Brand Name(s):

• Inlyta®

WHY is this medicine prescribed?

Axitinib is used to treat advanced renal cell carcinoma (RCC, a type of cancer that begins in the cells of the kidneys) in people who have not been treated successfully with another medication. Axitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

HOW should this medicine be used?

Axitinib comes as a tablet to take by mouth. It is usually taken with or without food two times a day. Take axitinib at around the same times every day, about 12 hours apart. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take axitinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole with a glass of water; do not split, chew, or crush them.

If you vomit after taking axitinib, do not take another dose. Continue your regular dosing schedule.

Your doctor may start you on a low dose of axitinib and gradually increase your dose, not more than once every 2 weeks. This depends on how well the medication works for you and any side effects you might experience. Talk to your doctor about how you are feeling during your treatment. Continue to take axitinib even if you feel well. Do not stop taking axitinib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medicine?

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

What SPECIAL PRECAUTIONS should I follow?

Before taking axitinib,

• tell your doctor and pharmacist if you are allergic to axitinib, any other medications, or any of the ingredients in axitinib tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: bosentan (Tracleer); carbamazepine (Carbatrol, Epitol, Tegretol); clarithromycin (Biaxin, in Prevpac); itraconazole (Sporanox); ketoconazole (Nizoral); medications to treat HIV/AIDs including atazanavir (Reyataz), efavirenz (Sustiva, in Atripla), etravirine (Intelence), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase); modafinil (Provigil); nafcillin; nefazodone; phenobarbital; phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampin (Rifamate, Rifater); rifapentine (Priftin); steroid medications such as dexamethasone (Decadron); telithromycin (Ketek); and voriconazole (Vfend).Many other medications may also interact with axitinib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor what herbal products you are taking, especially St John's wort.
• tell your doctor if you have a wound that has not healed, or if you have or have ever had bleeding problems; blood clots; high blood pressure; a heart attack; bleeding in the stomach or intestines; brain cancer; a pulmonary embolism (blood clot in your lung); a stroke or ministroke (TIA); or heart; liver; or thyroid disease.
• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are taking axitinib. You should use birth control to prevent pregnancy in yourself or your partner during your treatment with axitinib. Talk to your doctor about birth control methods that will work for you. If you or your partner becomes pregnant while taking axitinib, call your doctor. Axitinib may harm the fetus.
• tell your doctor if you are breast-feeding.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking axitinib. Your doctor will tell you to stop taking axitinib at least 24 hours before your surgery.

What SPECIAL DIETARY instructions should I follow?

Do not eat grapefruit or drink grapefruit juice while taking this medication.

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

What should I do IF I FORGET to take a dose?

If you miss a dose of axitinib, skip that dose and take your next dose at the regular time. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• dizziness
• seizures
• coughing up blood

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to axitinib. Your doctor will also check your blood pressure regularly during your treatment with axitinib.

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.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: June 15, 2012.