New paediatric dosing recommendations for atazanavir

The US atazanavir (Reyataz) capsule label has been updated to include the dosing recommendations for pediatric patients 6 to 18 years of age.

Atazanavir should not be administered to paediatric patients below the age of 3 months due to the risk of kernicterus (a type of brain damage caused by excessive levels of bilirubin).

Important changes made to the product label include the following:

Section 2.2 Recommended Pediatric Dosage was added to the label.

The recommended dosage of atazanavir for pediatric patients (6 to less than 18 years of age) is based on body weight and should not exceed the recommended adult dosage. Atazanavir capsules must be taken with food.

The data are insufficient to recommend dosing of atazanavir for any of the following:

  1. patients less than 6 years of age,
  2. without ritonavir in patients less than 13 years of age, and
  3. treatment-experienced paediatric patients with body weight less than 25 kg.

Source: FDA list serve

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