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Drugs & Medications

pazopanib

COMMON BRAND NAME(S): Votrient

GENERIC NAME(S): PAZOPANIB HCL

WARNINGS:

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 frequently, usually every 2 weeks. After 2 months, liver testing will be less frequent. Tell your doctor immediately if you develop symptoms of liver disease such as dark urine, yellow eyes/skin, persistent nausea/vomiting, stomach/abdominal pain. Your doctor may need to change your dosage or discontinue the drug.

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Uses

Pazopanib is used to treat kidney cancer. It may also be used to treat certain other types of cancer (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 in children, especially younger than 2 years of age, because of the risk of serious side effects.

How to use pazopanib

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, 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 taking this medication. Grapefruit can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details.

Medications that reduce/block stomach acid (such as antacids, H2 blockers, proton pump inhibitors-PPIs) 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 using these drugs safely. Consult your doctor or pharmacist if you are taking any of these medications.

Dosage is based on your medical condition, laboratory tests, response to treatment, and other medications you may be taking (see also Drug Interactions section). The usual maximum daily dose is 800 milligrams.

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 worsens.

Side Effects

See also Warning section.

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 persist or worsen, tell your doctor or pharmacist promptly.

Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals or limiting activity may help lessen some of these effects.

Many people have more frequent/loose stools or diarrhea while taking this medication. Diarrhea can cause a serious loss of body water (dehydration). Drink plenty of fluids and minerals (electrolytes) to replace what is lost. Tell your doctor immediately if you develop signs of dehydration (such as extreme thirst, decreased urination, muscle cramps, weakness, fainting).

If diarrhea persists or becomes a problem, your doctor may lower the dose or have you temporarily stop this medication. Do not stop or change the dose of this medicine without talking with your doctor. Tell your doctor immediately if you develop: persistent/severe diarrhea, abdominal or stomach pain/cramping, blood in your stool.

This medication may cause high blood pressure. Your doctor will check your blood pressure regularly while you are taking this medication and may start you on a medication to lower your blood pressure.

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

Many people using this medication have serious side effects and require a dosage reduction or drug discontinuation. However, your doctor has prescribed this drug because he or she 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: signs of an underactive thyroid (such as unusual weight gain, cold intolerance, slow heartbeat, unusual tiredness), signs of infection (such as fever, chills, persistent sore throat), wounds that do not heal, signs of congestive heart failure (such as swelling of the ankles/feet, trouble breathing, unusual tiredness), change in the amount of urine, unusual tiredness.

This drug can cause serious (rarely fatal) bleeding. Tell your doctor immediately 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.

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, slurred speech, sudden vision changes, confusion), signs of a blood clot in the arms/legs/lungs (such as pain/redness/swelling in the arm/leg/calf/groin, coughing up blood, chest pain, trouble breathing), signs of a certain brain condition (such as headache, seizure, confusion, decreased alertness, vision changes, blindness).

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.

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

Precautions

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, bleeding/clotting problem, 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 infrequently result in 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). Pazopanib may slow wound healing or cause healing wounds to reopen.

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 QT prolongation (see above).

Pazopanib is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

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: 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 directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. 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), certain antidepressants (such as nefazodone), macrolide antibiotics (such as clarithromycin), rifamycins (such as rifabutin, rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin, primidone), drugs used to treat HIV (such as ritonavir) 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. Therefore, before using this drug, report all medications you are currently using to your doctor or pharmacist.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as EKG, blood pressure, complete blood count, liver/thyroid function, blood minerals, urine protein) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

Keep all medical and laboratory appointments.

Missed Dose

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 and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

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.

MEDICAL ALERT: 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).

Information last revised June 2014. Copyright(c) 2014 First Databank, Inc.

Images

VOTRIENT 200 MG TABLET
VOTRIENT 200 MG TABLET
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VOTRIENT 200 MG TABLET
VOTRIENT 200 MG TABLET

Identification

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This medicine is a gray, oblong, film-coated tablet imprinted with "GS JT".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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