Abacavir
ZIAGEN
What it isNucleoside reverse-transcriptase inhibitor; HIV treatment.
Why this oneLack of renal clearance makes it useful when tenofovir is unsuitable.
What limits it⚑ Test HLA-B*5701 before treatment and never rechallenge after hypersensitivity; a possible cardiovascular signal remains debated.
FDA-approved for
- HIV-1 infection (1998)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| HIV-1 infection (with other antiretrovirals) | adult | 300 mg BID or 600 mg QD | 600 mg/day | 600 mg/day |
| HIV-1 infection (with other antiretrovirals) | pediatric ≥3 months, ≥14 kg for tablets | 8 mg/kg BID or 16 mg/kg QD | weight-based | 600 mg/day |
Renal Undefined
Hepatic Mild (Child-Pugh A): 200 mg BID (use oral solution); moderate or severe: contraindicated.
Instructions
- Screen for HLA-B*5701 allele before initiating or reinitiating therapy.
- Assess pediatric ability to swallow tablets; if unable, use the oral solution.
- Dispense the Medication Guide and Warning Card with each prescription and refill.
- Discontinue immediately and never restart if a hypersensitivity reaction is suspected.
Contraindications
- HLA-B*5701-positive patients
- Prior hypersensitivity reaction to abacavir
- Moderate or severe hepatic impairment
Cautions
- Lactic acidosis and severe hepatomegaly with steatosis (including fatal) with nucleoside analogues
- Immune reconstitution syndrome
- Possible myocardial infarction risk (evidence inconclusive); minimize modifiable cardiac risk factors
Adverse reactions
- Adults (≥10%): nausea, headache, malaise/fatigue, nausea and vomiting, dreams/sleep disorders
- Pediatric (≥5%): fever/chills, nausea and vomiting, skin rashes, ear/nose/throat infections
Pregnancy APR data show no increased birth-defect risk vs background (2.7%); abacavir crosses the placenta.
Lactation Present in human milk; per CDC, mothers with HIV in the U.S. should not breastfeed (HIV transmission risk).
⚠ BOXED WARNING
- Serious hypersensitivity reactions, HLA-B*5701-linked
Cost, est. cash$10–$500/month
Generic entry2012
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityAgent-specific renal, hepatic, hematologic, metabolic and drug-interaction toxicity.
Mechanism of action: Abacavir ballicule
