DOSING

How Tivdak is given

An infusion given once every 3 weeks

Your doctor will work with you to decide how many treatments you will need.

Caring for your eyes is very important when starting and receiving treatment with Tivdak. Your doctor will send you to an eye specialist to check your eye health and to monitor any new or worsening signs or symptoms of eye problems.

In addition, your care team will help you apply eye drops and cold packs during the infusion process. They will also advise you on eye drops to use at home in between Tivdak treatment cycles.

Each Tivdak infusion appointment includes:

In Chair Time ∼1 hour

  • Tivdak Administration of Eye Drops Icon

    Administration of eye drops

  • Tivdak Placement of Cold Packs Icon

    Placement of cold packs over your eyes

  • Tivdak Infusion Icon

    Infusion

Before starting Tivdak, tell your care team about any other medications

It’s important to tell your care team 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. You should also let your other healthcare providers know that you're starting treatment with Tivdak.

SIDE EFFECTS

Possible side effects

  • The most common serious side effects were problems moving food and stool through your gut (ileus), bleeding, pneumonia, tingling or numbness in the hands and feet, sepsis, constipation, and fever.

The most common side effects of Tivdak were:

  • Tivdak Side Effects Decreased Red Blood Cell and White Blood Cell Counts Icon

    Decreased red blood cell and white blood cell counts

  • Tivdak Side Effects Tiredness Icon

    Tiredness

  • Tivdak Side Effects Nausea Icon

    Nausea

  • Tivdak Side Effects Numbness Tingling Muscle Weakness Icon

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

  • Tivdak Side Effects Hair Loss (Alopecia) Icon

    Hair loss(alopecia)

  • Tivdak Side Effects Nosebleed (Epistaxis) Icon

    Nosebleed(epistaxis)

  • Tivdak Side Effects Changes in Kidney Function Blood Tests Icon

    Changes in kidney function blood tests

  • Tivdak Side Effects Dry Eye Icon

    Dry eye

  • Tivdak Side Effects Eye Problems (Conjunctival Disorders) Icon

    Eye problems(conjunctival disorders)

  • Tivdak Side Effects Bleeding (Hemorrhage) Icon

    Bleeding(hemorrhage)

  • Tivdak Side Effects Abnormal Blood Clotting Test Results Icon

    Abnormal blood clotting test results

  • Tivdak Side Effects Diarrhea Icon

    Diarrhea

  • Tivdak Side Effects Rash Icon

    Rash

These are not all the possible side effects of Tivdak. Any of these things can begin to happen in the days following your infusion. A side effect does not necessarily mean you have to stop treatment. Your oncologist may need to change, pause, or stop your treatment if you have new or worsening side effects. For more information see Important Facts about Tivdak.

If you notice any new or worsening side effects, tell your care team right away

Does a side effect mean I have to stop treatment?

Your oncologist may need to change, pause, or stop your treatment if you have certain side effects. If you notice any new or worsening side effects, tell your care team right away.

Is there anything I can do to help reduce side effects?

Tivdak Required Eye Care may help reduce the risk of eye problems. Your care team may also recommend other medications to help combat possible side effects such as nausea, constipation, and/or diarrhea. Talk to your care team about any discomfort or side effects you are experiencing.

Tivdak Required Eye Care

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.

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