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Valtrex
Generic Name: Valacyclovir Hydrochloride
Drug Category: DNA Polymerase Inhibitor
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 2 years old for a maximum duration of 1 year.
| Approved Uses |
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Indicated for: Adult Patients: Cold Sores (Herpes Labialis): • The treatment of cold sores (herpes labialis). The efficacy of Valtrex initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Genital Herpes: • Initial Episode: For the treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with Valtrex when initiated more than 72 hours after the onset of signs and symptoms has not been established. • Recurrent Episodes: For the treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with Valtrex when initiated more than 24 hours after the onset of signs and symptoms has not been established. • Suppressive Therapy: For the chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV-1 infected adults. The efficacy and safety of Valtrex for the suppression of genital herpes beyond 1 year in immunocompetent patients and beyond 6 months in HIV-1 infected patients have not been established. • Reduction of Transmission: The reduction of transmission of genital herpes in immunocompetent adults. The efficacy of Valtrex for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established. The efficacy of Valtrex for the reduction of transmission of genital herpes in individuals with multiple partners and non-heterosexual couples has not been established. Safer sex practices should be used with suppressive therapy. Herpes Zoster: • The treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of Valtrex when initiated more than 72 hours after the onset of rash and the efficacy and safety of Valtrex for treatment of disseminated herpes zoster have not been established. Pediatric Patients: Cold Sores (Herpes Labialis): • The treatment of cold sores (herpes labialis) in pediatric patients 12 years of age and older. The efficacy of Valtrex initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Chickenpox: • The treatment of chickenpox in immunocompetent pediatric patients 2 to under 18 years of age. Based on efficacy data from clinical trials with oral acyclovir, treatment with Valtrex should be initiated within 24 hours after the onset of rash. The efficacy and safety of Valtrex have NOT been established in:
Valacyclovir hydrochloride has not been shown to reduce transmission of sexually transmitted infections other than HSV-2. Data are not available for the use of VALTREX in pediatric patients with a creatinine clearance less than 50 mL/min/1.73 m2. Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome in some cases resulting in death, has occurred in patients with advanced HIV-1 disease and also in allogeneic bone marrow transplant and renal transplant recipients participating in clinical trials of VALTREX at doses of 8 grams per day. Cases of acute renal failure have been reported in: elderly patients with or without reduced renal function, in patients with underlying renal disease who received higher-than-recommended doses of VALTREX for their level of renal function, patients receiving other nephrotoxic drugs, and patients without adequate hydration. 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 valacyclovir hydrochloride for their level of renal function. There are no adequate and well-controlled studies of valacyclovir hydrochloride or acyclovir in pregnant women. Although there is no information on the presence of valacyclovir in human milk, its metabolite, acyclovir, is present in human milk following oral administration of valacyclovir. |
| Off-label Uses |
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• Cold sores in patients under the age of 12. GoToSource • Chickenpox in patients under the age of 2. GoToSource • Genital herpes in patients under the age of 18. GoToSource • Herpes zoster (shingles) in patients under the age of 18. GoToSource • Suppressive therapy in neonates and infants following neonatal herpes simplex virus infection. GoToSource • Use longer than 1 day for adult and pediatric cold sores. GoToSource • Use longer than 10 days for adult initial genital herpes. GoToSource • Use longer than 3 days for adult recurrent genital herpes. GoToSource • Use longer than 7 days for adult herpes zoster (shingles). GoToSource • Use longer than 6 months for suppression of genital herpes in adult HIV-1 infected patients. GoToSource • Use long than 1 year for suppression of genital herpes in immunocompetent adult patients. GoToSource • Use longer than 5 days for pediatric chickenpox. GoToSource • Use after development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer). GoToSource • Treatment initiated more than 72 hours after the onset of genital herpes signs and symptoms. GoToSource • Treatment initiated more than 24 hours after the onset of signs and symptoms of recurrent episodes of genital herpes in immunocompetent adults. GoToSource • Treatment initiated more than 72 hours after the onset of rash of adult disseminated herpes zoster (shingles). GoToSource • Cytomegalovirus and herpes simplex virus co-infected perigenital ulcers. GoToSource • Ramsay hunt syndrome. GoToSource • Prophylaxis for CMV infection in renal, heart and bone marrow transplantation. GoToSource • Herpes simplex encephalitis. GoToSource • Anti-sickling agent in sickle-cell anemia patients. GoToSource • Acute zonal occult outer retinopathy. GoToSource • EBV infectious mononucleosis. GoToSource • Persistent facial folliculitis. GoToSource • Hydroa vacciniforme. GoToSource • Symptoms of persistent schizophrenia. GoToSource |
| Adverse Events |
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Toxic hepatitis (liver inflammation). GoToSource Neurotoxicity in renal failure patients. GoToSource Psychosis with manic presentation. GoToSource Kidney injury. GoToSource Leukopenia (low white blood cell count). GoToSource Encephalopathy. GoToSource Symmetrical drug-related intertriginous and flexural exanthema (rash in skin folds). GoToSource Thrombotic thrombocytopenic purpura (blood clots forming in small blood vessels throughout the body). GoToSource |
| Litigation |
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No major injury lawsuits reported. |
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