Prescription Drug Information: Famciclovir

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

1 INDICATIONS & USAGE

1.1 Immunocompetent Adult Patients

Herpes labialis (cold sores): Famciclovir tablets are indicated for the treatment of recurrent herpes labialis.

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. The efficacy and safety of famciclovir tablets for the suppression of recurrent genital herpes beyond 1 year have 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.

1.3 Limitation of Use

The efficacy and safety of famciclovir tablets have not been established for:
• Patients <18 years of age
• Patients with first episode of genital herpes
• 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 & 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.

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 RegimensRecurrent Genital Herpes1000 mg every 12 hours for1 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 RegimensSuppression of RecurrentGenital Herpes250 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 or Genital Herpes in HIV-Infected Patients500 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

3 DOSAGE FORMS & STRENGTHS


Famciclovir tablets are available in 3 strengths:
• 125 mg : Off white, round, biconvex, film coated tablets, debossed with ‘I’ on one side and ’50′ on the other side
• 250 mg: Off white, round, biconvex, film coated tablets, debossed with ‘I’ on one side and ’49′ on the other side
• 500 mg: Off white, oval, film coated, biconvex tablets, debossed with ‘I’ on one side and ’48′ on the other side

4 CONTRAINDICATIONS

Famciclovir tablets are contraindicated in patients with known hypersensitivity to the product, its components, or penciclovir cream.

5 WARNINGS AND PRECAUTIONS

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 for their level of renal function. Dosage reduction is recommended when administering famciclovir to patients with renal impairment [see Dosage and Administration (2.3), Use in Specific Populations (8.6)].

6 ADVERSE REACTIONS

Acute renal failure is discussed in greater detail in other sections of the label [see Warnings and Precautions (5)].

The most common adverse events reported in at least 1 indication by >10% of adult patients treated with famciclovir are headache and nausea.

6.1 Clinical Trials Experience in Adult Patients

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Immunocompetent patients: The safety of famciclovir has been evaluated in active- and placebo-controlled clinical studies involving 163 famciclovir-treated patients with recurrent genital herpes (Famciclovir, 1000 mg twice daily); 1,197 patients with recurrent genital herpes treated with famciclovir as suppressive therapy (125 mg once daily to 250 mg three times daily) of which 570 patients received famciclovir (open-labeled and/or double-blind) for at least 10 months; and 447 famciclovir-treated patients with herpes labialis (Famciclovir, 1500 mg once daily or 750 mg twice daily). Table 2 lists selected adverse events. Table 2 Selected Adverse Events (all grades and without regard to causality) Reported by ≥ 2% of Patients in Placebo-Controlled Famciclovir Trials*

Incidence
Events Recurrent Genital Herpes Genital Herpes- Suppression§ Herpes Labialis
Famciclovir (n=163) % Placebo (n=166) % Famciclovir (n=458) % Placebo (n=63) % Famciclovir (n=447) % Placebo (n=254) %
Nervous System
Headache 13.5 5.4 39.3 42.9 8.5 6.7
Paresthesia 0.0 0.0 0.9 0.0 0.0 0.0
Migraine 0.6 0.6 3.1 0.0 0.2 0.0
Gastrointestinal
Nausea 2.5 3.6 7.2 9.5 2.2 3.9
Diarrhea 4.9 1.2 9.0 9.5 1.6 0.8
Vomiting 1.2 0.6 3.1 1.6 0.7 0.0
Flatulence 0.6 0.0 4.8 1.6 0.2 0.0
Abdominal Pain 0.0 1.2 7.9 7.9 0.2 0.4
Body as a Whole
Fatigue 0.6 0.0 4.8 3.2 1.6 0.4
Skin and Appendages
Pruritus 0.0 0.6 2.2 0.0 0.0 0.0
Incidence
Events Recurrent Genital Herpes Genital Herpes- Suppression§ Herpes Labialis
Famciclovir (n=163) % Placebo (n=166) % Famciclovir (n=458) % Placebo (n=63) % Famciclovir (n=447) % Placebo (n=254) %
Rash 0.0 0.0 3.3 1.6 0.0 0.0
Reproductive (Female)
Dysmenorrhea 1.8 0.6 7.6 6.3 0.4 0.0

*Patients may have entered into more than one clinical trial.

1 day of treatment

§ daily treatment

Table 3 lists selected laboratory abnormalities in genital herpes suppression trials.Table 3 Selected Laboratory Abnormalities in Genital Herpes Suppression Studies*

Parameter Famciclovir (n = 660) % Placebo (n = 210) %
Anemia (<0.8 x NRL) 0.1 0.0
Leukopenia (<0.75 x NRL) 1.3 0.9
Neutropenia (<0.8 x NRL) 3.2 1.5
AST (SGOT) (>2 x NRH) 2.3 1.2
ALT (SGPT) (>2 x NRH) 3.2 1.5
Total Bilirubin (>1.5 x NRH) 1.9 1.2
Serum Creatinine (>1.5 x NRH) 0.2 0.3
Amylase (>1.5 x NRH) 1.5 1.9
Lipase (>1.5 x NRH) 4.9 4.7

*Percentage of patients with laboratory abnormalities that were increased or decreased from baseline and were outside of specified ranges.

n values represent the minimum number of patients assessed for each laboratory parameter.

NRH = Normal Range High.

NRL = Normal Range Low.

HIV-infected patients: In HIV-infected patients, the most frequently reported adverse events for famciclovir (500 mg twice daily; n=150) and acyclovir (400 mg, 5x/day; n=143), respectively, were headache (17% vs. 15%), nausea (11% vs. 13%), diarrhea (7% vs. 11%), vomiting (5% vs. 4%), fatigue (4% vs. 2%), and abdominal pain (3% vs. 6%).

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