EZOVIR

What it is

EZOVIR contains famciclovir as the active ingredient, available in tablets of 125 mg, 250 mg, or 500 mg.

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. For recurrent genital herpes in immunocompetent patients, options include 125 mg twice daily for 5 days, or 500 mg once then 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 treating herpes simplex infections in immunocompromised adults, the recommended dose is 500 mg twice daily for seven days. For suppression of recurrent genital herpes 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. Therefore, in addition to therapy with famciclovir, it is recommended that patients use safer sex practices. Although animal studies have not shown any embryotoxic or teratogenic effects with famciclovir or penciclovir, the safety of famciclovir in human pregnancy has not been established. Famciclovir should therefore not be used during pregnancy unless the potential benefits are considered to outweigh the potential risks associated with treatment. Famciclovir should not be used by nursing mothers unless the potential benefits are considered to outweigh the potential risks associated with treatment. Following oral administration of famciclovir to lactating rats, penciclovir was excreted in milk at concentrations higher than those seen in plasma. There is no information on excretion in human milk. Patients who experience dizziness, somnolence, confusion or other central nervous system disturbances while taking EZOVIR should refrain from driving or operating machinery.

Contraindications

EZOVIR is contraindicated in patients with known hypersensitivity to famciclovir or other constituents of EZOVIR. It is also contraindicated in those patients who have shown hypersensitivity to penciclovir, the active metabolite of famciclovir.

Regulatory history

EZOVIR famciclovir 125 mg and 250 mg tablet blister packs were first listed on the ARTG on 13 October 2020, and the 500 mg formulation was first listed on the same date. EZOVIR Cold Sore Relief 500 mg tablet blister pack was first listed on 14 December 2020.