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Generic Name: Tivozanib
Trade Name: Fotivda

How is Fotivda used? Fotivda is indicated for adult patients with advanced renal cell carcinoma (RCC) who have had two or more prior therapies and experienced a relapse or progression of their cancer.

What is the mechanism of action? Fotivda is a vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor (TKI). VEGF receptors play a key role in the development of new blood vessels. Fotivda inhibits cancer growth by depriving cancer of nutrients and oxygen by blocking VEGF receptors.

How is Fotivda given (administered)? Fotivda is taken orally once daily, with or without food, and should be swallowed whole with a glass of water. Typically, Fotivda treatment follows a 28 day cycle of treatment with once daily Fotivda for 21 days then 7 days off treatment. If you miss a dose of Fotivda, do not take 2 doses in one day.

How are patients monitored? Patients will have scheduled meetings with their healthcare provider while they are being treated with Fotivda. Your healthcare provider will monitor your blood pressure after 2 weeks of treatment and at least monthly during treatment, monitor for symptoms of heart failure, perform urine tests to monitor for protein, and order blood tests to check your thyroid gland function, pancreas function and sodium and phosphate levels. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.

What are the most common side effects of treatment with Fotivda?

  • Tiredness
  • Cough
  • Diarrhea
  • Mouth sores
  • Decreased appetite
  • Decreased blood levels of sodium and phosphate
  • Nausea
  • Hoarseness
  • Increased levels of lipase in the blood
  • Low levels of thyroid hormones

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here and this drug was approved with a black box warning highlighting risk of very serious side effects.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Pay careful attention to the physician’s instructions and inform the physician of any and all side effects. Seek immediate medical attention right away for symptoms of bleeding, reversible posterior leukoencephalopathy syndrome (RPLS), or heart attack and blood clots.
  • If you take more than one dose of Fotivda in one day, call your doctor or seek immediate medical attention right away.
  • Tell your doctor if you plan to have surgery, including dental surgery, before or during treatment with Fotivda.
  • Drink a glass of water when you take Fotivda.
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Are there any special precautions patients should be aware of before starting treatment?

  • Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interact with treatment.
  • Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. You or your partner should not become pregnant during treatment with Fotivda. It is important to use effective birth control while undergoing treatment and for one month after your last dose of Fotivda. It is not known if Fotivda passes into breast milk; avoid breastfeeding during treatment and for 1 month after your last dose.
  • Patients should inform their physician about all medical conditions, including history of blood clots, heart problems, high blood pressure, bleeding problems, thyroid problems or liver problems.
  • Patients should inform their physician if they have an unhealed wound.
  • Patients should inform their physician if they have an allergy to aspirin or FD&C Yellow No. 6 (tartrazine).
  • Patients should inform their physician if they have had surgery recently or plan to have surgery including dental surgery.

When should patients notify their physician?

Tell your doctor if you experience any side effect that bothers you or does not go away. Get medical help right away if you experience:

  • Symptoms of heart attack or blood clots or blockage in your blood vessels including: chest pain or pressure; pain in arms, legs, back, neck or jaw; shortness of breath, numbness/weakness on one side of the body; leg swelling; trouble talking; headache; dizziness; severe stomach pain; decreased or loss of vision.
  • Symptoms of bleeding problems including unusual gum bleeding; red or black tar-like stools; heavy menstrual bleeding; unusual bruising; headaches, feeling dizzy or weak; severe or uncontrolled bleeding, coughing up blood or blood clots, pink or brown urine; vomiting blood or your vomit looks like coffee grounds; or unexpected pain, swelling or joint pain.
  • Call your doctor right away if you experience:
  • Symptoms of increased blood pressure including confusion, dizziness, shortness of breath, headaches or chest pain.
  • Symptoms of heart problems including shortness of breath or ankle swelling.
  • Symptoms of RPLS including headaches, seizures, confusion, blindness or vision changes or difficulty thinking.
  • Symptoms of allergic reaction.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated 03/19/21.

Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.