Side Effect Reporting
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.
Support & Resources
Indication
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.
Important Safety Information and BOXED WARNINGS
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. Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to use effective contraception during and after Erivedge
- 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
Warnings and Precautions
- 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
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
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, including the BOXED WARNING, for a complete discussion of the risks associated with Erivedge.