Finished product reference
Vismodegib
Capsule · Oral · 150 mg
- List code
- 51922
- Pharmacologic class
- Hedgehog Pathway Inhibitor
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 .
What it is and how it works
Mechanism of Action Vismodegib is an inhibitor of the Hedgehog pathway. Vismodegib binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction.
Mechanism class: Smoothened Receptor Antagonists
Indications
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. ERIVEDGE ® (vismodegib) 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.
Dosage and administration (summary)
The recommended dosage is 150 mg orally once daily. Important Safety Information Verify pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE . Recommended Dosage The recommended dosage of ERIVEDGE is 150 mg taken orally once daily, with or without food, until disease progression or until unacceptable toxicity . Swallow capsules whole. Do not open or crush capsules . If a dose of ERIVEDGE is missed, resume dosing with the next scheduled dose. Dosage Modifications for Adverse Reactions Withhold ERIVEDGE for up to 8 weeks for intolerable adverse reactions until improvement or resolution.
Contraindications
None. None.
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 ( 5.1 , 8.3 ) 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 ( 5.4 , 8.4 ) Embryo-Fetal Toxicity Based on its mechanism of action, ERIVEDGE can cause embryo-fetal death …
Pregnancy
Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ERIVEDGE during pregnancy. Report pregnancies to Genentech at 1-888-835-2555.
Storage and supply
Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) . Keep the bottle tightly closed to protect from moisture.
Source: Vismodegib (Erivedge) — US FDA prescribing information, 2024-12-02, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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