Erivedge
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"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.
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Erivedge
INDICATIONS
ERIVEDGE capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.
DOSAGE AND ADMINISTRATION
The recommended dose of ERIVEDGE is 150 mg taken orally once daily until disease progression or until unacceptable toxicity [see Clinical Studies].
ERIVEDGE may be taken with or without food. Swallow capsules whole. Do not open or crush capsules.
If a dose of ERIVEDGE is missed, do not make up that dose; resume dosing with the next scheduled dose.
HOW SUPPLIED
Dosage forms and Strengths
ERIVEDGE (vismodegib) capsules, 150 mg. The capsule has a pink opaque body and a grey opaque cap, with “150 mg” printed on the capsule body and “VISMO” printed on the capsule cap in black ink.
Storage And Handling
Each ERIVEDGE (vismodegib) capsule has a pink opaque body and a grey opaque cap with “150 mg” printed on the capsule body and “VISMO” printed on the capsule cap in black ink. ERIVEDGE capsules are available in bottles of 28 capsules (NDC 50242-140-01).
Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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. Revised: 01/2012
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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