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.

It is not known if this medicine is safe and effective in children.

Tivdak can cause serious side effects, including:

• Eye problems. Eye problems are common with Tivdak, and can also 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, before each dose, 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.
    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.
  • Do not wear contact lenses throughout your treatment unless you are told to use them by your eye specialist.

See Tivdak side effects for more information about side effects.

Before receiving Tivdak

Before receiving Tivdak, tell your healthcare provider about all of 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.
  Females who are able to become pregnant:
  • Your healthcare provider should do a pregnancy test before you start treatment.
  • You should use an effective birth control during treatment and for 2 months after your last dose.

Males with female partners who are able to become pregnant:

• • You should use an effective birth control during treatment and for 4 months after your last dose.
• are breastfeeding or plan to breastfeed. It is not known if Tivdak passes into your breast milk. Do not breastfeed during treatment and for 3 weeks after your last dose.

• Tivdak will be given to you by intravenous (IV) infusion into your vein over 30 minutes.
• Tivdak is usually given every 3 weeks.
• Your healthcare provider will decide how many infusions you need.
• Your healthcare provider will put cold packs on your eyes during each infusion.
• Your healthcare provider may decrease your dose, temporarily stop, or completely stop treatment if you have side effects.

Usual Adult Dose for Cervical Cancer

 - The recommended dose of Tivdak is 2 mg/kg (up to a maximum of 200 mg) given as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

Before receiving Tivdak, tell your healthcare provider about all of 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.
  Females who are able to become pregnant:
  • Your healthcare provider should do a pregnancy test before you start treatment.
  • You should use an effective birth control during treatment and for 2 months after your last dose.

Males with female partners who are able to become pregnant:

• • You should use an effective birth control during treatment and for 4 months after your last dose.
• are breastfeeding or plan to breastfeed. It is not known if Tivdak passes into your breast milk. Do not breastfeed during treatment and for 3 weeks after your last dose.

Tivdak can cause serious side effects, including:

• See Important information.
• Peripheral neuropathy. Nerve problems called peripheral neuropathy are common with Tivdak, and can also be serious. Tell your healthcare provider right away if you get numbness or tingling in your hands or feet or muscle weakness.
• Bleeding (hemorrhage). Bleeding problems are common with Tivdak, and can also be serious. Tell your healthcare provider right away if you get signs or symptoms of bleeding during treatment, 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 include:

• decreased red blood cell and white blood cell counts
• tiredness
• nausea
• hair loss (alopecia)
• nosebleed
• changes in kidney function blood tests
• dry eye
• abnormal blood clotting test results
• diarrhea
• rash

Tivdak may cause fertility problems in males, which may affect your ability to father children. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

Especially tell your doctor if you take the following medicines:

• antibiotics - clarithromycin
• antifungal medicines - itraconazole, ketoconazole, posaconazole, voriconazole
• HIV medicines containing atazanavir, darunavir, indinavir, nelfinavir, ritonavir, saquinavir, cobicistat
• mifepristone
• nefazodone