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: April 16, 2019; Last Reviewed: April 16, 2019

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

Generic Formulations:
Tablet:300 mg

Fixed-Dose Combination Tablets:

  • [Epzicom and Generic] Abacavir 600 mg/lamivudine 300 mg
  • [Triumeq] Abacavir 600 mg/dolutegravir 50 mg/lamivudine 300 mg
  • [Trizivir] Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg
Dosing Recommendations Selected Adverse Events
Neonate and Infant Dose
  • Abacavir is not approved for use in infants aged <3 months.
Infant and Child (Aged ≥3 Months) Dose
Oral Solution:
  • Abacavir 8 mg/kg twice daily (maximum 300 mg per dose) or abacavir 16 mg/kg once daily (maximum 600 mg per dose)
  • In infants and young children who are being treated with liquid formulations of abacavir, initiation with once-daily abacavir is not generally recommended. In older children who can be treated with pill formulations, therapy can be initiated with once-daily administration. In clinically stable patients who have undetectable viral loads and stable CD4 T lymphocyte cell counts while receiving the liquid formulation of abacavir twice daily, the abacavir dose can be changed from twice-daily dosing to once-daily doing with the liquid or tablet formulations (see text below).
Weight Band Dosing for Children and Adolescents 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)

Child and Adolescent (Weighing ≥25 kg) and Adult Dose
:
  • Abacavir 300 mg twice daily or 600 mg once daily
[Epzicom] Abacavir/Lamivudine
Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • One tablet once daily.
[Triumeq] Abacavir/Dolutegravir/Lamivudine
Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • One tablet once daily.
  • This fixed-dose combination (FDC) tablet can be used in patients who are antiretroviral (ARV)-naive or ARV-experienced (but integrase strand transfer inhibitor-naive) and who are not being treated with uridine diphosphate glucuronosyltransferase 1A1 or cytochrome P450 3A inducers.
  • The FDA-approved dose for pediatric patients is one tablet once daily for patients weighing ≥40 kg.
[Trizivir] Abacavir/Lamivudine/Zidovudine
Child and Adolescent (Weighing ≥30 kg) and Adult Dose:
  • One tablet twice daily.
  • Hypersensitivity reactions (HSRs) 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, shortness of breath).
Special Instructions
  • Test patients for the HLA-B*5701 allele before starting therapy to predict the risk of HSRs. Patients who test 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 the risk of serious, potentially fatal HSRs. Occurrence of an HSR 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 FDC tablets that contain abacavir, 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 glucuronyl transferase.
  • Eighty-two percent of abacavir metabolites are excreted in urine.
  • Abacavir requires a dose adjustment in patients with hepatic insufficiency.
  • Do not use FDCs such as Trizivir, Epzicom, and Triumeq (or the generic equivalents of these FDCs) in patients with impaired hepatic function, because the dose of abacavir cannot be adjusted.
  • Do not use Trizivir, Epzicom, and Triumeq (or the generic equivalents of these FDCs) in patients with creatinine clearance <50 mL/min and patients on dialysis, because the dose of lamivudine cannot be adjusted.

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