BOXED WARNING AND ADDITIONAL IMPORTANT SAFETY INFORMATION

EMBRYO-FETAL DEATH AND SEVERE BIRTH DEFECTS

Erivedge capsule can cause fetal harm when administered to a pregnant female based on its mechanism of action. Erivedge is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations
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. Female and male patients of reproductive potential should be counseled regarding pregnancy prevention and planning
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
FEMALE PATIENTS

Determine pregnancy status within 7 days prior to initiation of treatment in females of reproductive potential. For females with a negative pregnancy test, initiate a highly effective form of contraception (failure rate of less than 1%) prior to the first dose. Continue highly effective contraception during therapy and for 7 months after the last dose of Erivedge
MALE PATIENTS

Male patients should use condoms with spermicide, even after a vasectomy, during sexual intercourse with female partners while being treated with Erivedge and for 2 months after the last dose to avoid exposing an embryo or fetus to vismodegib
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
NURSING MOTHERS

It is not known whether vismodegib is excreted in human breast milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Erivedge, a decision should be made whether to discontinue nursing or to discontinue the drug, 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 ageusia
Amenorrhea has been observed in clinical trials in females of reproductive potential. Reversibility of fertility impairment is unknown. In 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

http://www.gene.com/gene/products/information/erivedge/pdf/erivedge_prescribing.pdf