Product Dossier
FAVIC
Product Dossier for FAVIC (famciclovir, Arrotex Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: famciclovir
- Therapeutic area: Infectious Disease
- Related brand: FAMVIR
- Related brand: FAMCICLOVIR- WGR
- Related brand: APO-FAMCICLOVIR
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
Favic is famciclovir, available in tablet strengths of 125 mg, 250 mg and 500 mg. Famciclovir is the oral form of penciclovir and is rapidly converted in vivo into penciclovir, which has demonstrable in vitro activity against herpes simplex viruses (HSV types 1 and 2) and varicella zoster virus (VZV).
Approved indications —
Treatment of herpes zoster infection in adult patients who commence therapy within 72 hours of the onset of rash, with greatest benefit occurring if the drug is started within 48 hours. — 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
Famciclovir can be taken without regard to meals.
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 therefore take appropriate steps for protected intercourse. Famciclovir has not been studied in patients with severe hepatic impairment. Conversion of famciclovir to the active metabolite penciclovir may be impaired in these patients resulting in lower penciclovir plasma concentrations, and thus possibly a decrease of efficacy of famciclovir. Special attention should be paid to patients with impaired renal function and dosage adjustment may be necessary. Appropriate dosage adjustments for renally impaired patients are provided in the dose and method of administration section.
Contraindications
Favic is contraindicated in patients with known hypersensitivity to famciclovir or any excipient in the formulation, or who have shown hypersensitivity to penciclovir.
Regulatory history
Favic was first approved on 4 April 2010. Three variants are registered on the Australian Register of Therapeutic Goods: FAVIC 125 mg tablets (ARTG 159602), FAVIC 250 mg tablets (ARTG 159611), and FAVIC 500 mg tablets (ARTG 159619), all listed on 7 April 2010.