famciclovir 125 MG Oral Tablet

INDICATIONS & USAGE Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients ( 1.1 ) • Herpes labialis (cold sores) o Treatment of recurrent episodes • Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes • Herpes zoster (shingles) Human Immunodeficiency Virus (HIV)-Infected Adult Patients ( 1.2 ) • Treatment of recurrent episodes of orolabial or genital herpes Limitation of Use The 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 episodes of orolabial or genital herpes in HIV-infected patients • Black and African American patients with recurrent genital herpes 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 Use The 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

DOSAGE AND ADMINISTRATION Famciclovir tablets may be taken with or without food. Immunocompetent Adult Patients ( 2.1 ) Herpes labialis (cold sores) 1500 mg as a single dose Genital herpes Treatment of recurrent episodes 1000 mg twice daily for 1 day Suppressive therapy 250 mg twice daily Herpes zoster (shingles) 500 mg every 8 hours for 7 days HIV-Infected Adult Patients ( 2.2 ) Recurrent episodes of orolabial or genital herpes 500 mg twice daily for 7 days Patients with renal impairment: Adjust dose based on creatinine clearance. ( 2.3 ) 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 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 Hemodialysis 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 Zoster 500 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

WARNINGS AND PRECAUTIONS Acute renal failure: May occur in patients with underlying renal disease who receive higher than recommended doses of famciclovir for their level of renal function. Reduce dosage in patients with renal impairment. ( 2.3 , 8.6 ) 5.1 Acute renal failure Cases of acute renal failure have been reported in patients with underlying renal disease who have received inappropriately high doses of famciclovir tablets for their level of renal function. Dosage reduction is recommended when administering famciclovir tablets to patients with renal impairment [see Dosage and Administration ( 2.3 ), Use in Specific Populations ( 8.6 )].

CONTRAINDICATIONS Famciclovir tablets are contraindicated in patients with known hypersensitivity to the product, its components, or Denavir ® (penciclovir cream). Known hypersensitivity to the product, its components, or Denavir ® (penciclovir cream). ( 4 )

Mechanism of Action Famciclovir is an orally administered prodrug of the anti-alpha herpes viral agent penciclovir [see Microbiology ( 12.4 ) ] .