ABAMUNE Tablets 300 mg
Each film-coated tablet contains:
Abacavir sulfate …… 300 mg
ABAMUNE Tablets, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection.
DOSAGE AND ADMINISTRATION
ABAMUNE Tablets may be taken with or without food.
The recommended oral dose of abacavir for adults is 600 mg daily administered as either 300 mg twice daily or 600 mg once daily in combination with other antiretroviral agents.
Dose a djustment in Hepatic Impairment:
The recommended dose of ABAMUNE Tablets in patients with mild hepatic impairment (Child-Pugh score: 5 to 6) is 200 mg twice daily. To enable dose reduction, abacavir oral solution (10 mL twice daily) should be used for the treatment of these patients. The safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate to severe hepatic impairment and, therefore, ABAMUNETablets are contraindicated in these patients.
Abacavir sulfate has been associated with fatal hypersensitivity reactions. ABAMUNE Tablets SHOULD NOT BE RESTARTED FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR (see WARNINGS AND PRECAUTIONS, and UNDESIRABLE EFFECTS).
ABAMUNE Tablets are contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products (see WARNINGS AND PRECAUTIONS ).
ABAMUNE Tablets are contraindicated in patients with moderate or severe hepatic impairment.
ABAMUNE Tablets 300 mg Container of 30 tablets
Clinically significant drug-drug interactions involving abacavir appear to be uncommon. However, simultaneous initiation of abacavir with drugs likely to cause systemic reactions or rash (such as sulfonamides, NNRTIs, or amprenavir) may complicate the evaluation of possible hypersensitivity reactions (see below).
A number of studies demonstrate that abacavir is effective in combination with lamivudine and either a protease inhibitor or a nonnucleoside reverse transcriptase inhibitor. However, several nucleoside-only regimens containing abacavir have been shown to produce inferior virologic responses compared with efavirenz-containing combinations. In initial therapy, patients receiving the triple-nucleoside combination of abacavir + zidovudine + lamivudine had higher rates of virologic failure (HIV viral load >200 copies/mL after week 16) than did treatment groups consisting of efavirenz combined with either abacavir + lamivudine + zidovudine or lamivudine + zidovudine. This was true in subjects with baseline viral load <100,000 copies/mL and in those with baseline viral load >100,000 copies/mL.
In an earlier study of treatment-naive subjects, a combination of abacavir + zidovudine + lamivudine achieved a rate of viral load suppression (to <400 RNA copies/mL) comparable to that seen with indinavir + zidovudine + lamivudine. In some analyses, however, viral load suppression to <50 RNA copies/mL occurred more frequently with the indinavir-containing regimen, particularly in participants with >100,000 copies/mL prior to treatment.
Three studies of the triple-nucleoside analogue combination of abacavir + lamivudine + tenofovir (with all drugs dosed once-daily) in previously untreated individuals have shown high rates of early virologic failure. The reasons for poor virologic response to this combination of are not yet known; pending further study, this regimen should be avoided.
Abacavir has also been studied as a component of subsequent protease inhibitor- and NNRTI-containing regimens in individuals with extensive antiretroviral experience.
ABAMUNE Should Be Stored in a Cool & Dry Place.