Votrient 200 mg tablet

Generic name:
Pazopanib - oral

Pronunciation
(paz-OH-pa-nib)

Brand name(s)
Votrient

Pazopanib can rarely cause very serious (possibly fatal) liver disease. Your doctor will order blood tests to check your liver before you start and while you are taking pazopanib. During the first 2 months of treatment, liver tests will be done often, usually every 2 weeks. After 2 months, liver testing will be less frequent. Tell your doctor right away if you develop symptoms of liver disease such as nausea/vomiting that doesn't stop, dark urine, yellow eyes/skin, stomach/abdominal pain. Your doctor may need to change your dosage or discontinue the drug.

Pazopanib is used to treat certain types of cancer (kidney, soft tissue sarcoma). Pazopanib belongs to a class of drugs known as tyrosine kinase inhibitors. It works by decreasing the blood supply to the cancer tumor to slow tumor growth.

This medication should not be used by children, especially those younger than 2 years of age, because of the risk of serious side effects.

Read the Medication Guide provided by your pharmacist before you start taking pazopanib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth without food as directed by your doctor, usually once daily. It is very important to take this medication on an empty stomach, at least 1 hour before or 2 hours after food.

Swallow this medication whole. Do not crush, chew, or break the tablets. Doing so can release all of the drug at once, increasing the risk of side effects.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Medications that reduce/block stomach acid (such as antacids, H2 blockers such as famotidine/ranitidine, proton pump inhibitors-PPIs such as omeprazole/lansoprazole) may reduce the absorption of pazopanib, making it work less well. Do not take H2 blockers or PPIs while using this medication. If you are taking antacids, ask your pharmacist about how to best take them, such as taking antacids at least several hours apart from when you take pazopanib. Ask your doctor or pharmacist if you are taking any of these medications.

The dosage is based on your medical condition, lab tests, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Your doctor will order lab tests to find the best dose for you. Keep all medical and lab appointments.

Do not increase your dose or take this drug more often than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Follow your doctor's instructions carefully.

Since this medication can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Tell your doctor if your condition gets worse.

See also Warning section.

Diarrhea, nausea/vomiting, headache, loss of appetite, weight loss, altered sense of taste, numbness/tingling/redness in hands/feet, or feeling tired/weak may occur. If these effects last or get worse, tell your doctor or pharmacist promptly.

Temporary hair loss and/or change in hair or skin color may occur. Normal hair growth should return after treatment has ended.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• symptoms of heart failure (such as swelling ankles/feet, unusual tiredness)
• signs of an underactive thyroid (such as unusual weight gain, cold intolerance, slow heartbeat)
• signs of infection (such as sore throat that doesn't go away, fever, chills, cough)
• wounds that do not heal

This drug can cause serious (rarely fatal) bleeding. Tell your doctor right away if you have any signs of unusual bleeding such as:

• bloody/black stools
• easy bleeding/bruising (such as nose bleed or bloody/pinkish urine)
• vomit that looks like coffee grounds
• severe stomach/abdominal pain
• coughing up blood

Pazopanib sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as:

• signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine)
• muscle spasms/weakness

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

Get medical help right away if you have any very serious side effects, including:

• fast/irregular heartbeat
• severe dizziness
• fainting
• symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)
• signs of a stroke (such as weakness on one side of the body, trouble speaking, vision changes, confusion)
• pain/redness/swelling in the arm/leg/calf/groin
• signs of a certain brain condition (such as headache, seizure, decreased alertness, blindness)
• sudden/severe back pain

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking pazopanib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease
• chest pain/heart attack
• high blood pressure
• stroke
• recent surgery/injury
• bleeding/clotting problem
• blood vessel problems (such as an aneurysm or a tear/break in the aorta or other blood vessels)
• intestinal or stomach problems (such as ulcer, fistula, pancreatitis)
• underactive thyroid

Pazopanib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using pazopanib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using pazopanib safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may cause wounds to heal slowly or poorly. Before having surgery, talk with your doctor about the risks and benefits of this medication. Your doctor may tell you to temporarily stop treatment with this medication at least 1 week before surgery. Ask your doctor for specific instructions about when to stop and when to restart treatment with pazopanib. Tell your doctor right away if you have wounds that are not healing well.

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Older adults may be more sensitive to the side effects of this drug, especially liver disease or QT prolongation (see above).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using pazopanib. Pazopanib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Men and women using this medication should ask about reliable forms of birth control during treatment and for at least 2 weeks after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 2 weeks after the last dose. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• irinotecan
• other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen, "blood thinners" such as warfarin)

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

Other medications can affect the removal of pazopanib from your body, which may affect how pazopanib works. Examples include azole antifungals (such as ketoconazole), nefazodone, rifamycins (such as rifabutin, rifampin), ritonavir, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin, primidone), among others.

Many drugs besides pazopanib may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as clarithromycin, erythromycin), among others. Before using this drug, report all medications you are currently using to your doctor or pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as EKG, blood pressure, complete blood count, liver/thyroid function, blood minerals, urine protein) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is less than 12 hours before your next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.