FAMCICLOVIR - famciclovir tablet, film coated
Greenstone LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use famciclovir safely and effectively. See full prescribing information for famciclovir tablets.
famciclovir tablets Initial U.S. Approval: 1994 INDICATIONS AND USAGEFamciclovir, a prodrug of penciclovir, is a nucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients (1.1)
HIV-Infected Adult Patients (1.2)
Limitation of Use (1.3) The efficacy and safety of famciclovir tablets have not been established for:
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSTablets: 125 mg, 250 mg, 500 mg. (3) CONTRAINDICATIONSWARNINGS AND PRECAUTIONSADVERSE REACTIONSThe most common adverse events reported in at least one indication by >10% of adult patients are headache and nausea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Greenstone LLC at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSProbenecid: May increase penciclovir levels. Monitor for evidence of penciclovir toxicity. (7.2) USE IN SPECIFIC POPULATIONSNursing mothers: Famciclovir should not be used in nursing mothers unless the potential benefits outweigh the potential risks associated with treatment. (8.3) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 11/2012 |
*Hemodialysis |
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Indication and Normal Dosage Regimen | Creatinine Clearance (mL/min) | Adjusted Dosage Regimen Dose (mg) | Dosing Interval |
Single-Day Dosing Regimens
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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 |
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20-39 | 500 | single dose |
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<20 | 250 | single dose |
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HD* | 250 | single dose following dialysis |
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Recurrent Herpes Labialis 1500 mg single dose | ≥60 | 1500 | single dose |
40-59 | 750 | single dose |
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20-39 | 500 | single dose |
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<20 | 250 | single dose |
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HD* | 250 | single dose following dialysis |
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Multiple-Day Dosing Regimens
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Suppression of Recurrent Genital Herpes 250 mg every 12 hours | ≥40 | 250 | every 12 hours |
20-39 | 125 | every 12 hours |
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<20 | 125 | every 24 hours |
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HD* | 125 | following each dialysis |
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Recurrent Orolabial or Genital Herpes in HIV-Infected Patients 500 mg every 12 hours | ≥40 | 500 | every 12 hours |
20-39 | 500 | every 24 hours |
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<20 | 250 | every 24 hours |
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HD* | 250 | following each dialysis |
Events | Incidence | ||||||
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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) % |
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* Patients may have entered into more than one clinical trial. ‡ 1 day of treatment § daily treatment |
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Nervous System
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Headache | 13.5 | 5.4 | 39.3 | 42.9 | 8.5 | 6.7 |
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Paresthesia | 0 | 0 | 0.9 | 0 | 0 | 0 |
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Migraine | 0.6 | 0.6 | 3.1 | 0 | 0.2 | 0 |
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Gastrointestinal
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Nausea | 2.5 | 3.6 | 7.2 | 9.5 | 2.2 | 3.9 |
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Diarrhea | 4.9 | 1.2 | 9 | 9.5 | 1.6 | 0.8 |
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Vomiting | 1.2 | 0.6 | 3.1 | 1.6 | 0.7 | 0 |
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Flatulence | 0.6 | 0 | 4.8 | 1.6 | 0.2 | 0 |
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Abdominal Pain | 0 | 1.2 | 7.9 | 7.9 | 0.2 | 0.4 |
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Body as a Whole
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Fatigue | 0.6 | 0 | 4.8 | 3.2 | 1.6 | 0.4 |
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Skin and Appendages
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Pruritus | 0 | 0.6 | 2.2 | 0 | 0 | 0 |
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Rash | 0 | 0 | 3.3 | 1.6 | 0 | 0 |
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Reproductive (Female)
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Dysmenorrhea | 1.8 | 0.6 | 7.6 | 6.3 | 0.4 | 0 |
Parameter | Famciclovir (n = 660)† % | Placebo (n = 210)† % |
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* 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. |
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Anemia (<0.8 x NRL) | 0.1 | 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 |
† CLCR is measured creatinine clearance. ‡ n=4. § CL/F consists of bioavailability factor and famciclovir to penciclovir conversion factor. |
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Parameter (mean ± S.D.) | CLCR† ≥60 (mL/min) (n=15) | CLCR 40 to 59 (mL/min) (n=5) | CLCR 20 to 39 (mL/min) (n=4) | CLCR <20 (mL/min) (n=3) |
CLCR (mL/min) | 88.1 ± 20.6 | 49.3 ± 5.9 | 26.5 ± 5.3 | 12.7 ± 5.9 |
CLR (L/hr) | 30.1 ± 10.6 | 13 ± 1.3‡
| 4.2 ± 0.9 | 1.6 ± 1 |
CL/F§ (L/hr) | 66.9 ± 27.5 | 27.3 ± 2.8 | 12.8 ± 1.3 | 5.8 ± 2.8 |
Half-life (hr) | 2.3 ± 0.5 | 3.4 ± 0.7 | 6.2 ± 1.6 | 13.4 ± 10.2 |
* Based on pharmacokinetic data from 17 studies. † AUC (0-inf) (mcg hr/mL)=area under the plasma concentration-time profile extrapolated to infinity. ‡ Cmax (mcg/mL)=maximum observed plasma concentration. § Tmax (h)=time to Cmax. |
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Dose | AUC (0-inf)†
(mcg hr/mL) | Cmax‡
(mcg/mL) | Tmax§
(h) |
125 mg | 2.24 | 0.8 | 0.9 |
250 mg | 4.48 | 1.6 | 0.9 |
500 mg | 8.95 | 3.3 | 0.9 |
1000 mg | 17.9 | 6.6 | 0.9 |
Recurrence Rates at 6 Months | Recurrence Rates at 12 Months |
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Famciclovir 250 mg twice daily (n=236) | Placebo (n=233) | Famciclovir 250 mg twice daily (n=236) | Placebo (n=233) |
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† Based on patient reported data; not necessarily confirmed by a physician. ‡ Patients recurrence-free at time of last contact prior to withdrawal. |
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Recurrence-free | 39% | 10% | 29% | 6% |
Recurrences†
| 47% | 74% | 53% | 78% |
Lost to follow-up‡
| 14% | 16% | 17% | 16% |
FAMCICLOVIR
famciclovir tablet, film coated |
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FAMCICLOVIR
famciclovir tablet, film coated |
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FAMCICLOVIR
famciclovir tablet, film coated |
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Labeler - Greenstone LLC (825560733) |