Product Dossier
FAMVIR
Product Dossier for FAMVIR (famciclovir, Atnahs Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Atnahs Pharma
- Active ingredient: famciclovir
- Therapeutic area: Infectious Disease
- Related brand: FAMCICLOVIR- WGR
- Related brand: FAVIC
- Related brand: APO-FAMCICLOVIR
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
FAMVIR 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
Key safety warnings
Greatest benefit occurs if FAMVIR is started within 48 hours of herpes zoster onset; efficacy has not been demonstrated in patients less than 50 years of age, although occasional younger patients with severe herpes zoster may benefit from therapy. 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 avoid sexual intercourse when symptoms are present, even if antiviral treatment has been initiated. Genital herpes can be transmitted in the absence of symptoms through asymptomatic viral shedding, so in addition to therapy with FAMVIR it is recommended that patients use safer sex practices. Patients who experience dizziness, somnolence, confusion or other central nervous system disturbances while taking FAMVIR should refrain from driving or operating machinery.
Contraindications
FAMVIR is contraindicated in patients with known hypersensitivity to famciclovir or other constituents of FAMVIR, and also in those patients who have shown hypersensitivity to penciclovir, the active metabolite of famciclovir.
PBS listing
The 250 mg tablet strength has 3 PBS items listed under streamlined restrictions at an ex-manufacturer price of A$18.22. The 500 mg tablet strength has 2 PBS items listed under streamlined restrictions at an ex-manufacturer price of A$48.61. The 125 mg tablet strength has 1 PBS item listed under streamlined restrictions at an ex-manufacturer price of A$17.35.
Regulatory history
FAMVIR 250 mg tablets were first listed on the ARTG in 1995, followed by the 125 mg strength in 1996 and the 500 mg strength in 1999.