Tivozanib is used to treat advanced renal cell carcinoma (RCC; cancer that begins in the kidneys) that has returned or did not respond to at least two other medications. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.

Tivozanib comes as a capsule to take by mouth. It is usually taken once daily with or without food for the first 21 days of a 28-day cycle. The cycle may be repeated as recommended by your doctor. Take tivozanib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tivozanib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with a glass of water; do not open them.

Your doctor may decrease your dose or temporarily or permanently stop your treatment if you experience certain side effects. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with tivozanib.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking tivozanib,

• tell your doctor and pharmacist if you are allergic to tivozanib, aspirin, tartrazine (a yellow dye in some processed foods and drugs), any other medications, or any of the ingredients in tivozanib capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking tivozanib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following herbal product may interact with tivozanib: St. John’s wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking tivozanib. Do not start this medication while taking tivozanib without discussing with your healthcare provider.
• tell your doctor if you have an unhealed wound or if you have or have ever had a bleeding problem; a blood clot; heart failure; a heart attack; high blood pressure; seizures; or heart, thyroid, kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are taking tivozanib. If you are female, you will need to have a pregnancy test before you start treatment, and you should use birth control to prevent pregnancy during your tivozanib treatment and for 1 month after your final dose. If you are male, you and your partner should use birth control to prevent pregnancy during your treatment with tivozanib and for 1 month after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. Tivozanib may decrease fertility in men and women. However, you should not assume that you or your partner cannot become pregnant. If you or your partner become pregnant while taking tivozanib, call your doctor. Tivozanib may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed during your treatment with tivozanib and for 1 month after your final dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tivozanib. Your doctor will probably tell you to stop taking tivozanib at least 24 days before your scheduled surgery because it can affect wound healing. Your doctor will tell you when to start taking tivozanib again after your surgery.
• you should know that tivozanib may cause high blood pressure. Your blood pressure should be checked regularly while you are taking tivozanib.

Unless your doctor tells you otherwise, continue your normal diet.

Skip the missed dose and continue your regular dosing schedule. Do not take two doses on the same day to make up for a missed one.

Tivozanib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• vomiting
• fatigue
• loss of appetite
• weight loss
• voice hoarseness
• back pain
• mouth sores
• cough
• shortness of breath

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• unusual bruising or bleeding
• bloody or black and tarry stools
• blood in urine
• vomiting or coughing up blood
• bleeding from gums
• seizures, headaches, vision changes, or confusion
• redness, swelling, and pain on hands and/or feet
• confusion, headache, dizziness, chest pain, or shortness of breath
• shortness of breath or swelling of ankles
• chest pain or pressure; numbness or weakness on one side of body; pain in arms, back, neck or jaw; difficulty talking; shortness of breath; sudden severe headache; vision changes; or swelling in arms or legs

Tivozanib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• severe chest pain; shortness of breath; rapid, irregular, or pounding heartbeat; headache; confusion; or blurred vision

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to tivozanib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Fotivda^®