Abacavir and Lamivudine
(a BAK a veer & la MI vyoo deen)
- Abacavir Sulfate and Lamivudine
- Lamivudine and Abacavir
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Epzicom: Abacavir 600 mg and lamivudine 300 mg [contains fd&c yellow #6 (sunset yellow)]
Generic: Abacavir 600 mg and lamivudine 300 mg
Brand Names: U.S.
- Antiretroviral, Reverse Transcriptase Inhibitor, Nucleoside (Anti-HIV)
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.
Use: Labeled Indications
HIV-1 infection: Treatment of HIV infection in combination with other antiretroviral agents
Hypersensitivity to abacavir, lamivudine, or any component of the formulation; patients who have the HLA-B*5701 allele; moderate or severe hepatic impairment
Canadian labeling: Additional contraindications (not in US labeling): Hepatic impairment (regardless of severity)
HIV-1 treatment: Oral: One tablet (abacavir 600 mg and lamivudine 300 mg) once daily. Note: Abacavir/lamivudine is a component of a recommended initial regimen with dolutegravir for ART treatment-naive patients who are HLA B*5701 negative (HHS [adult] 2015).
HIV-1 treatment: Children and Adolescents weighing ≥25 kg: Oral: One tablet (abacavir 600 mg and lamivudine 300 mg) once daily.
Dosing: Renal Impairment
CrCl ≥50 mL/minute: No dosage adjustment necessary.
CrCl <50 mL/minute: Use is not recommended.
Dosing: Hepatic Impairment
Mild impairment (Child-Pugh class A): Use is not recommended.
Moderate and severe impairment (Child-Pugh class B or C): Use is contraindicated.
Canadian labeling: Use is contraindicated (regardless of severity).
May be administered with or without food.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Cabozantinib: MRP2 Inhibitors may increase the serum concentration of Cabozantinib. Monitor therapy
Emtricitabine: LamiVUDine may enhance the adverse/toxic effect of Emtricitabine. Avoid combination
Methadone: May diminish the therapeutic effect of Abacavir. Abacavir may decrease the serum concentration of Methadone. Monitor therapy
Orlistat: May decrease the serum concentration of Antiretroviral Agents. Monitor therapy
Protease Inhibitors: May decrease the serum concentration of Abacavir. Monitor therapy
Trimethoprim: May increase the serum concentration of LamiVUDine. Monitor therapy
See individual agents as well as other combination products for additional information. Rates of adverse reactions were defined during combination therapy with other antiretrovirals.
1% to 10%:
Central nervous system: Abnormal dreams, anxiety, depression, dizziness, fatigue, headache, insomnia, malaise, migraine, vertigo
Dermatologic: Skin rash
Gastrointestinal: Abdominal pain, diarrhea, gastritis
Hypersensitivity: Hypersensitivity (including multiorgan failure and anaphylaxis; ≤9%; higher incidence in subjects carrying the HLA-B*5701 allele)
<1% (Limited to important or life-threatening): Abnormal breath sounds, alopecia, anemia (including pure red cell aplasia and severe anemias progressing on therapy), aplastic anemia, erythema multiforme, exacerbation of hepatitis B, hepatitis, hyperglycemia, immune reconstitution syndrome, increased creatine phosphokinase, lactic acidosis, liver steatosis, lymphadenopathy, myasthenia, paresthesia, peripheral neuropathy, redistribution of body fat, rhabdomyolysis, seizure, splenomegaly, Stevens-Johnson syndrome, stomatitis, weakness, wheezing
Concerns related to adverse effects:
• Fat redistribution: May cause redistribution of fat (eg, buffalo hump, peripheral wasting with increased abdominal girth, cushingoid appearance).
• Hypersensitivity reactions: [US Boxed Warning]: Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir, a component of abacavir/lamivudine. Patients who carry the HLA-B*5701 allele are at a higher risk for a hypersensitivity reaction to abacavir, although hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele. All patients should be screened for the HLA-B*5701 allele prior to initiating or reinitiation of therapy unless patients have had a previously documented HLA-B*5701 allele assessment. Discontinue abacavir/lamivudine if a hypersensitivity reaction is suspected. Abacavir is contraindicated in patients who have the HLA-B*5701 allele or in patients with a prior hypersensitivity reaction to abacavir. Reintroduction of any abacavir-containing product can result in life-threatening or fatal hypersensitivity reactions, even in patients who have no history of hypersensitivity to abacavir therapy. Such reactions can occur within hours. An allergy to abacavir should be documented in the medical record of allele-positive patients. Reactions usually occur within 9 days of starting abacavir; ~90% occur within 6 weeks, although these reactions may occur at any time during therapy (HHS [adult] 2015). These reactions usually include signs or symptoms from two or more of the following: Fever, skin rash, constitutional symptoms (malaise, fatigue, aches), respiratory symptoms (eg, pharyngitis, dyspnea, cough), and GI symptoms (eg, abdominal pain, diarrhea, nausea, vomiting). Other signs and symptoms include lethargy, headache, myalgia, edema, abnormal chest x-ray findings, arthralgia and paresthesia. Anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, myolysis, and death have occurred in association with hypersensitivity reactions. Physical findings (lymphadenopathy, mucous membrane lesions, and rash [maculopapular, urticarial or variable]) may occur. Erythema multiforme has also been reported. Laboratory abnormalities (eg, elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, and lymphopenia) may occur. Abacavir/lamivudine should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible and regardless of HLA-B*5701 status. Abacavir/lamivudine SHOULD NOT be restarted because more severe symptoms may occur within hours, including LIFE-THREATENING HYPOTENSION AND DEATH. If abacavir/lamivudine is restarted following an interruption in therapy not associated with symptoms of a hypersensitivity reaction, carefully evaluate the patient for previously unsuspected symptoms of hypersensitivity. Do not restart if hypersensitivity is suspected or cannot be ruled out regardless of HLA-B*5701 status. If abacavir/lamivudine is restarted, continually monitor for symptoms of a hypersensitivity reaction. Make the patient aware that reintroduction should only take place if medical care is readily accessible.
• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves’ disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation and treatment may be required.
• Lactic acidosis/hepatomegaly: [US Boxed Warning]: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues and other antiretrovirals. Use with caution in patients with risk factors for liver disease (risk may be increased with female gender, obesity, pregnancy or prolonged exposure) and discontinue treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity (transaminase elevation may/may not accompany hepatomegaly and steatosis).
• Coronary heart disease: Use has been associated with an increased risk of myocardial infarction (MI) in observational studies; however, based on a meta-analysis of 26 randomized trials, the FDA has concluded there is not an increased risk. Consider using with caution in patients with risks for coronary heart disease and minimizing modifiable risk factors (eg, hypertension, hyperlipidemia, diabetes mellitus, and smoking) prior to use.
• Chronic hepatitis B: [US Boxed Warning]: Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and HIV-1 and have discontinued lamivudine, which is 1 component of abacavir/lamivudine. Monitor patients closely for several months following discontinuation of therapy for chronic hepatitis B; clinical exacerbations may occur. Lamivudine-resistant HBV variants have been reported in coinfected patients using lamivudine as part of an antiretroviral regimen.
• Hepatic impairment: Due to fixed dose of combination product, use is not recommended with mild hepatic impairment. The US labeling contraindicates use in patients with moderate or severe hepatic impairment. The Canadian labeling contraindicates use in hepatic impairment regardless of severity.
• Renal impairment: Due to fixed dose of combination product, use is not recommended with renal impairment (CrCl <50 mL/minute).
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Duplicate therapy: Concomitant use of other abacavir or lamivudine-containing products with the fixed dose combination product should be avoided.
• Emtricitabine: Concomitant use of emtricitabine-containing products should be avoided.
• Interferon alfa: Use with caution in combination with interferon alfa with or without ribavirin in HIV/HBV coinfected patients; monitor closely for hepatic decompensation, anemia, or neutropenia; dose reduction or discontinuation of interferon and/or ribavirin may be required if toxicity is evident.
• Appropriate use: Do not use abacavir and lamivudine (plus efavirenz or plus atazanavir/ritonavir) in adolescent and adult HIV-1 patients with a pre-ART HIV RNA >100,000 copies/mL (HHS [adult] 2015).
Amylase, bilirubin, blood glucose, serum creatine kinase, liver enzymes, hematologic parameters, triglycerides, viral load, and CD4 count; HLA-B*5701 genotype status prior to initiation of therapy; signs and symptoms of hypersensitivity.
Animal reproduction studies have not been conducted with this combination. See individual agents. The Department of Health and Human Services (HHS) Perinatal HIV Guidelines consider abacavir in combination with lamivudine to be a preferred nucleoside reverse transcriptase inhibitor (NRTI) backbone for use in antiretroviral-naive pregnant women (do not use in women who are positive for the HLA-B*5701 allele). This backbone is not recommended with atazanavir or efavirenz if pretreatment HIV RNA is >100,000 copies/mL (HHS [perinatal] 2016). See individual agents.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience dizziness, headache, insomnia, loss of strength and energy, nausea, or diarrhea. Have patient report immediately to prescriber signs of allergic reaction with organ failure (fever, rash, fatigue, flu-like signs, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, cough, or difficulty breathing), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of lactic acidosis (fast breathing, tachycardia, abnormal heartbeat, vomiting, fatigue, shortness of breath, severe loss of strength and energy, severe dizziness, feeling cold, or muscle pain or cramps), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), severe dizziness, passing out, angina, depression, mouth sores, muscle pain, burning or numbness feeling, edema, change in body fat, or signs of infection (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
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- Drug class: antiviral combinations
Other brands: Epzicom