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PREZISTA(R) Now Available for Pediatric Patients Six Years of Age and Older as part of HIV Combination Therapy
Date:2/11/2009

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The following points should be considered when initiating therapy with PREZISTA/r in treatment-experienced pediatric patients:

  • Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA/r.
  • The use of other active agents with PREZISTA/r is associated with a greater likelihood of treatment response.

Pediatric Dosing Information

For pediatric patients (6 to <18 years of age and weighing at least 44 lbs [20 kg]), the dosage of PREZISTA/r is based on body weight and should not exceed the recommended treatment-experienced adult dose. PREZISTA tablets should be taken with ritonavir twice daily and with food.

Specific pediatric dosing is based on weight as follows:

  • At least 44 lbs to less than 66 lbs: 375 mg PREZISTA/50 mg ritonavir twice daily
  • At least 66 lbs to less than 88 lbs: 450 mg PREZISTA/60 mg ritonavir twice daily
  • 88 lbs or more: 600 mg PREZISTA/100 mg ritonavir twice daily

Before prescribing PREZISTA, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a tablet, the use of PREZISTA tablets may not be appropriate. Do not use PREZISTA once daily dosing in pediatric patients. The safety and efficacy of PREZISTA/r in pediatric patients ages 3 to <6 have not been established. Do not use PREZISTA/r in pediatric patients below 3 years of age.

Tibotec will also be introducing PREZISTA 150 mg tablets for pediatric patients, and expects these tablets to be available in the next several months.

About the DELPHI Study

DELPHI (TMC114-C212) is an open-label, Phase 2 trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of PREZISTA/r in combination with other a
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SOURCE Tibotec Therapeutics
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