Classes
DEA Class; Rx
Common Brand Names; Ziagen
- HIV, NRTIs;
- Antiretroviral Agents
Description
Synthetic guanosine nucleoside reverse transcriptase inhibitor (NRTI)
Indicated for the treatment of human immunodeficiency virus (HIV) infection
Associated with fatal hypersensitivity reactions during initial treatment and with reintroduction of therapy
Indications
Indicated for treatment of HIV infection in combination with other antiretroviral agents
Contraindications
Prior hypersensitivity reaction to abacavir
Presence of HLA-B*5701 allele
Moderate or severe hepatic impairment
Adverse Effects
- Nausea (17-19%)
- Headache (9-13%)
- Malaise/fatigue (12%)
- Nausea & vomiting (10%)
- Hypersensitivity reaction (2-8%)
- Diarrhea (5-7%)
- Musculoskeletal pain (5-7%)
- Hypertriglyceridemia (6%)
- Hepatic: AST increased (6%)
- Depression (4-6%)
- Fever/chills (3-6%)
- Viral respiratory infections (5%)
- Ear/nose/throat infections (4-5%)
- Rash (4-5%)
- Anxiety (3-5%)
- Thrombocytopenia (1%)
Warnings
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with nucleoside analogs, including abacavir; a majority of these cases have been in women; female gender and obesity may be risk factors; suspend dosing in those who develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity, which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations
Immune reconstitution syndrome reported with combination ART; during the initial treatment phase, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis); autoimmune disorders (eg, Graves disease, polymyositis, and Guillain-Barré syndrome) have also been reported
Use has been associated with increased risk of myocardial infarction in observational studies, but not in a meta-analysis of 26 randomized trials; caution with risks for coronary heart disease and minimizing modifiable risk factors, including smoking, hypertension, and hyperlipidemia, prior to use
Pregnancy and Lactation
Available data from the APR show no difference in the overall risk of birth defects for abacavir compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population
Abacavir is present in human milk; there is no information on effects of abacavir on breastfed infant or effects of drug on milk production
Maximum Dosage
600 mg/day PO.
600 mg/day PO.
16 mg/kg/day PO (Max: 600 mg/day).
16 mg/kg/day PO (Max: 600 mg/day).
3 to 11 months: 16 mg/kg/day PO.
1 to 2 months: Safety and efficacy have not been established; however, doses up to 8 mg/kg/day PO have been used off-label.
Safety and efficacy have not been established; however, doses up to 4 mg/kg/day PO have been used off-label.
How supplied
Abacavir
oral solution
- 20mg/mL
tablet
- 300mg
