Vemurafenib Oral tablet
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.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
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
history of irregular heartbeat
history of low levels of calcium, magnesium, or potassium in the blood
recent or ongoing radiation therapy
an unusual or allergic reaction to vemurafenib, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
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.
Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
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.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
certain antibiotics like clarithromycin, erythromycin, grepafloxacin, pentamidine, sparfloxacin, troleadomycin
certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
certain medicines for irregular heart beat like amiodarone, bepridil, dofetilide, dronedarone, encainide, flecainide, propafenone, quinidine
This medicine may also interact with the following medications:
antiviral medicines for HIV or AIDS
certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
certain medicines that treat or prevent blood clots like warfarin
other medicines that prolong the QT interval (cause an abnormal heart rhythm)
St. John's wort, Hypericum perforatum
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
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.
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 professional 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.
Men and women should use effective birth control while taking this medicine and for 2 months after stopping this medicine. Do not become pregnant while taking this medicine and for at least 2 months 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 professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.
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
changes in vision
eye pain or swelling
fast or irregular heartbeat
feeling faint or lightheaded, falls
general ill feeling or flu-like symptoms
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
redness, blistering, peeling or loosening of the skin, including inside the mouth
right upper belly pain
sensitivity to sunlight or sunburn
unusually weak or tired
yellowing of the eyes or skin
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
changes in taste
swelling of the ankles, feet, hands
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert