Abacavir Sulfate (9 brand names, 3 dosage forms, 1 route)
Available dosage forms: TABLET, SOLUTION, TABLET, FOR SUSPENSION.
Routes of administration: ORAL.
Brand Names
- ABACAVIR SULFATE
- ABACAVIR SULFATE AND LAMIVUDINE
- ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
- ABACAVIR SULFATE; LAMIVUDINE
- EPZICOM
- TRIUMEQ
- TRIUMEQ PD
- TRIZIVIR
- ZIAGEN
Boxed Warning
Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with ZIAGEN (abacavir). Patients who carry the HLA‑B5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA‑B5701 allele [see Warnings and Precautions (5.1)]. ZIAGEN is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA‑B5701-positive patients [see Contraindications (4), Warnings and Precautions (5.1)]. All patients should be screened for the HLA‑B5701 allele prior to initiating therapy with ZIAGEN or reinitiation of therapy with ZIAGEN, unless patients have a previously documented HLA‑B5701 allele assessment. Discontinue ZIAGEN immediately if a hypersensitivity reaction is suspected, regardless of HLA-B5701 status and even when other diagnoses are possible [see Contraindications (4), Warnings and Precautions (5.1)]. Following a hypersensitivity reaction to ZIAGEN, NEVER restart ZIAGEN or any other abacavir-containing product because more severe symptoms, including death can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity [see Warnings and Precautions (5.1)].
Indications and Usage
ZIAGEN tablets and oral solution, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.
Contraindications
ZIAGEN is contraindicated in patients: •who have the HLA‑B*5701 allele [see Warnings and Precautions (5.1)]. •with prior hypersensitivity reaction to abacavir [see Warnings and Precautions (5.1)]. •with moderate or severe hepatic impairment [see Use in Specific Populations (8.6)].
Adverse Reactions
The following adverse reactions are discussed in other sections of the labeling: •Serious and sometimes fatal hypersensitivity reactions [see Boxed Warning, Warnings and Precautions (5.1)]. •Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions (5.2)]. •Immune reconstitution syndrome [see Warnings and Precautions (5.3)]. •Myocardial infarction [see Warnings and Precautions (5.4)].
Mechanism of Action
Abacavir is an antiretroviral agent [see Microbiology (12.4)].
Overdosage
There is no known specific treatment for overdose with ZIAGEN. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required. It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis.