"June 8, 2012 -- Roche's Erivedge, newly approved for advanced basal cell carcinoma, is "the greatest advance in therapy yet seen for this disease," according to an editorial in the New England Journal of Medicine.
"It is a land"...
Read this Medication Guide before you start taking ERIVEDGE and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.
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:
- You should talk with your healthcare provider about the risks of ERIVEDGE to your unborn child.
- Your healthcare provider should do a pregnancy test within 7 days before you start taking ERIVEDGE to find out if you are pregnant.
- In order to avoid pregnancy, you should start using highly effective birth control before you start ERIVEDGE, and continue to use highly effective birth control during treatment, and for 7 months after your last dose of ERIVEDGE. Talk with your healthcare provider about what birth control method is right for you during this time.
- Talk to your healthcare provider right away if you have unprotected sex or if you think that your birth control has failed.
- Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.
- You should always use a condom with a spermicide, even if you have had a vasectomy, during sex with female partners while you are taking ERIVEDGE and for 2 months after your last dose to protect your female partner from being exposed to ERIVEDGE.
- Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking ERIVEDGE.
Exposure to ERIVEDGE during pregnancy
If you think that you or your female partner may have been exposed to ERIVEDGE during pregnancy, talk to your healthcare provider right away. Pregnant women are encouraged to participate in a program that collects information about exposure to ERIVEDGE during pregnancy, and the effects on the mother and her unborn child. This program is called the ERIVEDGE pregnancy pharmacovigilance program. You may participate in this program by calling the Genentech Adverse Event Line 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:
- are pregnant or plan to become pregnant. See “What is the most important information I should know about ERIVEDGE?”
- are breastfeeding or plan to breastfeed. It is not known if ERIVEDGE passes into your breast milk. You and your healthcare provider should decide if you will take ERIVEDGE 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.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take ERIVEDGE?
- Take ERIVEDGE exactly as your healthcare provider tells you.
- You can take ERIVEDGE with or without food.
- Swallow ERIVEDGE capsules whole. Do not open or crush the capsules.
- Take ERIVEDGE one time each day.
- If you miss a dose, skip the missed dose. Just take your next scheduled dose.
What should I avoid while taking ERIVEDGE?
- Do not donate blood or blood products while you are taking ERIVEDGE and for 7 months after your last dose.
What are the possible side effects of ERIVEDGE?
ERIVEDGE can cause serious side effects, including:
- See “What is the most important information I should know about ERIVEDGE?”
The most common side effects of ERIVEDGE are:
- muscle spasms
- hair loss
- change in how things taste or loss of taste
- weight loss
- decreased appetite
- joint aches
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ERIVEDGE. For more information, 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, Inc. at 1-888-835-2555.
How should I store ERIVEDGE?
- Store ERIVEDGE at room temperature between 68°F to 77°F (20°C to 25°C).
Keep ERIVEDGE and all medicines out of the reach of children.
General information about 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.
This Medication Guide summarizes the most important information about ERIVEDGE. If you would like more information, ask your health care provider. You can ask your healthcare provider or pharmacist for the FDA-approved information about ERIVEDGE that is written for healthcare professionals.
For more information, call 1-855-737-4833 or visit www.erivedge.com
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.
Last reviewed on RxList: 2/2/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Erivedge Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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