APX-VALACICLOVIR

What it is

APX-VALACICLOVIR is a film-coated tablet containing the active ingredient valaciclovir hydrochloride. The medicine is available in two strengths: 500 mg and 1000 mg capsule-shaped film-coated tablets. Valaciclovir is rapidly and almost completely converted in the body to aciclovir. Aciclovir is a specific inhibitor of herpes viruses with activity against herpes simplex viruses type 1 and type 2, varicella-zoster virus, and human cytomegalovirus.

Approved indications

— Treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash — Treatment of ophthalmic zoster — Treatment of recurrent herpes labialis (cold sores) — Treatment of clinical episodes of genital herpes simplex infections — Prevention of recurrent genital herpes — Reduction of transmission of genital herpes in patients suffering from recurrent genital herpes — Prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease

Dosing overview

Key safety warnings

Thrombotic thrombocytopenic purpura or haemolytic uraemic syndrome has occurred in patients with advanced HIV disease receiving valaciclovir at high doses, and treatment should be stopped immediately if clinical signs and symptoms consistent with these conditions occur. Drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, has been reported with valaciclovir treatment. Patients should be advised of the signs and symptoms, monitored closely for skin reactions, and the medicine should be withdrawn immediately if DRESS appears. Reversible neurological reactions including agitation, dizziness, confusion, hallucinations, and rarely decreased consciousness have been reported, usually in patients with renal impairment or other predisposing factors. In organ transplant patients receiving high doses (8 g daily) for CMV prophylaxis, neurological reactions occurred more frequently compared with lower doses, and valaciclovir should be discontinued if central nervous system reactions occur. Renal insufficiency or acute renal failure has been observed in patients taking valaciclovir and the dose must be reduced in patients with renal impairment. Patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored.

Contraindications

APX-VALACICLOVIR is contraindicated in patients known to be hypersensitive to valaciclovir, aciclovir or any component of the formulation.

Regulatory history

APX-VALACICLOVIR was first listed on the ARTG on 2 July 2020 in three variants: 500 mg and 1000 mg tablets in both blister pack and bottle presentations.