ELOVAX

What it is

ELOVAX is a tablet containing famciclovir as the active ingredient, available in strengths 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, the recommended dosage is either 125 mg twice daily for five days, or 500 mg followed by 250 mg every 12 hours for three doses, or 1000 mg twice daily for one day. For suppression of recurrent genital herpes, 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. In immunocompromised patients, the recommended dosage for herpes zoster is 500 mg three times daily for ten days. For treating 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, with increased risk of transmission during acute episodes. Patients should use condoms between episodes and avoid sexual intercourse when symptoms are present, even if treatment with an antiviral has been initiated. Genital herpes can be transmitted in the absence of symptoms through asymptomatic viral shedding, so safer sex practices are recommended in addition to therapy with famciclovir. Although animal studies have not shown embryotoxic or teratogenic effects, the safety of famciclovir in human pregnancy has not been established, and it should not be used during pregnancy unless potential benefits outweigh potential risks. Famciclovir should not be used by nursing mothers unless potential benefits outweigh potential risks, as penciclovir is excreted in milk in lactating rats at higher concentrations than plasma, although there is no information on excretion in human milk. Patients who experience dizziness, somnolence, confusion or other central nervous system disturbances should refrain from driving or operating machinery.

Contraindications

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

Regulatory history

ELOVAX famciclovir 125 mg, 250 mg, and 500 mg tablets were first listed on the ARTG on 9 February 2010. ELOVAX ONE DOSE famciclovir 500 mg was first listed on 8 January 2013.