Vismodegib
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-VISMODEGIB |
|---|---|
| Type | Drug |
| Aliases | ErivedgeВізомодегіб |
| Status | reviewed 2026-05-04 | pending_clinical_signoff |
| Diseases | DIS-BCC |
| Sources | SRC-NCCN-SKIN-2025 |
Drug Facts
| Class | Hedgehog pathway inhibitor (SMO antagonist) |
|---|---|
| Mechanism | First-in-class oral SMO (Smoothened) antagonist. Binds and inhibits SMO, blocking downstream HH (Hedgehog) signaling cascade (GLI1/GLI2 transcription factor activation). In BCC, activating SMO mutations or PTCH1 loss-of-function constitutively activate HH → tumor growth. ERIVANCE pivotal trial: ORR 43% (mBCC) / 30% (laBCC) with durable responses. FDA-approved 2012. |
| Typical dosing | 150 mg PO once daily, continuous until progression or unacceptable toxicity. Take with or without food. |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-05-04 |
Warnings
- Embryo-fetal toxicity — teratogenic, embryotoxic; contraindicated in pregnancy; verify negative pregnancy test before start; two contraceptive methods required
Notes
ERIVANCE trial (Sekulic 2012 NEJM): ORR 43% in metastatic BCC, 30% in locally advanced BCC; median duration of response ~7.6 months. Most patients discontinue due to AEs (primarily muscle cramps, alopecia, dysgeusia) rather than progression. Drug holiday strategy (intermittent dosing) investigated to reduce toxicity and potentially prevent resistance. Long-lasting drug due to plasma protein binding — must counsel on teratogenicity risk for weeks after stopping.
Used By
Regimens
REG-VISMODEGIB-BCC- Vismodegib monotherapy (locally advanced / metastatic BCC)