vismodegib: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
vismodegib: clinical details
Prescribing considerations
- Initiation and supervision should be by a specialist experienced in treating advanced basal cell carcinoma.
- Confirm that locally advanced disease is unsuitable for surgery or radiotherapy, or that metastatic disease is symptomatic.
- Complete Pregnancy Prevention Programme counselling, documentation, testing and prescribing requirements where applicable.
- Review all medicines and herbal products for strong enzyme inducers and relevant transporter interactions.
- Discuss potential amenorrhoea, uncertain reversibility of impaired female fertility and fertility preservation before treatment.
- Advise against blood donation during treatment and for 24 months afterwards; men must not donate semen during treatment and for 2 months afterwards.
Contraindications and cautions
- Hypersensitivity to vismodegib or an excipient.
- Pregnancy or breastfeeding.
- A person who could become pregnant but cannot or will not comply with the Pregnancy Prevention Programme.
- Concurrent St John’s wort.
- The capsule contains lactose and is unsuitable for certain rare hereditary disorders of galactose or lactose handling.
Monitoring
- Assess clinical benefit and tolerability regularly.
- For those who could become pregnant, arrange a supervised pregnancy test before treatment and monthly during treatment, including when amenorrhoeic.
- Monitor weight, nutritional intake, taste disturbance, muscle symptoms and other adverse effects that may impair treatment persistence.
- Evaluate new rash promptly and permanently discontinue if a severe cutaneous adverse reaction is diagnosed.
- Consider liver tests or creatine phosphokinase assessment when clinically indicated by symptoms or adverse-effect concerns.
- Closely monitor patients with severe renal impairment because clinical data are very limited.
Clinical pharmacology
Vismodegib is a small-molecule Smoothened inhibitor that blocks Hedgehog signal transduction. It is highly protein-bound, has nonlinear pharmacokinetics, is eliminated mainly through hepatic and faecal routes, and has prolonged persistence.
Formulation and product differences
- The selected UK product is a hard capsule containing lactose.
- The capsule must remain intact to prevent unintended exposure.
- Food does not have a clinically relevant effect on steady-state pharmacokinetics.
vismodegib preparations and strengths
Capsule
Route: Oral
Strengths: 150 mg
vismodegib interactions
Check prescribed, non-prescription and herbal products before treatment. Important examples include:
St John’s wort
Must not be used with vismodegib because it may reduce vismodegib exposure and effectiveness.
Rifampicin, carbamazepine and phenytoin
These strong enzyme inducers should generally be avoided because they may lower vismodegib exposure and effectiveness.
Hormonal contraceptives
Reduced contraceptive effectiveness cannot be excluded during longer treatment, so the Pregnancy Prevention Programme’s specified methods must be followed.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.