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Famciclovir is authorised in the world under the following brand names: Famvir.

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Famvir (Famciclovir) for Shingles

Indication: herpes zoster (shingles)

Drug Tradename: Famvir

Manufacturer: Novartis Pharmaceuticals Corporation

Other drugs mentioned:

* Zovirax (Acyclovir)

* Valtrex (Valaciclovir)

* Cytovene (Ganciclovir)

The FDA has granted marketing approval for famciclovir (Famvir/SmithKline Beecham) for the treatment of herpes zoster (shingles). Shingles is caused by the same virus – varicella-zoster virus (VZV) – that causes chickenpox. VZV is initially transmitted primarily by aerosolized droplets from skin lesions.

The virus replicates in the respiratory tract, moves to the bloodstream, and then migrates to the epithelium, where infection is manifested by varicella blisters.

The virus is capable of traveling up sensory nerves from the skin to the dorsal root ganglia, where it can establish latent infection in satellite cells around the neuron (rather than in the neuron itself). Cellular immunity normally keeps the virus in check, but immunodeficiency (due to age, disease, or therapy) results in reactivation of the latent virus.

The result is shingles, an extremely painful zosteriform rash that is restricted to the skin segments enervated by the ganglia where viral reactivation occurred. Pain can be prolonged (postherpetic neuralgia), severe, and very debilitating.

Famciclovir (Famvir) is an orally active prodrug of penciclovir, a nucleoside analog related to acyclovir. These drugs act by selectively inhibiting herpesvirus DNA polymerase, thus inhibiting herpesvirus DNA synthesis. They are able to interfere with viral replication at concentrations that have little effect on host DNA synthesis.

Famciclovir is given 500 mg every 8 hours, usually for 7 days. It is relatively well absorbed orally (bioavailability more than 50%) and rapidly converted to penciclovir.

Food delays absorption slightly but does not affect overall bioavailability. The active drug (penciclovir) is taken up preferentially by infected cells and phosphorylated by herpesvirus kinases to the active penciclovir triphosphate.

When administered every 8 hours for 5 days, plasma profiles of famciclovir/penciclovir following the first and last dose are similar. Terminal half-life is 2 to 3 hours; urinary recovery is 51% to 55% of a dose. In clinical trials, famciclovir was tolerated well, with a safety profile similar to that of placebo; there were no differences in the overall incidence of adverse events between the placebo and active-treatment groups, and use of famciclovir was not associated with abnormalities in hematology, clinical chemistry, or urinalysis.

In a nine-nation trial involving 545 patients, median time to elimination of zoster-associated pain was 28 days for patients receiving 750 mg famciclovir three times daily, 17 days for patients receiving 500 mg three times daily, and 12 days for patients receiving 250 mg three times daily, compared with 69 days for patients receiving acyclovir.

A trial comparing famciclovir with acyclovir (Zovirax/Wellcome) found the two drugs comparable with respect to times to full lesion crusting, elimination of acute pain, and elimination of post-herpetic neuralgia.

Adverse reactions in famciclovir- treated patients – nausea (12.5%), diarrhea (7.7%), and headache (22.7%) – were similar to those reported by acyclovir- treated patients. As in acyclovir trials, patients over age 50 benefitted more from famciclovir therapy than younger patients, and the drug was more effective when therapy was begun within the first 48 hours after onset of rash.

Famciclovir (Famvir) is the first anti-zoster drug to reach the market since acyclovir was approved for shingles 4 years ago.

Acyclovir has also been on the world market for 12 years for herpes simplex virus infections (genital herpes and cold sores) and was approved for chicken pox last January.

Currently acyclovir is Wellcome’s best-selling product, with worldwide sales of $1.3 billion. Famciclovir has certain advantages over acyclovir – less frequent dosing (three times a day versus five times a day) and a cheaper price (wholesale price $103 per 7-day course of therapy, compared with acyclovir’s $147 per 10-day course of therapy) – so Wellcome will probably lose some market share.

A number of additional antiviral agents are trying to enter this lucrative market, including Wellcome’s valaciclovir (an orally active acyclovir prodrug), Syntex’ oral version of ganciclovir. and Gilead’s HPMPC. However, Wellcome may be able to hang on to acyclovir’s market share by switching the drug from prescription to over-the-counter (OTC). Currently, acyclovir is available OTC in 10 countries, and the FDA is considering the possibility of OTC approval in the United States. Welcome has four studies underway to address concerns raised at a public hearing, including a study on resistant strains of herpesvirus.

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Dosage forms of Famciclovir:
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Famciclovir 500 mg tablet Famvir 500 mg tablet    

Synonyms of Famciclovir:

Famciclovirum [INN-Latin], FCV

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Therapeutic classes of Famciclovir:

Antiviral Agents, Nucleosides and Nucleotides, Prodrugs

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