Vemurafenib, Oral veh-muh-RAF-eh-nib

What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); kinase inhibitor

Generic and brand names: vemurafenib, oral; Zelboraf

What is this medicine used for?

This medicine is taken by mouth to treat a certain kind of spreading melanoma that is linked to an abnormal BRAF gene.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• heart disease
• liver or kidney problems
• long QT syndrome (problems with electrical activity in the heart muscle)
• low blood levels of potassium, calcium, or magnesium

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Use effective birth control during treatment with this medicine and for at least 2 months after you stop treatment. Do not breast-feed while you are taking this medicine.

Males: Use condoms during sexual intercourse with females of childbearing age while you are taking this medicine and for at least 2 months after you stop taking it.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Do not take more of it or for longer than prescribed. Taking too much increases the risk of serious side effects.

This medicine is usually taken in the morning and in the evening, about 12 hours apart. You may take this medicine with or without food. Swallow the tablets whole with water. Do not crush or chew them.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is within 4 hours of the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: fast or irregular heartbeat; fainting; dizziness; severe nausea or vomiting.

What should I watch out for?

This medicine may cause a different type of skin cancer. Your healthcare provider will check your skin regularly while you are taking this medicine, and for up to 6 months after you stop taking this medicine. Talk with your provider about this.

This medicine may cause a life-threatening irregular heartbeat. Tell your healthcare provider right away if you feel faint lightheaded, dizzy or have a fast or irregular heartbeat while taking this medicine.

This medicine may make your skin more sensitive to the sun, which may lead to painful sunburns. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and use a broad spectrum UVA/UVB sunscreen and lip balm (SPF 30 or higher) when you need to be outdoors. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

This medicine may cause a severe skin reaction and serious eye problems. Contact your healthcare provider if you have redness, pain, swelling, peeling, or blisters on your skin or in your mouth. Also contact your healthcare provider if you have any eye pain, swelling, or redness, or any vision changes. You will need to have blood and vision tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Chest pain; fast or irregular heartbeat; fainting; shortness of breath; dizziness; unexplained tiredness or weakness; unexplained swelling; pain, redness, swelling, peeling, or blisters on the face, palms of your hands, or soles of your feet; mouth sores or blisters; yellowish skin or eyes; dark urine; light colored bowel movements; severe stomach pain; severe nausea or vomiting; unexplained loss of appetite; eye pain or vision changes; mole or skin changes; sores that don't heal; numbness or tingling in hands or feet.

Other: Itchy skin; tiredness; diarrhea; constipation; change in taste; nausea; vomiting; hair loss; joint and muscle pain; back pain; headache; cough.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (Ery-Tabs, E.E.S.), isoniazid, levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent), norfloxacin (Noroxin), rifampin (Rifadin), rifabutin (Mycobutin), rifapentine (Priftin), and telithromycin (Ketek)
• antidepressants such as amitriptyline, doxepin, fluoxetine (Prozac), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), paroxetine (Paxil), and sertraline (Zoloft)
• antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (VFEND)
• anti-HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), pimozide (Orap), thioridazine, and ziprasidone (Geodon)
• antiseizure medicines such as carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin)
• arsenic trioxide (Trisenox)
• bosentan (Tracleer)
• bronchodilators such as aminophylline and theophylline
• caffeine
• conivaptan (Vaprisol)
• dexamethasone
• dextromethorphan, an ingredient in many cough and cold medicines such as Robitussin-DM
• heart medicines such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide (Tambocor), nicardipine (Cardene), propafenone (Rythmol), procainamide, quinidine, and sotalol (Betapace)
• imatinib (Gleevec)
• immunosuppressants such as cyclosporine (Gengraf, Sandimmune, Neoral), sirolimus (Rapamune), and tacrolimus (Prograf)
• methadone (Dolophine, Methadose)
• migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal) and ergotamine (Ergomar)
• St. John's wort
• tizanidine (Zanaflex)
• vandetanib (Caprelsa)
• warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.