Famvir (Famciclovir) - Indications and Dosage

INDICATIONS AND USAGE

Herpes Zoster

Famvir^® (famciclovir) is indicated for the treatment of acute herpes zoster (shingles).

Herpes Simplex Infections

Famvir is indicated for:

• treatment or suppression of recurrent genital herpes in immunocompetent patients.
  
• treatment of recurrent herpes labialis (cold sores) in immunocompetent patients.
  
• treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients.

DOSAGE AND ADMINISTRATION

Herpes Zoster

The recommended dosage is 500 mg every 8 hours for 7 days. Therapy should be initiated promptly as soon as herpes zoster is diagnosed. No data are available on efficacy of treatment started greater than 72 hours after rash onset.

Herpes Simplex Infections

Recurrent G enital H erpes

The recommended dosage is 1000 mg twice daily for 1 day.  Initiate therapy at the first sign or symptom if medical management of a genital herpes recurrence is indicated. The efficacy of Famvir^®  (famciclovir) has not been established when treatment is initiated more than 6 hours after onset of symptoms or lesions.

Suppression of R ecurrent Genital H erpes

The recommended dosage is 250 mg twice daily for up to 1 year. The safety and efficacy of Famvir therapy beyond 1 year of treatment have not been established.

Recurrent H erpes Labialis (C old S ores)

The recommended dosage is 1500 mg as a single dose. Initiate therapy at the earliest sign or symptom of a cold sore (e.g. tingling, itching or burning).

HIV-Infected Patients

For recurrent orolabial or genital herpes simplex infection, the recommended dosage is 500 mg twice daily for 7 days.

Patients with Reduced Renal Function

In patients with reduced renal function, dosage reduction is recommended (see PRECAUTIONS, General).

Table 7

Indication and Normal Dosage Regimen	Creatinine Clearance (mL/min.)	Adjusted Dosage Regimen Dose (mg)	Dosing Interval
Single-Day Dosing Regimens
Recurrent Genital Herpes 1000 mg every 12 hours for 1 day	≥60	1000	every 12 hours for 1 day
	40-59	500	every 12 hours for 1 day
	20-39	500	single dose
	<20	250	single dose
	HD*	250	single dose following dialysis
Recurrent Herpes Labialis 1500 mg single dose	≥60	1500	single dose
	40-59	750	single dose
	20-39	500	single dose
	<20	250	single dose
	HD*	250	single dose following dialysis
Multiple-Day Dosing Regimens
Herpes Zoster 500 mg every 8 hours	≥60	500	every 8 hours
	40-59	500	every 12 hours
	20-39	500	every 24 hours
	<20	250	every 24 hours
	HD*	250	following each dialysis
Suppression of Recurrent Genital Herpes 250 mg every 12 hours	≥40	250	every 12 hours
	20-39	125	every 12 hours
	<20	125	every 24 hours
	HD*	125	following each dialysis
Recurrent Orolabial and Genital Herpes Simplex Infection in HIV-Infected Patients 500 mg every 12 hours	≥40	500	every 12 hours
	20-39	500	every 24 hours
	<20	250	every 24 hours
	HD*	250	following each dialysis

*Hemodialysis

Administration with Food

When famciclovir was administered with food, penciclovir C_max decreased approximately 50%. Because the systemic availability of penciclovir (AUC) was not altered, it appears that Famvir may be taken without regard to meals.

HOW SUPPLIED

Famvir^® (famciclovir) is supplied as film-coated tablets as follows: 125 mg in bottles of 30; 250 mg in bottles of 30; and 500 mg in bottles of 30 and Single Unit Packages of 50 (intended for institutional use only).

Famvir 125 mg tablet:

White, round film-coated, biconvex, beveled edges, debossed with "FAMVIR" on one side and "125" on the other.

125 mg 30's…………………………………………………………...……NDC 0078-0366-15

Famvir 250 mg tablet:

White, round film-coated, biconvex, beveled edges, debossed with "FAMVIR" on one side and "250" on the other.

250 mg 30's………………………………………………………………...NDC 0078-0367-15

Famvir 500 mg tablet:

White, oval film-coated, biconvex, debossed with "FAMVIR" on one side and "500" on the other.

500 mg 30's…………………………………………………………….......NDC 0078-0368-15

500 mg SUP 50's…………………………………………………………...NDC 0078-0368-64

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

REV: DECEMBER 2008                                                 T2009-99

Distributed by:

Novartis Pharmaceuticals Corp.

East Hanover, NJ 07936

©Novartis