ERIVEDGE

What it is

Erivedge is vismodegib. Vismodegib is a low molecular weight, orally available inhibitor of the Hedgehog pathway. Vismodegib binds to and inhibits SMO thereby preventing Hedgehog signal transduction. Erivedge 150 mg hard capsules are available.

Approved indications

— Treatment of adult patients with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma where surgery and/or radiation therapy are not appropriate.

Dosing overview

The recommended daily dose of Erivedge is 150 mg. Erivedge should be taken once a day, with or without food. Capsules must be swallowed whole with water and must not be opened or crushed under any circumstances.

Key safety warnings

Severe cutaneous adverse reactions (SCARs) including cases of Stevens-Johnson syndrome/Toxic epidermal necrolysis (SJS/TEN), Drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP), which can be life-threatening, have been reported during post-marketing use. If the patient has developed any of these reactions with the use of vismodegib, treatment with vismodegib must not be restarted in this patient at any time. Erivedge may cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Hedgehog pathway inhibitors such as Erivedge have been demonstrated to be embryotoxic and/or teratogenic in multiple animal species and can cause severe midline defects, missing digits, and other irreversible malformations in the developing embryo or foetus. Patients should not donate blood or blood products while on treatment and for 24 months after the last dose of Erivedge. Erivedge may impair fertility. Amenorrhoea has been observed in clinical trials in women of child-bearing potential. Reversibility of fertility impairment is unknown.

Contraindications

Erivedge is contraindicated in pregnant women. Erivedge is contraindicated in women of child-bearing potential, unless two reliable methods of contraception are being used during treatment and for 24 months after the last dose. Erivedge is contraindicated in nursing mothers during the course of treatment and for 24 months after the last dose because of the potential to cause serious development defects in breast-fed infants and children.

PBS listing

Erivedge 150 mg capsules are listed on the PBS with authority required restriction at an ex-manufacturer price of A$6935.00.

Regulatory history

Erivedge was first approved on 9 May 2013. The product was listed on the Australian Register of Therapeutic Goods (ARTG 214475) on 3 December 2013. In March 2016, the PBAC recommended Authority Required listing of vismodegib for the treatment of metastatic or locally advanced basal cell carcinoma inappropriate for surgery and curative radiotherapy, based on an unmet clinical need with a proposed price reduction and Risk Share Agreement. In November 2017, the PBAC recommended a change to the listing for both initial and continuing treatment to remove the requirement for written confirmation from a surgeon and radiation oncologist in patients with metastatic BCC disease.