Skip to content
ClinCalc Pro
Menu
Calculators Drugs Pathways AI Dx Donate Get the App
Hedgehog pathway (SMO) inhibitor Pregnancy: Based on its mechanism of action and findings from animal reproduction studies, ERIVEDGE can cause embryo-fetal death or severe birth defects when administered to a pregnant woman; oral administration during organogenesis at doses below the 150 mg clinical dose was embryotoxic, fetotoxic and teratogenic in rats. There are no human data in pregnant women. Verify pregnancy status of females of reproductive potential within 7 days prior to initiating, and advise females of reproductive potential to use effective contraception during therapy and for 24 months after the final dose. Vismodegib is present in semen; advise males not to donate semen during and for 3 months after therapy. A pregnancy exposure registry monitors outcomes in women exposed during pregnancy.

Vismodegib (Specialist drug)

Brand names: Erivedge

Vismodegib is an oral Hedgehog pathway inhibitor used for symptomatic metastatic basal cell carcinoma or locally advanced disease unsuitable for surgery or radiotherapy.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 150 mg
Route: Oral — swallow capsules whole, with or without food; do not open or crush the capsules
Frequency: Once daily, until disease progression or until unacceptable toxicity
No UK SPC (eMC) record was fetched — this draft is distilled from the US prescribing information for ERIVEDGE (label date 2024-12-02) and must be verified against the UK SPC. Indication in the fetched label is advanced basal cell carcinoma. BEFORE STARTING: verify the pregnancy status of females of reproductive potential within 7 days prior to initiating treatment. MISSED DOSE: if a dose is missed, resume dosing with the next scheduled dose (do not make it up). DOSE MODIFICATION: withhold for up to 8 weeks for intolerable adverse reactions until improvement or resolution (treatment durations shorter than 8 weeks prior to interruption have not been studied). Permanently discontinue for severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS. Interrupt for severe or intolerable musculoskeletal adverse reactions, and permanently discontinue for recurrent, severe or intolerable musculoskeletal adverse reactions. Advise patients not to donate blood or blood products while receiving vismodegib and for 24 months after the final dose, and advise males not to donate semen during and for 3 months after therapy. PAEDIATRIC: safety and effectiveness have not been established in paediatric patients. Premature fusion of the epiphyses and precocious puberty have been reported in paediatric patients exposed to vismodegib, and in some cases epiphyseal fusion progressed after drug discontinuation. Verify any under-18 use against a children's formulary. Note: no drug interactions section was captured in the fetched bundle.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • None stated — the US label section 4 Contraindications reads 'None'

Side effects

  • Muscle spasms (most common, ≥10%)
  • Alopecia
  • Dysgeusia and ageusia
  • Weight loss, decreased appetite and fatigue
  • Nausea, vomiting, diarrhoea, constipation and arthralgias; labelled serious reactions include embryo-fetal toxicity, severe cutaneous adverse reactions (SJS, TEN, DRESS), musculoskeletal adverse reactions and premature fusion of the epiphyses

Clinical monograph

How it works

It inhibits Smoothened, a key transducer of the Hedgehog signalling pathway that is aberrantly activated in basal cell carcinoma.

Prescribing in practice

  • It is highly teratogenic and contraindicated in pregnancy; pregnancy prevention requirements and avoidance of blood and semen donation must be enforced.
  • Common effects include muscle spasms, alopecia, taste disturbance and weight loss, which may limit adherence.
  • It is a specialist medicine initiated and supervised by clinicians experienced in its use.

Monitoring

Monitor adherence to the pregnancy prevention programme and review tolerability including muscle, weight and electrolyte effects.

Counselling the patient

  • Effective contraception is essential during and for the specified period after treatment for both women and men, per the pregnancy prevention programme.
  • Do not donate blood during treatment or for the recommended period afterwards, and men should not donate semen.
  • Report muscle cramps, marked weight loss or loss of taste.

Evidence & guidelines

Approval was based on the ERIVANCE basal cell carcinoma study and is reflected in MHRA-approved labelling.

Reference: NICE; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

Calculators
Pathways