| Document Date: 2014-03-31 07:24:11
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Company Genentech Inc. / Inhibit Drug Transport Systems / Ames / / Facility Laboratory Abnormalities / / IndustryTerm black printing ink / blood products / administration site / healthcare / food / / MedicalCondition basal cell carcinoma / Severe Birth Defects ERIVEDGE / cancer / disease / body tremors / severe birth defects / benign cutaneous neoplasm / dysgeusia / Carcinogenesis / fluid-filled cysts / nausea / muscle spasms / Alopecia All Grades3 / degeneration/necrosis / WARNINGS AND PRECAUTIONS Embryo-fetal death / alopecia / azotemia / arthralgias / vomiting / hyponatremia / fatigue / advanced basal cell carcinoma / diarrhea / Nausea Diarrhea Constipation Vomiting General disorders / ageusia / constipation / metastatic basal cell carcinoma / hypokalemia / embryo-fetal death / / MedicalTreatment oral contraceptives / contraception / vasectomy / surgery / radiation / / Organization FDA / / / Position Counsel / Nausea Diarrhea Constipation Vomiting General / / Product Males ERIVEDGE capsule / talc / estradiol / The capsule / azithromycin / modafinil / Swallow capsules / INDICATIONS AND USAGE ERIVEDGE capsule / carbamazepine / ERIVEDGE capsule / Severe Birth Defects ERIVEDGE capsules / clarithromycin / erythromycin / rosiglitazone / fluconazole / / Technology Pharmacokinetics / radiation / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ERIVEDGE safely and effectively. See full prescribing information for ERIVEDGE. ERIVEDGE (vismodegib) capsule for or