Inlyta (axitinib) interferes with the growth of some cancer cells.
Inlyta is used to treat advanced kidney cancer.
Inlyta is usually given after other cancer medicine has been tried without success.
Important information
Do not use Inlyta if you are pregnant. It could harm the unborn baby. Use birth control to prevent pregnancy while you are receiving this medicine, whether you are a man or a woman. Inlyta use by either parent may cause birth defects or miscarriage.
Inlyta can increase your risk of serious bleeding. Stop using Inlyta 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 Inlyta 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.
Inlyta is usually taken once every 12 hours. It should be taken at evenly spaced intervals. Follow your doctor"s instructions.
To be sure this medication is not causing harmful effects, your kidney, thyroid, and liver function will need to be tested. Your blood pressure will also need to be checked often. Visit your doctor regularly.
Before taking this medicine
You should not use Inlyta if you are allergic to axitinib.
To make sure Inlyta is safe for you, tell your doctor if you have:
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liver disease;
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high blood pressure;
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a thyroid disorder;
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bleeding problems, or a wound that has not healed;
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recent stomach or intestinal bleeding;
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history of perforation (a hole or tear) in your stomach or intestines;
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history of a brain tumor; or
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a history of heart attack, heart failure, stroke, or blood clot.
FDA pregnancy category D. Do not use Inlyta if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.
See also: Pregnancy and breastfeeding warnings (in more detail)
Use birth control to prevent pregnancy while you are receiving this medicine, whether you are a man or a woman. Inlyta 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 Inlyta.
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 this medicine.
How should I take Inlyta?
Take Inlyta exactly as prescribed by your doctor. 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.
Inlyta 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 Inlyta with or without food.
Do not crush, chew, or break the 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 this medicine. 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.
Inlyta dosing information
Usual Adult Dose for Renal Cell Carcinoma:
5 mg orally twice daily.
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 Inlyta?
Grapefruit and grapefruit juice may interact with axitinib and lead to unwanted side effects. Avoid the use of grapefruit products while taking Inlyta.
Inlyta side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Inlyta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some people taking Inlyta 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:
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any unexpected pain or swelling, any wound that will not heal;
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a light-headed feeling, like you might pass out;
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chest pain or pressure, pain spreading to your jaw or shoulder, trouble breathing;
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shortness of breath (even with mild exertion), swelling, rapid weight gain;
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sudden vision loss, headache, confusion, thinking problems, seizure (convulsions);
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easy bruising, unusual bleeding (nosebleeds, bleeding gums), heavy menstrual bleeding, or any other bleeding that will not stop;
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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;
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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;
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signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;
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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
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dangerously high blood pressure-severe headache, blurred vision, buzzing in your ears, anxiety, shortness of breath, uneven heartbeats.
Common Inlyta side effects may include:
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nausea, vomiting, diarrhea, constipation;
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rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;
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increased blood pressure;
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weakness, tired feeling;
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decreased appetite, weight loss; or
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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.
See also: Side effects (in more detail)
What other drugs will affect Inlyta?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Inlyta, especially:
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.
