When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to axitinib or you are pregnant.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take each dose 12 hours apart.
• Swallow the tablet whole with a glass of water. Do not break, crush, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor for instructions.
• If you vomit after you take the medicine, do not take more. Just take your next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how axitinib works. Tell your doctor if you are using any of the following:
  
  • Bosentan, dexamethasone, modafinil, nafcillin, nefazodone, St John's wort
  • HIV/AIDS medicine, such as atazanavir, efavirenz, etravirine, indinavir, nelfinavir, ritonavir, saquinavir
  • Infection medicine, such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole
  • Seizure medicine, such as carbamazepine, phenobarbital, phenytoin
  • Tuberculosis medicine, such as rifabutin, rifampin, rifapentine
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant.
• Tell your doctor if you are breastfeeding, or if you have liver disease, high blood pressure, thyroid problems, or a history of a heart attack, heart failure, stroke, or blood clotting problems.
• This medicine may cause the following problems:
  
  • High blood pressure
  • Bleeding problems or blood clots
  • Heart failure
  • Tears or holes in your stomach or bowel
  • Thyroid changes
  • Reversible posterior leukoencephalopathy syndrome (RPLS)
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, coughing up blood
• Fast, slow, or pounding heartbeat
• Numbness or weakness on one side of your body, sudden or severe headache, pain in your calf, problems with vision, speech, or walking
• Red or brown urine, bloody or black stools, vomiting blood
• Redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
• Seizure, headache, confusion, trouble seeing
• Severe or ongoing stomach pain
• Swelling in your hands, ankles, or feet
• Tiredness, feeling too hot or cold, hair loss, weight gain, or voice changes
• Unusual bleeding, bruising, tiredness, or weakness

If you notice these less serious side effects, talk with your doctor:

• Decreased appetite and weight loss
• Diarrhea, constipation, nausea, or vomiting

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088