1 INDICATIONS AND USAGE
VALTREX is a nucleoside analogue DNA polymerase inhibitor indicated for:
Adult Patients (1.1)
Cold Sores (Herpes Labialis)
Genital Herpes
Treatment in immunocompetent patients (initial or recurrent episode)
Suppression in immunocompetent or HIV-1 infected patients
Reduction of transmission
Herpes Zoster
Pediatric Patients (1.2)
Cold Sores (Herpes Labialis)
Chickenpox
Limitations of Use (1.3)
The efficacy and safety of VALTREX have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1 infected patients.
1.1 Adult Patients
Cold Sores (Herpes Labialis): VALTREX (valacyclovir hydrochloride) Caplets are indicated for 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: VALTREX is indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with VALTREX when initiated more than 72hours after the onset of signs and symptoms has not been established.
Recurrent Episodes: VALTREX is indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with VALTREX when initiated more than 24hours after the onset of signs and symptoms has not been established.
Suppressive Therapy: VALTREX is indicated for 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 1year in immunocompetent patients and beyond 6months in HIV-1 infected patients have not been established.
Reduction of Transmission: VALTREX is indicated for the reduction of transmission of genital herpes in immunocompetent adults. The efficacy of VALTREX for the reduction of transmission of genital herpes beyond 8months 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 (see current Centers for Disease Control and Prevention [CDC] Sexually Transmitted Diseases Treatment Guidelines).
Herpes Zoster: VALTREX is indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of VALTREX when initiated more than 72hours after the onset of rash and the efficacy and safety of VALTREX for treatment of disseminated herpes zoster have not been established.
1.2 Pediatric Patients
Cold Sores (Herpes Labialis): VALTREX is indicated for the treatment of cold sores (herpes labialis) in pediatric patients aged greater than or equal to 12years. 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: VALTREX is indicated for the treatment of chickenpox in immunocompetent pediatric patients aged 2 to less than 18years. Based on efficacy data from clinical studies with oral acyclovir, treatment with VALTREX should be initiated within 24hours after the onset of rash [see Clinical Studies (14.4)].
1.3 Limitations of Use
The efficacy and safety of VALTREX have not been established in:
Immunocompromised patients other than for the suppression of genital herpes in HIV-1 infected patients with a CD4+ cell count greater than or equal to 100cells/mm3.
Patients aged less than 12years with cold sores (herpes labialis).
Patients aged less than 2years or greater than or equal to 18years with chickenpox.
Patients aged less than 18years with genital herpes.
Patients aged less than 18years with herpes zoster.
Neonates and infants as suppressive therapy following neonatal herpes simplex virus (HSV) infection.