Axitinib oral tablets

What is this medication?

AXITINIB (AX i TI nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat kidney cancers.

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

COMMON BRAND NAME(S): INLYTA

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

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

• bleeding disorders
• brain tumor
• heart disease
• high blood pressure
• history of blood clots
• liver disease
• recent or planning to have surgery
• stomach problems
• thyroid disease
• an unusual or allergic reaction to axitinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Do not cut, crush, or chew this medicine. Do not take with grapefruit juice. You can take this medicine with or without food. If it upsets your stomach, take it with food. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding 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, take it as soon as you can. If it is almost time for your next dose, take only that dose and skip your missed dose. Do not take double or extra doses.

What may interact with this medication?

This medicine may interact with the following medications:

• antiviral medicines for HIV or AIDS like atazanavir, efavirenz, etravirine, indinavir, nelfinavir, ritonavir, saquinavir
• bosentan
• clarithromycin
• dexamethasone
• grapefruit or grapefruit juice
• medicines for fungal infections like ketoconazole, itraconazole, voriconazole
• medicines for seizures like carbamazepine, phenobarbital, phenytoin
• modafinil
• nafcillin
• nefazodone
• rifabutin
• rifampin
• rifapentine
• St. John's Wort
• telithromycin

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 doctor for checks on your progress. Report any new symptoms promptly.

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

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Be careful brushing and 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.

Do not become pregnant while taking this medicine or for 1 week after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 1 week after stopping it. There is a potential for serious side effects to an unborn child. This medicine may interfere with the ability to have a child or father a child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 2 weeks after stopping it.

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:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• high blood pressure
• seizures
• signs and symptoms of bleeding such as 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 eye, gums, or nose
• signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm, or leg
• stomach pain

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

• constipation
• cough
• diarrhea
• loss of appetite
• nausea, vomiting

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.

Store tablets at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

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.