Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Protease Inhibitors (PIs)

Tipranavir

Last Updated: May 22, 2018; Last Reviewed: May 22, 2018

Tipranavir (TPV, Aptivus)
Tipranavir (TPV, Aptivus)
For additional information see Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Oral Solution: 100 mg tipranavir/mL, with 116 International Units (IU) vitamin E/mL
Capsules: 250 mg
Dosing Recommendations Selected Adverse Events
Note: Tipranavir must be boosted with ritonavir. The ritonavir boosting dose used for tipranavir is higher than the doses used for other protease inhibitors.

Pediatric (Aged <2 Years) Dose:
  • Not approved for use in children aged <2 years
Pediatric (Aged 2–18 Years) Dose:
Note: Not recommended for treatment-naive patients
Body Surface Area Dosing:
  • Tipranavir/ritonavir (TPV/r) 375 mg/m2/150 mg/m2, both twice daily (maximum dose is TPV/r 500 mg/200 mg, both twice daily)
Weight-Based Dosing:
  • TPV/r 14 mg/kg/6 mg/kg, both twice daily (maximum dose is TPV/r 500 mg/200 mg, both twice daily)
Adult Dose:
  • TPV/r 500 mg (as two 250-mg capsules)/200 mg, both twice daily
  • Note: Not recommended for treatment-naive patients
  • Rare cases of fatal and non-fatal intracranial hemorrhage
  • Skin rash (more common in children than adults)
  • Nausea, vomiting, diarrhea
  • Hepatotoxicity: elevated transaminases; clinical hepatitis
  • Hyperlipidemia
  • Hyperglycemia
  • Elevated creatine phosphokinase
Special Instructions
  • Administer tipranavir and ritonavir together and with food.
  • Tipranavir oral solution contains 116 IU vitamin E per mL, which is significantly higher than the reference daily intake for vitamin E. Patients taking the oral solution should avoid taking any form of supplemental vitamin E that contains more vitamin E than found in a standard multivitamin.
  • Tipranavir contains a sulfonamide moiety and should be used with caution in patients with sulfonamide allergy.
  • Store tipranavir oral solution at room temperature, 25°C (77°F); do not refrigerate or freeze. Oral solution must be used within 60 days after the bottle is first opened.
  • Store unopened bottles of oral tipranavir capsules in a refrigerator at 2°C to 8°C (36°F to 46°F). Once the bottle has been opened, capsules can be kept at room temperature (maximum of 77°F or 25°C) if used within 60 days.
  • Use tipranavir with caution in patients who may be at increased risk of intracranial hemorrhage, including individuals with brain lesion, head trauma, recent neurosurgery, coagulopathy, hypertension, or alcoholism, or who use anticoagulant or antiplatelet agents (including vitamin E).
  • Use of tipranavir is contraindicated in patients with moderate or severe hepatic impairment.
Metabolism/Elimination
  • Cytochrome P450 3A4 (CYP3A4) inducer and substrate
  • P-glycoprotein substrate
Tipranavir Dosing in Patients with Renal Impairment:
  • No dose adjustment is required.
Tipranavir Dosing in Patients with Hepatic Impairment:
  • No dose adjustment is required for mild hepatic impairment.
  • Use of tipranavir is contraindicated in patients with moderate-to-severe hepatic impairment.

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