Famciclovir (Page 2 of 7)

3 DOSAGE FORMS AND STRENGTHS

Famciclovir tablets are available in 3 strengths:

• 125 mg: White coloured, circular, film-coated, biconvex tablet debossed with ‘C’ and’269′ on one side and plain on other side.

• 250 mg: White coloured, circular, film-coated, biconvex tablet debossed with ‘C’ and ‘271’ on one side and plain on other side.

• 500 mg: White coloured, capsule shaped, film-coated, biconvex tablets debossed with ‘C272’ on one side and plain on other side.

4 CONTRAINDICATIONS

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

5 WARNINGS AND PRECAUTIONS

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 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 greater than 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 816 famciclovir-treated patients with herpes zoster (famciclovir, 250 mg three times daily to 750 mg three times daily); 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 Greater Than or Equal to 2% of Patients in Placebo-Controlled Famciclovir Tablets Trials*

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

7 days of treatment

1 day of treatment

§ daily treatment

Incidence
Events Herpes Zoster Recurrent Genital Herpes Genital Herpes- Suppression§ Herpes Labialis
Famciclovir (n=273) % Placebo (n=146) % Famciclovir (n=163) % Placebo (n=166) % Famciclovir (n=458) % Placebo (n=63) % Famciclovir (n=447) % Placebo (n=254) %
Nervous System
Headache 22.7 17.8 13.5 5.4 39.3 42.9 8.5 6.7
Paresthesia 2.6 0.0 0.0 0.0 0.9 0.0 0.0 0.0
Migraine 0.7 0.7 0.6 0.6 3.1 0.0 0.2 0.0
Gastrointestinal
Nausea 12.5 11.6 2.5 3.6 7.2 9.5 2.2 3.9
Diarrhea 7.7 4.8 4.9 1.2 9.0 9.5 1.6 0.8
Vomiting 4.8 3.4 1.2 0.6 3.1 1.6 0.7 0.0
Flatulence 1.5 0.7 0.6 0.0 4.8 1.6 0.2 0.0
Abdominal Pain 1.1 3.4 0.0 1.2 7.9 7.9 0.2 0.4
Body as a Whole
Fatigue 4.4 3.4 0.6 0.0 4.8 3.2 1.6 0.4
Skin and Appendages
Pruritus 3.7 2.7 0.0 0.6 2.2 0.0 0.0 0.0
Rash 0.4 0.7 0.0 0.0 3.3 1.6 0.0 0.0
Reproductive (Female)
Dysmenorrhea 0.0 0.7 1.8 0.6 7.6 6.3 0.4 0.0

Table 3 lists selected laboratory abnormalities in genital herpes suppression trials.

Table 3: Selected Laboratory Abnormalities in Genital Herpes Suppression Studies*

*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.

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

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%).

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.