ARX-ACICLOVIR

What it is

ARX-ACICLOVIR contains aciclovir in 200 mg or 800 mg tablets. The 200 mg tablets are capsule shaped, biconvex, white to off-white tablets debossed "200" on one side and "ACV" on the other side, while the 800 mg tablets are capsule shaped, biconvex, white to off-white tablets debossed "800" on one side and "ACV" on the other side.

Approved indications

— Treatment of first episode (primary or nonprimary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. — Treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. — The management of patients with advanced symptomatic human immunodeficiency virus (HIV) disease (CD4+ counts < 150 × 10°/L).

Dosing overview

For intermittent therapy, treatment should be initiated at the earliest sign or symptom (prodrome) of recurrence. Aciclovir is eliminated by renal clearance, therefore the dose must be reduced in patients with renal impairment.

Key safety warnings

Renal insufficiency or acute renal failure has been observed in patients taking acyclovir at the recommended dosage and/or with no previous renal conditions and may be associated with renal pain. Elderly patients are likely to have reduced renal function, and both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects. In the reported cases, these reactions were generally reversible on discontinuation of treatment. Care should be taken to maintain adequate hydration in patients receiving high oral doses of aciclovir. As aciclovir has been associated with reversible encephalopathic changes, it should be used with caution in patients with underlying neurological abnormalities, significant hypoxia or serious renal, hepatic or electrolyte abnormalities, and also in patients who have manifested neurological reactions to cytotoxic drugs or are receiving interferon or intrathecal methotrexate concomitantly. Resistant strains have been isolated in vitro and in animals following treatment with aciclovir; HSV strains resistant in vitro to aciclovir have also been isolated from immunocompromised as well as immunocompetent patients receiving aciclovir for herpes simplex infections, and therefore the potential for the development of resistant HSV strains in patients treated with aciclovir should be borne in mind.

Contraindications

Known hypersensitivity to aciclovir or valaciclovir.

Key adverse effects

Aciclovir tablets appear to be generally very well tolerated, and adverse effects are usually mild. Nausea and/or vomiting and headache were the most frequent adverse effects for short-term administration for treatment of genital herpes. For long-term suppressive therapy for genital herpes, nausea and/or vomiting, headache, diarrhoea, vertigo and arthralgia were the most frequent adverse effects. The most commonly reported adverse effect in clinical trials for treatment of herpes zoster was gastrointestinal disturbance. Very rare psychiatric and nervous system disorders include agitation, tremor, ataxia, dysarthria, psychotic symptoms, encephalopathy and coma. Common gastrointestinal disorders include nausea, vomiting, diarrhoea and abdominal pains.

Regulatory history

ARX-ACICLOVIR was first listed on the ARTG on 2011-08-09 for both the 200 mg and 800 mg tablet formulations.