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The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that the use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before taking this drug. vemurafenib
Generic Name: vemurafenib (VEM ue RAF e nib) Brand Names: Zelboraf What is vemurafenib?
Vemurafenib is a cancer medication that interferes with the growth and spread of cancer cells in the body. Vemurafenib is used to treat metastatic melanoma (skin cancer). Vemurafenib may also be used for purposes not listed in this medication guide. What is the most important information I should know
about vemurafenib?
Do not use vemurafenib if you are pregnant. It could harm the unborn baby. Before you take vemurafenib, tell your doctor if you have liver disease, an electrolyte imbalance (such as low levels of potassium or magnesium in your blood), or a personal or family history of Long QT syndrome. Using vemurafenib may increase your risk of developing other types of skin cancer. Report any new or worsening skin lesions to your doctor right away. There are many other drugs that can interact with vemurafenib. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you. What should I discuss with my healthcare provider before
taking vemurafenib?
You should not use vemurafenib if you are allergic to it. To make sure you can safely use vemurafenib, tell your doctor if you have any of these other conditions: • liver disease; • a heart rhythm disorder; • a personal or family history of Long QT syndrome; or • an electrolyte imbalance (such as low levels of potassium or magnesium in your Using vemurafenib may increase your risk of developing other types of skin cancer. Report any new or worsening skin lesions to your doctor right away. FDA pregnancy category D. Do not use vemurafenib if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether vemurafenib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using vemurafenib. How should I take vemurafenib?
Before you start treatment, your doctor may perform tests to make sure vemurafenib is the best treatment for your type of skin cancer. Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Vemurafenib is usually taken twice per day, as 2 tablets in the morning and 2 tablets in the evening. Follow your doctor's instructions. Take this medicine with a full glass of water. You may take vemurafenib with or without food. Do not crush, chew, or break a vemurafenib tablet. Swallow it whole. To make sure this medication is helping your condition and not causing harmful effects, your skin condition will need to be checked often. Your heart function may also need to be tested with an electrocardiogram (ECG or EKG) on a regular basis. You may also need eye exams. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor. Your doctor may want to check your skin for several months after you stop using vemurafenib. Visit your doctor regularly. Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 4 hours away. Do not take extra medicine to make up the missed dose. What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking vemurafenib?
Avoid exposure to sunlight or tanning beds. Vemurafenib can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Vemurafenib side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using vemurafenib and call your doctor at once if you have a serious side effect such as: • severe dizziness, fainting, fast or pounding heartbeats; • white patches on your eyes; • new or worsening skin lesions; or • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling. • joint pain; • tired feeling; • nausea; • hair loss; • mild rash or itching; • skin growths; or • blurred vision, increased sensitivity of your eyes to light. 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. Vemurafenib Dosing Information
Usual Adult Dose for Melanoma - Metastatic:
What other drugs will affect vemurafenib?
Many drugs can interact with vemurafenib. Below is just a partial list. Tell your doctor if you are using: • a blood thinner such as warfarin (Coumadin, Jantoven); • cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus • digoxin (digitalis, Lanoxin, Lanoxicaps); • theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl); • ADHD medication such as Adderall, Concerta, Daytana, Metadate, Ritalin, Strattera; • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifampin (Rifater, Rifadin, Rifamate), rifabutin (Mycobutin), rifapentine (Priftin), or telithromycin (Ketek); • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), desipramine (Norpramin), doxepin (Sinequan, Silenor), duloxetine (Cymbalta), fluoxetine (Prozac, Sarafem, Symbyax), nefazodone, nortriptyline (Pamelor), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), and others; • antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend); • cancer medicine such as doxorubicin (Adriamycin, Doxil), lomustine (CeeNU), • ergot medicine such as ergotamine (Ergomar, Cafergot) or dihydroergotamine • cough medicine such as dextromethorphan (Delsym, Robitussin Maximum Strength, Vicks 44, and others) or dihydrocodeine (Alahist DHC, J-Max DHC, Pancof-PD, Panlor, Trezix, Welltuss EXP, and others); • pain medication such as codeine (Tylenol #3), hydrocodone (Lortab, Vicodin, Vicoprofen), oxycodone (OxyContin, Combunox, Roxicodone, Percocet), or tramadol (Ultram, Ultracet); • heart or blood pressure medication such as betaxolol (Kerlone), captopril (Capoten), carvedilol (Coreg), labetalol (Normodyne), metoprolol (Dutoprol, Lopressor, Toprol), nicardipine (Cardene), pindolol (Visken), propranolol (Inderal), timolol (Blocadren); • a heart rhythm medication such as disopyramide (Norpace), flecainide (Tambocor), mexilitene (Mexitil), procainamide (Procan, Pronestyl), propafenone (Rythmol), or quinidine (Quin-G); • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); • medicine to treat psychiatric disorders, such as chlorpromazine (Thorazine), fluphenazine (Permitil), haloperidol (Haldol), pimozide (Orap), perphenazine (Trilafon), promethazine (Phenergan), risperidone (Risperdal), or thioridazine (Mellaril); or • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), divalproex (Depakote), phenobarbital (Solfoton), phenytoin (Dilantin), or valproic acid (Depakene, Stavzor). This list is not complete and there are many other drugs that can interact with vemurafenib. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you. Where can I get more information?
• Your pharmacist can provide more information about vemurafenib. • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01. Revision Date: 2011-9-20, 9:26:53 AM.

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