Acyclovir labeling updated to also include details for treating premature infants infected with herpes virus

Newborns infected with HSV can be appropriately treated with acyclovir, a drug typically prescribed to adults for the treatment of HSV infections.

The drug label for acyclovir now includes information for healthcare providers on recommended usage and dosage in newborns up to 3 months of age. The data that informed this label change came from a Pediatric Trials Network (PTN) open-label study titled “Safety and Efficacy of High-Dose Acyclovir in Infants with HSV or Suspected HSV (BPCA ACY02)” funded by the National Institutes of Health (NIH)’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

“With this label change, healthcare providers have clear guidance on how to use and prescribe this drug for their youngest patients”, said Perdita Taylor-Zapata, M.D., program lead for the Best Pharmaceuticals for Children Act (BPCA) at NICHD.

The study, published in the Pediatric Infectious Diseases Journal, examined the population pharmacokinetics of acyclovir in infants and showed that postmenstrual age (PMA) is associated with clearance and suggested dosing intervals as determined by PMA in infants with relatively normal renal function: 20 mg/kg every 12 hours in infants <30 weeks PMA, 20 mg/kg every 8 hours in infants 30 to <36 weeks PMA, and 20 mg/kg every 6 hours in infants 36–41 weeks PMA (Pediatr Infect Dis J. 2014 Jan;33(1):42-9)

Newborns and premature infants are vulnerable to serious and potentially life-threatening complications from herpes simplex (HSV) infection during pregnancy, labor and delivery or shortly after birth if the mother develops genital herpes near the end of her pregnancy. HSV infection in newborns can cause death or long-term problems such as blindness and damage to the brain and other organs.

(Source: NIH, February 8, 2019; Pediatr Infect Dis J. 2014 Jan;33(1):42-9)

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