FAMCICLOVIR- WGR

What it is

FAMCICLOVIR- WGR contains famciclovir as the active ingredient, available in tablet 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. In immunocompromised patients with herpes zoster, the recommended dosage is 500 mg three times daily for ten days. For recurrent genital herpes in immunocompetent patients, the recommended dosage is either 125 mg twice daily for 5 days, or 500 mg statim then 250 mg 12 hourly for 3 doses, or 1000 mg twice daily for 1 day. For suppression of recurrent genital herpes, the recommended dose is 250 mg twice daily. In immunocompromised patients with recurrent herpes simplex infections, 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 a day has been shown to be efficacious. For recurrent herpes labialis in immunocompetent patients, the recommended dosage is 1500 mg as a single dose or 750 mg twice daily at 12 hourly intervals for one day.

Key safety warnings

Reduced clearance of penciclovir is related to reduced renal function, and special attention should be given to dosages in patients with impaired renal function, with specific dosage modifications recommended based on creatinine clearance. 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 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 it is recommended that patients use safer sex practices in addition to therapy with famciclovir. Patients who experience dizziness, somnolence, confusion or other central nervous system disturbances while taking FAMCICLOVIR- WGR should refrain from driving or operating machinery.

Contraindications

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

Regulatory history

FAMCICLOVIR- WGR was first listed on the Australian Register of Therapeutic Goods on 12 January 2024, with three strengths registered: 125 mg, 250 mg, and 500 mg tablets in blister packs, sponsored by GM Pharma.