How is Vismodegib (Erythrocyte Hedgehog pathway inhibitor) administered?

From the Guidelines

Vismodegib is administered orally as a 150 mg capsule taken once daily. This dosing regimen is based on the most recent and highest quality study available, which reported the efficacy and safety of vismodegib in patients with advanced basal cell carcinoma 1. The medication is typically continued until disease progression or unacceptable toxicity occurs. Patients should swallow the capsule whole and not open, crush, or chew it.

Key Considerations

• Vismodegib is primarily used to treat advanced basal cell carcinoma, including metastatic or locally advanced cases that cannot be treated with surgery or radiation.
• The medication works by inhibiting the Hedgehog signaling pathway, which is abnormally activated in basal cell carcinomas, blocking tumor growth and inducing cancer cell death.
• Patients should be aware that vismodegib can cause serious birth defects or embryo-fetal death, so effective contraception is required during treatment and for 24 months after the final dose for both male and female patients.
• Common side effects include muscle spasms, hair loss, taste disturbances, weight loss, fatigue, nausea, and diarrhea, as reported in the ERIVANCE trial and other studies 1.

Administration and Monitoring

• Vismodegib should be taken orally once daily, with or without food.
• Patients should be monitored regularly for disease progression and unacceptable toxicity.
• The medication's efficacy and safety have been established in several clinical trials, including the ERIVANCE trial, which reported a response rate of 48% in patients with locally advanced basal cell carcinoma and 33% in patients with metastatic disease 1.

From the FDA Drug Label

ERIVEDGE (vismodegib) for oral administration is supplied in capsules containing 150 mg vismodegib Vismodegib is given orally in capsules containing 150 mg of the drug. 2

From the Research

Administration of Vismodegib

• Vismodegib is administered orally, with a typical dosage of 150 mg per day 3, 4, 5, 6.
• The medication is available in capsule form, with the approved dosage being 150 mg orally once daily 3.
• In some clinical trials, vismodegib was administered in different dosing regimens, such as 150 mg per day for 12 weeks, followed by periods of placebo or reduced dosing 7.
• Neoadjuvant administration of vismodegib, where the medication is given before surgery, has also been studied, with dosing ranging from 4 to 10 months before planned surgery 5.

Dosing Regimens

• A study compared two intermittent vismodegib dosing regimens in patients with multiple basal-cell carcinomas, with one group receiving 150 mg oral vismodegib per day for 12 weeks, and the other group receiving 150 mg oral vismodegib per day for 24 weeks, both followed by periods of placebo 7.
• Another study evaluated the pharmacokinetics of vismodegib with less frequent dosing, such as three times per week or once weekly, following a loading dose of 150 mg once daily for 11 days 6.
• The results of these studies suggest that vismodegib can be effective in various dosing regimens, but the optimal dosing schedule may depend on the specific patient population and clinical context 7, 6.