Vismodegib

ERIVEDGE 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. ERIVEDGE ® (vismodegib) is a hedgehog pathway inhibitor 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.

Vismodegib is an inhibitor of the Hedgehog pathway. Vismodegib binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction.

The recommended dosage is 150 mg orally once daily. Important Safety Information Verify pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE.

None. None.

Boxed warning (embryo-fetal toxicity erivedge): can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ERIVEDGE is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations. Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE. Embryo-Fetal Toxicity: Advise patients not to donate blood or blood products while receiving ERIVEDGE and for 24 months after the final dose of ERIVEDGE. Advise males not to donate semen during and for 3 months after therapy. Severe Cutaneous Adverse Reactions: Permanently discontinue ERIVEDGE in patients with these reactions. Musculoskeletal Adverse Reactions: Temporary dose interruption or discontinuation may be required for these reactions. Premature fusion of the epiphyses

The following clinically significant adverse reactions are described elsewhere in the labeling: Embryo-Fetal Toxicity Severe Cutaneous Adverse Reactions Musculoskeletal Adverse Reactions Premature Fusion of the Epiphyses The most common adverse reactions (incidence of ≥ 10%) are muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia.

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). Keep the bottle tightly closed to protect from moisture.