SHILOVA

What it is

Valaciclovir Sandoz contains the active ingredient valaciclovir hydrochloride. The medicine is available in two strengths: 500 mg and 1000 mg as white to off-white capsule shaped film coated tablets.

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

For herpes zoster: 1000 mg three times a day for seven days. For cold sores: 2000 mg twice daily for 1 day with the second dose taken about 12 hours (no sooner than 6 hours) after the first dose. For genital herpes, first clinical presentation requires 500 mg twice a day for 5 to 10 days, and for recurrent episodes, 500 mg twice daily for 5 days. For prevention of genital herpes: 500 mg once daily in patients with fewer than 10 recurrences per year, 1000 mg once daily in patients with 10 or more recurrences per year, or 500 mg twice daily in immunocompromised patients. For reduction of transmission of genital herpes: 500 mg once daily in immunocompetent heterosexual adults with less than 10 recurrences per year. For prophylaxis of cytomegalovirus infection: 2 g four times a day for 90 days, to be initiated as early as possible post-transplant.

Key safety warnings

Thrombotic thrombocytopenic purpura or haemolytic uraemic syndrome (TTP/HUS), in some cases resulting in death, has occurred in patients with advanced HIV disease and in transplant recipients. Treatment with valaciclovir should be stopped immediately if clinical signs, symptoms, and laboratory abnormalities consistent with TTP/HUS occur. Drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, has been reported in association with valaciclovir treatment. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of DRESS appear, valaciclovir should be withdrawn immediately. Reversible neurological reactions including agitation, dizziness, confusion, hallucinations, rarely decreased consciousness and very rarely tremor, ataxia, dysarthria, convulsions, encephalopathy and coma have been reported. These events are usually seen in patients with renal impairment or with other predisposing factors. Renal insufficiency or acute renal failure has been observed in patients taking valaciclovir at the recommended dosage and/or with no previous renal conditions. Care should be taken to ensure adequate fluid intake in patients who are at risk of dehydration, particularly the elderly, and adequate hydration should be maintained for all patients.

Contraindications

Valaciclovir Sandoz is contraindicated in patients known to be hypersensitive to valaciclovir, aciclovir or any component of the formulation.

PBS listing

Valaciclovir Sandoz is registered on the ARTG but specific PBS listing details including strengths, item count, restriction type, and ex-manufacturer price are not provided in the available source documents.

Regulatory history

Valaciclovir 500 mg and 1000 mg tablets branded as SHILOVA were first listed on the Australian Register of Therapeutic Goods on 25 October 2011.