Vemurafenib oral tablets

What is this medicine?

VEMURAFENIB (Vem ue RAF e nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat melanoma, a type of skin cancer, and Erdheim-Chester disease.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice. Take doses approximately 12 hours apart.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• dark urine

• eye pain or swelling

• fast or irregular heartbeat

• feeling faint or lightheaded, falls

• general ill feeling or flu-like symptoms

• light-colored stools

• loss of appetite

• new wart; skin sore or reddish bump that bleeds or does not heal; change in size or color of a mole

• pain, tingling, numbness in the hands or feet

• rash, fever, and swollen lymph nodes

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• right upper belly pain

• sensitivity to sunlight or sunburn

• thickening of the palms of your hands or soles of your feet

• tightening of the fingers inward

• unusually weak or tired

• vomiting

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• changes in taste

• decreased appetite

• diarrhea

• dizziness

• dry skin

• hair loss

• headache

• joint pain

• muscle pain

• nausea

• swelling of the ankles, feet, hands

• tired

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cisapride

• dronedarone

• fluconazole

• pimozide

• posaconazole

• saquinavir

• thioridazine

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS

• caffeine

• certain antibiotics like clarithromycin, erythromycin, telithromycin

• certain medicines for fungal infections like itraconazole, ketoconazole, voriconazole

• certain medicines for irregular heart beat

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• certain medicines that treat or prevent blood clots like warfarin

• dextromethorphan

• digoxin

• nefazodone

• midazolam

• other medicines that prolong the QT interval (cause an abnormal heart rhythm) like dofetilide, ziprasidone

• rifabutin

• rifampin

• rifapentine

• St. John's wort, Hypericum perforatum

• tizanidine

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is less than 4 hours until your next scheduled dose, do not make up for the missed dose and just take your next dose at your regular time. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original container. Keep tightly closed. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• eye disease, vision problems

• heart disease

• history of irregular heartbeat

• history of low levels of calcium, magnesium, or potassium in the blood

• kidney disease

• liver disease

• recent or ongoing radiation therapy

• an unusual or allergic reaction to vemurafenib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor for regular check ups. You will need to have blood work while you are taking this medicine.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

Tell your doctor or health care provider right away if you have any change in your eyesight.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Do not become pregnant while taking this medicine and for 2 weeks after your last dose. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is potential for serious side effects to an unborn child. Talk to your health care provider or pharmacist for more information. Do not breast-feed an infant while taking this medicine and for 2 weeks after your last dose.