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

Pazopanib is also used to treat soft tissue sarcoma (a tumor that can develop in or around muscles, tendons, joints, organs, or blood vessels). Pazopanib is usually given after other treatments have failed.

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

Pazopanib can cause severe or life-threatening liver problems. You will need frequent blood tests to check your liver function.

Call your doctor at once if you have: nausea, vomiting, upper stomach pain, loss of appetite, tiredness, easy bruising, dark urine, or jaundice (yellowing of the skin or eyes).

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.

Take pazopanib on an empty stomach, at least 1 hour before or 2 hours after a meal.

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

Pazopanib can cause severe or life-threatening infections, liver problems, or high blood pressure. You will need frequent medical tests.

If you need surgery, tell the surgeon ahead of time that you are using pazopanib. You may need to stop using the medicine for at least 7 days before and 2 weeks after your surgery. Ask your doctor before restarting pazopanib after surgery.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Renal Cell Carcinoma:

800 mg orally once a day until disease progression or unacceptable toxicity

Uses:
-Advanced renal cell carcinoma (RCC)
-Advanced soft tissue sarcoma (STS) with prior chemotherapy

Usual Adult Dose for Soft Tissue Sarcoma:

800 mg orally once a day until disease progression or unacceptable toxicity

Uses:
-Advanced renal cell carcinoma (RCC)
-Advanced soft tissue sarcoma (STS) with prior chemotherapy

Tell your doctor if you have ever had:

• liver disease;

• heart disease, heart rhythm disorder, long QT syndrome;

• high blood pressure;

• a blood clot or stroke;

• headaches, seizures, or vision problems;

• a thyroid disorder;

• kidney disease;

• a perforation (a hole or tear) in your stomach or intestines;

• a fistula (an abnormal passageway) within your stomach or intestines;

• stomach bleeding, intestinal bleeding, or if you have coughed up blood in the past 6 months; or

• a surgery (recent or planned).

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

Both men and women using pazopanib should use effective birth control to prevent pregnancy. Pazopanib can harm an unborn baby if the mother or father is using this medicine. Keep using birth control for at least 2 weeks after your last dose.

If you are a man whose sex partner is pregnant or could become pregnant, use condoms even if you have had a vasectomy.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using pazopanib.

You should not breastfeed while you are using pazopanib, and for at least 2 weeks after your last dose.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses at one time.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Do not eat grapefruit or drink grapefruit juice while taking this medication.

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

Ask your doctor before using an antacid. Do not take an antacid within several hours before or after taking pazopanib. Avoid taking stomach acid reducers (Axid, Nexium, Pepcid, Prevacid, Prilosec, Protonix, Tagamet, Zantac, Zegerid) while taking pazopanib.

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

Pazopanib can cause life-threatening blood clots in the small blood vessels inside your organs, such as your brain or kidneys. Seek medical help right away if you have symptoms of this condition, such as a fever, tiredness, decreased urination, bruising, or nosebleeds.

Pazopanib may cause serious side effects. Call your doctor at once if you have:

• severe chest pain or headache, confusion, pounding in your neck or ears;

• a seizure;

• ongoing cough or breathing problems;

• unusual bleeding or bruising;

• any wound or surgical incision that will not heal;

• heart problems--swelling, rapid weight gain, shortness of breath, fast or pounding heartbeats, fluttering in your chest, sudden dizziness (like you might pass out);

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• liver problems--nausea, vomiting, upper stomach pain, loss of appetite, tiredness, dark urine, or jaundice (yellowing of the skin or eyes).

• signs of infection--fever, runny nose, sore throat, body aches, skin sores, pain or burning when you urinate;

• signs of stomach bleeding--stomach pain or swelling, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• signs of a stroke or blood clot--sudden numbness or weakness, severe headache, slurred speech, vision problems, chest pain, sudden shortness of breath, pain or cold feeling in an arm or leg; or

• signs of tumor cell breakdown--tiredness, muscle cramps or spasms, tingling, vomiting, diarrhea, fast or slow heart rate, little or no urination.

Liver problems may be more likely in adults older than 65.

Common side effects of pazopanib may include:

• nausea, vomiting, diarrhea, stomach pain;

• loss of appetite, weight loss;

• trouble breathing;

• tumor pain, bone pain, muscle pain;

• headache, feeling tired;

• changes in hair or skin color; or

• changes in your sense of taste.

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.

Tell your doctor about all your other medicines, especially:

• an antibiotic;

• an antidepressant;

• cholesterol medicine that contains simvastatin (Zocor, Vytorin, Juvisync, Simcor);

• heart rhythm medication;

• HIV or AIDS medications; or

• stomach acid reducers such as Nexium, Prilosec, Tagamet, and others.

This list is not complete. Other drugs may affect pazopanib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.