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Drugs & Medications

vemurafenib

COMMON BRAND NAME(S): Zelboraf

GENERIC NAME(S): VEMURAFENIB

Uses

Vemurafenib is used to treat a type of skin cancer (melanoma) that has spread or cannot be removed by surgery and has a certain type of abnormal "BRAF" gene. Vemurafenib works by slowing the growth of skin cancer cells. It belongs to a class of drugs known as kinase inhibitors.

How to use vemurafenib

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

Take this medication by mouth with or without food as directed by your doctor, usually twice daily about 12 hours apart. Swallow whole with a glass of water. Do not crush or chew this medication. If you vomit after taking your dose, do not take an extra dose of this medication. Take the next dose of the medication at the regularly scheduled time.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Tell your doctor if your condition persists or worsens.

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

Side Effects

Hair loss, dry skin, headache, nausea, vomiting, diarrhea, swelling of ankles/feet/hands, or joint/muscle pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Vemurafenib may cause other types of skin cancer (such as cutaneous squamous cell carcinoma and melanoma) that usually does not spread to other parts of the body. (See also Notes section.) Tell your doctor right away if you have any skin changes including: new wart, skin sore, change in size/color of a mole, skin bump that bleeds or does not heal.

Infrequently, vemurafenib may also cause or worsen other types of cancer (such as non-cutaneous squamous cell carcinomas of the head and neck; cancers with RAS mutations, such as certain types of leukemias). Consult your doctor for more details.

Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as blurred vision, blind spot/shadows in the center of your vision, sensitivity to light), fast/irregular heartbeat, severe dizziness, fainting, liver problems (symptoms such as loss of appetite, extreme tiredness, stomach/abdominal pain, dark urine, yellowing eyes/skin).

Vemurafenib can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rash that could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any rash.

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, fever, swollen glands, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, change in the amount of urine.

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 vemurafenib, 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.

Vemurafenib 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 vemurafenib, 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 vemurafenib safely.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

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

Older adults may be more sensitive to the side effects of this drug, especially skin changes, nausea, decreased appetite, swelling of ankles/feet/hands, and QT prolongation (see above).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the risks and benefits with your doctor. It is important that men and women taking this medication use reliable forms of birth control (including condoms and/or diaphragms with spermicide) while taking this medication and for 2 months after treatment stops. If you become pregnant, think you may be pregnant, or cause a pregnancy, contact your doctor immediately.

It is unknown if this medication passes into breast milk. Because of possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

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.

A product that may interact with this drug is: ipilimumab.

Many drugs besides vemurafenib may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, quinidine, procainamide, sotalol, and certain antipsychotic medications (such as pimozide, thioridazine, ziprasidone), among others.

Other medications can affect the removal of vemurafenib from your body, which may affect how vemurafenib works. Examples include azole antifungals (such as ketoconazole, itraconazole), macrolide antibiotics (such as clarithromycin), HIV protease inhibitors (such as ritonavir, atazanavir), telithromycin, nefazodone, rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Vemurafenib can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include caffeine, warfarin, among others.

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 BRAF testing, liver function tests, EKG, blood mineral levels) will be performed before starting and while you are taking this medication to monitor your progress or check for side effects. Consult your doctor for more details.

Keep all appointments as it is important to have regular skin exams (such as every 2 months) while taking and for up to 6 months after stopping treatment with vemurafenib.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is within 4 hours of 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. Keep this medication in the original container away from light and moisture. Do not store in the bathroom. Keep all medication 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.

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

Images

ZELBORAF 240 MG TABLET
ZELBORAF 240 MG TABLET
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ZELBORAF 240 MG TABLET
ZELBORAF 240 MG TABLET

Identification

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This medicine is a pinkish-white, oblong, film-coated tablet imprinted with "VEM".

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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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