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Vismodegib oral

Updated 2 Feb 2023 | Vismodegib


Oral formulations of vismodegib

Drugs List

  • ERIVEDGE 150mg capsules
  • vismodegib 150mg capsules
  • Therapeutic Indications


    Locally advanced basal cell carcinoma (other treatment unsuitable)
    Metastatic basal cell carcinoma


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.


    The recommended dose is 150mg once daily until disease progression or unacceptable toxicity.

    Treatment interruptions of up to 4 weeks are allowed based on patient tolerability.

    Additional Dosage Information

    Missed Doses
    If a dose is missed, do not take the missed dose and resume with the next as scheduled.


    Children under 18 years
    Patients not compliant with Pregnancy Prevention Programme
    Patients not registered with Pregnancy Prevention Programme

    Precautions and Warnings

    Females of childbearing potential
    Glucose-galactose malabsorption syndrome
    Lactose intolerance
    Severe renal impairment

    Do not exceed 28 days of treatment on one prescription
    Give pre-treatment counselling and consideration of oocyte cryopreservation
    Staff & patients: Must comply with Pregnancy Prevention Programme
    Treatment to be initiated and supervised by a specialist
    Contains lactose
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Exclude pregnancy before issuing each prescription
    Monitor for signs of cutaneous squamous cell carcinoma
    Advise patient to seek advice at first indications of pregnancy
    Discontinue and do not restart if severe cutaneous adverse reactions occur
    Advise patient not to take St John's wort concurrently
    Female: May cause infertility
    Female: Contraception required during and for 2 years after treatment
    Female: Two reliable methods of contraception must be used simultaneously
    Male: Use of condoms required during and for 2 months after treatment
    Breastfeeding: Do not breastfeed during & for 24 months after treatment
    Patients must not donate semen during or for 2 months after treatment
    Patients should not donate blood during or for 2 years after treatment

    Pregnancy Prevention Programme
    This agent is a powerful human teratogen, inducing a high frequency of severe and life-threatening birth defects. It must never be used by women who are pregnant or by women who could become pregnant unless all the conditions of the manufacturers Pregnancy Prevention Programme (PPP) are met. The conditions of the PPP must be fulfilled for all male and female patients. Refer to the manufacturers documentation for full details and requirements for the PPP.

    Only prescribers and pharmacies registered with the programme are allowed to prescribe and dispense the product. Prescriber, patient and dispensing pharmacist must each comply fully with the PPP.

    The PPP outlines specific criteria for determination of child bearing potential, required testing, suitable contraception, specific patient counselling, prescribing and dispensing requirements.

    The prescriber must ensure that: The patient complies with the conditions of the PPP. The patient confirms that they understand the conditions of the PPP.

    Prior to initiation and at each monthly consultation
    Perform pregnancy testing in women of child bearing potential to exclude pregnancy before commencement of treatment, before each monthly prescription request and at each extension of the authorisation to receive the drug. Testing is required in women of child bearing potential who practice absolute and continuous abstinence.

    The pregnancy test must be medically supervised and have a minimum sensitivity of 25 mIU/ml.

    Adequately counsel patients of the potential risks and the necessary precautions, warnings and required compliance with the PPP.

    Pregnancy and Lactation


    Vismodegib is contraindicated during pregnancy.

    Use of vismodegib during pregnancy is contraindicated by the manufacturer. Animal studies have shown teratogenic effect. Human data is limited and as such a potential risk cannot be ruled out. Refer to the manufacturers documentation for requirements and responsibilities under the Pregnancy Prevention Programme in the event of pregnancy.


    Vismodegib is contraindicated during breastfeeding.

    Use of vismodegib when breastfeeding is contraindicated by the manufacturer. The presence of vismodegib in human breast milk is unknown. Effects on exposed infants are unknown.

    Side Effects

    Abdominal pain
    Abnormal liver function tests
    Acute generalised exanthematous pustulosis
    Acute hepatic injury
    Aspartate aminotransferase increased
    Back pain
    Decreased appetite
    Drug rash with eosinophilia and systemic symptoms (DRESS)
    Flank pain
    Gamma glutamyl transferase (GGT) increased
    Hair growth abnormal
    Increase in alkaline phosphatase
    Increases in hepatic enzymes
    Muscle spasm
    Musculoskeletal pain
    Non-cardiac chest pain
    Painful extremities
    Precocious puberty
    Premature closure of epiphyses
    Serum bilirubin increased
    Squamous cell carcinoma
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis
    Upper abdominal pain
    Weight loss


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: June 2019

    Reference Sources

    Summary of Product Characteristics: Erivedge 150mg hard capsules. Roche Products Limited. Revised November 2019.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.