Axitinib (ax-I-ti-nib)

Treats kidney cancer.

Brand Name(s):

Inlyta

When This Medicine Should Not Be Used:

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 at least 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: If you miss a dose or vomit after you take the medicine, take your next dose at the normal time. Do not take extra medicine to make up for the missed dose.
• 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
  • Medicine to treat an infection (including clarithromycin, itraconazole, ketoconazole, rifabutin, rifampin, rifapentine, telithromycin, voriconazole)
  • Medicine to treat HIV/AIDS (including atazanavir, efavirenz, etravirine, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir)
  • Medicine to treat seizures (including carbamazepine, phenobarbital, phenytoin)
• 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. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 1 week after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 1 week after the last dose.
• Do not breastfeed during treatment and for at least 2 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, diabetes, high blood cholesterol, high blood pressure, thyroid problems, stomach or bowel bleeding, or a history of heart attack, heart failure, stroke, or blood clotting problems. Tell your doctor if you had a recent surgery.
• This medicine may cause the following problems:
  • High blood pressure
  • Bleeding problems
  • Blood clots, including deep vein thrombosis, pulmonary embolism
  • Heart problems (including heart failure)
  • Stomach or bowel problems (including tear or hole)
  • Thyroid problems
  • Increased levels of protein in your urine
  • Reversible posterior leukoencephalopathy syndrome (RPLS, a central nervous system disorder)
  • Liver problems
• 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.
• You may also receive medicines to help prevent nausea and vomiting.
• Tell any doctor who treats you that you are using this medicine. This medicine may affect the way your body heals from cuts and wounds. You may need to stop using it for at least 2 days before you have surgery. Wait for at least 2 weeks after major surgery, or until adequate wound healing before taking this medicine again.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• 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
• Bloody or cloudy urine
• Chest pain, trouble breathing, coughing up blood
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes, cloudy urine
• 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
• Redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
• Seizures, 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, or weakness

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

• Constipation, diarrhea, decreased appetite, weight loss
• Muscle pain
• Sores or white patches on your lips, mouth, or throat

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