Trade Names:Epzicom- Tablets abacavir 600 mg (as sulfate)/lamivudine 300 mg
Inhibits replication of HIV by incorporating into HIV DNA and producing incomplete, nonfunctional DNA.
Treatment of HIV-1 infection in combination with other antiretroviral agents.
Hypersensitivity to any component of product; hepatic function impairment.
PO 1 tablet daily (abacavir sulfate 600 mg/lamivudine 300 mg), in combination with other antiretroviral agents.
Store at 59° to 86°F.
Ethanol decreases the elimination of abacavir, causing an increase in overall exposure.Interferon alfa
Hepatic decomposition (some fatal) has occurred in HIV-1/HCV coinfected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin.Methadone
Methadone Cl increased 22% during coadministration. Methadone may delay the absorption of abacavir/lamivudine, resulting in a decrease in bioavailability.Ribavirin
Ribavirin may reduce the phosphorylation of lamivudine.Trimethoprim/Sulfamethoxazole
Lamivudine serum levels may be elevated, increasing the pharmacologic and adverse effects.Zalcitabine
Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of one another.
None well documented.
Insomnia (9%); fatigue/malaise (8%); depression/depressed mood, headache/migraine (7%); dizziness/vertigo (6%); abnormal dreams, anxiety (5%); paresthesia, peripheral neuropathy, seizures (postmarketing).
Rash (5%); alopecia, erythema multiforme, Stevens-Johnson syndrome, TEN (postmarketing).
Diarrhea, nausea (6%); abdominal pain/gastritis (5%); pancreatitis, stomatitis (postmarketing).
Anemia including pure red cell aplasia and severe anemia progressing with therapy, aplastic anemia, lymphadenopathy, splenomegaly (postmarketing).
Lactic acidosis and hepatic steatosis, posttreatment exacerbation of hepatitis B (postmarketing).
Drug hypersensitivity (9%); sensitization reactions (including anaphylaxis), urticaria (postmarketing).
Anemia; elevation of bilirubin, amylase, and lipase levels; elevations of blood glucose and triglycerides; LFT abnormalities; neutropenia; thrombocytopenia.
CPK elevation, muscle weakness, rhabdomyolysis (postmarketing).
Abnormal breath sounds/wheezing (postmarketing).
Pyrexia (5%); redistribution/accumulation of body fat, weakness (postmarketing).
Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir. The hypersensitivity reaction is a multiorgan syndrome usually characterized by signs or symptoms in 2 or more of the following groups: fever, rash, GI (eg, abdominal pain, nausea, vomiting), constitutional (eg, aches, fatigue, malaise), and respiratory (eg, cough, dyspnea, pharyngitis). Permanently discontinue if hypersensitivity reaction occurs. Patients carrying the HLA-B∗5710 allele are at a high risk for experiencing a hypersensitivity reaction to abacavir. Do not restart any abacavir-containing product following a hypersensitivity reaction. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, may occur. Severe acute exacerbation of hepatitis B has been reported in patient coinfected with hepatitis B virus (HBV) and HIV-1 and who have discontinued lamivudine. Closely monitor hepatic function for at least several months after discontinuation of abacavir/lamivudine in patients who are coinfected with HIV-1 and HBV.
Prior to starting or reintroducing therapy with abacavir, screening for the HLA-B∗5701 allele is recommended and may decrease the risk of hypersensitivity reactions. Patients who test negative for the allele may develop hypersensitivity reaction to abacavir; however, this occurs less frequently than in HLA-B∗5701–postive patients.Discontinuation
Ensure hepatic function is closely monitored for at least several months following discontinuation of abacavir/lamivudine in patients who are coinfected with HBV and HIV. Ensure an anti-HBV therapy has been considered.Lactic acidosis
Monitor patient for signs of lactic acidosis. If patient develops cold feeling, dizziness, light-headedness, profound weakness or tiredness, slow or irregular heartbeat, or unexpected stomach discomfort, withhold drug.
Category C .
HIV-infected mothers should not breast-feed their infants.Abacavir
Excreted in breast milk.
Safety and efficacy not established.
Use with caution because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Do not administer to patient who has had a suspected or documented hypersensitivity reaction to abacavir. Abacavir has been associated with fatal hypersensitivity reactions and should not be restarted following a hypersensitivity reaction to abacavir.
Because this is a fixed-dose tablet, do not use for patients requiring dosage adjustment (CrCl less than 50 mL/min).
Because this is a fixed-dose tablet and the dosage of the individual components cannot be altered, it is contraindicated in patients with hepatic function impairment.
Must be used in combination with other antiretroviral agents from different pharmacologic classes (not with other nucleoside/nucleotide reverse transcriptase inhibitors).
Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance, have been observed in patients receiving antiretroviral therapy.
Abacavir/lamivudine contains fixed doses of 2 nucleoside analogs, abacavir and lamivudine, and should not be coadministered with other abacavir- and/or lamivudine-containing products.
Not appropriate for the treatment of chronic HBV in patients dually infected with HIV-1 and HBV.
Has been reported in patients receiving combination antiretroviral therapy, including abacavir/lamivudine. During the initial phase of treatment, patients may develop an inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium ), necessitating further evaluation and treatment.
Use of abacavir within the 6 mo prior to combined antiretroviral therapy may increase the risk of MI.
In patients treated with lamivudine for chronic HBV, clinical and laboratory evidence of hepatitis exacerbations have occurred after discontinuation of lamivudine.
Patients with prolonged prior nucleoside reverse transcriptase inhibitor (NRTI) exposure or who have HIV-1 isolates containing multiple mutations conferring NRTI resistance have limited response to abacavir. Thus, consider potential cross-resistance between abacavir and other NRTIs when selecting new regimens for therapy-experienced patients.
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