Erivedge® (vismodegib) 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.
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
- 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 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
- Advise patients not to donate blood or blood products while receiving Erivedge and for at least 7 months after the last dose of Erivedge
- 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
- 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%)
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see the full Prescribing Information, for a complete discussion of the risks associated with Erivedge, including the BOXED WARNING and the Medication Guide.