Tivozanib Oral Capsules

What is this medication?

TIVOZANIB (tye VOE za nib) targets proteins in cancer cells and stops the cancer cells from growing. It treats renal cell cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): FOTIVDA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bleeding disorder
• blood clots
• having surgery
• heart attack
• heart failure
• high blood pressure
• liver disease
• protein in your urine
• stroke or transient ischemic attack
• thyroid disease
• unhealed wound
• an unusual or allergic reaction to tivozanib, aspirin, other medicines, foods, FD&C Yellow No. 5 (tartrazine), other dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with water. Take it as directed on the prescription label. Do not cut, crush or chew this medicine. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your health care provider tells you to stop.

This medicine is taken in "cycles." There will be days that you do not take it. Talk to your health care provider if you have questions about when to take your medicine. It is very important to follow the exact schedule. Taking it more often than directed can cause serious side effects.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• certain medicines for sleep or anxiety
• rifampin
• St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

You may need blood work while you are taking this medicine.

Do not become pregnant while taking this medicine or for 1 month after stopping it. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant.There is potential for serious harm to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine or for 1 month after stopping it.

Males who get this medicine must use a condom during sex with females who can get pregnant. If you get a woman pregnant, there is potential for serious harm to an unborn child. You will need to continue wearing a condom for 1 month after stopping the medicine. Tell your health care provider right away if you think your partner might be pregnant.

This medicine may make it more difficult to get pregnant or father a child. Talk to your health care provider if you are concerned about your fertility.

This medicine may increase your risk to bruise or bleed. Call your health care provider if you notice any unusual bleeding.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Before having surgery or dental work, talk to your health care provider to make sure it is ok. This medicine can increase the risk of poor healing of your surgical site or wound. You will need to stop this medicine for 24 days before surgery. After surgery, wait at least 2 weeks before restarting this medicine. Make sure the surgical site or wound is healed enough before restarting this medicine. Talk to your health care provider if questions.

This medicine may increase blood sugar. Ask your health care provider if changes in diet or medicines are needed if you have diabetes.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• bleeding (bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose)
• blood clot (chest pain; shortness of breath; pain, swelling, or warmth in the leg)
• confusion
• heart attack (trouble breathing; pain or tightness in the chest, neck, back or arms; unusually weak or tired)
• heart failure (trouble breathing; fast, irregular heartbeat; sudden weight gain; swelling of the ankles, feet, hands; unusually weak or tired)
• increase in blood pressure
• light-colored stool
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• protein in your urine
• seizures
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• cough
• diarrhea
• hoarseness
• lack or loss of appetite
• mouth sores
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.