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Overview: Fotivda is used to treat kidney cancer. It works to slow the growth of cancer cells. The most common side effects are tiredness, high blood pressure, diarrhea, nausea, and hoarse voice. Keep all appointments, including those for blood tests. Get emergency help if you have sudden weakness, chest pain, trouble breathing, swelling in an arm or leg, unusual bleeding, severe stomach pain, or seizures. Fotivda comes as a capsule that you can swallow.

Uses

What is Fotivda used for?

Fotivda (tivozanib) is commonly used to treat certain people with renal cell carcinoma (RCC), a type of kidney cancer.

Fotivda may also be used for other conditions as determined by your health care provider.

How does Fotivda work (mechanism of action)?

Fotivda is a type of medicine known as a tyrosine kinase inhibitor. It works by targeting specific proteins on cancer cells. By blocking the actions of these proteins, Fotivda prevents new blood vessels from growing and can prevent cancer cells from growing or spreading.

How is Fotivda supplied (dosage forms)?

Brands and other names

  • Fotivda

Dosage forms and strengths

  • 0.89 mg, 1.34 mg oral capsules

How should I store Fotivda?

Fotivda should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Fotivda?

The most common side effects of Fotivda are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Tiredness
  • High blood pressure (see below)
  • Diarrhea
  • Loss of appetite
  • Nausea or vomiting
  • Voice changes or hoarseness
  • Thyroid problems (see below)
  • Cough
  • Mouth sores
  • Low levels of sodium or phosphate in your blood
  • High levels of lipase in your blood

There may be other side effects of Fotivda that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Fotivda?

While less common, the most serious side effects of Fotivda are described below, along with what to do if they happen.

Severe Allergic Reactions. Fotivda may cause allergic reactions, which can be serious. Stop taking Fotivda and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

High Blood Pressure (Hypertension). Fotivda may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your health care provider if your blood pressure increases while taking this medicine. Fotivda may cause severely high blood pressure in some people. 

If you measure your blood pressure and the top number (systolic) is 180 or higher or the bottom number (diastolic) is 120 or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but look out for and tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness or confusion
  • Trouble breathing
  • Nausea or vomiting
  • Blurry or other changes to vision
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling of skipped heartbeats

Heart Failure. Fotivda may increase your risk of heart failure, which can be life-threatening. Tell your health care provider right away if you have any of the following symptoms of heart failure.

  • Shortness of breath or trouble breathing, especially while lying down
  • Swelling in your feet, ankles, or legs
  • Unusually fast weight gain
  • Unusual tiredness

Blood Clots. Fotivda may cause a blood clot in your arteries or veins. A blood clot that travels to your lungs is called a pulmonary embolism. A blood clot in your legs or arms is called a deep venous thrombosis. A blood clot can block blood flow and lead to a stroke or heart attack. Tell your health care provider if you have had a heart attack or chest pain from unstable angina, especially in the last six months. Get emergency help if you have any of the following signs of a blood clot, stroke, or heart attack.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Fast breathing or shortness of breath
  • Pain, swelling, warmth, or tenderness in your arm or leg
  • Weakness or numbness on one side of your body
  • Sudden headache or vision changes
  • Trouble speaking

Protein in Your Urine (Proteinuria). Fotivda may cause an unusually high amount of protein in your pee (urine). This can be a sign of kidney problems and may not cause any symptoms at first. To watch for this side effect, your health care provider will test your urine before you start Fotivda and regularly during treatment. Tell your health care provider right away if you have foamy pee or need to pee more often than usual.

Severe Bleeding. Fotivda can increase your risk of severe bleeding that can lead to death. Some people with serious bleeding may need a blood transfusion or surgery. Call your health care provider right away if you have any of the following signs of severe bleeding while taking Fotivda.

  • Unusual bruising or bleeding
  • Pink, red, or brown urine (pee)
  • Feeling faint or weak
  • Stomach pain
  • Vomit with blood that looks like coffee grounds
  • Coughing up blood or blood clots
  • Black or tarry poop

Tear or Tunnel in the Gut. Fotivda can increase your risk of fistulas (tunnels between organs in your body) or tears (perforation) in your gut. Call your health care provider or get help right away if you have stomach pain that feels severe or does not go away.

Thyroid Problems. Fotivda can change the activity of your thyroid gland, which can lead to low thyroid hormones. Less commonly, this can lead to high thyroid hormones. To watch for this side effect, your health care provider will check your thyroid hormone levels before you start Fotivda and regularly during treatment. Keep all appointments for blood tests. Tell your health care provider if you notice symptoms of thyroid problems, such as changes in your weight, heart rate, bowel movements, or energy levels.

Wound Healing Problems. Fotivda can make it hard for your body to heal wounds. Tell your health care provider if you have any planned or emergency surgeries or if you have any injuries or wounds that are not healing while taking Fotivda.

Posterior Reversible Encephalopathy Syndrome (PRES). Fotivda may cause a rare but serious brain condition called PRES. PRES involves swelling and narrowing of blood vessels in your brain. If PRES is not treated, it can lead to a stroke. Call your health care provider right away if you have the following symptoms of PRES.

  • Changes in thinking or behavior
  • Confusion or hallucinations
  • Sudden decrease or change in vision
  • Sudden severe headache
  • Seizures

Warnings & Precautions

Who should not take Fotivda?

Allergies to Ingredients. People who are allergic to any of the following should not take Fotivda.

  • Fotivda
  • Tivozanib
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Fotivda.

What should I know about Fotivda before taking it?

Do not take Fotivda unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Fotivda with other people, even if they have the same condition as you. It may harm them.

Keep Fotivda out of the reach of children.

Swallow Fotivda whole with a full glass of water. Do not open the capsules.

If you are able to get a partner pregnant, you should use condoms while taking Fotivda and for one month after your last dose. If your partner becomes pregnant during your treatment with Fotivda, tell your health care provider right away.

Fotivda may make it difficult for you to get pregnant or get your partner pregnant. Talk to your health care provider if you may want to have children one day.

What should I tell my health care provider before taking Fotivda?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Fotivda is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • High blood pressure
  • Heart problems, including heart failure or angina
  • Thyroid problems
  • Problems with blood clots, including a heart attack, stroke, or vision changes
  • Bleeding problems
  • Liver problems
  • Unhealed wounds
  • Recent or planned surgery, including dental surgery

Allergy to Aspirin or Yellow Dye. Fotivda 0.89 mg capsules contain a yellow dye called Yellow 5 (tartrazine). People who are allergic or sensitive to aspirin are more likely to react to this dye, which may cause trouble breathing. Tell your health care provider if you have had a reaction to aspirin or yellow dye in the past. (Note: Fotivda 1.34 mg capsules do not contain yellow dye.) 

Other Medicines and Supplements. Fotivda may interact with other medicines and supplements. Before taking Fotivda, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Fotivda can cause harm to a fetus. Your health care provider may give you a test to make sure you are not pregnant before you start Fotivda. If you can get pregnant, you should use birth control while taking Fotivda and for one month after your last dose. Tell your health care provider right away if you are pregnant, think you may be pregnant, or plan to become pregnant.

Breastfeeding. Do not breastfeed while taking Fotivda and for 1 month after your last dose. It is not known if Fotivda passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Fotivda?

For more information about Fotivda, you can visit the drugmaker’s website at www.fotivda.com or call them at 833-368-4832.

Interactions

Does Fotivda interact with foods or drinks?

There are no known interactions between Fotivda and foods or drinks.

It is unknown if drinking alcohol will affect Fotivda.

Does Fotivda interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are taking rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis.

Some other medicines or supplements may alter the blood levels of Fotivda. Tell your health care provider about all medicines that you take or have recently taken. 

This may not be a complete list of medicines that can interact with Fotivda. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally take too much Fotivda?

If you or someone else has taken too much Fotivda, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Fotivda?

If you miss a dose of Fotivda, skip the missed dose and only take the next dose at the scheduled time. Do not take two doses on the same day. Do not take double or extra doses.