Axitinib

Generic Name: axitinib (ax-I-ti-nib)
Brand Name: Inlyta

Axitinib is used for:

Treating patients with advanced kidney cancer when a previous treatment has not worked.

Axitinib is a tyrosine kinase inhibitor. It works by blocking certain substances in the body that contribute to cancer growth.

Do NOT use axitinib if:

  • you are allergic to any ingredient in axitinib
  • you have recently had bleeding in the stomach or bowels or untreated cancer that has spread to the brain
  • you are taking carbamazepine, dexamethasone, a hydantoin (eg, phenytoin), phenobarbital, primidone, a rifamycin (eg, rifampin), or St. John's wort

Contact your doctor or health care provider right away if any of these apply to you.

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Before using axitinib:

Some medical conditions may interact with axitinib. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have high blood pressure, kidney or liver problems, bleeding problems, thyroid problems, or a wound that has not fully healed
  • if you have a history of stomach or bowel problems (eg, ulcer, tearing, fistula, bleeding) or blood clots (eg, in your legs, lungs, eye), or you are at risk of developing these problems
  • if you have a history of angina attacks, heart attack, stroke, or transient ischemic attack (TIA) ("mini-stroke") or you are at risk of developing these problems
  • if you have had a brain problem called reversible posterior leukoencephalopathy syndrome (RPLS)
  • if you are or will be having surgery, or you have recently had surgery
  • if you take medicine for high blood pressure

Some MEDICINES MAY INTERACT with axitinib. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, ketoconazole), macrolide antibiotics (eg, clarithromycin), nefazodone, protease inhibitors (eg, boceprevir, ritonavir), or telithromycin because they may increase the risk of axitinib's side effects
  • Bosentan, carbamazepine, dexamethasone, efavirenz, etravirine, hydantoins (eg, phenytoin), modafinil, nafcillin, phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort because they may decrease axitinib's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if axitinib may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use axitinib:

Use axitinib as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with axitinib. Talk to your pharmacist if you have questions about this information.
  • Take axitinib by mouth with or without food.
  • Take each dose about 12 hours apart unless your doctor tells you otherwise.
  • Swallow axitinib whole with a glass of water. Do not break, crush, or chew before swallowing.
  • Do not eat grapefruit or drink grapefruit juice while you use axitinib.
  • If you vomit after taking a dose of axitinib, do not take an additional dose. Go back to your regular dosing schedule.
  • If you miss a dose of axitinib, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use axitinib.

Important safety information:

  • Axitinib may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use axitinib with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Tell your doctor or dentist that you take axitinib before you receive any medical or dental care, emergency care, or surgery. You will need to stop axitinib at least 24 hours before planned surgery as directed by your doctor. Your doctor will decide when you should start to take it again.
  • High blood pressure has been reported in patients who take axitinib. If this occurs, it is usually seen within the first month after treatment starts. However, it has been seen as early as 4 days after treatment starts. Contact your doctor if you develop symptoms of high blood pressure (eg, severe or persistent headache or dizziness, vision changes).
  • Axitinib may rarely cause a serious brain problem called reversible posterior leukoencephalopathy syndrome (RPLS). Contact your doctor right away if you experience severe headache, seizures, sluggishness, confusion, problems thinking, or vision changes (eg, loss of vision).
  • Women who may become pregnant should use effective birth control while they are taking axitinib. Check with your doctor if you have questions about effective birth control.
  • Men who may father a child should use effective birth control while taking axitinib. Check with your doctor if you have questions about effective birth control. If your partner becomes pregnant, contact your doctor right away.
  • Severe and sometimes fatal bleeding has been reported in patients taking axitinib. Contact your doctor right away if you develop blood in the urine, coughing or spitting up blood, severe or persistent nosebleed, or other unusual bruising or bleeding.
  • Severe and sometimes fatal stomach or bowel problems (eg, tearing, fistula) have rarely occurred in patients taking axitinib. Contact your doctor right away if you develop severe or persistent stomach pain, black tarry or bloody stools, or vomiting blood or a substance that looks like coffee grounds.
  • Tell your doctor if you have a wound that does not heal.
  • Lab tests, including liver and thyroid function, urine protein levels, and blood pressure, may be performed while you use axitinib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Axitinib should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Axitinib may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using axitinib while you are pregnant. It is not known if axitinib is found in breast milk. Do not breast-feed while taking axitinib.

Possible side effects of axitinib:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; cough; diarrhea; dizziness; dry skin, mouth, or eyes; headache; hoarseness; indigestion; joint pain; loss of appetite; mild hair loss; mild stomach pain; nausea; taste changes; tiredness; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; blood in the urine; calf or leg pain, swelling, redness, or tenderness; chest, jaw, or arm pain; confusion; coughing or spitting up blood; fainting; feeling hot or cold; fever, chills, or persistent cough or sore throat; mouth or tongue swelling or soreness; muscle cramps or aches; one-sided weakness; rash, redness, itching, or peeling of the skin on the palms of your hands or soles of your feet; severe or persistent headache, dizziness, or stomach pain; severe or persistent nosebleed; severe or persistent tiredness or weakness; shortness of breath; slurred speech; sudden, severe nausea or vomiting; sudden unusual sweating; unusual bruising or bleeding; unusual weight changes; vision changes; voice changes; vomiting blood or a substance that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coughing or spitting up blood; seizures; severe or persistent headache or dizziness.

Proper storage of axitinib:

Store axitinib at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep axitinib out of the reach of children and away from pets.

General information:

  • If you have any questions about axitinib, please talk with your doctor, pharmacist, or other health care provider.
  • Axitinib is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take axitinib or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about axitinib. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to axitinib. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using axitinib.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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