APO-FAMCICLOVIR

What it is

APO-FAMCICLOVIR contains famciclovir 125 mg, 250 mg, or 500 mg as the active ingredient in film-coated tablets.

Approved indications —

Treatment of herpes zoster infection in adult patients who commence therapy within 72 hours of the onset of rash. — Treatment of recurrent episodes of genital herpes in adults and adolescents 12 years of age and older. — Suppression of recurrent genital herpes. — Treatment of recurrent herpes labialis (cold sores) in immunocompetent adult patients. — Treatment of uncomplicated herpes zoster in immunocompromised patients. — Treatment of recurrent herpes simplex in immunocompromised patients. — Suppression of recurrent herpes simplex in immunocompromised patients.

Dosing overview

For herpes zoster in immunocompetent patients, the recommended dosage is 250 mg three times daily for seven days. Greatest benefit occurs if treatment is started within 48 hours. For recurrent genital herpes in immunocompetent patients, the recommended dosage is either 125 mg twice daily for 5 days, or 500 mg as a single dose followed by 250 mg every 12 hours for 3 doses, or 1000 mg twice daily for 1 day. For suppression of recurrent genital herpes in immunocompetent patients, the recommended dose is 250 mg twice daily. For recurrent herpes labialis, the recommended dosage is 1500 mg as a single dose or 750 mg twice daily at 12 hourly intervals for one day. For herpes zoster in immunocompromised patients, the recommended dosage is 500 mg three times daily for ten days. For treatment of recurrent herpes simplex infections in immunocompromised adults, the recommended dose is 500 mg twice daily for seven days. For suppression of recurrent genital herpes infections in HIV patients, a dose of 500 mg twice daily has been shown to be efficacious.

Key safety warnings

Genital herpes is a sexually transmitted disease, and the risk of transmission is increased during acute episodes. Patients should be advised to use condoms between episodes to reduce the risk of transmission and to avoid sexual intercourse when symptoms are present, even if treatment with an antiviral has been initiated. Genital herpes can also be transmitted in the absence of symptoms through asymptomatic viral shedding, and patients should use safer sex practices in addition to therapy with famciclovir. Famciclovir has not been studied in patients with severe hepatic impairment, and conversion to the active metabolite may be impaired in these patients, resulting in lower plasma concentrations and possibly decreased efficacy. Special attention should be paid to patients with impaired renal function and dosage adjustment may be necessary. Patients who experience dizziness, somnolence, confusion or other central nervous system disturbances while taking APO-FAMCICLOVIR should refrain from driving or operating machinery.

Contraindications

APO-FAMCICLOVIR is contraindicated in patients with known hypersensitivity to famciclovir or other constituents of the product, and also in those patients who have shown hypersensitivity to penciclovir, the active metabolite of famciclovir.

Regulatory history

APO-FAMCICLOVIR was first listed on the ARTG on 12 May 2010, with registrations for 125 mg and 250 mg tablet formulations in both blister pack and bottle presentations. The 500 mg tablet formulations in blister pack and bottle presentations were first listed on 10 August 2011.