From the Guidelines
Vismodegib is given orally as a 150 mg capsule taken once daily, with or without food. 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. Vismodegib requires no dose adjustments for patients with mild, moderate, or severe renal impairment or mild to moderate hepatic impairment, as stated in the study by Sekulic et al 1. The medication works by inhibiting the Hedgehog signaling pathway, specifically by binding to and inhibiting Smoothened (SMO), a transmembrane protein involved in Hedgehog signal transduction. This mechanism makes it effective for treating advanced basal cell carcinoma, including locally advanced basal cell carcinoma that has recurred after surgery or in patients who are not candidates for surgery or radiation, as shown in the ERIVANCE trial 1. Patients should be advised that vismodegib can cause severe 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.
Key Considerations
- The dose of vismodegib is 150 mg, taken orally once daily, as specified in the study by Sekulic et al 1.
- The medication should be continued until disease progression or unacceptable toxicity occurs.
- Patients should be advised of the potential risks of vismodegib, including severe birth defects or embryo-fetal death, and effective contraception should be used during treatment and for 24 months after the final dose.
- Vismodegib has been shown to be effective in treating advanced basal cell carcinoma, including locally advanced basal cell carcinoma, as demonstrated in the ERIVANCE trial 1 and the STEVIE trial 1.
Administration and Monitoring
- Patients should swallow the capsule whole and not open, crush, or chew it.
- Vismodegib requires no dose adjustments for patients with mild, moderate, or severe renal impairment or mild to moderate hepatic impairment.
- Patients should be monitored for adverse events, including serious adverse events, and treatment should be discontinued if unacceptable toxicity occurs.
From the FDA Drug Label
ERIVEDGE (vismodegib) for oral administration is supplied in capsules containing 150 mg vismodegib The administration route of vismodegib is oral. Vismodegib is supplied in capsules containing 150 mg of the active ingredient. 2
From the Research
Administration of Vismodegib
- Vismodegib is administered orally, with a typical dose of 150 mg per day 3, 4, 5.
- The medication can be taken with or without food, as a high-fat meal increases plasma exposure to a single dose of vismodegib, but there are no pharmacokinetic or safety differences between fasting and fed groups at steady-state 6.
- Vismodegib is available as a 150-mg capsule, and the approved dosage is 150 mg orally once daily 5.
Dosing Regimens
- Different dosing regimens of vismodegib have been studied, including continuous daily dosing and intermittent dosing schedules 3, 7.
- A study compared two intermittent vismodegib dosing regimens in patients with multiple basal-cell carcinomas, with treatment group A receiving 150 mg oral vismodegib per day for 12 weeks, then three rounds of 8 weeks of placebo daily followed by 12 weeks of 150 mg vismodegib daily, and treatment group B receiving 150 mg oral vismodegib per day for 24 weeks, then three rounds of 8 weeks of placebo daily followed by 8 weeks of 150 mg vismodegib daily 3.
- Another study evaluated the pharmacokinetics of vismodegib in patients with advanced solid tumors, with dosing regimens including 150 mg once daily, three times a week, or once a week, following a loading dose of 150 mg once daily for 11 days 7.