Pronunciation: axIT i nib

Brand: Inlyta

What is the most important information I should know about axitinib?

Axitinib can increase your risk of serious bleeding. Stop using axitinib and call your doctor at once if you have severe stomach pain, bloody or tarry stools, coughing up blood, or any heavy or unusual bleeding.

Some people taking axitinib have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.

What is axitinib?

Axitinib interferes with the growth of some cancer cells.

Axitinib is used to treat advanced kidney cancer.

Axitinib is usually given after other cancer medicine has been tried without success.

Axitinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking axitinib?

You should not use axitinib if you are allergic to it.

To make sure axitinib is safe for you, tell your doctor if you have:

  • liver disease;
  • high blood pressure;
  • a thyroid disorder;
  • bleeding problems, or a wound that has not healed;
  • recent stomach or intestinal bleeding;
  • history of perforation (a hole or tear) in your stomach or intestines;
  • history of a brain tumor; or
  • a history of heart attack, heart failure, stroke, or blood clot.

Do not use axitinib if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Use birth control to prevent pregnancy while you are receiving axitinib, whether you are a man or a woman. Axitinib use by either parent may cause birth defects or miscarriage.

Call your doctor at once if a pregnancy occurs while either sexual partner is taking axitinib.

It is not known whether axitinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using axitinib.

How should I take axitinib?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Axitinib should be taken at evenly spaced intervals, usually once every 12 hours. Follow your doctor's instructions.

Take this medicine with a full glass of water. You may take axitinib with or without food.

Do not crush, chew, or break an axitinib tablet. Swallow it whole.

Your blood pressure will need to be checked often. You may also need frequent medical tests to be sure this medicine is not causing harmful effects.

If you need surgery, tell the surgeon ahead of time that you are using axitinib. You will need to stop using the medicine at least 24 hours before a planned surgery.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If you vomit after taking the medicine, or if you miss a dose, take the medicine at your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking axitinib?

Grapefruit and grapefruit juice may interact with axitinib and lead to unwanted side effects. Avoid the use of grapefruit products while taking axitinib.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

What are the possible side effects of axitinib?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people taking axitinib have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.

Also call your doctor at once if you have:

  • any unexpected pain or swelling, any wound that will not heal;
  • a light-headed feeling, like you might pass out;
  • chest pain or pressure, pain spreading to your jaw or shoulder, trouble breathing;
  • shortness of breath (even with mild exertion), swelling, rapid weight gain;
  • sudden vision loss, headache, confusion, thinking problems, seizure (convulsions);
  • easy bruising, unusual bleeding (nosebleeds, bleeding gums), heavy menstrual bleeding, or any other bleeding that will not stop;
  • signs of stomach bleeding --severe stomach pain, red or pink urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • symptoms of a blood clot --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot in your leg --pain, swelling, warmth, or redness in one or both legs;
  • signs of a thyroid problem --sudden weight gain or loss, feeling very weak or tired, muscle pain, feeling hot or cold, hair loss, changes in your menstrual periods, hoarse or deepened voice; or
  • dangerously high blood pressure -severe headache, blurred vision, buzzing in your ears, anxiety, shortness of breath, uneven heartbeats.

Common side effects may include:

  • nausea, vomiting, diarrhea, constipation;
  • rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;
  • increased blood pressure;
  • weakness, tired feeling;
  • decreased appetite, weight loss; or
  • hoarse voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect axitinib?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • bosentan;
  • dexamethasone;
  • modafinil;
  • St. John's wort;
  • an antibiotic or antifungal medicine;
  • an antidepressant;
  • HIV or AIDS medication;
  • medicine to treat asthma or tuberculosis; or
  • seizure medicine.

This list is not complete. Other drugs may interact with axitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about axitinib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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