Zelboraf

Generic Name: vemurafenib (VEM ue RAF e nib)
Brand Names: Zelboraf

What is Zelboraf?

Zelboraf (vemurafenib) is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Zelboraf is used to treat metastatic melanoma (skin cancer).

Zelboraf may also be used for purposes not listed in this medication guide.

Important information about Zelboraf

Do not use Zelboraf if you are pregnant. It could harm the unborn baby.

Before you take Zelboraf, 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.

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Using Zelboraf 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 Zelboraf. 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.

Before taking Zelboraf

You should not use Zelboraf if you are allergic to vemurafenib.

To make sure you can safely use Zelboraf, 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 blood).

Using Zelboraf 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 Zelboraf 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 Zelboraf.

See also: Zelboraf pregnancy and breastfeeding warnings (in more detail)

How should I take Zelboraf?

Before you start treatment with Zelboraf, your doctor may perform tests to make sure vemurafenib is the best treatment for your type of skin cancer.

Take Zelboraf 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.

Zelboraf 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 Zelboraf with or without food. Do not crush, chew, or break a Zelboraf 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 Zelboraf. Visit your doctor regularly.

Store Zelboraf 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 Zelboraf?

Avoid exposure to sunlight or tanning beds. Zelboraf can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Zelboraf side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Zelboraf: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Zelboraf 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.

Less serious Zelboraf side effects may include:

• 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.

See also: Zelboraf side effects (in more detail)

What other drugs will affect Zelboraf?

Many drugs can interact with Zelboraf. 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 (Prograf);

• digoxin (digitalis, Lanoxin, Lanoxicaps);

• theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);

• ADHD medication such as Adderall, Concerta, Daytrana, 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), tamoxifen (Soltamox);

• ergot medicine such as ergotamine (Ergomar, Cafergot) or dihydroergotamine (D.H.E. 45, Migranal Nasal Spray);

• 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 Zelboraf. 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 Zelboraf.