Axitinib (By mouth)

Introduction

Axitinib (ax-I-ti-nib)

Treats late-stage kidney cancer.

Brand Name(s)

Inlyta

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• 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.
• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.Take each dose of medicine 12 hours apart.
• Swallow the tablet whole. Do not break, crush, or chew it.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor for instructions.
• If you vomit after taking your medicine, call your doctor or pharmacist for instructions.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you also use medicine to treat HIV/AIDS (such as atazanavir, efavirenz, etravirine, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, or Viracept®), medicine to treat an infection (such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole, Biaxin®, Ketek®, Nizoral®, or Sporanox®), medicine to treat tuberculosis (such as rifabutin, rifampin, rifapentine, Mycobutin®, Priftin®, Rifadin®, or Rimactane®), medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, Luminal®, or Tegretol®), medicine to treat depression (such as nefazodone, Serzone®), or St John's wort. Tell your doctor if you also use bosentan (Tracleer®), dexamethasone (Decadron®, Hexadrol®), modafinil (Provigil®), or nafcillin (Nallpen®, Unipen®).
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine

• This medicine can cause birth defects if it is used by the mother while she is pregnant or by the father when his sexual partner becomes pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding or if you have kidney disease, liver disease, bleeding problems, high blood pressure, brain cancer, stomach or bowel problems, thyroid problems, or a history of blood clotting problems.
• This medicine may cause serious heart and blood vessel problems. Call your doctor right away if you have chest pain, numbness or weakness on one side of your body, pain in your arms, jaw, back, or neck, or trouble breathing.
• Check with your doctor right away if you have severe stomach pain, bloody or black tarry stools, nausea, or vomiting of material that looks like coffee grounds. These could be symptoms of a serious bowel problem.
• This medicine may increase your chance of bleeding and cause wounds to heal more slowly. Avoid rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when you use sharp objects, including razors and fingernail clippers.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• Check with your doctor right away if you have headaches, seizures, confusion, or problems with vision while you are using this medicine. These could be symptoms of a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS).
• This medicine may cause a skin problem called hand-foot syndrome. Check with your doctor right away if you have any redness, pain, swelling, or blisters on the palms of your hands or the soles of your feet.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Cancer medicines can cause nausea and/or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
• Your blood pressure should be checked regularly during your treatment.

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, or coughing up blood
• Cloudy, red, or dark brown urine or red or black stools
• Fast, slow, or pounding heartbeat
• Confusion or seizures
• Numbness or weakness in your arm or leg, or on one side of your body
• Pain in your lower leg (calf)
• Redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
• Severe stomach pain
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, tiredness, or weakness
• Vomiting of blood or material that looks like coffee grounds

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

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

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