Vemurafenib (By mouth)

Introduction

Vemurafenib (vem-ue-RAF-e-nib)

Treats skin cancer (melanoma) that has spread or cannot be removed by surgery.

Brand Name(s)

Zelboraf

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. The first dose should be taken in the morning, and the second dose in the evening. The two doses should be taken 12 hours apart.
• You may take this medicine with or without food.
• Swallow the tablet whole with a glass of water. Do not crush, break, or chew it.
• Keep using this medicine for the full treatment time, even if you feel better after the first few doses.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose. If you miss a dose or forget to use your medicine, you may still take it up to 4 hours before your next regular dose time.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using a blood thinner (such as warfarin, Coumadin®), dextromethorphan (Benylin®), midazolam (Versed®), or any product containing caffeine. Tell your doctor if you are also using dofetilide (Tikosyn®), medicine for depression (such as amitriptyline, fluoxetine, nortriptyline, Elavil®, Pamelor®, Prozac®, Sarafem®, or Vivactil®), certain antibiotics (such as erythromycin, levofloxacin, moxifloxacin, sparfloxacin, Avelox®, Levaquin®, or Zagam®), or medicine to treat mental illness (such as haloperidol, mesoridazine, pimozide, prochlorperazine, quetiapine, thioridazine, ziprasidone, Compazine®, Geodon®, Haldol®, Mellaril®, Orap®, Serentil®, or Seroquel®).
• Make sure your doctor knows if you are also using medicine to treat HIV/AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, or Viracept®), medicine to treat an infection (such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole, Biaxin®, Ketek®, Nizoral®, or Sporanox®), medicine to treat tuberculosis (such as rifampin, rifabutin, rifapentine, Mycobutin®, Priftin®, Rifadin®, or Rimactane®), medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, Luminal®, or Tegretol®), or medicine to treat depression (such as nefazodone, Serzone®).

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, liver disease, heart rhythm problems (such as long QT syndrome, QT prolongation), slow heartbeat, mineral imbalance (such as high or low potassium, calcium, magnesium), or a history of skin cancer.
• This medicine may increase your risk of having cutaneous squamous cell carcinoma (cuSCC). This is more likely to occur if you are more than 65 years of age, have too much sun exposure, or a history of skin cancer. Your doctor may want your skin to be tested and checked for any new skin lesions before treatment and every 2 months while you are using this medicine.
• This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you have a rash; itching; hoarseness; lightheadedness or dizziness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
• Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.
• This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• This medicine may make your skin more sensitive to sunlight. Avoid overexposing your skin to sunlight. Use sunscreen or sunblock lotions and lip balms with a sun protection factor (SPF) of at least 30 on a regular basis when you are outdoors. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds.
• Check with your doctor right away if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs while you are receiving this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Blurred vision or eye pain.
• Fast or uneven heartbeat.
• Lightheadedness or fainting.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.
• Severe sunburn.
• Swelling in your hands, ankles, or feet.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Back, bone, joint, or muscle pain.
• Change or loss of taste.
• Cough.
• Decreased appetite.
• Dry skin.
• Hair thinning or patchy hair loss.
• Headache or dizziness.
• Mild rash or itching skin.
• Nausea, vomiting, diarrhea, constipation, or stomach pain.
• Pain in the arms or legs.
• Tiredness or weakness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088