Axitinib is used to treat advanced kidney cancer.

Axitinib is sometimes given after at least one other cancer treatment did not work or has stopped working.

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

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

Tell your doctor if you have ever had:

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

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Axitinib can cause harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using axitinib.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because axitinib can harm an unborn baby.

It is not safe to breast-feed a baby while you are using this medicine. Also do not breast-feed for at least 2 weeks after your last dose.

Use Axitinib (Inlyta) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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:

• chest pain or pressure, pain spreading to your jaw or shoulder, trouble breathing;
• sudden numbness or weakness, problems with vision or speech;
• headache, confusion, thinking problems, seizure (convulsions);
• a light-headed feeling, like you might pass out;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• heavy menstrual bleeding;
• any bleeding that will not stop;
• liver problems--severe nausea or vomiting, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• heart problems--swelling, rapid weight gain, feeling short of breath;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• signs of a thyroid problem--sudden weight gain or loss, feeling very weak or tired, muscle pain, feeling hot or cold, hair loss, hoarse or deepened voice.

Common side effects may include:

• liver problems;
• stomach pain;
• muscle and bone pain;
• abnormal blood tests;
• mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina;
• cough, shortness of breath;
• headache;
• nausea, vomiting, diarrhea, constipation;
• rash, itching, redness, and peeling skin on your hands or feet;
• feeling weak or tired;
• increased blood pressure;
• 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.

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