Famciclovir

FAMCICLOVIR — famciclovir tablet, film coated
Rising Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

1.1 Immunocompetent Adult Patients

Herpes labialis (cold sores): Famciclovir tablets are indicated for the treatment of recurrent herpes labialis in adult patients.
Genital herpes:
Recurrent episodes: Famciclovir tablets are indicated for the treatment of recurrent episodes of genital herpes. The efficacy of famciclovir tablets when initiated more than 6 hours after onset of symptoms or lesions has not been established.

Suppressive therapy: Famciclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in adult patients. The efficacy and safety of famciclovir tablets for the suppression of recurrent genital herpes beyond 1 year have not been established.
Herpes zoster (shingles): Famciclovir tablets are indicated for the treatment of herpes zoster in adult patients. The efficacy of famciclovir tablets when initiated more than 72 hours after onset of rash has not been established.

1.2 HIV-Infected Adult Patients

Recurrent orolabial or genital herpes: Famciclovir tablets are indicated for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected adults. The efficacy of famciclovir tablets when initiated more than 48 hours after onset of symptoms or lesions has not been established.
Limitation of UseThe efficacy and safety of famciclovir tablets have not been established for:

• Patients with first episode of genital herpes
• Patients with ophthalmic zoster
• Immunocompromised patients other than for the treatment of recurrent orolabial or genital herpes in HIV-infected patients
• Black and African American patients with recurrent genital herpes

2 DOSAGE AND ADMINISTRATION

Famciclovir tablets may be taken with or without food.

2.1 Dosing Recommendation in Immunocompetent Adult Patients

Herpes labialis (cold sores): The recommended dosage of famciclovir tablets for the treatment of recurrent herpes labialis is 1500 mg as a single dose. Therapy should be initiated at the first sign or symptom of herpes labialis (e.g., tingling, itching, burning, pain, or lesion).
Genital herpes:
Recurrent episodes:
The recommended dosage of famciclovir tablets for the treatment of recurrent episodes of genital herpes is 1000 mg twice daily for 1 day. Therapy should be initiated at the first sign or symptom of a recurrent episode (e.g., tingling, itching, burning, pain, or lesion).

Suppressive therapy: The recommended dosage of famciclovir tablets for chronic suppressive therapy of recurrent episodes of genital herpes is 250 mg twice daily.
Herpes zoster (shingles): The recommended dosage of famciclovir tablets for the treatment of herpes zoster is 500 mg every 8 hours for 7 days. Therapy should be initiated as soon as herpes zoster is diagnosed.

2.2 Dosing Recommendation in HIV-Infected Adult Patients

Recurrent orolabial or genital herpes: The recommended dosage of famciclovir tablets for the treatment of recurrent orolabial or genital herpes in HIV-infected patients is 500 mg twice daily for 7 days. Therapy should be initiated at the first sign or symptom of a recurrent episode (e.g., tingling, itching, burning, pain, or lesion).

2.3 Dosing Recommendation in Patients with Renal Impairment

Dosage recommendations for adult patients with renal impairment are provided in Table 1 [ see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Table 1: Dosage Recommendations for Adult Patients with Renal Impairment

* Hemodialysis
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 to 59	500	every 12 hours for 1 day
	20 to 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 to 59	750	single dose
	20 to 39	500	single dose
	< 20	250	single dose
	HD*	250	single dose following dialysis
Multiple-Day Dosing Regimens
Herpes Zoster500 mg every 8 hours	≥ 60	500	every 8 hours
	40 to 59	500	every 12 hours
	20 to 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 to 39	125	every 12 hours
	< 20	125	every 24 hours
	HD*	125	following each dialysis
Recurrent Orolabial or Genital Herpes in HIV-Infected Patients 500 mg every 12 hours	≥ 40	500	every 12 hours
	20 to 39	500	every 24 hours
	< 20	250	every 24 hours
	HD*	250	following each dialysis