axitinib

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is axitinib?

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.

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

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.

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.

How should I take axitinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

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

If you vomit shortly after taking axitinib, 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.

What happens if I miss a dose?

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

What happens if I overdose?

What should I avoid while taking axitinib?

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

What are the possible side effects of axitinib?

• 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.

What other drugs will affect axitinib?

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 affect 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.

Where can I get more information?

Your pharmacist can provide more information about axitinib.