Famvir (Famciclovir)
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Famvir (Famciclovir)

FAMVIR
(famciclovir)

DRUG DESCRIPTION

The active ingredient in FAMVIR tablets is famciclovir, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir is known as 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate. Its molecular formula is C14H19N5O4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure

FAMVIR (famciclovir) Structural Formula Illustration

Famciclovir is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir is freely soluble ( > 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2%-3% w/v) monohydrate. Famciclovir is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08.

FAMVIR tablets contain 125 mg, 250 mg or 500 mg of famciclovir, together with the following inactive ingredients: hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose, magnesium stearate, polyethylene glycols, sodium starch glycolate and titanium dioxide.

What are the possible side effects of famciclovir (Famvir)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • nausea, vomiting, stomach pain;
  • diarrhea,
  • headache, tired feeling;
  • dizziness, sleepiness;
  • mild itching or skin rash;
  • numbness or tingly feeling; or
  • confusion.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA...

Read All Potential Side Effects and See Pictures of Famvir »

What are the precautions when taking famciclovir (Famvir)?

Before taking famciclovir, tell your doctor or pharmacist if you are allergic to it; or to penciclovir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems.

This drug may rarely make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may contain lactose. If you have certain conditions such as galactose intolerance, severe lactase deficiency (not lactose or milk intolerance), or...

Read All Potential Precautions of Famvir »

Last reviewed on RxList: 2/16/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Immunocompetent Adult Patients

Herpes labialis (cold sores): FAMVIR is indicated for the treatment of recurrent herpes labialis.

Genital herpes

Recurrent episodes: FAMVIR is indicated for the treatment of recurrent episodes of genital herpes. The efficacy of FAMVIR when initiated more than 6 hours after onset of symptoms or lesions has not been established.

Suppressive therapy: FAMVIR is indicated for chronic suppressive therapy of recurrent episodes of genital herpes. The efficacy and safety of FAMVIR for the suppression of recurrent genital herpes beyond 1 year have not been established.

Herpes zoster (shingles): FAMVIR is indicated for the treatment of herpes zoster. The efficacy of FAMVIR when initiated more than 72 hours after onset of rash has not been established.

HIV-Infected Adult Patients

Recurrent orolabial or genital herpes: FAMVIR is indicated for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected adults. The efficacy of FAMVIR when initiated more than 48 hours after onset of symptoms or lesions has not been established.

Limitation of Use

The efficacy and safety of FAMVIR have not been established for:

  • Patients < 18 years of age
  • 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

FAMVIR may be taken with or without food.

Dosing Recommendation in Immunocompetent Adult Patients

Herpes labialis (cold sores): The recommended dosage of FAMVIR 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 FAMVIR 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 FAMVIR for chronic suppressive therapy of recurrent episodes of genital herpes is 250 mg twice daily.

Herpes zoster (shingles): The recommended dosage of FAMVIR 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.

Dosing Recommendation in HIV-Infected Adult Patients

Recurrent orolabial or genital herpes: The recommended dosage of FAMVIR 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).

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, CLINICAL PHARMACOLOGY].

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 Herpes1000 mg every 12 hours for 1 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 Regimens
Herpes Zoster 500 mg every 8 hours ≥ 60 500 every 8 hours
40-59 500 every 12 hours
20-39 500 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
20-39 125 every 12 hours
< 20 1 25 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
20-39 500 every 24 hours
< 20 250 every 24 hours
HD* 250 following each dialysis
*Hemodialysis

HOW SUPPLIED

Dosage Forms And Strengths

FAMVIR tablets are available in three strengths:

  • 125 mg: White, round film-coated, biconvex, beveled edges, debossed with “FAMVIR” on one side and “125” on the other side
  • 250 mg: White, round film-coated, biconvex, beveled edges, debossed with “FAMVIR” on one side and “250” on the other side
  • 500 mg: White, oval film-coated, biconvex, debossed with “FAMVIR” on one side and “500” on the other side

Storage And Handling

FAMVIR tablets are supplied as film-coated tablets as follows: 125 mg in bottles of 30; 250 mg in bottles of 30; 500 mg in bottles of 30 and Single Unit Packages of 50 (intended for institutional use only).

FAMVIR 125 mg tablet: White, round film-coated, biconvex, beveled edges, debossed with “FAMVIR” on one side and “125” on the other.
125 mg 30's…………………………………………… NDC 0078-0366-15

FAMVIR 250 mg tablet: White, round film-coated, biconvex, beveled edges, debossed with “FAMVIR” on one side and “250” on the other.
250 mg 30's…………………………………………… NDC 0078-0367-15

FAMVIR 500 mg tablet: White, oval film-coated, biconvex, debossed with “FAMVIR” on one side and “500” on the other.
500 mg 30's…………………………………………… NDC 0078-0368-15
500 mg SUP 50's……………………………………… NDC 0078-0368-64

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. Revised January 2012

Last reviewed on RxList: 2/16/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Acute renal failure is discussed in greater detail in other sections of the label [see WARNINGS AND PRECAUTIONS].

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

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 FAMVIR has been evaluated in active- and placebo-controlled clinical studies involving 816 FAMVIR-treated patients with herpes zoster (FAMVIR, 250 mg three times daily to 750 mg three times daily); 163 FAMVIR-treated patients with recurrent genital herpes (FAMVIR, 1000 mg twice daily); 1,197 patients with recurrent genital herpes treated with FAMVIR as suppressive therapy (125 mg once daily to 250 mg three times daily) of which 570 patients received FAMVIR (open-labeled and/or double-blind) for at least 10 months; and 447 FAMVIR-treated patients with herpes labialis (FAMVIR, 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 Famvir Trials*

Events Incidence
Herpes Zoster† Recurrent Genital Herpes‡ Genital Herpes-Suppression§ Herpes Labialis‡
Famvir
(n=273)
%
Placebo
(n=146)
%
Famvir
(n=163)
%
Placebo
(n=166)
%
Famvir
(n=458)
%
Placebo
(n=63)
%
Famvir
(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 0.7 1.8 0.6 7.6 6.3 0.4 0.0
*Patients may have entered into more than one clinical trial.
†7 days of treatment
‡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 Famvir
(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 FAMVIR (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%).

Postmarketing Experience

The adverse events listed below have been reported during post-approval use of FAMVIR. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

Blood and lymphatic system disorders: Thrombocytopenia

Hepatobiliary disorders: Abnormal liver function tests, cholestatic jaundice

Nervous system disorders: Dizziness, somnolence

Psychiatric disorders: Confusion (including delirium, disorientation, and confusional state occurring predominantly in the elderly), hallucinations

Skin and subcutaneous tissue disorders: Urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema (e.g. face, eyelid, periorbital, and pharyngeal edema.)

Read the Famvir (famciclovir) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Potential for FAMVIR to Affect Other Drugs

The steady-state pharmacokinetics of digoxin were not altered by concomitant administration of multiple doses of famciclovir (500 mg three times daily). No clinically significant effect on the pharmacokinetics of zidovudine, its metabolite zidovudine glucuronide, or emtricitabine was observed following a single oral dose of 500 mg famciclovir coadministered with zidovudine or emtricitabine.

An in vitro study using human liver microsomes suggests that famciclovir is not an inhibitor of CYP3A4 enzymes.

Potential for Other Drugs to Affect Penciclovir

No clinically significant alterations in penciclovir pharmacokinetics were observed following single-dose administration of 500 mg famciclovir after pre-treatment with multiple doses of allopurinol, cimetidine, theophylline, zidovudine, promethazine, when given shortly after an antacid (magnesium and aluminum hydroxide), or concomitantly with emtricitabine. No clinically significant effect on penciclovir pharmacokinetics was observed following multiple-dose (three times daily) administration of famciclovir (500 mg) with multiple doses of digoxin.

Concurrent use with probenecid or other drugs significantly eliminated by active renal tubular secretion may result in increased plasma concentrations of penciclovir.

The conversion of 6-deoxy penciclovir to penciclovir is catalyzed by aldehyde oxidase. Interactions with other drugs metabolized by this enzyme and/or inhibiting this enzyme could potentially occur. Clinical interaction studies of famciclovir with cimetidine and promethazine, in vitro inhibitors of aldehyde oxidase, did not show relevant effects on the formation of penciclovir. Raloxifene, a potent aldehyde oxidase inhibitor in vitro, could decrease the formation of penciclovir. However, a clinical drug-drug interaction study to determine the magnitude of interaction between penciclovir and raloxifene has not been conducted.

Last reviewed on RxList: 2/16/2012
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

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 FAMVIR for their level of renal function. Dosage reduction is recommended when administering FAMVIR to patients with renal impairment [see DOSAGE AND ADMINISTRATION, Use In Specific Populations].

Patient Counseling Information

See FDA-Approved Patient Labeling (PATIENT INFORMATION)

There is no evidence that FAMVIR will affect the ability of a patient to drive or to use machines. However, patients who experience dizziness, somnolence, confusion or other central nervous system disturbances while taking FAMVIR should refrain from driving or operating machinery.

Because FAMVIR contains lactose (FAMVIR 125 mg, 250 mg and 500 mg tablets contain lactose 26.9 mg, 53.7 mg and 107.4 mg, respectively), patients with rare hereditary problems of galactose intolerance, a severe lactase deficiency or glucose-galactose malabsorption should be advised to discuss with their healthcare provider before taking FAMVIR.

Herpes Labialis (Cold Sores)

Patients should be advised to initiate treatment at the earliest sign or symptom of a recurrence of cold sores (e.g., tingling, itching, burning, pain, or lesion). Patients should be instructed that treatment for cold sores should not exceed 1 dose. Patients should be informed that FAMVIR is not a cure for cold sores.

Genital Herpes

Patients should be informed that FAMVIR is not a cure for genital herpes. There are no data evaluating whether FAMVIR will prevent transmission of infection to others. Because genital herpes is a sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital herpes is frequently transmitted in the absence of symptoms through asymptomatic viral shedding. Therefore, patients should be counseled to use safer sex practices.

If episodic therapy for recurrent genital herpes is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode.

There are no data on safety or effectiveness of chronic suppressive therapy of longer than one year duration.

Herpes Zoster (Shingles)

There are no data on treatment initiated more than 72 hours after onset of zoster rash. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Two-year dietary carcinogenicity studies with famciclovir were conducted in rats and mice. An increase in the incidence of mammary adenocarcinoma (a common tumor in animals of this strain) was seen in female rats receiving the high dose of 600 mg/kg/day (1.1 to 4.5x the human systemic exposure at the recommended total daily oral dose ranging between 500 mg and 2000 mg, based on area under the plasma concentration curve comparisons [24 hr AUC] for penciclovir). No increases in tumor incidence were reported in male rats treated at doses up to 240 mg/kg/day (0.7 to 2.7x the human AUC), or in male and female mice at doses up to 600 mg/kg/day (0.3 to 1.2x the human AUC).

Mutagenesis

Famciclovir and penciclovir (the active metabolite of famciclovir) were tested for genotoxic potential in a battery of in vitro and in vivo assays. Famciclovir and penciclovir were negative in in vitro tests for gene mutations in bacteria (S. typhimurium and E. coli) and unscheduled DNA synthesis in mammalian HeLa 83 cells (at doses up to 10,000 and 5,000 mcg/plate, respectively). Famciclovir was also negative in the L5178Y mouse lymphoma assay (5000 mcg/mL), the in vivo mouse micronucleus test (4800 mg/kg), and rat dominant lethal study (5000 mg/kg). Famciclovir induced increases in polyploidy in human lymphocytes in vitro in the absence of chromosomal damage (1200 mcg/mL). Penciclovir was positive in the L5178Y mouse lymphoma assay for gene mutation/chromosomal aberrations, with and without metabolic activation (1000 mcg/mL). In human lymphocytes, penciclovir caused chromosomal aberrations in the absence of metabolic activation (250 mcg/mL). Penciclovir caused an increased incidence of micronuclei in mouse bone marrow in vivo when administered intravenously at doses highly toxic to bone marrow (500 mg/kg), but not when administered orally.

Impairment of fertility

Testicular toxicity was observed in rats, mice, and dogs following repeated administration of famciclovir or penciclovir. Testicular changes included atrophy of the seminiferous tubules, reduction in sperm count, and/or increased incidence of sperm with abnormal morphology or reduced motility. The degree of toxicity to male reproduction was related to dose and duration of exposure. In male rats, decreased fertility was observed after 10 weeks of dosing at 500 mg/kg/day (1.4 to 5.7x the human AUC). The no observable effect level for sperm and testicular toxicity in rats following chronic administration (26 weeks) was 50 mg/kg/day (0.15 to 0.6x the human systemic exposure based on AUC comparisons). Testicular toxicity was observed following chronic administration to mice (104 weeks) and dogs (26 weeks) at doses of 600 mg/kg/day (0.3 to 1.2x the human AUC) and 150 mg/kg/day (1.3 to 5.1x the human AUC), respectively.

Famciclovir had no effect on general reproductive performance or fertility in female rats at doses up to 1000 mg/kg/day (2.7 to 10.8x the human AUC).

Two placebo-controlled studies in a total of 130 otherwise healthy men with a normal sperm profile over an 8-week baseline period and recurrent genital herpes receiving oral FAMVIR (250 mg twice daily) (n=66) or placebo (n=64) therapy for 18 weeks showed no evidence of significant effects on sperm count, motility or morphology during treatment or during an 8-week follow-up.

Use In Specific Populations

Pregnancy

Pregnancy category B. After oral administration, famciclovir (prodrug) is converted to penciclovir (active drug). There are no adequate and well-controlled studies of famciclovir or penciclovir use in pregnant women. No adverse effects on embryofetal development were observed in animal reproduction studies using famciclovir and penciclovir at doses higher than the maximum recommended human dose (MRHD) and human exposure. Because animal reproduction studies are not always predictive of human response, famciclovir should be used during pregnancy only if needed.

In animal reproduction studies, pregnant rats and rabbits received oral famciclovir at doses (up to 1000 mg/kg/day) that provided 2.7 to 10.8 times (rats) and 1.4 to 5.4 times (rabbits) the human systemic exposure based on AUC. No adverse effects were observed on embryo-fetal development. In other studies, pregnant rats and rabbits received intravenous famciclovir at doses (360 mg/kg/day) 1.5 to 6 times (rats) and (120 mg/kg/day) 1.1 to 4.5 times (rabbits) or penciclovir at doses (80 mg/kg/day) 0.3 to 1.3 times (rats) and (60 mg/kg/day) 0.5 to 2.1 times (rabbits) the MRHD based on body surface area comparisons. No adverse effects were observed on embryo-fetal development.

Pregnancy exposure reporting. To monitor maternal-fetal outcomes of pregnant women exposed to FAMVIR, Novartis Pharmaceuticals Corporation maintains a FAMVIR Pregnancy Reporting system. Physicians are encouraged to report their patients by calling 1-888-NOW-NOVA (669-6682).

Nursing Mothers

It is not known whether famciclovir (prodrug) or penciclovir (active drug) are excreted in human milk. Following oral administration of famciclovir to lactating rats, penciclovir was excreted in breast milk at concentrations higher than those seen in the plasma. There are no data on the safety of FAMVIR in infants. FAMVIR should not be used in nursing mothers unless the potential benefits are considered to outweigh the potential risks associated with treatment.

Pediatric Use

The efficacy of FAMVIR has not been established in pediatric patients. The pharmacokinetic profile and safety of famciclovir (experimental granules mixed with OraSweet® or tablets) were studied in three open-label studies.

Study 1 was a single-dose pharmacokinetic and safety study in infants 1 month to < 1 year of age who had an active herpes simplex virus (HSV) infection or who were at risk for HSV infection. Eighteen subjects were enrolled and received a single dose of famciclovir experimental granules mixed with OraSweet® based on the patient's body weight (doses ranged from 25 mg to 175 mg). These doses were selected to provide penciclovir systemic exposures similar to the penciclovir systemic exposures observed in adults after administration of 500 mg famciclovir. The efficacy and safety of famciclovir have not been established as suppressive therapy in infants following neonatal HSV infections. In addition, the efficacy cannot be extrapolated from adults to infants because there is no similar disease in adults. Therefore, famciclovir is not recommended in infants.

Study 2 was an open-label, single-dose pharmacokinetic, multiple-dose safety study of famciclovir experimental granules mixed with OraSweet® in children 1 to < 12 years of age with clinically suspected HSV or varicella zoster virus (VZV) infection. Fifty-one subjects were enrolled in the pharmacokinetic part of the study and received a single body weight adjusted dose of famciclovir (doses ranged from 125 mg to 500 mg). These doses were selected to provide penciclovir systemic exposures similar to the penciclovir systemic exposures observed in adults after administration of 500 mg famciclovir. Based on the pharmacokinetic data observed with these doses in children, a new weight-based dosing algorithm was designed and used in the multiple-dose safety part of the study. Pharmacokinetic data were not obtained with the revised weight-based dosing algorithm.

A total of 100 patients were enrolled in the multiple-dose safety part of the study; 47 subjects with active or latent HSV infection and 53 subjects with chickenpox. Patients with active or latent HSV infection received famciclovir twice a day for seven days. The daily dose of famciclovir ranged from 150 mg to 500 mg twice daily depending on the patient's body weight. Patients with chickenpox received famciclovir three times daily for seven days. The daily dose of famciclovir ranged from 150 mg to 500 mg three times daily depending on the patient's body weight. The clinical adverse events and laboratory test abnormalities observed in this study were similar to these seen in adults. The available data are insufficient to support the use of famciclovir for the treatment of children 1 to < 12 years of age with chickenpox or infections due to HSV for the following reasons:

Chickenpox: The efficacy of famciclovir for the treatment of chickenpox has not been established in either pediatric or adult patients. Famciclovir is approved for the treatment of herpes zoster in adult patients. However, extrapolation of efficacy data from adults with herpes zoster to children with chickenpox would not be appropriate. Although chickenpox and herpes zoster are caused by the same virus, the diseases are different.

Genital herpes: Clinical information on genital herpes in children is limited. Therefore, efficacy data from adults cannot be extrapolated to this population. Further, famciclovir has not been studied in children 1 to < 12 years of age with recurrent genital herpes. None of the children in Study 2 had genital herpes.

Herpes labialis: There are no pharmacokinetic and safety data in children 1 to < 12 years of age to support a famciclovir dose that provides penciclovir systemic exposures comparable to the penciclovir systemic exposures in adults after a single dose administration of 1500 mg. Moreover, no efficacy data have been obtained in children 1 to < 12 years of age with recurrent herpes labialis.

Study 3 was an open-label, single-arm study to evaluate the pharmacokinetics, safety, and antiviral activity of a single 1500 mg dose (three 500 mg tablets) of famciclovir in children 12 to < 18 years of age with recurrent herpes labialis. A total of 53 subjects were enrolled in the study; 10 subjects in the pharmacokinetic part of the study and 43 subjects in the non-pharmacokinetic part of the study. All enrolled subjects weighed ≥ 40 kg. The 43 subjects enrolled in the nonpharmacokinetic part of the study had active recurrent herpes labialis and received a single 1500 mg dose of famciclovir within 24 hours after the onset of symptoms (median time to treatment initiation was 21 hours). The safety profile of famciclovir observed in this study was similar to that seen in adults. The median time to healing of patients with non-aborted lesions was 5.9 days.

In a phase 3 trial in adults in which patients received a single 1500 mg dose of famciclovir or placebo, the median time to healing among patients with non-aborted lesions was 4.4 days in the famciclovir 1500 mg single-dose group and 6.2 days in the placebo group. Of note, in the adult study treatment was initiated by patients within one hour after the onset of symptoms [see Clinical Studies]. Based on the efficacy results in Study 3, famciclovir is not recommended in children 12 to < 18 years of age with recurrent herpes labialis.

Geriatric Use

Of 816 patients with herpes zoster in clinical studies who were treated with FAMVIR, 248 (30.4%) were ≥ 65 years of age and 103 (13%) were ≥ 75 years of age. No overall differences were observed in the incidence or types of adverse events between younger and older patients. Of 610 patients with recurrent herpes simplex (type 1 or type 2) in clinical studies who were treated with FAMVIR, 26 (4.3%) were > 65 years of age and 7 (1.1%) were > 75 years of age. Clinical studies of FAMVIR in patients with recurrent genital herpes did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently compared to younger subjects.

No famciclovir dosage adjustment based on age is recommended unless renal function is impaired [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. In general, appropriate caution should be exercised in the administration and monitoring of FAMVIR in elderly patients reflecting the greater frequency of decreased renal function and concomitant use of other drugs.

Patients with Renal Impairment

Apparent plasma clearance, renal clearance, and the plasma-elimination rate constant of penciclovir decreased linearly with reductions in renal function. After the administration of a single 500 mg famciclovir oral dose (n=27) to healthy volunteers and to volunteers with varying degrees of renal impairment (CLCR ranged from 6.4 to 138.8 mL/min), the following results were obtained (Table 4):

Table 4 : Pharmacokinetic Parameters of Penciclovir in Subjects with Different Degrees of Renal Impairment

Parameter (mean ± S.D.) CLcr† ≥ 60 (mL/min)
(n=15)
CLcr 40-59 (mL/min)
(n=5)
CLCR 20-39 (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 13.0 ± 1.3* 4.2 ± 0.9 1.6 ± 1.0
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
†CLcr is measured creatinine clearance.
‡ n=4.
§ CL/F consists of bioavailability factor and famciclovir to penciclovir conversion factor.

In a multiple-dose study of famciclovir conducted in subjects with varying degrees of renal impairment (n=18), the pharmacokinetics of penciclovir were comparable to those after single doses.

A dosage adjustment is recommended for patients with renal impairment [see DOSAGE AND ADMINISTRATION].

Patients with Hepatic Impairment

Mild or moderate hepatic impairment (chronic hepatitis [n=6], chronic ethanol abuse [n=8], or primary biliary cirrhosis [n=1]) had no effect on the extent of availability (AUC) of penciclovir following a single dose of 500 mg famciclovir. However, there was a 44% decrease in penciclovir mean maximum plasma concentration (Cmax) and the time to maximum plasma concentration (tmax) was increased by 0.75 hours in patients with hepatic impairment compared to normal volunteers. No dosage adjustment is recommended for patients with mild or moderate hepatic impairment. The pharmacokinetics of penciclovir has not been evaluated in patients with severe hepatic impairment. Conversion of famciclovir to the active metabolite penciclovir may be impaired in these patients resulting in a lower penciclovir plasma concentrations, and thus possibly a decrease of efficacy of famciclovir (see section 12 CLINICAL PHARMACOLOGY).

Black and African American Patients

In a randomized, double-blind, placebo-controlled trial conducted in 304 immunocompetent Black and African American adults with recurrent genital herpes there was no difference in median time to healing between patients receiving FAMVIR or placebo. In general, the adverse reaction profile was similar to that observed in other FAMVIR clinical trials for adult patients [see ADVERSE REACTIONS]. The relevance of these study results to other indications in Black and African American patients is unknown [see Clinical Studies].

Last reviewed on RxList: 2/16/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Appropriate symptomatic and supportive therapy should be given. Penciclovir is removed by hemodialysis.

CONTRAINDICATIONS

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

Last reviewed on RxList: 2/16/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Famciclovir is an orally administered prodrug of the antiviral agent penciclovir.

Pharmacokinetics

Famciclovir is the diacetyl 6-deoxy analog of the active antiviral compound penciclovir. Following oral administration famciclovir undergoes rapid and extensive metabolism to penciclovir and little or no famciclovir is detected in plasma or urine. Penciclovir is predominantly eliminated unchanged by the kidney. Therefore, the dose of FAMVIR needs to be adjusted in patients with different degrees of renal impairment [see DOSAGE AND ADMINISTRATION].

Pharmacokinetics in adults

Absorption and Bioavailability

The absolute bioavailability of penciclovir is 77 ± 8% as determined following the administration of a 500 mg famciclovir oral dose and a 400 mg penciclovir intravenous dose to 12 healthy male subjects.

Penciclovir concentrations increased in proportion to dose over a famciclovir dose range of 125 mg to 1000 mg administered as a single dose. Table 5 shows the mean pharmacokinetic parameters of penciclovir after single administration of FAMVIR to healthy male volunteers.

Table 5 : Mean Pharmacokinetic Parameters of Penciclovir in Healthy Adult Subjects*

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
* 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.

Following oral single-dose administration of 500 mg famciclovir to seven patients with herpes zoster, the AUC (mean ± SD), Cmax, and tmax were 12.1±1.7 mcg hr/mL, 4.0±0.7 mcg/mL, and 0.7±0.2 hours, respectively. The AUC of penciclovir was approximately 35% greater in patients with herpes zoster as compared to healthy volunteers. Some of this difference may be due to differences in renal function between the two groups.

There is no accumulation of penciclovir after the administration of 500 mg famciclovir three times daily for 7 days.

Penciclovir Cmax decreased approximately 50% and tmax was delayed by 1.5 hours when a capsule formulation of famciclovir was administered with food (nutritional content was approximately 910 Kcal and 26% fat). There was no effect on the extent of availability (AUC) of penciclovir. There was an 18% decrease in Cmax and a delay in tmax of about 1 hour when famciclovir was given 2 hours after a meal as compared to its administration 2 hours before a meal. Because there was no effect on the extent of systemic availability of penciclovir, FAMVIR can be taken without regard to meals.

Distribution

The volume of distribution (Vdβ) was 1.08±0.17 L/kg in 12 healthy male subjects following a single intravenous dose of penciclovir at 400 mg administered as a 1-hour intravenous infusion. Penciclovir is < 20% bound to plasma proteins over the concentration range of 0.1 to 20 mcg/mL. The blood/plasma ratio of penciclovir is approximately 1.

Metabolism

Following oral administration, famciclovir is deacetylated and oxidized to form penciclovir. Metabolites that are inactive include 6-deoxy penciclovir, monoacetylated penciclovir, and 6-deoxy monoacetylated penciclovir (5%, < 0.5% and < 0.5% of the dose in the urine, respectively). Little or no famciclovir is detected in plasma or urine. An in vitro study using human liver microsomes demonstrated that cytochrome P450 does not play an important role in famciclovir metabolism. The conversion of 6-deoxy penciclovir to penciclovir is catalyzed by aldehyde oxidase. Cimetidine and promethazine, in vitro inhibitors of aldehyde oxidase, did not show relevant effects on the formation of penciclovir in vivo [see DRUG INTERACTIONS].

Elimination

Approximately 94% of administered radioactivity was recovered in urine over 24 hours (83% of the dose was excreted in the first 6 hours) after the administration of 5 mg/kg radiolabeled penciclovir as a 1-hour infusion to three healthy male volunteers. Penciclovir accounted for 91% of the radioactivity excreted in the urine.

Following the oral administration of a single 500 mg dose of radiolabeled famciclovir to three healthy male volunteers, 73% and 27% of administered radioactivity were recovered in urine and feces over 72 hours, respectively. Penciclovir accounted for 82% and 6-deoxy penciclovir accounted for 7% of the radioactivity excreted in the urine. Approximately 60% of the administered radiolabeled dose was collected in urine in the first 6 hours.

After intravenous administration of penciclovir in 48 healthy male volunteers, mean ± SD total plasma clearance of penciclovir was 36.6±6.3 L/hr (0.48±0.09 L/hr/kg). Penciclovir renal clearance accounted for 74.5±8.8% of total plasma clearance.

Renal clearance of penciclovir following the oral administration of a single 500 mg dose of famciclovir to 109 healthy male volunteers was 27.7±7.6 L/hr. Active tubular secretion contributes to the renal elimination of penciclovir.

The plasma elimination half-life of penciclovir was 2.0±0.3 hours after intravenous administration of penciclovir to 48 healthy male volunteers and 2.3±0.4 hours after oral administration of 500 mg famciclovir to 124 healthy male volunteers. The half-life in 17 patients with herpes zoster was 2.8±1.0 hours and 2.7±1.0 hours after single and repeated doses, respectively.

Special populations

Geriatric patients: Based on cross study comparison, penciclovir AUC was 40% higher and penciclovir renal clearance was 22% lower in elderly subjects (n=18, age 65-79 years) as compared with younger subjects Some of this difference may be due to differences in renal function between the two groups. No famciclovir dosage adjustment based on age is recommended unless renal function is impaired [see DOSAGE AND ADMINISTRATION, Use in Specific Populations.]

Patients with renal impairment: In subjects with varying degrees of renal impairment, apparent plasma clearance, renal clearance, and the plasma-elimination rate constant of penciclovir decreased linearly with reductions in renal function, after both single and repeated dosing [see Use In Specific Populations]. A dosage adjustment is recommended for patients with renal impairment [see DOSAGE AND ADMINISTRATION].

Patients with hepatic impairment: Mild or moderate hepatic impairment had no effect on the extent of availability (AUC) of penciclovir [see Use In Specific Populations]. No dosage adjustment is recommended for patients with mild or moderate hepatic impairment. The effect of severe hepatic impairment on the pharmacokinetics of penciclovir has not been evaluated.

HIV-infected patients: Following oral administration of a single dose of 500 mg famciclovir to HIV-positive patients, the pharmacokinetic parameters of penciclovir were comparable to those observed in healthy subjects.

Gender: The pharmacokinetics of penciclovir were evaluated in 18 healthy male and 18 healthy female volunteers after single-dose oral administration of 500 mg famciclovir. AUC of penciclovir was 9.3±1.9 mcg hr/mL and 11.1±2.1 mcg hr/mL in males and females, respectively. Penciclovir renal clearance was 28.5±8.9 L/hr and 21.8±4.3 L/hr, respectively.

These differences were attributed to differences in renal function between the two groups. No famciclovir dosage adjustment based on gender is recommended.

Race: A retrospective evaluation was performed to compare the pharmacokinetic parameters obtained in Black and Caucasian subjects after single and repeat once-daily, twice-daily, or three times-daily administration of famciclovir 500 mg. Data from a study in healthy volunteers (single dose), a study in subjects with varying degrees of renal impairment (single and repeat dose) and a study in subjects with hepatic impairment (single dose) did not indicate any significant differences in the pharmacokinetics of penciclovir between Black and Caucasian subjects.

Virology

Mechanism of action

Famciclovir is a prodrug of penciclovir, which has demonstrated inhibitory activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2) and varicella zoster virus (VZV). In cells infected with HSV-1, HSV-2 or VZV, the viral thymidine kinase phosphorylates penciclovir to a monophosphate form that, in turn, is converted by cellular kinases to the active form penciclovir triphosphate. Biochemical studies demonstrate that penciclovir triphosphate inhibits HSV-2 DNA polymerase competitively with deoxyguanosine triphosphate. Consequently, herpes viral DNA synthesis and, therefore, replication are selectively inhibited. Penciclovir triphosphate has an intracellular half-life of 10 hours in HSV-1-, 20 hours in HSV-2- and 7 hours in VZV-infected cells grown in culture. However, the clinical significance of the intracellular half-life is unknown.

Antiviral activity

In cell culture studies, penciclovir is inhibitory to the following herpes viruses: HSV-1, HSV-2 and VZV. The antiviral activity of penciclovir against wild type strains grown on human foreskin fibroblasts was assessed with a plaque reduction assay and staining with crystal violet 3 days postinfection for HSV and 10 days postinfection for VZV. The median EC50 values of penciclovir against laboratory and clinical isolates of HSV-1, HSV-2, and VZV were 2 μM (range 1.2 to 2.4 μM, n = 7), 2.6 μM (range 1.6 to 11 μM, n = 6), and 34 μM (range 6.7 to 71 μM, n = 6), respectively.

Resistance

Penciclovir-resistant mutants of HSV and VZV can result from mutations in the viral thymidine kinase (TK) and DNA polymerase genes. Mutations in the viral TK gene may lead to complete loss of TK activity (TK negative), reduced levels of TK activity (TK partial), or alteration in the ability of viral TK to phosphorylate the drug without an equivalent loss in the ability to phosphorylate thymidine (TK altered). The median EC50 values observed in a plaque reduction assay with penciclovir resistant HSV-1, HSV-2, and VZV were 69 μM (range 14 to 115 μM, n = 6), 46 μM (range 4 to > 395 μM, n = 9), and 92 μM (range 51 to 148 μM, n = 4), respectively. The possibility of viral resistance to penciclovir should be considered in patients who fail to respond or experience recurrent viral shedding during therapy.

Cross-resistance

Cross-resistance has been observed among HSV DNA polymerase inhibitors. The most commonly encountered acyclovir resistant mutants that are TK negative are also resistant to penciclovir.

Animal Toxicology

Juvenile toxicity study in rats

In juvenile rats, famciclovir was administered daily at doses of 0, 40, 125, or 400 mg/kg/day for 10 weeks beginning on post-partum Day 4. There were no treatment related deaths or clinical observations. The toxicity of famciclovir was not enhanced in juvenile rats compared to that in the adult animals.

Clinical Studies

Herpes Labialis (Cold Sores)

A randomized, double-blind, placebo-controlled trial was conducted in 701 immunocompetent adults with recurrent herpes labialis. Patients self-initiated therapy within 1 hour of first onset of signs or symptoms of a recurrent herpes labialis episode with FAMVIR 1500 mg as a single dose (n=227), FAMVIR 750 mg twice daily (n=220) or placebo (n=254) for 1 day. The median time to healing among patients with non-aborted lesions (progressing beyond the papule stage) was 4.4 days in the FAMVIR 1500 mg single-dose group (n=152) as compared to 6.2 days in the placebo group (n=168). The median difference in time to healing between the placebo and FAMVIR 1500 mg treated groups was 1.3 days (95% CI: 0.6 – 2.0). No differences in proportion of patients with aborted lesions (not progressing beyond the papule stage) were observed between patients receiving FAMVIR or placebo: 33% for FAMVIR 1500 mg single dose and 34% for placebo. The median time to loss of pain and tenderness was 1.7 days in FAMVIR 1500 mg single dose-treated patients versus 2.9 days in placebo-treated patients.

Genital Herpes

Recurrent episodes

A randomized, double-blind, placebo-controlled trial was conducted in 329 immunocompetent adults with recurrent genital herpes. Patients self-initiated therapy within 6 hours of the first sign or symptom of a recurrent genital herpes episode with either FAMVIR 1000 mg twice daily (n=163) or placebo (n=166) for 1 day. The median time to healing among patients with non-aborted lesions (progressing beyond the papule stage) was 4.3 days in FAMVIR-treated patients (n=125) as compared to 6.1 days in placebo-treated patients (n=145). The median difference in time to healing between the placebo and FAMVIR-treated groups was 1.2 days (95% CI: 0.5 to 2.0). Twenty-three percent of FAMVIR-treated patients had aborted lesions (no lesion development beyond erythema) versus 13% in placebo-treated patients. The median time to loss of all symptoms (e.g., tingling, itching, burning, pain, or tenderness) was 3.3 days in FAMVIR-treated patients vs. 5.4 days in placebo-treated patients.

A randomized (2:1), double-blind, placebo-controlled trial was conducted in 304 immunocompetent Black and African American adults with recurrent genital herpes. Patients self-initiated therapy within 6 hours of the first sign or symptom of a recurrent genital herpes episode with either FAMVIR 1000 mg twice daily (n=206) or placebo (n=98) for 1 day. The median time to healing among patients with non-aborted lesions was 5.4 days in FAMVIR-treated patients (n=152) as compared to 4.8 days in placebo-treated patients (n=78). The median difference in time to healing between the placebo and FAMVIR-treated groups was -0.26 days (95% CI: -0.98 to 0.40).

Suppressive therapy

Two randomized, double-blind, placebo-controlled, 12-month trials were conducted in 934 immunocompetent adults with a history of 6 or more recurrences of genital herpes episodes per year. Comparisons included FAMVIR 125 mg three times daily, 250 mg twice daily, 250 mg three times daily, and placebo. At 12 months, 60% to 65% of patients were still receiving FAMVIR and 25% were receiving placebo treatment. Recurrence rates at 6 and 12 months in patients treated with the 250 mg twice daily dose are shown in Table 6.

Table 6 : Recurrence Rates at 6 and 12 Months in Adults with Recurrent Genital Herpes on Suppressive Therapy

  Recurrence Rates at 6 Months Recurrence Rates at 12 Months
Famvir 250 mg twice daily
(n=236)
Placebo
(n=233)
Famvir 250 mg twice daily
(n=236)
Placebo
(n=233)
Recurrence-free 39% 10% 29% 6%
Recurrences† 47% 74% 53% 78%
Lost to follow-up‡ 14% 16% 17% 16%
†Based on patient reported data; not necessarily confirmed by a physician.
‡Patients recurrence-free at time of last contact prior to withdrawal.

FAMVIR-treated patients had approximately 1/5 the median number of recurrences as compared to placebo-treated patients. Higher doses of FAMVIR were not associated with an increase in efficacy.

Recurrent Orolabial or Genital Herpes in HIV-Infected Patients

A randomized, double-blind trial compared famciclovir 500 mg twice daily for 7 days (n=150) with oral acyclovir 400 mg 5 times daily for 7 days (n=143) in HIV-infected patients with recurrent orolabial or genital herpes treated within 48 hours of lesion onset. Approximately 40% of patients had a CD4+ count below 200 cells/mm³, 54% of patients had anogenital lesions and 35% had orolabial lesions. Famciclovir therapy was comparable to oral acyclovir in reducing new lesion formation and in time to complete healing.

Herpes Zoster (Shingles)

Two randomized, double-blind trials, 1 placebo-controlled and 1 active-controlled, were conducted in 964 immunocompetent adults with uncomplicated herpes zoster. Treatment was initiated within 72 hours of first lesion appearance and was continued for 7 days.

In the placebo-controlled trial, 419 patients were treated with either FAMVIR 500 mg three times daily (n=138), FAMVIR 750 mg three times daily (n=135) or placebo (n=146). The median time to full crusting was 5 days among FAMVIR 500 mg-treated patients as compared to 7 days in placebo-treated patients. The times to full crusting, loss of vesicles, loss of ulcers, and loss of crusts were shorter for FAMVIR 500 mg-treated patients than for placebo-treated patients in the overall study population. The effects of FAMVIR were greater when therapy was initiated within 48 hours of rash onset; it was also more profound in patients 50 years of age or older. Among the 65.2% of patients with at least 1 positive viral culture, FAMVIR treated patients had a shorter median duration of viral shedding than placebo-treated patients (1 day and 2 days, respectively).

There were no overall differences in the duration of pain before rash healing between FAMVIR- and placebo-treated groups. In addition, there was no difference in the incidence of pain after rash healing (postherpetic neuralgia) between the treatment groups. In the 186 patients (44.4% of total study population) who developed postherpetic neuralgia, the median duration of postherpetic neuralgia was shorter in patients treated with FAMVIR 500 mg than in those treated with placebo (63 days and 119 days, respectively). No additional efficacy was demonstrated with higher dose of FAMVIR.

In the active-controlled trial, 545 patients were treated with one of three doses of FAMVIR three times daily or with acyclovir 800 mg five times daily. Times to full lesion crusting and times to loss of acute pain were comparable for all groups and there were no statistically significant differences in the time to loss of postherpetic neuralgia between FAMVIR and acyclovir-treated groups.

Last reviewed on RxList: 2/16/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

FAMVIR®
(Fam'-veer)
(famciclovir) Tablets

Read this Patient Information before you start taking FAMVIR and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is FAMVIR?

Famvir is a prescription antiviral medicine used to:

  • treat outbreaks of cold sores (fever blisters) in healthy adults
  • treat outbreaks of genital herpes in healthy adults
  • decrease the number of outbreaks of genital herpes in healthy adults
  • treat outbreaks of herpes simplex lesions in or around the mouth, genitals, and anal area in people infected with HIV
  • treat shingles (herpes zoster) in adults with normal immune system

It is not known if FAMVIR is safe and effective in children younger than 18 years of age.

FAMVIR is not a cure for herpes. It is not known if FAMVIR can stop the spread of herpes to others. If you are sexually active, you can pass herpes to your partner even if you are taking FAMVIR. Herpes can be transmitted even if you do not have active symptoms. You should continue to practice safer sex to lower the chances of spreading genital herpes to others. Do not have sexual contact with your partner during an outbreak of genital herpes or if you have any symptoms of genital herpes. Use a condom made of latex or polyurethane when you have a sexual contact. Ask your healthcare provider for more information about safer sex practices.

Who should not take FAMVIR?

Do not take FAMVIR if you are allergic to any of its ingredients or to Denavir® (penciclovir cream). See the end of this Patient Information leaflet for a complete list of ingredients in FAMVIR.

What should I tell my healthcare provider before taking FAMVIR?

Before you start taking FAMVIR, tell your healthcare provider if you:

  • have kidney or liver problems
  • have a rare genetic problem with galactose intolerance, a severe lactase deficiency or you do not absorb glucose-galactose (malabsorption)
  • are pregnant or planning to become pregnant. It is not known if FAMVIR will harm your unborn baby
  • Pregnancy Exposure Reporting: Novartis Pharmaceuticals Corporation collects pregnancy reports which are reported on a voluntary basis. In case of pregnancy, talk to your healthcare provider about reporting your pregnancy.
  • are breast-feeding or plan to breast-feed.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

  • any other medicines and products you use to treat herpes outbreaks
  • probenecid (Probalan)

Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist every time you get a new medicine.

How should I take FAMVIR?

  • Take FAMVIR exactly as prescribed
  • Your healthcare provider will tell you how many FAMVIR to take and when to take them. Your dose of FAMVIR and how often you take it may be different depending on your condition
  • FAMVIR can be taken with or without food
  • It is important for you to finish all of the medicine as prescribed, even if you begin to feel better
  • Your symptoms may continue even after you finish all of your FAMVIR. This does not mean that you need more medicine, since you have already finished a full course of FAMVIR and it will continue to work in your body. Talk to your healthcare provider if you have any questions about your condition and your treatment

What are the possible side effects of FAMVIR?

The most common side effects of FAMVIR include:

Talk to your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of FAMVIR. Ask your healthcare provider or pharmacist for more information.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store FAMVIR?

  • Store FAMVIR at room temperature between 59° and 86°F (15° to 30°C).

Keep FAMVIR and all medicines out of reach from children.

General information about FAMVIR

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use FAMVIR for a condition for which it was not prescribed. Do not give FAMVIR to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about FAMVIR. If you would like more information, talk with your healthcare provider. Your healthcare provider or pharmacist can give you information about FAMVIR that is written for health professionals. For more information, go to www.FAMVIR.com or call 1-888-669-6682.

What are the ingredients in FAMVIR?

Active ingredient: famciclovir

Inactive ingredients: hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose, magnesium stearate, polyethylene glycols, sodium starch glycolate, and titanium dioxide

Last reviewed on RxList: 2/16/2012
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

FAMVIR®
(Fam'-veer)
(famciclovir) Tablets

Read this Patient Information before you start taking FAMVIR and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is FAMVIR?

Famvir is a prescription antiviral medicine used to:

  • treat outbreaks of cold sores (fever blisters) in healthy adults
  • treat outbreaks of genital herpes in healthy adults
  • decrease the number of outbreaks of genital herpes in healthy adults
  • treat outbreaks of herpes simplex lesions in or around the mouth, genitals, and anal area in people infected with HIV
  • treat shingles (herpes zoster) in adults with normal immune system

It is not known if FAMVIR is safe and effective in children younger than 18 years of age.

FAMVIR is not a cure for herpes. It is not known if FAMVIR can stop the spread of herpes to others. If you are sexually active, you can pass herpes to your partner even if you are taking FAMVIR. Herpes can be transmitted even if you do not have active symptoms. You should continue to practice safer sex to lower the chances of spreading genital herpes to others. Do not have sexual contact with your partner during an outbreak of genital herpes or if you have any symptoms of genital herpes. Use a condom made of latex or polyurethane when you have a sexual contact. Ask your healthcare provider for more information about safer sex practices.

Who should not take FAMVIR?

Do not take FAMVIR if you are allergic to any of its ingredients or to Denavir® (penciclovir cream). See the end of this Patient Information leaflet for a complete list of ingredients in FAMVIR.

What should I tell my healthcare provider before taking FAMVIR?

Before you start taking FAMVIR, tell your healthcare provider if you:

  • have kidney or liver problems
  • have a rare genetic problem with galactose intolerance, a severe lactase deficiency or you do not absorb glucose-galactose (malabsorption)
  • are pregnant or planning to become pregnant. It is not known if FAMVIR will harm your unborn baby
  • Pregnancy Exposure Reporting: Novartis Pharmaceuticals Corporation collects pregnancy reports which are reported on a voluntary basis. In case of pregnancy, talk to your healthcare provider about reporting your pregnancy.
  • are breast-feeding or plan to breast-feed.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

  • any other medicines and products you use to treat herpes outbreaks
  • probenecid (Probalan)

Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist every time you get a new medicine.

How should I take FAMVIR?

  • Take FAMVIR exactly as prescribed
  • Your healthcare provider will tell you how many FAMVIR to take and when to take them. Your dose of FAMVIR and how often you take it may be different depending on your condition
  • FAMVIR can be taken with or without food
  • It is important for you to finish all of the medicine as prescribed, even if you begin to feel better
  • Your symptoms may continue even after you finish all of your FAMVIR. This does not mean that you need more medicine, since you have already finished a full course of FAMVIR and it will continue to work in your body. Talk to your healthcare provider if you have any questions about your condition and your treatment

What are the possible side effects of FAMVIR?

The most common side effects of FAMVIR include:

Talk to your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of FAMVIR. Ask your healthcare provider or pharmacist for more information.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store FAMVIR?

  • Store FAMVIR at room temperature between 59° and 86°F (15° to 30°C).

Keep FAMVIR and all medicines out of reach from children.

General information about FAMVIR

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use FAMVIR for a condition for which it was not prescribed. Do not give FAMVIR to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about FAMVIR. If you would like more information, talk with your healthcare provider. Your healthcare provider or pharmacist can give you information about FAMVIR that is written for health professionals. For more information, go to www.FAMVIR.com or call 1-888-669-6682.

What are the ingredients in FAMVIR?

Active ingredient: famciclovir

Inactive ingredients: hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose, magnesium stearate, polyethylene glycols, sodium starch glycolate, and titanium dioxide

Last reviewed on RxList: 2/16/2012
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Famvir Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

FAMCICLOVIR - ORAL

(fam-SYE-kloe-vir)

COMMON BRAND NAME(S): Famvir

USES: Famciclovir is used to treat infections caused by certain types of viruses. It treats shingles caused by herpes zoster. It also treats outbreaks of herpes simplex that cause cold sores around the mouth, sores around the anus, and genital herpes. In people with frequent outbreaks of genital herpes, famciclovir is used to help reduce the number of future episodes.

Famciclovir is an antiviral drug. However, it is not a cure for these infections. The viruses that cause these infections continue to live in the body even between outbreaks. Famciclovir decreases the severity and length of these outbreaks. It helps the sores heal faster, keeps new sores from forming, and decreases pain/itching. This medication may also help reduce how long pain remains after the sores heal. In addition, in people with a weakened immune system, famciclovir can decrease the risk of the virus spreading to other parts of the body and causing serious infections.

HOW TO USE: Take this medication by mouth with or without food, usually 2 to 3 times a day or as directed by your doctor.

This medication works best when started at the first sign of an outbreak, as directed by your doctor. It may not work as well if you delay treatment.

Dosage is based on your medical condition and response to treatment.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.

Continue to take this medication until the full prescribed amount is finished. Do not change your dose, skip any doses, or stop this medication early without your doctor's approval.

Tell your doctor if your condition persists or worsens.

Disclaimer

Famvir Consumer (continued)

SIDE EFFECTS: Headache, nausea, and diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, slowed thinking, confusion, hallucinations), dizziness, drowsiness.

Tell your doctor immediately if any of these rare but serious side effects occur: change in the amount of urine, yellowing eyes/skin, easy bruising/bleeding.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Famvir (famciclovir) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking famciclovir, tell your doctor or pharmacist if you are allergic to it; or to penciclovir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems.

This drug may rarely make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may contain lactose. If you have certain conditions such as galactose intolerance, severe lactase deficiency (not lactose or milk intolerance), or glucose-galactose malabsorption that require you to restrict your intake of lactose, consult your doctor or pharmacist before taking this medication.

Kidney function declines as you grow older. This medication is removed by the kidneys. Older adults may be more sensitive to the side effects of this drug, especially dizziness, drowsiness, confusion, and change in the amount of urine.

Famciclovir does not protect against the spread of genital herpes. To lower the chance of giving herpes to your partner, do not have sexual contact during an outbreak or if you have symptoms. You can spread genital herpes even if you do not have symptoms. Therefore, always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. It may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Disclaimer

Famvir Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact your poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor directs you to do so. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Famvir Patient Information Including Side Effects

Brand Names: Famvir

Generic Name: famciclovir (Pronunciation: fam SYE klo veer)

What is famciclovir (Famvir)?

Famciclovir is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Famciclovir will not cure herpes, but it can lessen the symptoms of the infections.

Famciclovir is used to treat infections caused by herpes viruses, including genital herpes, cold sores, shingles, and chicken pox.

There is no cure for herpes and famciclovir will not prevent you from developing symptoms in the future.

Famciclovir may also be used for other purposes not listed in this medication guide.

Famciclovir 125 mg-TEV

round, white, imprinted with 93, 8117

Famciclovir 250 mg-TEV

round, white, imprinted with 93, 8118

Famciclovir 500 mg-TEV

oblong, white, imprinted with 93, 8119

Famvir 125 mg

round, white, imprinted with FAMVIR, 125

Famvir 250 mg

round, white, imprinted with FAMVIR, 250

Famvir 500 mg

oblong, white, imprinted with FAMVIR, 500

What are the possible side effects of famciclovir (Famvir)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • nausea, vomiting, stomach pain;
  • diarrhea,
  • headache, tired feeling;
  • dizziness, sleepiness;
  • mild itching or skin rash;
  • numbness or tingly feeling; or
  • confusion.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Famvir (famciclovir) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about famciclovir (Famvir)?

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

Treatment with famciclovir should be started as soon as possible after the first appearance of symptoms (such as tingling, burning, blisters).

Herpes infections are contagious and you can infect other people, even while you are being treated with famciclovir. Avoid letting infected areas come into contact with other people. Avoid touching an infected area and then touching your eyes. Wash your hands frequently to prevent passing the infection to others.

Side Effects Centers

Famvir Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking famciclovir (Famvir)?

Do not take famciclovir if you are allergic to penciclovir cream (Denavir).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • kidney disease;
  • a weak immune system;
  • galactose intolerance;
  • severe lactase deficiency; or
  • glucose-galactose malabsorption.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Your name may need to be listed on a pregnancy registry if you become pregnant while using this medication. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether famciclovir had any effect on the baby.

It is not known whether famciclovir passes into breast milk, or if it could harm a nursing baby. Do not take famciclovir without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 18 years old.

How should I take famciclovir (Famvir)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Treatment with famciclovir should be started as soon as possible after the first appearance of symptoms (such as tingling, burning, blisters).

Take each dose with a full glass of water. Drink plenty of water while you are taking famciclovir to keep your kidneys working properly.

Famciclovir can be taken with or without food. Taking famciclovir with food may decrease stomach upset.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. To prevent recurrent genital herpes, you may need to take famciclovir twice daily for up to 1 year. Follow your doctor's instructions.

Lesions caused by herpes viruses should be kept as clean and dry as possible. Wearing loose clothing may help to prevent irritation of the lesions.

Store famciclovir at room temperature away from moisture and heat.

Side Effects Centers

Famvir Patient Information including If I Miss a Dose

What happens if I miss a dose (Famvir)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Famvir)?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a famciclovir overdose are unknown.

What should I avoid while taking famciclovir (Famvir)?

Herpes infections are contagious and you can infect other people, even while you are being treated with famciclovir. Avoid letting infected areas come into contact with other people. Avoid touching an infected area and then touching your eyes. Wash your hands frequently to prevent passing the infection to others.

Famciclovir will not prevent the spread of genital herpes. Avoid sexual intercourse or use a latex condom to prevent spreading the virus to others.

Famciclovir can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What other drugs will affect famciclovir (Famvir)?

Before taking famciclovir, tell your doctor if you are also taking probenecid (Benemid). If you are using probenecid, you may not be able to use famciclovir, or you may need dosage adjustments or special tests during treatment.

This list is not complete and there may be other drugs that can interact with famciclovir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about famciclovir.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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