e taking ZELBORAF. These may be symptoms related to QT prolongation.
Abnormal liver function tests. Your healthcare provider should do blood tests to check your liver function before you start taking ZELBORAF and during treatment. Tell your healthcare provider right away if you get any of these symptoms of a liver problem during treatment:
your skin or the whites of your eyes turn yellow
you feel tired
your urine turns dark or brown (tea color)
you have nausea or vomiting
you do not want to eat
pain on the right side of your stomach
Eye problems. You should have your eyes examined before and while you are taking your ZELBORAF. Tell your healthcare provider right away if you get these symptoms during treatment with ZELBORAF:
eye pain, swelling, or redness,
blurred vision or other vision changes during treatment with ZELBORAF
New melanoma lesions. You may develop new melanoma lesions while taking ZELBORAF. Check your skin and tell your healthcare provider right away about any skin changes.
The most common side effects of ZELBORAF include:
joint pain
rash (see " Severe skin reactions " above)
hair loss
tiredness
sunburn or sun sensitivity
nausea
itching
warts
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all possible side effects of ZELBORAF. For more information about side effects, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Genentech at 1-888-835-2555.
How should I store ZELBORAF?
Store ZELBORAF at room temperature between 68°F to 77°F (20°C to 25°C).
Store ZELBORAF in the original container with the lid tightly closed.
Ask your healthcare provider or pharmacist how to safely throw away (dispose of) any unused or expired ZELBORAF.
Keep ZELBORAF and all medicine out of the reach of children.
General information about ZELBORAF
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZELBORAF for a condition for which it was not prescribed. Do not give ZELBORAF to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about ZELBORAF. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ZELBORAF that is written for health professionals.
For more information, call Genentech at 1-888-835-2555.
What are the ingredients in ZELBORAF?
Active ingredient: vemurafenib
Inactive ingredients: hypromellose acetate succinate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hydroxypropyl cellulose.
Coating: pinkish white: poly(vinyl alcohol), titanium dioxide, polyethylene glycol 3350, talc, and iron oxide red.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
MG Issued: August 2011
Distributed by:
Genentech USA, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990
ZELBORAF is a registered trademark of Genentech, Inc.
Co-promoted by: Genentech USA, Inc. and Daiichi Sankyo, Inc.
ZFT_5185426_MG_082011_K
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© 2011 Genent
