Abacavir and Lamivudine
Pronunciation
(a BAK a veer & la MI vyoo deen)
U.S. Brand Names
Epzicom™
Synonyms
Abacavir Sulfate and Lamivudine; Lamivudine and Abacavir
Generic Available
No
Use
Treatment of HIV infections in combination with other antiretroviral agents
Pregnancy Risk Factor
C
Pregnancy Implications
See individual agents.
Lactation
Enters breast milk/contraindicated
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%)
Overdosage/Toxicology
See individual agents.
Stability
Store at controlled room temperature of 25°C (77°F).
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-dependent DNA polymerase activities of reverse transcriptase.
Pharmacodynamics/Kinetics
See individual agents.
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.
Administration
May be administered with or without food.
Monitoring Parameters
Amylase, bilirubin, liver enzymes, hematologic parameters, viral load, and CD4 count
Dietary Considerations
May be taken with or without food.
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.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause anxiety, abnormal dreams, dizziness, depression, fatigue, lethargy, malaise, insomnia, and headache
Mental Health: Effects on Psychiatric Treatment
Side effects mimic depressive symptoms; use caution with benzodiazepines, CNS depressants, or antidepressants. May rarely cause neutropenia; use caution with clozapine and carbamazepine.
Dosage Forms
Tablet, film-coated: Abacavir 600 mg and lamivudine 300 mg
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