An NRTI - It is used with other medicines to treat HIV
FDA Alerts
Serious and sometimes fatal hypersensitivity reactions reported. These hypersensitivity reactions are a multiorgan syndrome usually characterized by a sign or symptom in ≥2 of the following groups: fever, rash, GI (including nausea, vomiting, diarrhea, abdominal pain), constitutional (including generalized malaise, fatigue, aching), and respiratory (including dyspnea, cough, pharyngitis). (See Hypersensitivity Reactions under Cautions.)
Individuals who carry the human leukocyte antigen (HLA)-B*5701 allele are at high risk for a hypersensitivity reaction. Prior to initiation of abacavir therapy, screening for the HLA-B*5701 allele is recommended. Screening also is recommended prior to reinitiation of abacavir therapy in patients who previously tolerated the drug whose HLA-B*5701 status is unknown. (See Hypersensitivity Reactions under Cautions.)
Discontinue abacavir as soon as a hypersensitivity reaction is suspected. Permanently discontinue if hypersensitivity cannot be ruled out regardless of the patient's HLA-B*5701 status, even when other diagnoses are possible.
Do not restart abacavir or any abacavir-containing preparation following a hypersensitivity reaction because more severe symptoms can recur within hours and have included potentially life-threatening hypotension and death. Severe or fatal hypersensitivity reactions can occur within hours after reintroduction of abacavir in patients with no identified history or unrecognized symptoms of abacavir hypersensitivity.
Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported rarely in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs) alone or in conjunction with other antiretrovirals. (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)
The fixed-combination preparation Epzicom® contains 2 NRTIs (abacavir and lamivudine) and the fixed-combination preparation Trizivir® contains 3 NRTIs (abacavir, lamivudine, zidovudine); these are intended only for patients whose regimen would otherwise include abacavir and the other components.
If using Epzicom® or Trizivir®, consider that severe, acute exacerbations of hepatitis B virus (HBV) infection have been reported when lamivudine was discontinued in patients coinfected with HBV and HIV. Closely monitor hepatic function for at least several months following discontinuance of Epzicom® or Trizivir® in patients coinfected with HBV and HIV. If appropriate, initiation of therapy for HBV infection may be warranted.
If using Trizivir®, consider that zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in those with advanced HIV infection, and that prolonged zidovudine use has been associated with symptomatic myopathy.
Treatment of HIV-1 infection in conjunction with other antiretrovirals in adults, adolescents, and pediatric patients.
A preferred NRTI for use in multiple-drug antiretroviral regimens for initial therapy in adults who test negative for the human leukocyte antigen (HLA)-B*5701 allele. (See Hypersensitivity Reactions under Cautions.)
Fixed-combination preparation containing abacavir and lamivudine (Epzicom®) used in conjunction with other antiretrovirals in adults.
Fixed-combination preparation containing abacavir, lamivudine, and zidovudine (Trizivir®) used for triple NRTI treatment of HIV-1 infection in adults and adolescents; can be used alone or in conjunction with other antiretrovirals. If using Trizivir®, consider that data are limited regarding use of the fixed combination in patients with higher viral loads (>100,000 copies/mL) at baseline.
Because of inferior antiretroviral activity, a triple NRTI regimen of abacavir, lamivudine, and zidovudine is not recommended for initial therapy.
Because of a high rate of virologic failure, a triple NRTI regimen of abacavir, lamivudine (or emtricitabine), and tenofovir is not recommended in treatment-naive or previously treated patients.
Postexposure Prophylaxis of HIV
Postexposure prophylaxis of HIV infection† in individuals who have had nonoccupational exposure to blood, genital secretions, or other potentially infectious body fluids of a person known to be infected with HIV when that exposure represents a substantial risk for HIV transmission. Used in conjunction with other antiretrovirals.
Dosage and Administration
General
To reduce the risk of a hypersensitivity reaction, screen for HLA-B*5701 before initiating abacavir. (See Hypersensitivity Reactions under Cautions.)
Administration
Oral Administration
Administer single-entity preparation (Ziagen®) or fixed-combination preparations (Epzicom®, Trizivir®) orally without regard to meals.
Since dosage of abacavir and lamivudine cannot be adjusted individually, the fixed-combination preparation containing abacavir and lamivudine (Epzicom®) should not be used in pediatric patients; patients with impaired renal function (i.e., Clcr <50 mL/minute); patients with hepatic impairment; or patients who experience dose-limiting adverse effects.
Since dosage of the drugs cannot be adjusted individually, the fixed-combination preparation containing abacavir, lamivudine, and zidovudine (Trizivir®) should not be used in pediatric patients; adolescents or adults with low body weight (i.e., <40 kg); patients with impaired renal function (i.e., Clcr <50 mL/minute); patients with hepatic impairment; or patients who experience dose-limiting adverse effects.
A copy of the manufacturer’s Medication Guide and Warning Card should be dispensed to individuals receiving abacavir each time they are given a new or refill prescription of the drug; patients should be instructed to carry the warning card with them. The guide and warning card provide information on potentially life-threatening hypersensitivity reactions, including information on how to recognize such reactions.
Dosage
Available as abacavir sulfate; dosage expressed in terms of abacavir.
Dosage of Epzicom® or Trizivir® expressed as number of tablets.
Abacavir must be used in conjunction with other antiretrovirals. The fixed-combination preparation containing abacavir and lamivudine (Epzicom®) is used with other antiretrovirals; the fixed-combination preparation containing abacavir, lamivudine, and zidovudine (Trizivir®) may be used alone or in conjunction with other antiretrovirals.
Pediatric Patients
Treatment of HIV Infection
Oral
Children and adolescents 3 months to 16 years of age: 8 mg/kg (up to 300 mg) twice daily.
Trizivir®: 1 tablet twice daily in adolescents weighing ≥40 kg.
Adults
Treatment of HIV Infection
Oral
300 mg twice daily or 600 mg once daily.
Epzicom®: 1 tablet once daily.
Trizivir®: 1 tablet twice daily in adults weighing ≥40 kg.
Postexposure Prophylaxis of HIV
Nonoccupational Exposure
Oral
300 mg twice daily or 600 mg once daily.†
Initiate postexposure prophylaxis as soon as possible following exposure (preferably ≤72 hours after exposure) and continue for 28 days.†
Special Populations
Hepatic Impairment
Treatment of HIV Infection
Oral
Adults with mild hepatic impairment (Child-Pugh score 5–6): 200 mg twice daily (i.e., 10 mL of oral solution twice daily). Safety and efficacy not established in those with moderate to severe hepatic impairment.
Epzicom® and Trizivir® not recommended in those with impaired hepatic function.
Renal Impairment
Treatment of HIV Infection
No dosage recommendations available for patients with impaired renal function. Some experts state dosage adjustments not needed.
Geriatric Patients
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.
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