Vismodegib oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of vismodegib
Drugs List
Therapeutic Indications
Uses
Locally advanced basal cell carcinoma (other treatment unsuitable)
Metastatic basal cell carcinoma
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Adults
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.
Contraindications
Children under 18 years
Patients not compliant with Pregnancy Prevention Programme
Patients not registered with Pregnancy Prevention Programme
Breastfeeding
Galactosaemia
Pregnancy
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
Pregnancy
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.
Lactation
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
Ageusia
Alopecia
Amenorrhoea
Arthralgia
Aspartate aminotransferase increased
Asthenia
Back pain
Constipation
Decreased appetite
Dehydration
Diarrhoea
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dysgeusia
Dyspepsia
Fatigue
Flank pain
Gamma glutamyl transferase (GGT) increased
Hair growth abnormal
Hypogeusia
Hyponatraemia
Increase in alkaline phosphatase
Increases in hepatic enzymes
Infertility
Madarosis
Muscle spasm
Musculoskeletal pain
Myalgia
Nausea
Non-cardiac chest pain
Pain
Painful extremities
Precocious puberty
Premature closure of epiphyses
Pruritus
Rash
Serum bilirubin increased
Squamous cell carcinoma
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Upper abdominal pain
Vomiting
Weight loss
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
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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