Pronunciation (a BAK a veer & la MI vyoo deen)

U.S. Brand Names EpzicomTM

Synonyms Abacavir Sulfate and Lamivudine; Lamivudine and Abacavir

Therapeutic Category
Antiretroviral Agent, Reverse Transcriptase Inhibitor (Nucleoside)
Use Treatment of HIV infections in combination with other antiretroviral agents

Pregnancy Risk Factor C

Pregnancy Implications See individual agents.

Contraindications Hypersensitivity to abacavir, lamivudine, or any component of the formulation; hepatic impairment. Do not rechallenge patients who have experienced hypersensitivity to abacavir.

Warnings/Precautions Should always be used as a component of a multidrug regimen. Serious and sometimes fatal hypersensitivity reactions have occurred in patients taking abacavir. Patients exhibiting symptoms from two or more of the following: fever, skin rash, constitutional symptoms (eg, malaise, fatigue, aches), respiratory symptoms (eg, pharyngitis, dyspnea, cough) and GI symptoms (eg, abdominal pain, nausea, vomiting) should discontinue therapy immediately and seek medical attention. Abacavir should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible. Abacavir SHOULD NOT be restarted because more severe symptoms may occur within hours, including LIFE-THREATENING HYPOTENSION AND DEATH. Fatal hypersensitivity reactions have occurred following the reintroduction of abacavir in patients whose therapy was interrupted (interruption in drug supply, temporary discontinuation while treating other conditions). Reactions occurred within hours. In some cases, signs of hypersensitivity may have been previously present, but attributed to other medical conditions (acute onset respiratory diseases, gastroenteritis, reactions to other medications). If abacavir is restarted following an interruption in therapy, evaluate the patient for previously unsuspected symptoms of hypersensitivity. Do not restart if hypersensitivity is suspected or if hypersensitivity cannot be ruled out. To report these events on abacavir hypersensitivity, a registry has been established (1-800-270-0425).
Following discontinuation of lamivudine, severe acute exacerbations of hepatitis B in patients co-infected with HBV and HIV have been reported. Monitor patients closely for several months following discontinuation of therapy for chronic hepatitis B; clinical exacerbations may occur.

Lactic acidosis and severe hepatomegaly with steatosis (sometimes fatal) have occurred with antiretroviral nucleoside analogues; female gender, obesity, and prolonged treatment may increase the risk of hepatotoxicity. Due to fixed dose of combination product, use is not recommended with renal or hepatic impairment or in pediatric patients.

Adverse Reactions Percentages reported with once daily abacavir, lamivudine, and efavirenz administration. Also see individual agents.

1% to 10%: Central nervous system: Fatigue/malaise (7%), headache/migraine (7%), insomnia (7%), dizziness/vertigo (6%), pyrexia (5%), abnormal dreams (4%), anxiety (3%)
Dermatologic: Rash (5%)
Gastrointestinal: Nausea (6%), diarrhea (5%), abdominal pain/gastritis (4%)
Miscellaneous: Hypersensitivity (9%)

Overdose/Toxicology See individual agents.

Drug Interactions See individual agents.

Mechanism of Action Nucleoside reverse transcriptase inhibitor combination.

Abacavir is a guanosine analogue which is phosphorylated to carbovir triphosphate which interferes with HIV viral RNA dependent DNA polymerase resulting in inhibition of viral replication.

Lamivudine is a cytosine analog. After lamivudine is triphosphorylated, the principle mode of action is inhibition of HIV reverse transcription via viral DNA chain termination; inhibits RNA- and DNA-dependent DNA polymerase activities of reverse transcriptase.

Pharmacodynamics/Kinetics See individual agents.

Usual Dosage Oral: Adults: HIV: One tablet (abacavir 600 mg and lamivudine 300 mg) once daily

Dosage adjustment in renal impairment: Clcr<50 mL/minute: Use not recommended

Dosage adjustment in hepatic impairment: Use not recommended.

Dietary Considerations May be administered with or without food.

Administration May be administered with or without food.

Monitoring Parameters Amylase, bilirubin, liver enzymes, hematologic parameters, viral load, and CD4 count

Additional Information A medication guide is available and should be dispensed with each new prescription or refill. A warning card is also available and patients should be instructed to carry this card with them.

A high rate of early virologic nonresponse was observed when abacavir, lamivudine, and tenofovir were used as the initial regimen in treatment-naive patients. Use of this combination is not recommended; patients currently on this regimen should be closely monitored for modification of therapy.

Dosage Forms Tablet, film-coated: Abacavir 600 mg and lamivudine 300 mg