ERIVEDGE- vismodegib capsule
|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Revised: 01/2019|
|What is the most important information I should know about ERIVEDGE?
ERIVEDGE can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects.
For females who can become pregnant:
There is a Pregnancy Exposure Registry for females taking ERIVEDGE who become pregnant. The purpose of this registry is to monitor the health of you and your unborn baby. If you think that you or your female partner may have been exposed to ERIVEDGE during pregnancy, talk to your healthcare provider right away. If you become pregnant during treatment with ERIVEDGE, you or your healthcare provider should report your pregnancy to Genentech at 1-888-835-2555.
|What is ERIVEDGE?
ERIVEDGE is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body, or that has come back after surgery or that your healthcare provider decides cannot be treated with surgery or radiation.
It is not known if ERIVEDGE is safe and effective in children.
|What should I tell my healthcare provider before taking ERIVEDGE?
Before taking ERIVEDGE, tell your healthcare provider if you:
|How should I take ERIVEDGE?
|What should I avoid while taking ERIVEDGE?
|What are the possible side effects of ERIVEDGE?
ERIVEDGE can cause serious side effects, including:
|ERIVEDGE can cause absence of menstrual periods (amenorrhea) in females who are able to become pregnant. It is not known if amenorrhea is permanent. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects of ERIVEDGE.
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, Inc. at 1-888-835-2555.
|How should I store ERIVEDGE?
|General information about the safe and effective use of ERIVEDGE
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ERIVEDGE for a condition for which it was not prescribed. Do not give ERIVEDGE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ERIVEDGE that is written for health professionals.
|What are the ingredients in ERIVEDGE?
Active ingredient: vismodegib
Inactive ingredients: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, povidone, sodium starch glycolate, talc, magnesium stearate (non-bovine). The capsule shell contains gelatin, titanium dioxide, red iron oxide, and black iron oxide. The black printing ink contains shellac and black iron oxide.
Manufactured by: Patheon, Inc. Mississauga, Canada
Distributed by: Genentech USA, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990
ERIVEDGE is a registered trademark of Genentech, Inc.
©2019 Genentech, Inc.
For more information, call 1-855-737-4833 or go to www.erivedge.com