Tivdak and you

Is Tivdak right for you?

Tivdak is for people who have cervical cancer that has returned, or has spread, and have had chemotherapy that did not work or is no longer working

You are not alone.

In up to 60% of women with cervical cancer, their disease will spread to other parts of the body within 2 years after initial treatment. When cancer spreads or comes back, treatments you have taken before for your cervical cancer may not be right for you anymore.

Tivdak is a different type of treatment

What is Tivdak?

Tivdak is not a chemotherapy

Tivdak is the first-and-only treatment of its kind approved for advanced cervical cancer on or after chemotherapy

Tivdak is unlike any medicine you have taken before for your cervical cancer. It is a different treatment called an antibody-drug conjugate, or ADC, which attacks cells that have a special protein.

How Tivdak is thought to work

Based on lab studies

  • Tivdak attaches to a special protein

    Tivdak attaches to a special protein on the outside of the cancer cell called Tissue Factor

  • Tivdak is absorbed into the cell

    Tivdak is absorbed into the cell

  • Tivdak releases its cell-killing medicine

    Once inside, Tivdak releases its cell-killing medicine

The special protein, Tissue Factor, is also present on normal cells. So, Tivdak can still harm normal cells and cause side effects.

How Tivdak Could Help You

With Tivdak, some patients saw their tumors shrink or had no detectable tumors

Results for some patients may last longer than 8 months

Tivdak was studied in a clinical trial of 101 women with cervical cancer that has returned or has spread, and who have received chemotherapy that did not work or is no longer working.

What could this mean for you?

With Tivdak treatment

24%

of women had a
response to Tivdaka

(Objective Response: 24/101)

Among the women
who had a response

∼30% saw no
detectable tumors

(Complete Response: 7/24 responders)

Among the women
who had a response

>70% saw
their tumors shrink

(Partial Response: 17/24 responders)

For those who responded to Tivdak, there was a 50% chance that they would continue to respond after 8.3 months

The length of time that women responded to Tivdak ranged from 1.4 to 11 months.

aTivdak was studied in a clinical trial of 101 women with advanced cervical cancer.

What are the possible side effects?

Learn more

Helpful tools while taking Tivdak

  • Tivdak Patient Brochure Icon
    Patient Brochure

    An overview of Tivdak and what to expect from treatment.

    Download

  • Tivdak Discussion Guide Icon
    Tivdak Discussion Guide

    FAQs and topics to review with your care team.

    Download

Getting started on Tivdak

Learn more

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

Eye problems are common with TIVDAK and can be serious. 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 dose of TIVDAK, and as needed for any new or worsening signs and 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:

  • You should use steroid eye drops before each infusion and as prescribed for 72 hours after each infusion.

  • You should use vasoconstrictor eye drops right before each infusion.

  • You should 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:

Peripheral neuropathy (nerve problems) 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 (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you get 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, 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 get new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

The most common side effects of TIVDAK include:

  • Decreased red blood cell and white blood cell counts

  • Tiredness

  • Nausea

  • Numbness or tingling in your hands or feet, or muscle weakness (peripheral neuropathy)

  • Hair loss (alopecia)

  • Nosebleed (epistaxis)

  • Eye problems (conjunctival disorders)

  • Bleeding (hemorrhage)

  • Changes in kidney function blood tests

  • Dry eye

  • Abnormal blood clotting test results

  • Diarrhea

  • Rash

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.

  • 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 are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK.

    • You should 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 are able to become pregnant:

    • You should 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 the possible side effects of TIVDAK. Discuss side effects with your healthcare provider. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch or call 1-800-FDA-1088.

Please see Important Facts about TIVDAK including 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

TIVDAK was FDA-approved based on a clinical study that measured how many patients had a tumor response and how long that response lasted. Continued approval is dependent on the results of an ongoing study to confirm the benefit of TIVDAK.

Important Safety Information

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

Eye problems are common with TIVDAK and can be serious. 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.

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

Eye problems are common with TIVDAK and can be serious. 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 dose of TIVDAK, and as needed for any new or worsening signs and 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:

  • You should use steroid eye drops before each infusion and as prescribed for 72 hours after each infusion.

  • You should use vasoconstrictor eye drops right before each infusion.

  • You should 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:

Peripheral neuropathy (nerve problems) 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 (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you get 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, 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 get new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

The most common side effects of TIVDAK include:

  • Decreased red blood cell and white blood cell counts

  • Tiredness

  • Nausea

  • Numbness or tingling in your hands or feet, or muscle weakness (peripheral neuropathy)

  • Hair loss (alopecia)

  • Nosebleed (epistaxis)

  • Eye problems (conjunctival disorders)

  • Bleeding (hemorrhage)

  • Changes in kidney function blood tests

  • Dry eye

  • Abnormal blood clotting test results

  • Diarrhea

  • Rash

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.

  • 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 are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK.

    • You should 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 are able to become pregnant:

    • You should 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 the possible side effects of TIVDAK. Discuss side effects with your healthcare provider. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch or call 1-800-FDA-1088.

Please see Important Facts about TIVDAK including 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

TIVDAK was FDA-approved based on a clinical study that measured how many patients had a tumor response and how long that response lasted. Continued approval is dependent on the results of an ongoing study to confirm the benefit of TIVDAK.

Read More

You are now leaving
Tivdak.com