Tivozanib is used to treat advanced kidney cancer in adults, after at least two other cancer treatments did not work or have stopped working.

Tivozanib may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Tivozanib is given in a 28-day treatment cycle. You may need to use the medicine only during the first 21 days of each cycle. Your doctor will determine how long to treat you with this medicine.

You may take tivozanib with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it.

Your blood pressure will need to be checked often. You may also need blood or urine tests.

You may be given other medication to help prevent nausea, vomiting, or high blood pressure. Keep using these medicines for as long as your doctor has prescribed.

If you need surgery or dental work, tell your surgeon or dentist you currently use this medicine. You should stop taking tivozanib for at least 24 days before a planned surgery.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Renal Cell Carcinoma:

1.34 mg orally once a day for 21 days followed by 7 days off (28-day cycle) until disease progression or unacceptable toxicity

Use: For adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following 2 or more prior systemic therapies

Tell your doctor if you have ever had:

• heart problems;

• high blood pressure;

• a blood clot, heart attack, or stroke;

• bleeding problems;

• surgery, including oral surgery;

• a wound that has not healed;

• a thyroid disorder;

• liver disease; or

• an allergy to aspirin or yellow dye (tartrazine).

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using tivozanib should use effective birth control to prevent pregnancy. Tivozanib can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 1 month after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using tivozanib.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

Skip the missed dose and use your next dose at the regular time. Do not use two doses in the same day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause severely high blood pressure.

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.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tivozanib may cause serious side effects. Call your doctor at once if you have:

• severe headache, confusion, dizziness;

• a seizure;

• chest pain, shortness of breath;

• blurred vision, pounding in your neck or ears;

• swelling in your lower legs, rapid weight gain;

• any wound that will not heal;

• easy bruising or bleeding (nosebleeds, bleeding gums);

• signs of bleeding inside your body--weakness, dizziness; pink or brown urine; abnormal vaginal bleeding; bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• signs of a blood clot--sudden numbness or weakness on one side of the body, chest pain, problems with vision or speech, pain or swelling in an arm or leg; or

• kidney problems--swelling, puffy eyes, foamy urine.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of tivozanib may include:

• nausea, vomiting, diarrhea, loss of appetite;

• feeling weak or tired;

• cough, hoarse voice;

• mouth sores; or

• abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect tivozanib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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.