Sonidegib
Hedgehog pathway inhibitors
Hedgehog pathway inhibitorsHigh alert
An error with this medicine can cause serious harm: double checks and protocols are used.Pregnancy: contraindicated
Contraindicated in pregnancy (EU label). Sonidegib carries a high risk of embryo-fetal death or birth defects: pregnancy tests and contraception for many months after treatment…
An oral Smoothened blocker for locally advanced basal cell carcinoma, taken on an empty stomach. Muscle damage and birth defects are the key risks.
Quick facts
- Group
- Hedgehog pathway inhibitors
- Target
- Smoothened (SMO) receptor
- Key effects
- Muscle spasms and pain · Hair loss · Taste change
- Monitor
- Pregnancy test before starting · Creatine kinase
- ATC
- L01XJ02
No doses: the clinician sets them by the current guideline.
Mechanism of action
No structure with sonidegib was found. The figure shows vismodegib, another Smoothened inhibitor, in the same transmembrane pocket of human Smoothened.
Sonidegib binds Smoothened, the signalling protein that the Hedgehog pathway uses. When PTCH1 is lost, as in most basal cell carcinomas, Smoothened drives GLI transcription factors continuously; sonidegib shuts this down and the tumour stops growing.
- Sonidegib binds Smoothened (SMO)
- GLI transcription factors switch off
- Basal cell carcinoma stops growing
Indications
- Locally advanced basal cell carcinoma that recurred after surgery or radiation, or that cannot be treated with them. Basal cell carcinoma →
Adverse effects
Common
- Muscle spasms and pain
- Hair loss
- Taste change, decreased appetite, weight loss
- Nausea, diarrhoea, abdominal pain
- Fatigue, itching, missed periods
Contraindications
- Hypersensitivity to sonidegib
- Pregnancy (EU label)
Key interactions
- St John's wort
- Can lower sonidegib levels; avoided.
- Grapefruit and its juice
- Can raise sonidegib levels; discussed with the treating team.
What is monitored
- Pregnancy test before starting
- Creatine kinase (CK) at baseline and during treatment, and kidney function
- Muscle pain, weakness or dark urine
Administration and safety
- Oral capsules on an empty stomach, at the same time each day.
- No blood donation during treatment and for many months after; men do not donate semen.
Pregnancy and breastfeeding
Contraindicated in pregnancy (EU label). Sonidegib carries a high risk of embryo-fetal death or birth defects: pregnancy tests and contraception for many months after treatment are required, men use condoms, and blood donation is avoided.
Nursing care
- Confirm a negative pregnancy test and reliable contraception; men use condoms even after vasectomy.
- Teach to report unexplained muscle pain, tenderness, weakness or dark urine.
- Check CK as ordered.
- Teach about taste and hair changes; support nutrition.
Pharmacokinetics
- Absorption
- Oral capsules once a day on an empty stomach (before or well after a meal).
Test yourself
Think of the answer, then tap the question to see it.
How is sonidegib taken relative to food?
On an empty stomach.
Which laboratory test watches its muscle toxicity?
Creatine kinase (CK).
Which cancer is sonidegib used for?
Locally advanced basal cell carcinoma.
Connections
← Back to the class: Hedgehog pathway inhibitors
Educational content on how drugs work; not a prescribing guide and no substitute for a health professional's advice. No doses are given.
Sources: Sonidegib: MedlinePlus Drug Information (MedlinePlus (U.S. National Library of Medicine), 2019); Sonidegib - NCI (National Cancer Institute, 2020); EMA: product information for sonidegib (European Medicines Agency, 2025); ATCDDD - ATC/DDD Index (WHO Collaborating Centre for Drug Statistics Methodology, 2026).
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Representative model, for educational purposes only.