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

Treats melanoma (skin cancer) and Erdheim-Chester Disease (ECD).

Brand Name(s):

Zelboraf

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Doses should be taken 12 hours apart.
• Swallow the tablet whole with a glass of water. Do not crush, break, or chew it.
• If you vomit after you take the medicine, do not take an extra dose. Wait and take your next dose at the normal time.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If it is more than 4 hours before your next dose, take the tablet as soon as you can. If it is less than 4 hours until your next dose, skip the missed dose then take your next dose at the regular time. Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

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

• Some medicines can affect how vemurafenib works. Tell your doctor if you are using any of the following:
  • Atazanavir, carbamazepine, clarithromycin, dextromethorphan, digoxin, indinavir, ipilimumab, itraconazole, ketoconazole, midazolam, nefazodone, nelfinavir, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, ritonavir, saquinavir, telithromycin, tizanidine, voriconazole
  • Blood thinner (including warfarin)

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective birth control during treatment with this medicine and for 2 weeks after your last dose.
• Do not breastfeed during treatment with this medicine and for 2 weeks after the last dose.
• Tell your doctor if you have liver disease, kidney disease, heart failure, heart rhythm problems, or eye problems. Tell your doctor if you had or are planning to have radiation treatment.
• This medicine may cause the following problems:
  • New skin and non-skin cancer, including melanoma, squamous cell cancer, or myeloid neoplasm
  • Serious skin reactions
  • Changes in heart rhythm, including QT prolongation
  • Liver problems
  • Eye or vision problems
  • Kidney problems
  • Muscle, bone, and connective tissue disease, including Dupuytren contracture or plantar fascial fibromatosis
• 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.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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, red skin rash
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Decrease in how much or how often you urinate, bloody urine, lower back or side pain
• Eye pain, vision changes
• Fast, pounding, or uneven heartbeat, fainting, dizziness, lightheadedness
• Skin changes, including moles or new sores
• Unusual thickening of the palms of your hands with tightening of the fingers inward
• Unusual thickening of the soles which may be painful

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

• Diarrhea
• Hair thinning or loss
• Headache
• Joint or muscle pain
• Tiredness

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