Erivedge® (vismodegib)

• Full Prescribing Information including boxed WARNINGS
• Material Safety Data Sheet

Indication

ERIVEDGE®(vismodegib) capsule 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.

Important Safety Information and BOXED WARNINGS

Embryo-Fetal Death and Severe Birth Defects 

• Erivedge capsule can cause fetal harm when administered to a pregnant woman based on its mechanism of action 
• Verify pregnancy status prior to the initiation of Erivedge. Advise male and female patients of these risks. Advise female patients of the need for contraception during and after treatment and advise male patients of the potential risk of Erivedge exposure through semen.   
• Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant
• Immediately report exposure to Erivedge during pregnancy and encourage women who may have been exposed to Erivedge during pregnancy, either directly or through seminal fluid, to participate in the Erivedge pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at (888) 835-2555 

Blood Donation 

• Advise patients not to donate blood or blood products while receiving Erivedge and for at least 7 months after the last dose of Erivedge July 18, 2012 

Nursing Mothers 

• Inform female patients of the potential for serious adverse reactions in nursing infants from Erivedge, taking into account the importance of the drug to the mother 

Adverse Reactions 

• The most common adverse reactions (≥10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusiaIn clinical trials, a total of 3 of 10 premenopausal women developed amenorrhea while receiving Erivedge
• Treatment-emergent grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%)  

Please see the accompanying full Prescribing Information for a complete discussion of the risks associated with Erivedge, including the BOXED WARNING and the Medication Guide.