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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Nucleoside and Nucleotide Analogue Reverse Transcriptase Inhibitors (NRTIs)

Abacavir

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

Abacavir (ABC, Ziagen)
Abacavir (ABC, Ziagen)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Tablets: 300 mg (scored)
Pediatric Oral Solution: 20 mg/mL
Fixed-Dose Combination Tablets:
  • [Epzicom] Abacavir 600 mg plus lamivudine 300 mg
  • [Trizivir] Abacavir 300 mg plus lamivudine 150 mg plus zidovudine 300 mg
  • [Triumeq] Abacavir 600 mg plus dolutegravir 50 mg plus lamivudine 300 mg
Generic Formulations:
  • Abacavir sulfate 300 mg tablets
  • Fixed-dose combination tablets of abacavir 300 mg plus lamivudine 150 mg
  • Fixed-dose combination tablets of abacavir 300 mg plus lamivudine 150 mg plus zidovudine 300 mg
Dosing Recommendations Selected Adverse Events
Neonate/Infant Dose
  • Not approved for infants aged <3 months.
Pediatric Dose
Oral Solution (Aged ≥3 Months):
  • 8 mg/kg (maximum 300 mg per dose) twice daily or 16 mg/kg once daily (maximum 600 mg per dose) (see text below).
  • In infants and young children being treated with liquid formulations of abacavir, initiation with once-daily abacavir is not generally recommended. In clinically stable patients with undetectable viral load and stable CD4 T lymphocyte (CD4) cell count/percentage for more than 6 months (24 weeks) on liquid formulation of abacavir twice daily, dose can be changed from twice daily to once daily with liquid or tablet formulations (see text below).
Weight Band Dosing (Weighing ≥14 kg)
Weight Scored 300-mg Tablet
Twice Daily AM Dose Twice Daily PM Dose Once Daily Dose
14 kg to <20 kg ½ tablet (150 mg) ½ tablet (150 mg) 1 tablet (300 mg)
>20 kg to <25 kg ½ tablet (150 mg) 1 tablet (300 mg) 1½ tablets (450 mg)
≥25 kg 1 tablet (300 mg) 1 tablet (300 mg) 2 tablets (600 mg)

  • In patients who can be treated with pill formulations, therapy can be initiated with once-daily administration.
Adolescent (Weighing ≥25 kg) and Adult Dose:
  • 300 mg twice daily or 600 mg once daily
[Trizivir] Abacavir plus Lamivudine plus Zidovudine
Adolescent (Weighing ≥40 kg) and Adult Dose:
  • One tablet twice daily.
[Epzicom] Abacavir plus Lamivudine
Adolescent (Weighing ≥25 kg) and Adult Dose:
  • One tablet once daily.
[Triumeq] Abacavir plus Dolutegravir plus Lamivudine
Adolescent (Weighing ≥40 kg) and Adult Dose:
  • One tablet once daily.
  • For use in patients who are antiretroviral (ARV) treatment-naive or treatment-experienced (but INSTI-naive) and not being treated with UGT1A1/CYP3A inducers.
  • Hypersensitivity reactions (HSR) can be fatal. HSRs usually occur during the first few weeks of starting therapy. Symptoms may include fever, rash, nausea, vomiting, malaise or fatigue, loss of appetite, and respiratory symptoms (e.g., cough and shortness of breath).
Special Instructions
  • Test patients for the HLA-B*5701 allele before starting therapy to predict risk of HSR. Patients positive for the HLA-B*5701 allele should not be given abacavir. Patients with no prior HLA-B*5701 testing who are tolerating abacavir do not need to be tested.
  • Warn patients and parents about risk of serious, potentially fatal HSRs. Occurrence of HSRs requires immediate and permanent discontinuation of abacavir. Do not re-challenge.
  • Abacavir can be given without regard to food. Oral solution does not require refrigeration.
  • When using fixed-dose combination (FDC) tablets, see other sections of the Drug Appendix for special instructions and additional information about the individual components of the FDC.
Metabolism/Elimination
  • Systemically metabolized by alcohol dehydrogenase and glucuronyltransferase.
  • Active metabolite is 82% renally excreted.
  • Abacavir requires dosage adjustment in hepatic insufficiency.
  • Do not use fixed-dose combinations such as Trizivir, Epzicom, and Triumeq (or the fixed-dose combination’s generic equivalents) in patients with impaired hepatic function, because the dose of abacavir cannot be adjusted.
  • Do not use Trizivir, Epzicom, and Triumeq (or the fixed-dose combination’s generic equivalents) in patients with creatinine clearance <50 mL/min and patients on dialysis (because of the fixed dose of lamivudine).

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