Inlyta is a prescription medicine that interferes with the growth of some cancer cells.

Inlyta is used to treat advanced kidney cancer (advanced renal cell carcinoma).

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

It is not known if Inlyta is safe and effective in children.

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.

Axitinib 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 this medicine 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.

Take Inlyta exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Inlyta should be taken at evenly spaced intervals, usually once every 12 hours.

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

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking Inlyta, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Your blood pressure will need to be checked often. You may also need frequent medical tests.

If you need surgery, tell your surgeon you currently use Inlyta. 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.

Usual Adult Dose for Renal Cell Carcinoma:

Initial dose: 5 mg orally twice a day
Maintenance dose: Increase or decrease dose based on individual safety and tolerability
Dose range: 2 to 10 mg twice a day

Comments: Doses should be taken approximately 12 hours apart.

Use: For the treatment of advanced renal cell carcinoma after the failure of 1 prior systemic therapy.

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:

• 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 Inlyta.

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.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

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

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

Get emergency medical help if you have 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:

• 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 Inlyta 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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with axitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.