ings and Precautions (5.6)].
Other Common Events
Other commonly reported adverse events included arthralgia, rash, alopecia, fatigue, photosensitivity reactions, nausea, pruritus and skin papilloma [see Adverse Reactions (6.1)].
ZELBORAF is a registered trademark of Genentech, Inc.
Co-promoted by: Genentech USA, Inc. and Daiichi Sankyo, Inc.
Distributed by:
Genentech USA, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990
ZFT_5185426_PI_082011_K
10131338
PI Issued: August 2011
© 2011 Genentech, Inc. All rights reserved.
FDA-Approved Patient Labeling
MEDICATION GUIDE
ZELBORAF™ (ZEL-bor-raf)
(vemurafenib)
tablet
Read this Medication Guide before you start taking ZELBORAF™ and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about ZELBORAF?
ZELBORAF may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). CuSCC usually does not spread to other parts of the body.
Check your skin and tell your healthcare provider right away about any skin changes including a:
new wart
skin sore or reddish bump that bleeds or does not heal
change in size or color of a mole
A healthcare provider should check your skin before you start taking ZELBORAF, and every two months while taking ZELBORAF to look for any new skin cancers. Your healthcare provider may continue to check your skin for six months after you stop taking ZELBORAF.
See "What are the possible side effects of ZELBORAF?" for more information about side effects.
What is ZELBORAF?
ZELBORAF is a prescription medicine used to treat a type of skin cancer called melanoma,
that has spread to other parts of the body or cannot be removed by surgery, and
that has a certain type of abnormal "BRAF" gene
It is not known if ZELBORAF is safe and effective in children under 18 years of age.
What should I tell my healthcare provider before taking ZELBORAF?
Before you start taking ZELBORAF, tell your healthcare provider if you:
have any heart problems, including a condition called long QT syndrome
have liver or kidney problems
have been told that you have low blood levels of potassium, calcium, or magnesium
plan to have surgery, dental or other medical procedures
have any other medical conditions
are pregnant or plan to become pregnant. ZELBORAF may harm your unborn baby.
Females who are able to become pregnant, and males who take ZELBORAF should use birth control during treatment and for 2 months after stopping ZELBORAF.
Talk to your healthcare provider about birth control methods that may be right for you.
Tell your healthcare provider right away if you become pregnant during treatment with ZELBORAF.
are breastfeeding or plan to breastfeed. It is not known if ZELBORAF passes into your breast milk. You and your healthcare provider should decide if you will take ZELBORAF or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially, tell your healthcare provider if you take:
the blood thinner warfarin sodium (Coumadin, Jantoven)
antifungal medi
