Votrient is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Pazopanib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

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

Votrient is also used to treat soft tissue sarcoma (a tumor that can develop in or around muscles, tendons, joints, organs, or blood vessels).

Votrient is usually given after other cancer medications have been tried without successful treatment of soft tissue sarcoma.

You should not use Votrient if you have severe liver disease. 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).

Votrient can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

Before taking this medicine

To make sure Votrient is safe for you, 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;

• a thyroid disorder;

• headaches, seizures, or vision problems;

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

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

• stomach or intestinal bleeding; or

• a surgery within the past 7 days.

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

Do not use Votrient if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and 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 while taking Votrient, and for at least 2 weeks after your last dose. You should use condoms even if you have had a vasectomy.

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

Take Votrient exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take Votrient 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.

Votrient 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 your surgery.

Store Votrient at room temperature away from moisture and heat.

Usual Adult Dose for Renal Cell Carcinoma:

800 mg orally once a day without food, at least 1 hour before or 2 hours after a meal

Comments:
-Limitation of Use: The efficacy of the drug for adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated.
-Dose should not exceed 800 mg.
-Swallow tablets whole with water; do not break or crush due to potential for increased rate of absorption which may affect systemic exposure.
-Do not take missed dose if less than 12 hours until the next dose.
-Avoid grapefruit or grapefruit juice as it may increase plasma concentration of the drug.
-There is no specific antidote for overdosage of the drug. Treatment should consist of general supportive measures.

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 without food, at least 1 hour before or 2 hours after a meal

Comments:
-Limitation of Use: The efficacy of the drug for adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated.
-Dose should not exceed 800 mg.
-Swallow tablets whole with water; do not break or crush due to potential for increased rate of absorption which may affect systemic exposure.
-Do not take missed dose if less than 12 hours until the next dose.
-Avoid grapefruit or grapefruit juice as it may increase plasma concentration of the drug.
-There is no specific antidote for overdosage of the drug. Treatment should consist of general supportive measures.

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

To make sure Votrient is safe for you, 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;

• a thyroid disorder;

• headaches, seizures, or vision problems;

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

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

• stomach or intestinal bleeding; or

• a surgery within the past 7 days.

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

Do not use Votrient if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and 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 while taking Votrient, and for at least 2 weeks after your last dose. You should use condoms even if you have had a vasectomy.

You should not breastfeed while you are using Votrient, 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.

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 Votrient. Avoid taking stomach acid reducers (Axid, Nexium, Pepcid, Prevacid, Prilosec, Protonix, Tagamet, Zantac, Zegerid) while taking Votrient.

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

Call your doctor or get emergency medical help if you have signs of dangerously high blood pressure: severe chest pain, severe headache, blurred vision, pounding in your neck or ears, anxiety, shortness of breath, or feeling like you might pass out.

Call your doctor at once if you have:

• headache, confusion, change in mental status, vision changes, seizure;

• sudden chest pain, wheezing, dry cough;

• unusual bleeding or bruising;

• any wound or surgical incision that will not heal;

• fast or pounding heartbeats, fluttering in your chest, and sudden dizziness (like you might pass out);

• heart problems - swelling, rapid weight gain, feeling short of breath;

• 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;

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

• 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, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

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

Common Votrient side effects 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 interact wth pazopanib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.