Adult: 150 mg once daily. Continue until disease progression or unacceptable toxicity occurs. Dosing interruption or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).
Oral Locally advanced basal cell carcinoma
Adult: In cases that have recurred following surgery or in patients who are not candidates for surgery or radiation therapy: 150 mg once daily. Continue until disease progression or unacceptable toxicity occurs. Dosing interruption or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).
Administration
Vismodegib May be taken with or without food.
Contraindications
Women of childbearing potential who cannot comply with pregnancy prevention programme (i.e. using 2 methods of recommended contraception). Pregnancy and lactation.
Special Precautions
Patient undergoing blood, blood products or semen donation. Severe renal impairment.
Adverse Reactions
Significant: Musculoskeletal effects (e.g. increased serum creatine phosphokinase [CPK], muscle spasms, arthralgia). Cardiac disorders: Chest pain. Eye disorders: Madarosis. Gastrointestinal disorders: Dysgeusia, ageusia, hypogeusia, nausea, diarrhoea, constipation, vomiting, dyspepsia, abdominal pain. General disorders and administration site conditions: Fatigue, asthenia. Investigations: Increased hepatic enzymes, decreased weight. Metabolism and nutrition disorders: Decreased appetite, dehydration. Musculoskeletal and connective tissue disorders: Pain in extremities, myalgia, flank and back pain. Reproductive system and breast disorders: Amenorrhoea. Skin and subcutaneous tissue disorders: Alopecia, pruritus, rash, abnormal hair growth. Potentially Fatal: Severe cutaneous adverse reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
Women of childbearing potential must use 2 proven birth control methods during therapy and for 24 months after the last dose. Men with female partners of reproductive potential must use a condom (even after a vasectomy) during therapy and for 3 months after the last dose. Discontinue breastfeeding during therapy and for 24 months after the last dose. Do not donate blood or blood products during therapy and for 24 months after the last dose. Men should not donate semen during therapy and for 3 months after the last dose.
Monitoring Parameters
Evaluate pregnancy status within 7 days before treatment initiation and monthly during treatment. Obtain CPK and creatinine levels before and during treatment. Assess for signs and symptoms of cutaneous adverse reactions and musculoskeletal reactions.
Drug Interactions
Decreased plasma concentration with strong CYP inducers (e.g. rifampicin, carbamazepine, phenytoin). May reduce the contraceptive effect of contraceptive steroids. May increase exposure of OATP1B1 substrates (e.g. rosuvastatin, bosentan, ezetimibe, glibenclamide, repaglinide, valsartan), topotecan and sulfasalazine.
Food Interaction
Decreased exposure with St. John's wort.
Action
Description: Mechanism of Action: Vismodegib is a selective Hedgehog pathway inhibitor. It acts by binding and inhibiting the Smoothened (SMO) transmembrane protein, thereby blocking the Hedgehog signal transduction. Pharmacokinetics: Absorption: Absorbed from the gastrointestinal tract. Bioavailability: Approx 32%. Time to peak plasma concentration: Approx 2.4 days. Distribution: Volume of distribution: 16.4-26.6 L. Plasma protein binding: >99%, mainly to serum albumin and α1-acid glycoprotein. Metabolism: Metabolised via oxidation, glucuronidation and pyridine ring cleavage. Excretion: Via faeces (82%); urine (approx 4%). Elimination half-life: Approx 4 days (continuous daily dosing); approx 12 days (single dose).
Chemical Structure
Vismodegib Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 24776445, Vismodegib. https://pubchem.ncbi.nlm.nih.gov/compound/Vismodegib. Accessed July 28, 2025.
Storage
Store between 15-30°C. Protect from moisture. Follow applicable procedures for receiving, handling, administration, and disposal.
L01XJ01 - vismodegib ; Belongs to the class of hedgehog pathway inhibitors. Used in the treatment of cancer.
References
Brayfield A, Cadart C (eds). Vismodegib. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/07/2025.Erivedge 150 mg Hard Capsules (Roche Products Limited). MHRA. https://products.mhra.gov.uk. Accessed 08/07/2025.Erivedge Capsule (Genentech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/07/2025.Joint Formulary Committee. Vismodegib. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/07/2025.Roche Products (New Zealand) Limited. Erivedge 150 mg Hard Capsules data sheet 12 August 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 08/07/2025.Vismodegib. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 08/07/2025.Vismodegib. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 08/07/2025.
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