Famciclovir

F

Class: Nucleosides and Nucleotides
VA Class: AM800
Chemical Name: 2-[2-(2-Amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate (ester)
Molecular Formula: C14H19N5O4
CAS Number: 104227-87-4
Brands: Famvir

Introduction

Antiviral; prodrug of penciclovir; nucleoside derived from guanine.1 3 4

Uses for Famciclovir Genital Herpes

Treatment of initial episodes of genital herpes† in immunocompetent or HIV-infected adults and adolescents.26 36 37

Episodic treatment of recurrent episodes of genital herpes in immunocompetent1 26 27 36 37 43 or HIV-infected adults and adolescents.1 26 37

Chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent1 26 36 37 or HIV-infected adults and adolescents.28

CDC and others recommend oral acyclovir, oral famciclovir, or oral valacyclovir as drugs of choice for treatment of initial episodes of genital herpes and for episodic treatment or chronic suppressive therapy of recurrent genital herpes.26 36 37

Herpes Labialis

Episodic treatment of herpes labialis (perioral herpes, cold sores, fever blisters) in immunocompetent adults1 43 or HIV-infected adults and adolescents.

Mucocutaneous Herpes Simplex Virus (HSV) Infections

Treatment of recurrent mucocutaneous HSV infections in HIV-infected adults and adolescents.1 46

Chronic suppressive or maintenance therapy (secondary prophylaxis) against recurrence of HSV infections† in HIV-infected adults or adolescents who have frequent or severe recurrences.27 28 35 46

Herpes Zoster

Treatment of acute, localized herpes zoster (shingles, zoster) in immunocompetent adults and adolescents.1 11 27 37

Treatment of localized dermatomal herpes zoster in HIV-infected adults or adolescents†.46 If cutaneous lesions are extensive or there is clinical evidence of visceral involvement, IV acyclovir should be used for initial treatment.46

Hepatitis B Virus Infection

Has been used for management of chronic hepatitis B virus (HBV) infection†, including control of HBV recurrence in organ or bone marrow transplant recipients†.30 32 33 34 Safety and efficacy for HBV infection not established.29 30 31 32 33 34

CDC, National Institutes of Health (NIH), and IDSA state that famciclovir is not recommended for treatment of HBV infection in HIV-infected individuals since the drug is less active than lamivudine against HBV and is not active against lamivudine-resistant HBV.46

Famciclovir Dosage and Administration Administration Oral Administration

Administer orally without regard to meals.1

Dosage Pediatric Patients Genital Herpes Oral

Adolescents should receive dosage recommended for adults with genital herpes.27 (See Adults under Dosage and Administration.)

Mucocutaneous Herpes Simplex Virus (HSV) Infections Chronic Suppression of Recurrent Episodes Oral

HIV-infected adolescents: 250 mg twice daily for chronic suppressive or maintenance therapy (secondary prophylaxis) of HSV† infections in those with frequent or severe recurrences.28

Herpes Zoster Oral

Local dermatomal herpes zoster in HIV-infected adolescents†: 500 mg three times daily for 7–10 days recommended by CDC and other experts.46

Adults Genital Herpes Treatment of First Episodes† Oral

Immunocompetent adults: 250 mg 3 times daily for 7–10 days recommended by CDC and others; duration of treatment may be extended if healing is incomplete after 10 days.26 36 37

HIV-infected adults: 500 mg twice daily for 7–14 days recommended by CDC and others.46

Episodic Treatment of Recurrent Episodes Oral

Immunocompetent adults: 1 g twice daily for 1 day1 26 27 or 125 mg twice daily for 5 days.26 27 36 37

HIV-infected adults: 500 mg twice daily for 5–10 days recommended by CDC and others;26 37 46 alternatively, continue for 7–14 days.46

Initiate therapy at first sign or symptom of an episode;1 efficacy not established if initiated >6 hours after onset of signs or symptoms.1

Suppressive Therapy of Recurrent Episodes Oral

Immunocompetent adults: 250 mg twice daily.1 26 36 37

HIV-infected adults: 500 mg twice daily recommended by CDC.26

Manufacturer states chronic suppressive therapy may be given for up to 1 year.1

Because frequency of recurrent episodes diminishes over time in many patients, CDC and others recommend that suppressive antiviral therapy be discontinued periodically (e.g., once yearly) to assess the need for continued therapy.26 36

Herpes Labialis Oral

Immunocompetent adults: 1.5 g as a single dose.1

Initiate therapy at first prodromal symptom (e.g., tingling, itching, burning).1

Mucocutaneous Herpes Simplex Virus (HSV) Infections Episodic Treatment of Recurrent Episodes Oral

HIV-infected adults: 500 mg every 12 hours for 7 days for treatment of recurrent infections (orolabial or genital herpes).1 Some experts recommend 7–14 days.46

Suppressive Therapy of Recurrent Episodes Oral

HIV-infected adults: 250 mg twice daily for chronic suppressive or maintenance therapy (secondary prophylaxis) of HSV† in those with frequent or severe recurrences.28

Herpes Zoster Oral

Immunocompetent adults: 500 mg every 8 hours for 7 days.1 27 37 47

Local dermatomal herpes zoster in HIV-infected adults†: 500 mg three times daily for 7–10 days recommended by CDC and other experts.46

Initiate therapy promptly as soon as diagnosed;1 efficacy not established if initiated >72 hours after rash onset.1

Special Populations Renal Impairment Genital Herpes Dosage for Episodic Treatment of Recurrent Genital Herpes in Renal Impairment1

Clcr (mL/min)

Dosage

?60

1 g every 12 hours for 1 day1

40–59

500 mg every 12 hours for 1 day1

20–39

500 mg as a single dose1

<20

250 mg as a single dose1

Hemodialysis Patients

250 mg as a single dose following dialysis1

Dosage for Suppressive Therapy of Recurrent Genital Herpes in Renal Impairment1

Clcr (mL/min)

Daily Dosage

?40

250 mg every 12 hours1

20–39

125 mg every 12 hours1

<20

125 mg once every 24 hours1

Hemodialysis Patients

125 mg following each dialysis1

Herpes Labialis Dosage for Episodic Treatment of Recurrent Herpes Labialis in Renal Impairment1

Clcr (mL/min)

Dosage

?60

1.5 g as a single dose1

40–59

750 mg as a single dose1

20–39

500 mg as a single dose1

<20

250 mg as a single dose1

Hemodialysis Patients

250 mg as a single dose following dialysis1

Mucocutaneous Herpes Simplex Virus (HSV) Infections Dosage for Episodic Treatment of Recurrent HSV (Orolabial or Genital Herpes) in HIV-infected Individuals with Renal Impairment1

Clcr (mL/min)

Daily Dosage

?40

500 mg every 12 hours1

20–39

500 mg once every 24 hours1

<20

250 mg once every 24 hours1

Hemodialysis Patients

250 mg following each dialysis1

Herpes Zoster Dosage for Treatment of Herpes Zoster in Renal Impairment1

Clcr (mL/min)

Daily Dosage

?60

500 mg every 8 hours1

40–59

500 mg every 12 hours1

20–39

500 mg once every 24 hours1

<20

250 mg once every 24 hours1

Hemodialysis Patients

250 mg following each dialysis1

Cautions for Famciclovir Contraindications

Known hypersensitivity to famciclovir or penciclovir or any ingredient in the formulation.1

Warnings/Precautions General Precautions Renal Effects

Use of inappropriately high dosage for the level of renal function has resulted in acute renal failure in patients with underlying renal disease.1 Adjust dosage based on Clcr.1 2 14 (See Renal Impairment under Dosage and Administration.)

Genital Herpes

Not a cure for genital herpes.1

Avoid sexual contact while lesions and/or symptoms are present due to risk of infecting sexual partners.1 Infection can be transmitted in the absence of symptoms through asymptomatic viral shedding.1

Although recommended by CDC and others for treatment of initial episodes of genital herpes,26 36 37 manufacturer says efficacy not established.1

Herpes Zoster

Efficacy not established for treatment of disseminated or ophthalmic herpes zoster or for treatment of herpes zoster in immunocompromised individuals.1

Lactose Intolerance

Patients with galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption should not receive famciclovir tablets.1 Each 125-, 250-, or 500-mg tablet contains 26.9, 53.7, or 107.4 mg of lactose, respectively.1

Specific Populations Pregnancy

Category B.1

Lactation

Distributed into milk in rats; not known whether distributed into human milk.1 18

Pediatric Use

Safety and efficacy not established in infants or children <18 years of age.1 4

Geriatric Use

Experience in geriatric adults (?65 years of age) with herpes zoster indicate adverse effects are similar to those in younger adults.1 14

Insufficient experience in geriatric adults with recurrent herpes simplex to determine whether they respond differently than younger adults.1

Use with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1

Hepatic Impairment

Pharmacokinetics not evaluated in patients with severe uncompensated hepatic impairment.1 4

Renal Impairment

Dosage adjustment necessary based on degree of renal impairment.1 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Headache,1 4 6 11 14 15 20 21 nausea,1 4 6 11 14 18 21 diarrhea,1 4 6 14 15 20 21 vomiting.1 4 6 14 15 21

Interactions for Famciclovir

Not metabolized by CYP isoenzymes.1

Drugs Eliminated by Renal Excretion

Potential increased plasma penciclovir concentrations when used concomitantly with other drugs eliminated by active renal tubular secretion (e.g., probenecid).1

Drugs Metabolized by Aldehyde Oxidase

Potential pharmacokinetic interaction with other drugs metabolized by aldehyde oxidase.1

Specific Drugs

Drug

Interaction

Allopurinol

No clinically important alterations in penciclovir pharmacokinetics1

Cimetidine

No clinically important alterations in penciclovir pharmacokinetics1

Digoxin

No clinically important alterations in digoxin pharmacokinetics1

Probenecid

Potential increased penciclovir concentrations1

Theophylline

No clinically important alterations in penciclovir pharmacokinetics1

Zidovudine

No clinically important alterations in penciclovir or zidovudine pharmacokinetics1

Famciclovir Pharmacokinetics Absorption Bioavailability

Famciclovir, a prodrug of penciclovir, is rapidly and well absorbed following oral administration and metabolized to penciclovir.1 40 41 Little or no prodrug is present in plasma or urine.1

Absolute bioavailability of penciclovir is 77% following oral administration of famciclovir;1 41 peak penciclovir plasma concentrations attained within 0.5–0.9 hours.1 2 40 42

Pharmacokinetics in HIV-infected patients similar to healthy individuals.1

Food

Administration of famciclovir with food decreases peak penciclovir plasma concentrations and delays time to peak concentrations but does not affect penciclovir AUC.1

Distribution Extent

Not known whether penciclovir crosses the placenta.

Not known whether penciclovir is distributed into human milk.1

Plasma Protein Binding

Penciclovir <20% bound to plasma proteins.1

Elimination Metabolism

Famciclovir is deacetylated and oxidized to penciclovir.1 Penciclovir is phosphorylated to penciclovir triphosphate (the active metabolite) in cells infected with HSV-1, HSV-2, or VZV.1 41 The inactive metabolite 6-deoxy penciclovir is converted to penciclovir by aldehyde oxidase.1

Famciclovir not metabolized by CYP enzymes.1

Elimination Route

Famciclovir eliminated principally by the kidneys as penciclovir and other metabolites.1 40 42 73% of an oral famciclovir dose eliminated in urine and 27% eliminated in feces within 72 hours.1 40

Half-life

Elimination half-life of penciclovir after oral administration of famciclovir 1.6–3 hours.1 2 3 40

Intracellular half-life of penciclovir triphosphate in cells infected with HSV-1 or HSV-2 is 10 and 20 hours, respectively;1 41 intracellular half-life in VZV-infected cells is 7–14 hours.1 41

Special Populations

AUC of penciclovir not affected when oral famciclovir used in patients with well-compensated chronic liver disease (chronic hepatitis, chronic ethanol abuse, primary biliary cirrhosis).1 Pharmacokinetics not evaluated in severe uncompensated hepatic impairment.1

Renal clearance decreased and terminal elimination half-life increased in patients with renal impairment;2 40 half-life 6.2 hours if Clcr 20–39 mL/minute and 13.4 hours if Clcr <20 mL/minute.1

AUC may be greater and renal clearance decreased in geriatric patients ?65 years of age, presumably because of decreased renal function.1

Stability Storage Oral Tablets

15–30°C.1

Actions and SpectrumActions

Famciclovir is the diacetyl 6-deoxy analog of penciclovir.1 Prodrug with no antiviral activity until converted in vivo to penciclovir and subsequently to the active penciclovir triphosphate.1 5 6 12 13 17

Active against various Herpesviridae including herpes simplex virus types 1 and 2 (HSV-1 and HSV-2), varicella-zoster virus (VZV), and Epstein-Barr virus (EBV).1 5 6 7 8 9 12 13 17 Also active against hepatitis B virus (HBV).29 30 31 32 33 34 Only limited activity in vitro against cytomegalovirus (CMV).6 9 17

Penciclovir triphosphate exerts its antiviral activity by interfering with DNA synthesis; the drug competes with deoxyguanosine triphosphate for viral DNA polymerase, inhibits DNA chain elongation, and inhibits viral replication.1

Resistance to penciclovir reported in HSV and VZV.1

Advice to Patients

Advise patients that famciclovir is not a cure for genital herpes, and there are no data evaluating whether famciclovir prevents transmission of genital herpes to others.1

Importance of avoiding sexual contact with uninfected partners while lesions and/or symptoms of genital herpes are present since there is a risk of transmission.1 Genital herpes can be transmitted in the absence of symptoms through asymptomatic viral shedding.1

Advise patients to avoid driving or operating machinery if they experience dizziness, drowsiness, confusion, or other CNS disturbances; there is no evidence that famciclovir affects ability to drive or operate machinery.1

Importance of informing clinician of existing or contemplated concomitant therapy, including prescription or nonprescription drugs.1

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

Importance of advising patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Famciclovir

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

125 mg

Famvir

Novartis

250 mg

Famvir

Novartis

500 mg

Famvir

Novartis

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Famciclovir 125MG Tablets (TEVA PHARMACEUTICALS USA): 30/$159.99 or 90/$455.97

Famciclovir 250MG Tablets (TEVA PHARMACEUTICALS USA): 30/$169.99 or 90/$479.95

Famciclovir 500MG Tablets (TEVA PHARMACEUTICALS USA): 30/$326 or 90/$950.02

Famvir 125MG Tablets (NOVARTIS): 30/$201 or 90/$567.97

Famvir 250MG Tablets (NOVARTIS): 30/$216.99 or 90/$619.99

Famvir 500MG Tablets (NOVARTIS): 30/$401.97 or 90/$1153.03

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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21. Saltzman R, Boon R. The safety of famciclovir in patients with herpes zoster. Curr Ther Res. 1995; 56:219-25.

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29. Korba BE, Boyd MR. Penciclovir is a selective inhibitor of hepatitis B virus replication in cultured human hepatoblastoma cells. Antimicrob Agents Chemother. 1996; 40:1282-4. [PubMed 8723485]

30. Lee WM. Hepatitis B virus infection. N Engl J Med. 1997; 337:1733-45. [IDIS 395818] [PubMed 9392700]

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32. Lau GK, Liang R, Wu PC et al. Use of famciclovir to prevent HBV reactivation in HBsAg-positive recipients after allogeneic bone marrow transplantation. J Hepatol. 1998; 28:359-68. [PubMed 9551671]

33. Han SH, Kinkhabwala M, Martin P et al. Resolution of recurrent hepatitis B in two liver transplant recipients treated with famciclovir. Am J Gastroenterol. 1998; 93:2245-7. [IDIS 417410] [PubMed 9820407]

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35. Schacker T, Hu HL, Koelle DM et al. Famciclovir for the suppression of symptomatic and asymptomatic herpes simplex virus reactivation in HIV-infected persons: a double-blind, placebo-controlled trial. Ann Intern Med. 1998; 128:21-8. [IDIS 398423] [PubMed 9424977]

36. Anon. Drugs for sexually transmitted infections. Treat Guidel Med Lett. 2004; 2:67-74. [PubMed 15529116]

37. Anon. Drugs for non-HIV viral infections. Treat Guidel Med Lett. 2005; 3:23-32.

38. Tyring S, Engst R, Corriveau C et al. Famciclovir for ophthalmic zoster: a randomised aciclovir controlled study. B J Ophthalmol. 2001; 85:576-81.

39. Tyring S, Belanger R, Bezwoda W et al. A randomized, double-blind trial of famciclovir versus acyclovir for the treatment of localized dermatomal herpes zoster in immunocompromised patients. Cancer Invest. 2001; 19:13-22. [PubMed 11291551]

40. Filer CW, Allen GD, Brown TA et al. Metabolic and pharmacokinetic studies following oral administration of 14C-famciclovir to healthy subjects. Xenobiotica. 1994; 24:357-68. [PubMed 8059539]

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42. Pue MA, Pratt SK, Fairless AJ et al. Linear pharmacokinetics of penciclovir following administration of single oral doses of famciclovir 125, 250, 500 and 750 mg to healthy volunteers. J Antimicrob Chemother. 1994; 33:119-27. [IDIS 325073] [PubMed 8157552]

43. Spruance SL, Bodsworth N, Resnick H et al. Single-dose, patient-initiated famciclovir: a randomized, double-blind, placebo-controlled trial for episodic treatment of herpes labialis. J Am Acad Dermatol. 2006; 55:47-53. [PubMed 16781291]

44. Aoki F, Tyring S, Diaz-Mitoma F et al. Single-day, patient-initiated famciclovir therapy for recurrent genital herpes: a randomized, double-blind, placebo-controlled trial. Clin Infect Dis. 2006; 42:8-13. [PubMed 16323085]

45. Novartis. Famvir (famciclovir) tablets prescribing information. East Hanover, NJ; 2001 Apr.

46. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association/Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-15):1-112.

47. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-exposed and infected children: recommendations from CDC, the National Institutes of Health, and the Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53( RR-14):1-92.

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Famciclovir

.