guide about TIVDAK including an IMPORTANT WARNING at tivdak.com.

Tivdak vs Traditional Chemotherapy

  • Dr. HODEIB:

    Hi, I’m Dr. Melissa Hodeib, I’m a GYN oncologist, and I specialize in treating patients with cervical cancer. I wanted to talk to you about a treatment that works differently, so let’s talk about Tivdak.

    Narrator:

    TIVDAK is a prescription medicine used to treat adults with cervical cancer that has returned or has spread to other parts of the body, and who have had chemotherapy that did not work or is no longer working.

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    And remember to review Important Safety Information at the end of this video, which covers more information on eye problems.

    You should also read the Important Facts about Tivdak, including an IMPORTANT WARNING for eye problems, at tivdak.com.

    Dr. HODEIB:

    Now that we’ve covered that, let’s talk about how Tivdak is different from traditional chemotherapy.

    As you consider your treatment options, you may wonder, is Tivdak the same as traditional chemotherapy? The short answer is no.

    Tivdak is not like traditional chemotherapy.

    But one thing that’s important to note, is that Tivdak is an infusion.

    Tivdak is a type of treatment called an antibody-drug conjugate, or ADC. ADCs are not like traditional chemotherapy. Chemotherapy targets all cells that divide to fight cervical cancer, while ADCs attach to a special protein on the outside of cancer cells. The special protein, called Tissue Factor, is also present on normal cells. So Tivdak can still harm normal cells, which may cause side effects.

    Be sure to check with your doctor to see if Tivdak may be right for you.

    Looking for more information? Check out the full Talking Tivdak video series to learn more.

    Keep watching for more Important Safety Information about Tivdak, including an important warning, and see the full Prescribing Information and Medication Guide at tivdak.com.

    Narrator:

    What is TIVDAK?

    TIVDAK is a prescription medicine used to treat adults with cervical cancer:

    • that has returned or has spread to other parts of the body, and
    • who have received chemotherapy that did not work or is no longer working.

    Important Safety Information

    What is the most important information I should know about TIVDAK?

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems. Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or symptoms of eye problems.

    Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with TIVDAK. Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems:

    • Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops 3 times a day for 3 days after each infusion
    • Use vasoconstrictor eye drops right before each infusion
    • Use lubricating eye drops throughout treatment and for 30 days after your last dose of TIVDAK

    Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist.

    What are the possible side effects of TIVDAK?

    Serious side effects of TIVDAK may include:

    Eye problems. See “What is the most important information I should know about TIVDAK?”

    Nerve problems (peripheral neuropathy) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you have new or worsening numbness or tingling in your hands or feet or muscle weakness.

    Bleeding problems (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider or get medical help right away if you have signs or symptoms of bleeding during treatment with TIVDAK, including blood in your stools or black stools (looks like tar), blood in your urine, cough up or vomit blood, unusual vaginal bleeding, or any unusual or heavy bleeding.

    Lung problems. TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you have new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

    Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you have signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:

    • Skin reactions that look like rings (target lesions)
    • Rash or itching that continues to get worse
    • Blistering or peeling of the skin
    • Painful sores or ulcers in your mouth, nose, throat, or genital area
    • Fever or flu-like symptoms
    • Swollen lymph nodes

    The most common side effects of TIVDAK include:

    • Decreased red blood cell counts
    • Numbness or tingling in your hands or feet
    • Eye problems (conjunctival disorders)
    • Nausea
    • Tiredness
    • Changes in liver function blood tests
    • Nosebleed
    • Hair loss (alopecia)
    • Bleeding (hemorrhage)

    Your healthcare provider may decrease your dose of TIVDAK, temporarily stop, or completely stop treatment if you have side effects.

    What should I tell my healthcare provider before receiving TIVDAK?

    Tell your healthcare provider about all your medical conditions, including if you:

    • have a history of vision or eye problems
    • have numbness or tingling in your hands or feet
    • have bleeding problems
    • have liver problems
    • are pregnant or plan to become pregnant; TIVDAK can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TIVDAK

    • are breastfeeding (nursing) or plan to breastfeed. It is not known if TIVDAK passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of TIVDAK

      Females who can become pregnant:

      • Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK
      • Use an effective method of birth control during your treatment and for at least 2 months after the last dose of TIVDAK

      Males with female partners who can become pregnant:

      • Use effective birth control during treatment and for 4 months after the last dose of TIVDAK

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TIVDAK with certain other medicines may cause side effects.

    These are not all of the possible side effects of TIVDAK. Discuss side effects with your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088.

    Please see the full Prescribing Information with Medication Guide about TIVDAK including an IMPORTANT WARNING at tivdak.com.

How Tivdak Works: A Different Kind of Treatment

  • NARRATOR:

    Let's take a closer look at Tivdak, a different kind of treatment for cervical cancer called an antibody-drug conjugate or ADC.

    Tivdak is a prescription medicine used to treat adults with cervical cancer:

    • that has returned or has spread to other parts of the body, and
    • who have received chemotherapy that did not work or is no longer working.

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    Tivdak is the first treatment of its kind approved for advanced cervical cancer and works differently from traditional chemotherapy.

    It's an antibody-drug conjugate or ADC.

    Unlike traditional chemotherapy, ADCs attack cells that have a specific protein in the body.

    As an ADC, Tivdak is made up of 3 parts: an antibody that targets the specific protein in the body, the medicine that kills the cell (the drug), and a linker (conjugate) that holds them together. Now, let's take a deeper look at how Tivdak is thought to work.

    Tivdak attaches to a specific protein called Tissue Factor that lives on the outside of some types of tumor cells.

    Tissue Factor is also present on some normal cells, so Tivdak may harm them, causing side effects.

    After attaching to Tissue Factor, Tivdak enters the cell. And once it's inside the cell, the drug is released.  Then the drug damages and kills the cell.

    Since Tivdak specifically attaches to Tissue Factor, it may offer a more targeted approach than traditional chemotherapy.

    Keep watching for more Important Safety Information about Tivdak, including an IMPORTANT WARNING, and see the full Prescribing Information and Medication Guide at tivdak.com.

    What is TIVDAK?

    TIVDAK is a prescription medicine used to treat adults with cervical cancer:

    • that has returned or has spread to other parts of the body, and
    • who have received chemotherapy that did not work or is no longer working.

    Important Safety Information

    What is the most important information I should know about TIVDAK?

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems. Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or symptoms of eye problems.

    Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with TIVDAK. Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems:

    • Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops 3 times a day for 3 days after each infusion
    • Use vasoconstrictor eye drops right before each infusion
    • Use lubricating eye drops throughout treatment and for 30 days after your last dose of TIVDAK

    Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist.

    What are the possible side effects of TIVDAK?

    Serious side effects of TIVDAK may include:

    Eye problems. See “What is the most important information I should know about TIVDAK?”

    Nerve problems (peripheral neuropathy) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you have new or worsening numbness or tingling in your hands or feet or muscle weakness.

    Bleeding problems (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider or get medical help right away if you have signs or symptoms of bleeding during treatment with TIVDAK, including blood in your stools or black stools (looks like tar), blood in your urine, cough up or vomit blood, unusual vaginal bleeding, or any unusual or heavy bleeding.

    Lung problems. TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you have new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

    Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you have signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:

    • Skin reactions that look like rings (target lesions)
    • Rash or itching that continues to get worse
    • Blistering or peeling of the skin
    • Painful sores or ulcers in your mouth, nose, throat, or genital area
    • Fever or flu-like symptoms
    • Swollen lymph nodes

    The most common side effects of TIVDAK include:

    • Decreased red blood cell counts
    • Numbness or tingling in your hands or feet
    • Eye problems (conjunctival disorders)
    • Nausea
    • Tiredness
    • Changes in liver function blood tests
    • Nosebleed
    • Hair loss (alopecia)
    • Bleeding (hemorrhage)

    Your healthcare provider may decrease your dose of TIVDAK, temporarily stop, or completely stop treatment if you have side effects.

    What should I tell my healthcare provider before receiving TIVDAK?

    Tell your healthcare provider about all your medical conditions, including if you:

    • have a history of vision or eye problems
    • have numbness or tingling in your hands or feet
    • have bleeding problems
    • have liver problems
    • are pregnant or plan to become pregnant; TIVDAK can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TIVDAK

    • are breastfeeding (nursing) or plan to breastfeed. It is not known if TIVDAK passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of TIVDAK

      Females who can become pregnant:

      • Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK
      • Use an effective method of birth control during your treatment and for at least 2 months after the last dose of TIVDAK

      Males with female partners who can become pregnant:

      • Use effective birth control during treatment and for 4 months after the last dose of TIVDAK

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TIVDAK with certain other medicines may cause side effects.

    These are not all of the possible side effects of TIVDAK. Discuss side effects with your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088.

    Please see the full Prescribing Information with Medication Guide about TIVDAK including an IMPORTANT WARNING at tivdak.com.

Key Terms to Know

  • Dr. HODEIB:

    Hi, I’m Dr. Melissa Hodeib, with Talking Tivdak. I’m here to talk to you about a few key words on cervical cancer treatment.

    Narrator:

    TIVDAK is a prescription medicine used to treat adults with cervical cancer that has returned or has spread to other parts of the body, and who have had chemotherapy that did not work or is no longer working.

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    And remember to review Important Safety Information at the end of this video, which covers more information on eye problems.

    You should also read the Important Facts about Tivdak, including an IMPORTANT WARNING for eye problems, at tivdak.com.

    Dr. HODEIB:

    Now, let’s chat about a few key words to understand when it comes to cervical cancer.

    When you’re doing research to discover treatment options for your cervical cancer, there are many common terms used that I think are important to define.

    Those include recurrent, metastatic, overall survival, objective response, and adverse reaction.

    When you think of the word recurrent, I like to think of it as a period of time where you have no evidence of cancer. And then a scan may be done, where the cancer has shown up again.

    Metastatic means that the cancer starts in one origin of the body and then spreads to distant sites.

    Overall survival is a measurement used in clinical studies to help determine whether or not a treatment is effective. It is the length of time that patients have lived, starting from either the date of diagnosis or the date that treatment had begun.

    Objective response is a way to measure how a treatment affects specific tumors over time. Objective response is the percentage of patients who either had their tumors shrink, or showed no signs of cancer after treatment. 

    When you think of the word adverse reaction, I like to think of this as a side effect a drug may have.

    Understanding these terms truly empowers you to make the right decision for your cancer treatment.

    Be sure to check with your doctor to see if Tivdak may be right for you.

    Looking for more information? Check out the full Talking Tivdak video series to learn more.

    Keep watching for more Important Safety Information about Tivdak, including an important warning, and see the Full Prescribing Information and Medication Guide at tivdak.com.

    Narrator:

    What is TIVDAK?

    TIVDAK is a prescription medicine used to treat adults with cervical cancer:

    • that has returned or has spread to other parts of the body, and
    • who have received chemotherapy that did not work or is no longer working.

    Important Safety Information

    What is the most important information I should know about TIVDAK?

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems. Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or symptoms of eye problems.

    Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with TIVDAK. Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems:

    • Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops 3 times a day for 3 days after each infusion
    • Use vasoconstrictor eye drops right before each infusion
    • Use lubricating eye drops throughout treatment and for 30 days after your last dose of TIVDAK

    Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist.

    What are the possible side effects of TIVDAK?

    Serious side effects of TIVDAK may include:

    Eye problems. See “What is the most important information I should know about TIVDAK?”

    Nerve problems (peripheral neuropathy) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you have new or worsening numbness or tingling in your hands or feet or muscle weakness.

    Bleeding problems (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider or get medical help right away if you have signs or symptoms of bleeding during treatment with TIVDAK, including blood in your stools or black stools (looks like tar), blood in your urine, cough up or vomit blood, unusual vaginal bleeding, or any unusual or heavy bleeding.

    Lung problems. TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you have new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

    Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you have signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:

    • Skin reactions that look like rings (target lesions)
    • Rash or itching that continues to get worse
    • Blistering or peeling of the skin
    • Painful sores or ulcers in your mouth, nose, throat, or genital area
    • Fever or flu-like symptoms
    • Swollen lymph nodes

    The most common side effects of TIVDAK include:

    • Decreased red blood cell counts
    • Numbness or tingling in your hands or feet
    • Eye problems (conjunctival disorders)
    • Nausea
    • Tiredness
    • Changes in liver function blood tests
    • Nosebleed
    • Hair loss (alopecia)
    • Bleeding (hemorrhage)

    Your healthcare provider may decrease your dose of TIVDAK, temporarily stop, or completely stop treatment if you have side effects.

    What should I tell my healthcare provider before receiving TIVDAK?

    Tell your healthcare provider about all your medical conditions, including if you:

    • have a history of vision or eye problems
    • have numbness or tingling in your hands or feet
    • have bleeding problems
    • have liver problems
    • are pregnant or plan to become pregnant; TIVDAK can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TIVDAK

    • are breastfeeding (nursing) or plan to breastfeed. It is not known if TIVDAK passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of TIVDAK

      Females who can become pregnant:

      • Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK
      • Use an effective method of birth control during your treatment and for at least 2 months after the last dose of TIVDAK

      Males with female partners who can become pregnant:

      • Use effective birth control during treatment and for 4 months after the last dose of TIVDAK

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TIVDAK with certain other medicines may cause side effects.

    These are not all of the possible side effects of TIVDAK. Discuss side effects with your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088.

    Please see the full Prescribing Information with Medication Guide about TIVDAK including an IMPORTANT WARNING at tivdak.com.

What to Know as You Get Started

  • Dr. CRAFTON:

    Hi, I’m Dr. Sarah Crafton, I’m a GYN oncologist, and I specialize in treating patients with cervical cancer. I’m here with Talking Tivdak. Today, I’ll share some information to help you understand what to expect throughout your treatment with Tivdak.

    Narrator:

    TIVDAK is a prescription medicine used to treat adults with cervical cancer that has returned or has spread to other parts of the body, and who have had chemotherapy that did not work or is no longer working.

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment. 

    And remember to review Important Safety Information at the end of this video, which covers more information on eye problems.

    You should also read the Important Facts about Tivdak, including an IMPORTANT WARNING for eye problems, at tivdak.com.

    Dr. CRAFTON:

    Now let’s chat about a few things you should know when getting started with Tivdak.

    Moving forward with Tivdak, you will have a Tivdak infusion every three weeks. Each infusion will last 30 minutes, but plan for an hour of chair time total. This will include a few tasks to help you care for your eyes.

    In my practice, I see my patients before every infusion. This is a really important visit so that we can review their symptoms and side effects, as well as any questions or concerns they have.

    Specific to Tivdak, we talk a lot about eye protection. That will mean coordinating eye care provider visits, as well as using 3 eye drops—2 prescription eye drops, and 1 over-the-counter. And you should bring all 3 of them with you on the day of infusion.

    This is just an introduction to the Tivdak Required Eye Care. Please visit tivdak.com for the full eye care information and tips that can help you stay on track.

    It’s typical to see your doctor throughout your treatment, and they will be doing exams during this time. In addition, they’ll be ordering scans to measure and see if the cancer is getting smaller. Starting a new treatment can be overwhelming, but as time goes on it will be easier to coordinate care.

    Looking for more information? Check out the full Talking Tivdak video series to learn more.

    Keep watching for more Important Safety Information about Tivdak, including an important warning, and see the Full Prescribing Information and Medication Guide at tivdak.com.

    Narrator:

    What is TIVDAK?

    TIVDAK is a prescription medicine used to treat adults with cervical cancer:

    • that has returned or has spread to other parts of the body, and
    • who have received chemotherapy that did not work or is no longer working.

    Important Safety Information

    What is the most important information I should know about TIVDAK?

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems. Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or symptoms of eye problems.

    Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with TIVDAK. Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems:

    • Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops 3 times a day for 3 days after each infusion
    • Use vasoconstrictor eye drops right before each infusion
    • Use lubricating eye drops throughout treatment and for 30 days after your last dose of TIVDAK

    Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist.

    What are the possible side effects of TIVDAK?

    Serious side effects of TIVDAK may include:

    Eye problems. See “What is the most important information I should know about TIVDAK?”

    Nerve problems (peripheral neuropathy) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you have new or worsening numbness or tingling in your hands or feet or muscle weakness.

    Bleeding problems (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider or get medical help right away if you have signs or symptoms of bleeding during treatment with TIVDAK, including blood in your stools or black stools (looks like tar), blood in your urine, cough up or vomit blood, unusual vaginal bleeding, or any unusual or heavy bleeding.

    Lung problems. TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you have new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

    Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you have signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:

    • Skin reactions that look like rings (target lesions)
    • Rash or itching that continues to get worse
    • Blistering or peeling of the skin
    • Painful sores or ulcers in your mouth, nose, throat, or genital area
    • Fever or flu-like symptoms
    • Swollen lymph nodes

    The most common side effects of TIVDAK include:

    • Decreased red blood cell counts
    • Numbness or tingling in your hands or feet
    • Eye problems (conjunctival disorders)
    • Nausea
    • Tiredness
    • Changes in liver function blood tests
    • Nosebleed
    • Hair loss (alopecia)
    • Bleeding (hemorrhage)

    Your healthcare provider may decrease your dose of TIVDAK, temporarily stop, or completely stop treatment if you have side effects.

    What should I tell my healthcare provider before receiving TIVDAK?

    Tell your healthcare provider about all your medical conditions, including if you:

    • have a history of vision or eye problems
    • have numbness or tingling in your hands or feet
    • have bleeding problems
    • have liver problems
    • are pregnant or plan to become pregnant; TIVDAK can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TIVDAK

    • are breastfeeding (nursing) or plan to breastfeed. It is not known if TIVDAK passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of TIVDAK

      Females who can become pregnant:

      • Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK
      • Use an effective method of birth control during your treatment and for at least 2 months after the last dose of TIVDAK

      Males with female partners who can become pregnant:

      • Use effective birth control during treatment and for 4 months after the last dose of TIVDAK

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TIVDAK with certain other medicines may cause side effects.

    These are not all of the possible side effects of TIVDAK. Discuss side effects with your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088.

    Please see the full Prescribing Information with Medication Guide about TIVDAK including an IMPORTANT WARNING at tivdak.com.

Partnering With Your Doctor

  • Dr. CRAFTON:

    Hi, I’m Dr. Sarah Crafton, a GYN oncologist, and I specialize in treating patients with cervical cancer. I’m here with Talking Tivdak to talk a little bit about the patient-doctor relationship and how important it is to communicate with your doctor regularly.

    Narrator:

    TIVDAK is a prescription medicine used to treat adults with cervical cancer that has returned or has spread to other parts of the body, and who have had chemotherapy that did not work or is no longer working.

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    And remember to review Important Safety Information at the end of this video, which covers more information on eye problems.

    You should also read the Important Facts about Tivdak, including an IMPORTANT WARNING for eye problems, at tivdak.com.

    Dr. CRAFTON:

    Now let’s talk about partnering with your doctor during treatment.

    It is really important for patients and doctors to have open communication. When it comes to the patient-doctor relationship, we are a team together. As doctors and nurses, we want our patients to feel comfortable talking to us and keeping us updated on how things are going during treatment. It’s especially important to let your doctor know if you’re experiencing any side effects.

    When it comes to reporting those side effects, the sooner we know the better.

    And it is not your job to figure out if what you’re experiencing is from the treatment itself, the disease, or something completely unrelated. It is our job to figure that out, but we can only do that once you tell us what you’re feeling, and what’s going on.

    We need real-time, live feedback to best understand how to tailor the dose to you, including modifying your Tivdak dose or discontinuing treatment with Tivdak if needed.

    In my practice, I like to communicate with patients directly before every infusion. And we also have opportunities for patients to call and message us even when they’re not there for treatment.

    It is really important for you to speak with your doctor’s office to understand what communication they prefer.

    Stay connected with your doctor and reach out to them right away if you’re experiencing any side effects.

    Looking for more information? Check out the full Talking Tivdak video series to learn more.

    Keep watching for more Important Safety Information about Tivdak, including an important warning, and see the full Prescribing Information and Medication Guide at tivdak.com.

    Narrator:

    What is TIVDAK?

    TIVDAK is a prescription medicine used to treat adults with cervical cancer:

    • that has returned or has spread to other parts of the body, and
    • who have received chemotherapy that did not work or is no longer working.

    Important Safety Information

    What is the most important information I should know about TIVDAK?

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems. Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or symptoms of eye problems.

    Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with TIVDAK. Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems:

    • Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops 3 times a day for 3 days after each infusion
    • Use vasoconstrictor eye drops right before each infusion
    • Use lubricating eye drops throughout treatment and for 30 days after your last dose of TIVDAK

    Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist.

    What are the possible side effects of TIVDAK?

    Serious side effects of TIVDAK may include:

    Eye problems. See “What is the most important information I should know about TIVDAK?”

    Nerve problems (peripheral neuropathy) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you have new or worsening numbness or tingling in your hands or feet or muscle weakness.

    Bleeding problems (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider or get medical help right away if you have signs or symptoms of bleeding during treatment with TIVDAK, including blood in your stools or black stools (looks like tar), blood in your urine, cough up or vomit blood, unusual vaginal bleeding, or any unusual or heavy bleeding.

    Lung problems. TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you have new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

    Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you have signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:

    • Skin reactions that look like rings (target lesions)
    • Rash or itching that continues to get worse
    • Blistering or peeling of the skin
    • Painful sores or ulcers in your mouth, nose, throat, or genital area
    • Fever or flu-like symptoms
    • Swollen lymph nodes

    The most common side effects of TIVDAK include:

    • Decreased red blood cell counts
    • Numbness or tingling in your hands or feet
    • Eye problems (conjunctival disorders)
    • Nausea
    • Tiredness
    • Changes in liver function blood tests
    • Nosebleed
    • Hair loss (alopecia)
    • Bleeding (hemorrhage)

    Your healthcare provider may decrease your dose of TIVDAK, temporarily stop, or completely stop treatment if you have side effects.

    What should I tell my healthcare provider before receiving TIVDAK?

    Tell your healthcare provider about all your medical conditions, including if you:

    • have a history of vision or eye problems
    • have numbness or tingling in your hands or feet
    • have bleeding problems
    • have liver problems
    • are pregnant or plan to become pregnant; TIVDAK can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TIVDAK

    • are breastfeeding (nursing) or plan to breastfeed. It is not known if TIVDAK passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of TIVDAK

      Females who can become pregnant:

      • Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK
      • Use an effective method of birth control during your treatment and for at least 2 months after the last dose of TIVDAK

      Males with female partners who can become pregnant:

      • Use effective birth control during treatment and for 4 months after the last dose of TIVDAK

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TIVDAK with certain other medicines may cause side effects.

    These are not all of the possible side effects of TIVDAK. Discuss side effects with your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088.

    Please see the full Prescribing Information with Medication Guide about TIVDAK including an IMPORTANT WARNING at tivdak.com.

Tips to Help During Treatment

  • Dr. CRAFTON:

    Hi, I’m Dr. Sarah Crafton. I’m a GYN oncologist, and I specialize in treating women with cervical cancer. Today, I’m here with Talking Tivdak. We are going to be talking about your infusion appointment and how to keep you as comfortable as possible during treatment.

    Narrator:

    TIVDAK is a prescription medicine used to treat adults with cervical cancer that has returned or has spread to other parts of the body, and who have had chemotherapy that did not work or is no longer working.

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    And remember to review Important Safety Information at the end of this video, which covers more information on eye problems.

    You should also read the Important Facts about Tivdak, including an IMPORTANT WARNING for eye problems, at tivdak.com.

    Dr. CRAFTON:

    Now that we’ve covered that, let’s get into the tips that can help during treatment with Tivdak.

    Starting any new treatment can be overwhelming, and we want to give you some hints to make the process as easy and comfortable as possible. Some patients dress in comfortable clothes, bring a blanket, or even a friend. Your eyes will be covered by a cold pack, and this a very important step to help prevent the side effects and symptoms that you may experience. Because you won’t be able to see, it’s really important to prepare things to keep you entertained, which could be a podcast, a playlist, or recorded books.

    Just make sure it’s at least an hour of material to get you through the entire infusion.

    When it comes to treatment with Tivdak, the eye care is a very important component. This includes seeing your eye care professional before every infusion, but also includes using 3 different types of eye drops. 2 of those are prescription and 1 is over-the-counter.

    In our practice we ask patients to pick these up in advance and have them with them on the day of infusion so that we can educated them on the schedule and frequency of use.

    This is a really important step to help protect your eyes during treatment.

    Keeping track of the eye care with Tivdak can be overwhelming at first. Some patients make notes for themselves, some patients use their family or friends to help them. Or you can register for TivdakTexts, and this will send you notifications and reminders of using your eye drops.

    The Tivdak Eye Drop Tracker in the Patient Brochure can be downloaded from tivdak.com. This can help you stay on track as you use the eye drops.

    This is just an introduction to the Tivdak Required Eye Care. Please visit tivdak.com for the full information on eye care and tips that can help you stay on track.

    Looking for more information? Check out the full Talking Tivdak video series to learn more.

    Keep watching for more Important Safety Information about Tivdak, including an important warning, and see the full Prescribing Information and Medication Guide at tivdak.com.

    Narrator:

    What is TIVDAK?

    TIVDAK is a prescription medicine used to treat adults with cervical cancer:

    • that has returned or has spread to other parts of the body, and
    • who have received chemotherapy that did not work or is no longer working.

    Important Safety Information

    What is the most important information I should know about TIVDAK?

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems. Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or symptoms of eye problems.

    Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with TIVDAK. Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems:

    • Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops 3 times a day for 3 days after each infusion
    • Use vasoconstrictor eye drops right before each infusion
    • Use lubricating eye drops throughout treatment and for 30 days after your last dose of TIVDAK

    Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist.

    What are the possible side effects of TIVDAK?

    Serious side effects of TIVDAK may include:

    Eye problems. See “What is the most important information I should know about TIVDAK?”

    Nerve problems (peripheral neuropathy) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you have new or worsening numbness or tingling in your hands or feet or muscle weakness.

    Bleeding problems (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider or get medical help right away if you have signs or symptoms of bleeding during treatment with TIVDAK, including blood in your stools or black stools (looks like tar), blood in your urine, cough up or vomit blood, unusual vaginal bleeding, or any unusual or heavy bleeding.

    Lung problems. TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you have new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

    Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you have signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:

    • Skin reactions that look like rings (target lesions)
    • Rash or itching that continues to get worse
    • Blistering or peeling of the skin
    • Painful sores or ulcers in your mouth, nose, throat, or genital area
    • Fever or flu-like symptoms
    • Swollen lymph nodes

    The most common side effects of TIVDAK include:

    • Decreased red blood cell counts
    • Numbness or tingling in your hands or feet
    • Eye problems (conjunctival disorders)
    • Nausea
    • Tiredness
    • Changes in liver function blood tests
    • Nosebleed
    • Hair loss (alopecia)
    • Bleeding (hemorrhage)

    Your healthcare provider may decrease your dose of TIVDAK, temporarily stop, or completely stop treatment if you have side effects.

    What should I tell my healthcare provider before receiving TIVDAK?

    Tell your healthcare provider about all your medical conditions, including if you:

    • have a history of vision or eye problems
    • have numbness or tingling in your hands or feet
    • have bleeding problems
    • have liver problems
    • are pregnant or plan to become pregnant; TIVDAK can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TIVDAK

    • are breastfeeding (nursing) or plan to breastfeed. It is not known if TIVDAK passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of TIVDAK

      Females who can become pregnant:

      • Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK
      • Use an effective method of birth control during your treatment and for at least 2 months after the last dose of TIVDAK

      Males with female partners who can become pregnant:

      • Use effective birth control during treatment and for 4 months after the last dose of TIVDAK

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TIVDAK with certain other medicines may cause side effects.

    These are not all of the possible side effects of TIVDAK. Discuss side effects with your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088.

    Please see the full Prescribing Information with Medication Guide about TIVDAK including an IMPORTANT WARNING at tivdak.com.

Caring for Your Eyes 

  • NURSE GAIL:

    If you’re starting to have the conversation with your doctor about your next cervical cancer treatment, I’m sure you have a lot on your mind. As a nurse practitioner, a lot of my patients feel anxious about going through the process of starting their next therapy. I know how intimidating it can be when you don’t know what the next step looks like, but I find that sharing information is the best way to help my patients get started. To help you feel prepared as you begin treatment with Tivdak, or tisotumab vedotin-tftv, let’s talk about what you can expect.

    Narrator:

    You may have heard of Tivdak before. It’s a prescription medicine used to treat adults with cervical cancer that has returned or has spread to other parts of the body, and who have had chemotherapy that did not work or is no longer working.

    NURSE GAIL:

    Tivdak is different from other treatments you’ve taken before for your cervical cancer. While some side effects may be familiar to you, it's important to know that eye problems are common with Tivdak and can be serious.

    Narrator:

    Eye problems are common with Tivdak and can be severe. Tivdak can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss.

    Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    And remember to review Important Safety Information at the end of this video, which covers more information on eye problems.

    You should also read the Important Facts about Tivdak, including an IMPORTANT WARNING for eye problems, at tivdak.com.

    NURSE GAIL:

    While eye problems may be new to you, there are steps you can follow that may help reduce your risk of eye problems. Before we go over these steps, it can help to understand why Tivdak might affect your eyes. Tivdak is designed to attach to a special protein called Tissue Factor, or TF. Some cancers, including cervical cancer, have this special protein. TF is also present on some normal cells, including on cells in the eyes. Eye problems may develop if Tivdak travels to the eye cells.

    While taking Tivdak, you’ll follow a set of steps designed to help reduce the risk of eye problems. Tivdak Required Eye Care includes some things you’ll do before, during, and after each infusion.

    First, your doctor will send you to an eye specialist to check your eyes before starting treatment and before each Tivdak infusion.

    Narrator:

    You may also need to visit an eye specialist if you experience any new or worsening eye problems during treatment, so be sure to let your doctor know if you notice any changes to your eyes.

    NURSE GAIL:

    Before you start treatment, your doctor will prescribe 3 types of eye drops: steroid, vasoconstrictor, and lubricating drops.

    Narrator:

    Steroid drops may help protect against redness, swelling, and itchiness. Vasoconstrictor drops may help keep Tivdak from affecting your eyes by reducing blood flow in the eyes. Lubricating drops may help reduce and relieve dryness and discomfort. Bring all 3 eye drops with you to your infusions. You’ll use them at each infusion appointment and between infusions.

    NURSE GAIL:

    At each appointment, I help my patients out with a few steps. A nurse or a member of your care team may be there to help you as you apply steroid drops and vasoconstrictor drops right before the infusion. Then, they’ll give you a cold pack to place over the eye area throughout the infusion of Tivdak.

    Narrator:

    For the remainder of your infusion day, you’ll apply your steroid drops 2 more times, and for the 2 days following infusion day, apply your steroid drops 3 times per day or as instructed by your care team.

    NURSE GAIL:

    Use your lubricating drops as often as needed or as prescribed throughout the treatment and for 30 days after your last Tivdak infusion. While on treatment, avoid wearing contact lenses unless your eye specialist says you can use them. It’s best to avoid anything that might irritate your eyes.

    If it sounds like a lot to remember, don’t worry—there are plenty of resources on tivdak.com to help you along the way. You can also sign up for TivdakTexts to receive helpful reminders throughout treatment. These text messages can help you keep track of your eye drop schedule and your infusion appointments. And you can always ask your care team any questions you have.

    Talk to your doctor about Tivdak to continue your treatment conversation.

    Keep watching for more important information about Tivdak, including an IMPORTANT WARNING.

    Narrator:

    What is TIVDAK?

    TIVDAK is a prescription medicine used to treat adults with cervical cancer:

    • that has returned or has spread to other parts of the body, and
    • who have received chemotherapy that did not work or is no longer working.

    Important Safety Information

    What is the most important information I should know about TIVDAK?

    Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

    Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems. Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or symptoms of eye problems.

    Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with TIVDAK. Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems:

    • Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops 3 times a day for 3 days after each infusion
    • Use vasoconstrictor eye drops right before each infusion
    • Use lubricating eye drops throughout treatment and for 30 days after your last dose of TIVDAK

    Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist.

    What are the possible side effects of TIVDAK?

    Serious side effects of TIVDAK may include:

    Eye problems. See “What is the most important information I should know about TIVDAK?”

    Nerve problems (peripheral neuropathy) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you have new or worsening numbness or tingling in your hands or feet or muscle weakness.

    Bleeding problems (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider or get medical help right away if you have signs or symptoms of bleeding during treatment with TIVDAK, including blood in your stools or black stools (looks like tar), blood in your urine, cough up or vomit blood, unusual vaginal bleeding, or any unusual or heavy bleeding.

    Lung problems. TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you have new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

    Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you have signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:

    • Skin reactions that look like rings (target lesions)
    • Rash or itching that continues to get worse
    • Blistering or peeling of the skin
    • Painful sores or ulcers in your mouth, nose, throat, or genital area
    • Fever or flu-like symptoms
    • Swollen lymph nodes

    The most common side effects of TIVDAK include:

    • Decreased red blood cell counts
    • Numbness or tingling in your hands or feet
    • Eye problems (conjunctival disorders)
    • Nausea
    • Tiredness
    • Changes in liver function blood tests
    • Nosebleed
    • Hair loss (alopecia)
    • Bleeding (hemorrhage)

    Your healthcare provider may decrease your dose of TIVDAK, temporarily stop, or completely stop treatment if you have side effects.

    What should I tell my healthcare provider before receiving TIVDAK?

    Tell your healthcare provider about all your medical conditions, including if you:

    • have a history of vision or eye problems
    • have numbness or tingling in your hands or feet
    • have bleeding problems
    • have liver problems
    • are pregnant or plan to become pregnant; TIVDAK can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TIVDAK

    • are breastfeeding (nursing) or plan to breastfeed. It is not known if TIVDAK passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of TIVDAK

      Females who can become pregnant:

      • Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK
      • Use an effective method of birth control during your treatment and for at least 2 months after the last dose of TIVDAK

      Males with female partners who can become pregnant:

      • Use effective birth control during treatment and for 4 months after the last dose of TIVDAK

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TIVDAK with certain other medicines may cause side effects.

    These are not all of the possible side effects of TIVDAK. Discuss side effects with your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088.

    Please see the full Prescribing Information with Medication Guide about TIVDAK including an IMPORTANT WARNING at tivdak.com.