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
Boxed Warning and Additional Important Safety Information
- Based on its mechanism of action, 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
- Verify pregnancy status of females of reproductive potential within 7 days prior to initiating Erivedge therapy. Advise females of
reproductive potential to use effective contraception during and after Erivedge therapy. Advise males of the potential risk of Erivedge exposure
through semen and to use condoms with a pregnant partner or a female partner of reproductive potential. Advise pregnant women of the potential
risks to a fetus
- Advise female patients and female partners of male patients to contact their healthcare provider with a known or suspected pregnancy. Report
pregnancies to Genentech at (888) 835-2555
- Advise females of reproductive potential to use effective contraception during therapy with Erivedge and for 7 months after the final dose
- Advise males of the potential risk to an embryo or fetus if a female partner of reproductive potential is exposed to Erivedge. Advise male
patients to use condoms with a pregnant partner or a female partner of reproductive potential, even after a vasectomy, during therapy and for 3 months
after the final dose of Erivedge
- Advise patients not to donate blood or blood products while receiving Erivedge and for 7 months after the final dose of Erivedge
- Vismodegib is present in semen. It is not known if the amount of vismodegib in semen can cause embryo-fetal harm. Advise male patients not to
donate semen during and for 3 months after the final dose of Erivedge
- No data are available regarding the presence of vismodegib in human milk, the effects of the drug on the breastfed infant, or the effects of the
drug on milk production. Because of the potential for serious adverse reactions in breastfed infants from Erivedge, advise a nursing woman that
breastfeeding is not recommended during therapy with Erivedge and for 7 months after the final dose
- The most common adverse reactions (≥10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite,
constipation, arthralgias, vomiting, and ageusia
- Amenorrhea can occur in females of reproductive potential. Reversibility of amenorrhea 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 full Prescribing Information for a complete discussion of the risks
associated with Erivedge, including the BOXED WARNING and the Medication
- Erivedge® (vismodegib) capsule Prescribing Information. Genentech, Inc. May 2015.
- Sekulic A, Migden MR, Oro AE, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N
Engl J Med. 2012;366(23):2171-2179.