Tivozanib (tye-VOE-za-nib)

Treats kidney cancer.

Brand Name(s):

Fotivda

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the capsule whole with a glass of water. Do not open, crush, break, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose, take your next dose at the normal time. Do not take extra medicine to make up for the missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how tivozanib works. Tell your doctor if you are using rifampin.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 1 month after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 1 month after the last dose.
• Do not breastfeed during treatment and for at least 1 month after the last dose.
• Tell your doctor if you have kidney disease, liver disease, high blood pressure, thyroid problems, bleeding problems, or a history of heart failure, heart attack, stroke, or blood clotting problems. Tell your doctor if you plan to have or had a recent surgery.
• This medicine may cause the following problems:
  • High blood pressure
  • Heart problems, including heart failure
  • Increased risk for blood clots, heart attack, or stroke
  • Bleeding problems
  • Increased levels of protein in your urine, which may lead to kidney damage
  • Thyroid problems
  • Reversible posterior leukoencephalopathy syndrome (RPLS, a central nervous system disorder)
• Tell any doctor who treats you that you are using this medicine. This medicine may affect the way your body heals from cuts and wounds. You may need to stop using it for at least 24 days before you have surgery. Wait for at least 2 weeks after major surgery, or until adequate wound healing before taking this medicine again.
• This medicine contains a yellow dye called tartrazine, which may cause serious allergic reactions (including asthma). Tell your doctor if you have any allergies (including an aspirin allergy).
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or cloudy urine
• Blurred vision, confusion, drowsiness, seizures
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, fainting
• Constipation, depression, feeling cold, muscle cramps and stiffness, weight gain, unusual tiredness or weakness
• Hoarseness, sore throat, voice changes
• Numbness or weakness in your arm or leg, or on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Slow or fast heartbeat, lightheadedness, dizziness
• Swelling in your hands, ankles, or feet
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, decreased appetite
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088