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Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome (TTP/HUS)
TTP/HUS, in some cases resulting in death, has occurred in patients with advanced HIV disease and also in allogeneic bone marrow transplant and renal transplant recipients participating in clinical trials of VALTREX (valacyclovir hydrochloride) at doses of 8 grams per day. Treatment with VALTREX (valacyclovir hydrochloride) should be stopped immediately if clinical signs, symptoms, and laboratory abnormalities consistent with TTP/HUS occur.
Acute Renal Failure
Cases of acute renal failure have been reported in:
- Elderly patients with or without reduced renal function. Caution should be exercised when administering VALTREX (valacyclovir hydrochloride) to geriatric patients, and dosage reduction is recommended for those with impaired renal function [see DOSAGE AND ADMINISTRATION, Use in Specific Populations].
- Patients with underlying renal disease who received higher than recommended doses of VALTREX (valacyclovir hydrochloride) for their level of renal function. Dosage reduction is recommended when administering VALTREX to patients with renal impairment [see DOSAGE AND ADMINISTRATION, Use in Specific Populations].
- Patients receiving other nephrotoxic drugs. Caution should be exercised when administering VALTREX (valacyclovir hydrochloride) to patients receiving potentially nephrotoxic drugs.
- Patients without adequate hydration. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. Adequate hydration should be maintained for all patients.
Central Nervous System Effects
Central nervous system adverse reactions, including agitation, hallucinations, confusion, delirium, seizures, and encephalopathy, have been reported in both adult and pediatric patients with or without reduced renal function and in patients with underlying renal disease who received higher than recommended doses of VALTREX (valacyclovir hydrochloride) for their level of renal function. Elderly patients are more likely to have central nervous system adverse reactions. VALTREX (valacyclovir hydrochloride) should be discontinued if central nervous system adverse reactions occur [see ADVERSE REACTIONS, Use in Specific Populations].
Patient Counseling Information
See FDA-Approved Patient Labeling.
Importance of Adequate Hydration
Patients should be advised to maintain adequate hydration.
Cold Sores (Herpes Labialis)
Patients should be advised to initiate treatment at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). There are no data on the effectiveness of treatment initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer). Patients should be instructed that treatment for cold sores should not exceed 1 day (2 doses) and that their doses should be taken about 12 hours apart. Patients should be informed that VALTREX (valacyclovir hydrochloride) is not a cure for cold sores.
Patients should be informed that VALTREX (valacyclovir hydrochloride) is not a cure for genital herpes. 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 in combination with suppressive therapy with VALTREX (valacyclovir hydrochloride) . Sex partners of infected persons should be advised that they might be infected even if they have no symptoms. Type-specific serologic testing of asymptomatic partners of persons with genital herpes can determine whether risk for HSV-2 acquisition exists.
VALTREX (valacyclovir hydrochloride) has not been shown to reduce transmission of sexually transmitted infections other than HSV-2.
If medical management of a genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode.
There are no data on the effectiveness of treatment initiated more than 72 hours after the onset of signs and symptoms of a first episode of genital herpes or more than 24 hours after the onset of signs and symptoms of a recurrent episode.
There are no data on the safety or effectiveness of chronic suppressive therapy of more than 1 year's duration in otherwise healthy patients. There are no data on the safety or effectiveness of chronic suppressive therapy of more than 6 months' duration in HIV-infected patients.
There are no data on treatment initiated more than 72 hours after onset of the zoster rash. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster.
Patients should be advised to initiate treatment at the earliest sign or symptom of chickenpox.
This product's prescribing information may have been updated. Please refer to www.gsk.com for the most current version.
Carcinogenesis, Mutagenesis, Impairment of Fertility
The data presented below include references to the steady-state acyclovir AUC observed in humans treated with 1 gram VALTREX (valacyclovir hydrochloride) given orally 3 times a day to treat herpes zoster. Plasma drug concentrations in animal studies are expressed as multiples of human exposure to acyclovir [see CLINICAL PHARMACOLOGY].
Valacyclovir was noncarcinogenic in lifetime carcinogenicity bioassays at single daily doses (gavage) of valacyclovir giving plasma acyclovir concentrations equivalent to human levels in the mouse bioassay and 1.4 to 2.3 times human levels in the rat bioassay. There was no significant difference in the incidence of tumors between treated and control animals, nor did valacyclovir shorten the latency of tumors.
Valacyclovir was tested in 5 genetic toxicity assays. An Ames assay was negative in the absence or presence of metabolic activation. Also negative were an in vitro cytogenetic study with human lymphocytes and a rat cytogenetic study.
In the mouse lymphoma assay, valacyclovir was not mutagenic in the absence of metabolic activation. In the presence of metabolic activation (76% to 88% conversion to acyclovir), valacyclovir was mutagenic.
Valacyclovir was mutagenic in a mouse micronucleus assay.
Valacyclovir did not impair fertility or reproduction in rats at 6 times human plasma levels.
Use In Specific Populations
Pregnancy Category B. There are no adequate and well-controlled studies of VALTREX (valacyclovir hydrochloride) or acyclovir in pregnant women. Based on prospective pregnancy registry data on 749 pregnancies, the overall rate of birth defects in infants exposed to acyclovir in-utero appears similar to the rate for infants in the general population. VALTREX (valacyclovir hydrochloride) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
A prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999. There were 749 pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximates that found in the general population. However, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses.
Animal reproduction studies performed at oral doses that provided up to 10 and 7 times the human plasma levels during the period of major organogenesis in rats and rabbits, respectively, revealed no evidence of teratogenicity.
Following oral administration of a 500 mg dose of VALTREX (valacyclovir hydrochloride) to 5 nursing mothers, peak acyclovir concentrations (Cmax) in breast milk ranged from 0.5 to 2.3 times (median 1.4) the corresponding maternal acyclovir serum concentrations. The acyclovir breast milk AUC ranged from 1.4 to 2.6 times (median 2.2) maternal serum AUC. A 500 mg maternal dosage of VALTREX (valacyclovir hydrochloride) twice daily would provide a nursing infant with an oral acyclovir dosage of approximately 0.6 mg/kg/day. This would result in less than 2% of the exposure obtained after administration of a standard neonatal dose of 30 mg/kg/day of intravenous acyclovir to the nursing infant. Unchanged valacyclovir was not detected in maternal serum, breast milk, or infant urine. Caution should be exercised when VALTREX (valacyclovir hydrochloride) is administered to a nursing woman.
VALTREX (valacyclovir hydrochloride) is indicated for treatment of cold sores in pediatric patients ≥ 12 years of age and for treatment of chickenpox in pediatric patients 2 to < 18 years of age [see INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION].
The use of VALTREX (valacyclovir hydrochloride) for treatment of cold sores is based on 2 double-blind, placebo-controlled clinical trials in healthy adults and adolescents ( ≥ 12 years of age) with a history of recurrent cold sores [see Clinical Studies].
The use of VALTREX (valacyclovir hydrochloride) for treatment of chickenpox in pediatric patients 2 to < 18 years of age is based on single-dose pharmacokinetic and multiple-dose safety data from an open-label trial with valacyclovir and supported by efficacy and safety data from 3 randomized, double-blind, placebo-controlled trials evaluating oral acyclovir in pediatric patients with chickenpox [see DOSAGE AND ADMINISTRATION, ADVERSE REACTIONS, CLINICAL PHARMACOLOGY, Clinical Studies].
The efficacy and safety of valacyclovir have not been established in pediatric patients:
- < 12 years of age with cold sores
- < 18 years of age with genital herpes
- < 18 years of age with herpes zoster
- < 2 years of age with chickenpox
for suppressive therapy following neonatal HSV infection.
The pharmacokinetic profile and safety of valacyclovir oral suspension in children < 12 years of age were studied in 3 open-label studies. No efficacy evaluations were conducted in any of the 3 studies.
Study 1 was a single-dose pharmacokinetic, multiple-dose safety study in 27 pediatric patients 1 to < 12 years of age with clinically suspected varicella-zoster virus (VZV) infection [see DOSAGE AND ADMINISTRATION, ADVERSE REACTIONS, CLINICAL PHARMACOLOGY, Clinical Studies].
Study 2 was a single-dose pharmacokinetic and safety study in pediatric patients 1 month to < 6 years of age who had an active herpes virus infection or who were at risk for herpes virus infection. Fifty-seven subjects were enrolled and received a single dose of 25 mg/kg valacyclovir oral suspension. In infants and children 3 months to < 6 years of age, this dose provided comparable systemic acyclovir exposures to that from a 1 gram dose of valacyclovir in adults (historical data). In infants 1 month to < 3 months of age, mean acyclovir exposures resulting from a 25 mg/kg dose were higher (Cmax: ↑30%, AUC: ↑60%) than acyclovir exposures following a 1 gram dose of valacyclovir in adults. Acyclovir is not approved for suppressive therapy in infants and children following neonatal HSV infections; therefore valacyclovir is not recommended for this indication because efficacy cannot be extrapolated from acyclovir.
Study 3 was a single-dose pharmacokinetic, multiple-dose safety study in 28 pediatric patients 1 to < 12 years of age with clinically suspected HSV infection. None of the children enrolled in this study had genital herpes. Each subject was dosed with valacyclovir oral suspension, 10 mg/kg twice daily for 3 to 5 days. Acyclovir systemic exposures in pediatric patients following valacyclovir oral suspension were compared with historical acyclovir systemic exposures in immunocompetent adults receiving the solid oral dosage form of valacyclovir or acyclovir for the treatment of recurrent genital herpes. The mean projected daily acyclovir systemic exposures in pediatric patients across all age-groups (1 to < 12 years of age) were lower (Cmax: ↓20%, AUC: ↓33%) compared with the acyclovir systemic exposures in adults receiving valacyclovir 500 mg twice daily, but were higher (daily AUC: ↑16%) than systemic exposures in adults receiving acyclovir 200 mg 5 times daily. Insufficient data are available to support valacyclovir for the treatment of recurrent genital herpes in this age-group because clinical information on recurrent genital herpes in young children is limited; therefore, extrapolating efficacy data from adults to this population is not possible. Moreover, valacyclovir has not been studied in children 1 to < 12 years of age with recurrent genital herpes.
Of the total number of subjects in clinical studies of VALTREX (valacyclovir hydrochloride) , 906 were 65 and over, and 352 were 75 and over. In a clinical study of herpes zoster, the duration of pain after healing (post-herpetic neuralgia) was longer in patients 65 and older compared with younger adults. Elderly patients are more likely to have reduced renal function and require dose reduction. Elderly patients are also more likely to have renal or CNS adverse events [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].
Dosage reduction is recommended when administering VALTREX (valacyclovir hydrochloride) to patients with renal impairment [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/24/2011
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