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n: a-BAK-a-vir SUL-fate/la-MIV-ue-deen/zye-DOE-vue-deen Class: Nucleoside analog reverse transcriptase inhibitor combination
- Tablets abacavir sulfate 300 mg/lamivudine 150 mg/zidovudine 300 mg
Inhibits replication of HIV by incorporation into HIV DNA and production of incomplete, nonfunctional DNA.
Rapidly absorbed and extensively distributed. Oral bioavailability 86%.Lamivudine
Rapidly absorbed and extensively distributed. Oral bioavailability 86%.Zidovudine
Rapidly absorbed and extensively distributed. Oral bioavailability 64%.
Binding of abacavir to human plasma proteins is approximately 50%. Binding of abacavir to plasma proteins was independent of concentration. Vd approximately 0.86 L/kg.Lamivudine
Binding to plasma protein is low. Vd approximately 1.3 L/kg.Zidovudine
Binding to plasma protein is low. Vd approximately 1.6 L/kg.
In humans, abacavir, lamivudine, and zidovudine are not significantly metabolized by CYP-450 enzymes.Abacavir
The primary routes of elimination of abacavir are metabolism by alcohol dehydrogenase to form the 5'-carboxylic acid and glucuronyl transferase to form the 5'-glucuronide.Lamivudine
Approximately 70% of an intravenous dose of lamivudine is recovered as unchanged drug in the urine. Metabolism of lamivudine is a minor route of elimination. In humans, the only known metabolite is the trans-sulfoxide metabolite (approximately 5% of an oral dose after 12 hours).Zidovudine
Zidovudine is eliminated primarily by hepatic metabolism. The major metabolite of zidovudine is 3'-azido-3'-deoxy-5'-O-β-D-glucopyranuronosylthymidine (GZDV). GZDV AUC is about 3-fold greater than the zidovudine AUC.
Abacavir approximately 0.8 L/h/kg; lamivudine approximately 0.33 L/h/kg; zidovudine approximately 1.6 L/h/kg.Renal Cl
Abacavir approximately 0.007 L/h/kg; lamivudine approximately 0.22 L/h/kg; zidovudine approximately 0.34 L/h/kg.Elimination half-life
Abacavir approximately 1.45 h; lamivudine 5 to 7 h; zidovudine 0.5 to 3 h.Food effects
Administration of abacavir/lamivudine/zidovudine with food did not alter the extent of abacavir, lamivudine, and zidovudine absorption (AUC), as compared with administration under fasted conditions.
Use alone or in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Patients with hepatic impairment; patients with previously demonstrated hypersensitivity to abacavir or any component of the product; never restart any abacavir-containing product following a hypersensitivity reaction, regardless of HLA-B*570 status.
PO 1 tablet twice daily.
Store at controlled room temperature (59° to 86°F).
Zidovudine plasma concentrations may be reduced, decreasing the pharmacologic effects.Atovaquone, fluconazole, methadone, probenecid, valproic acid
Zidovudine plasma concentrations may be elevated, increasing the pharmacologic and adverse reactions.Doxorubicin, ribavirin, stavudine
Antagonistic relationship has been demonstrated between these agents and zidovudine.Ethanol
Abacavir plasma concentrations may be elevated, increasing the pharmacologic and adverse reactions.Food
When administered with a high-fat meal, the abacavir, lamivudine, and zidovudine C max may be decreased; however, Trizivir may be given with or without food.Ganciclovir, interferon-alpha, other bone marrow suppressive or cytotoxic agents
May increase the hematologic toxicity of zidovudine.Methadone
Abacavir may increase methadone Cl, necessitating a dosage increase in some patients.Phenytoin
Zidovudine Cl may be decreased. Phenytoin levels may increase, decrease, or not change.Trimethoprim/sulfamethoxazole
Serum concentrations of lamivudine may be elevated, increasing the pharmacologic and adverse reactions.Zalcitabine
Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of each other.
None well documented.
Headache (13%); fatigue, malaise (12%); depression (6%); anxiety (5%); dizziness, insomnia and other sleep disorders, paresthesia, peripheral neuropathy, seizures (postmarketing).
Skin rash (5%); alopecia, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria (postmarketing).
Ear/nose/throat infections (5%).
Nausea (19%); nausea/vomiting (10%); diarrhea (7%); abdominal pain, anorexia, decreased appetite, dyspepsia, oral mucosal pigmentation, stomatitis (postmarketing).
Anemia, aplastic anemia, lymphadenopathy, splenomegaly, thrombocytopenia (postmarketing).
Elevated bilirubin, elevated transaminases, hepatic steatosis, lactic acidosis, pancreatitis, posttreatment exacerbation of hepatitis (postmarketing).
Elevated CPK (7%); increased ALT (6%); neutropenia (5%); hyperamylasemia, hypertriglyceridemia (2%).
Body accumulation/fat redistribution, hyperglycemia (postmarketing).
Musculoskeletal pain (5%); arthralgia, muscle weakness, myalgia, rhabdomyolysis (postmarketing).
Viral respiratory infections (5%); abnormal breath sounds/wheezing (postmarketing).
Hypersensitivity (8%); fever/chills (6%); anaphylaxis, vasculitis, weakness (postmarketing).
Intended only for patients whose regimen would otherwise include abacavir, lamivudine, and zidovudine.Hypersensitivity reactions
Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir. The reaction is a multi-organ clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups: (1) fever; (2) rash; (3) GI, including abdominal pain, diarrhea, nausea, or vomiting; (4) constitutional, including achiness, fatigue, or generalized malaise; (5) respiratory, including cough, dyspnea, or pharyngitis. Discontinue Trizivir as soon as a hypersensitivity reaction is suspected. Permanently discontinue Trizivir if hypersensitivity cannot be ruled out, even when other diagnoses are possible. Patients carrying the HLA-B*5710 allele are at a high risk for experiencing a hypersensitivity reaction to abacavir.
Following a hypersensitivity reaction to abacavir, never restart Trizivir or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death.
Reintroduction of Trizivir or any other abacavir-containing product, even in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy, can result in serious or fatal hypersensitivity reactions.Hematologic toxicity
Zidovudine has been associated with hematologic toxicity, including neutropenia and severe anemia. Prolonged zidovudine use has been associated with symptomatic myopathy.Lactic acidosis and severe hepatomegaly
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with use of nucleoside analogues alone or in combination.Exacerbations of hepatitis B
Severe acute exacerbations of hepatitis B have been reported in patients coinfected with hepatitis B virus (HBV) and HIV who have discontinued lamivudine. Closely monitor hepatic function with clinical and laboratory follow-up for at least several months in patients who discontinue Trizivir and are coinfected with HIV and HBV. Initiation of anti–hepatitis B therapy may be warranted.
Frequently monitor blood cell counts in patients with advanced HIV disease and in patients receiving combination therapy with Trizivir , interferon alpha, and ribavirin. Periodically monitor blood cell counts in HIV-infected patients with asymptomatic or early HIV disease.Hepatic
Monitor patients with coinfection with HBV and HIV for posttreatment exacerbations of hepatitis B for several months after stopping treatment. Closely monitor patients receiving combination therapy with Trizivir , interferon alpha, and ribavirin; hepatic decompensation has been reported.Hypersensitivity reaction
Monitor patient for signs/symptoms of allergic reaction to abacavir. Discontinue use if a sign or symptom in 2 or more of the following groups is noted: fever; rash; GI, including abdominal pain, diarrhea, nausea, or vomiting; constitutional, including achiness, fatigue, or generalized malaise; and respiratory, including cough, dyspnea, or pharyngitis. If hypersensitivity reaction is documented, ensure the reaction is reported to Abacavir Hypersensitivity Registry as noted in the package insert.Lactic acidosis
Monitor patient for signs/symptoms of lactic acidosis (profound weakness or tiredness; unexpected stomach discomfort; feeling cold, dizzy, or light-headed; slow or irregular heartbeat). Withhold drug if suspected.
Category C .
HIV-infected mothers should not breast-feed their infants.Abacavir
Undetermined.Lamivudine and zidovudine
Excreted in breast milk.
Not intended for use in children. Do not administer to adolescents who weigh less than 40 kg (88 lb) because it is a fixed-dose tablet that cannot be adjusted for this population.
Use with caution, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and comorbidity.
Fatal hypersensitivity reactions have been associated with abacavir use and have occurred within hours after reintroduction of abacavir in patients who have no identified history or unrecognized symptoms of hypersensitivity.
Because this is a fixed-dose combination, do not use for patients requiring dose adjustments (eg, CrCl less than 50 mL/min).
Contraindicated in patients with impaired hepatic function because this is a fixed-dose combination that cannot be adjusted for hepatically impaired patients.
Use with caution in patients who have bone marrow compromise evidenced by granulocyte count less than 1,000 cells/mm 3 or Hgb less than 9.5 g/dL.
Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, breast enlargement, and cushingoid appearance have been reported. Mechanism and long-term consequences of these events is unknown.
Contains abacavir, lamivudine, and zidovudine in a fixed-dose tablet. Ensure patient is not receiving abacavir, lamivudine, or zidovudine in any other doseforms. Because the dose cannot be adjusted, do not administer to patients who weigh less than 40 kg or other patients who may require a dose adjustment (eg, dose-related toxicity, hepatic or renal impairment).
Has been reported in patients treated with combination antiretroviral therapy.
Use of abacavir within the 6 months prior to combined antiretroviral therapy may increase the risk of MI.
Myopathy and myositis, with pathological changes similar to that produced by HIV disease, have been associated with prolonged use of zidovudine.
In patients treated with lamivudine for chronic HBV, there is clinical and laboratory evidence of hepatitis exacerbations 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, potential cross-resistance between abacavir and other NRTIs should be considered when selecting new regimens for therapy-experienced patients.
Confusion, dizziness, drowsiness, headache, lethargy, nausea, vomiting.
Copyright © 2009 Wolters Kluwer Health.
Not all side effects for abacavir / lamivudine / zidovudine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
Applies to abacavir / lamivudine / zidovudine: oral tablet
In addition to its needed effects, some unwanted effects may be caused by abacavir / lamivudine / zidovudine. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking abacavir / lamivudine / zidovudine:More common
Some of the side effects that can occur with abacavir / lamivudine / zidovudine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
Applies to abacavir / lamivudine / zidovudine: oral tablet
The adverse effects are sometimes difficult to distinguish from the symptomatology observed during the clinical course of AIDS, as well as from the possible adverse effects of other drugs used in the treatment of HIV infection. Many of the side effects associated with nucleoside reverse transcriptase inhibitor therapy (myopathy, pancreatitis, liver failure, lactic acidosis, etc.) are attributable to their direct toxic effect on mitochondria which causes decreased mitochondrial energy-generating capacity.[Ref]
Abacavir hypersensitivity is a clinical syndrome affecting multiple organs generally characterized by a sign or symptom in two or more of the following groups:
(3) Gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain)
(4) Constitutional (including generalized malaise, fatigue, or achiness)
(5) Respiratory (including dyspnea, cough, or pharyngitis)
A strong predictor of hypersensitivity reaction may be the presence of human leukocyte antigen subtype B*5701 (HLA-B*5701). Analyzing past studies, patients testing positive for the HLA-B*5701 allele had a greater risk (61% to about 70%) of developing hypersensitivity reactions with abacavir, while patients without the HLA-B*5701 allele had a low risk (less than 1% to 4%); therefore, screening for the HLA-B*5701 allele is recommended prior to starting abacavir treatment. Therapy with an abacavir-containing regimen is not recommended for HLA-B*5701-positive patients and should be considered only with close medical supervision under exceptional conditions where potential benefit outweighs the risk. Considerably less frequently, HLA-B*5701-negative patients may experience hypersensitivity reaction with abacavir.
Abacavir should be permanently discontinued as soon as a hypersensitivity reaction is suspected. Severe or fatal hypersensitivity reactions can also occur within hours after restarting abacavir in patients who have no identified history or unrecognized symptoms of this reaction. It should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible, to minimize the risk of a life-threatening hypersensitivity reaction.[Ref]
Hypersensitivity side effects associated with abacavir have included serious and sometimes fatal hypersensitivity reactions. Frequently observed signs and symptoms have included, but were not limited to, fever, skin rash (maculopapular, urticarial, or variable appearance), fatigue, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, malaise, achiness, dyspnea, and cough. Other symptoms of abacavir hypersensitivity have included lethargy, myolysis, edema, abnormal chest X-ray (infiltrates), paresthesia, anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, death, lymphadenopathy, mucous membrane lesions (conjunctivitis and stomatitis), elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, and lymphopenia. Hypersensitivity reaction (Grades 2 to 4; 8%) has been reported when abacavir was administered with lamivudine and zidovudine. Sensitization reactions (including anaphylaxis) and urticaria have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Gastrointestinal side effects of at least moderate intensity have included nausea (19%), nausea and vomiting (10%), and diarrhea (7%) when abacavir was administered with lamivudine and zidovudine. Abdominal cramps have been reported. Oral ulcerations and lesions have been observed with the use of lamivudine and flatulence has been reported with the use of zidovudine. Pancreatitis was observed in the expanded access program. Abdominal pain, anorexia and/or decreased appetite, pancreatitis, oral mucosal pigmentation, stomatitis, and dyspepsia have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Severe acute exacerbations of hepatitis, including fatalities, have been reported in patients coinfected with hepatitis B virus and HIV-1 who have discontinued antihepatitis B therapy, including lamivudine. The causal relationship to stopping lamivudine treatment is unknown.[Ref]
Hepatic side effects have included elevated ALT (greater than 5 times ULN; 6%) and liver function test abnormalities when abacavir was administered with lamivudine and zidovudine. The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration. One patient with preexisting hepatitis B developed acute hepatic failure two weeks after starting zidovudine therapy. Increased gamma-glutamyltransferase was observed in the expanded access program. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretroviral agents. Hepatic decompensation, sometimes fatal, has been reported in patients coinfected with HIV-1 and hepatitis C virus who were receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin. Lactic acidosis and hepatic steatosis, elevated bilirubin, elevated transaminases, and posttreatment exacerbations of hepatitis B have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Nervous system side effects of at least moderate intensity have included headache (13%) when abacavir was administered with lamivudine and zidovudine. Generalized seizures, status epilepticus, confusion, paresthesia, somnolence, vertigo, and Wernicke's syndrome have been reported, although rarely, with the use of zidovudine. Insomnia and other sleep disorders, paresthesia, peripheral neuropathy, seizures, and dizziness have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Other side effects of at least moderate intensity have included malaise and fatigue (12%), fever and/or chills (6%), and non-site-specific pain (less than 1%) when abacavir was administered with lamivudine and zidovudine. Weakness has been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Metabolic side effects have included elevated creatine phosphokinase (greater than 4 times ULN; 7%), hypertriglyceridemia (greater than 750 mg/dL; 2%), hyperamylasemia (greater than 2 times ULN; 2%), and hyperglycemia (greater than 13.9 mmol/L; less than 1%). Redistribution and/or accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients taking antiretroviral agents; however, a causal relationship has not been established. Although progressive subcutaneous fat wasting has been attributed to the use of protease inhibitors, nucleoside reverse transcriptase inhibitors may have an independent contribution. Hyperglycemia and redistribution/accumulation of body fat have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Progressive subcutaneous fat wasting has been observed in patients naive to protease inhibitors, however, not to the same degree as in patients on a combination regimen that includes a protease inhibitor.[Ref]
Bluish or brownish-black discoloration of nails has developed during the first month or two of zidovudine therapy and usually disappeared within 2 months if the drug was discontinued. Discoloration has occurred as longitudinal streaks or transverse bands.
Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving abacavir primarily in combination with medications known to be associated with SJS and TEN, respectively. Due to overlap of clinical signs and symptoms between abacavir hypersensitivity and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be permanently discontinued in such cases.[Ref]
Dermatologic side effects of at least moderate intensity have included skin rashes (5%) when abacavir was administered with lamivudine and zidovudine. Hair loss has been associated with lamivudine therapy in a few patients. Several cases of nailbed hyperpigmentation have been associated with zidovudine. Leukocytoclastic vasculitis with eosinophilia and fever has also been reported with the use of zidovudine. Rash and Sweet's syndrome have been reported with abacavir. Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme have been reported during postmarketing experience with abacavir. Alopecia, erythema multiforme, and Stevens-Johnson syndrome have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Hematologic side effects have included neutropenia (less than 750/mm3; 5%) when abacavir was administered with lamivudine and zidovudine. The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration. Agranulocytosis has been reported after the addition of abacavir to a multi-drug regimen. Hematologic toxicity (including neutropenia and severe anemia) has been reported with zidovudine. Aplastic anemia, anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, thrombocytopenia, and splenomegaly have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Zidovudine has been associated with hematologic toxicity (including neutropenia and severe anemia), particularly in patients with advanced HIV-1 disease. Abacavir / lamivudine / zidovudine should be used with caution in patients with bone marrow suppression indicated by granulocyte count below 1000 cells/mm3 or hemoglobin less than 9.5 g/dL. Frequent blood counts are strongly recommended in patients with advanced HIV-1 disease treated with abacavir / lamivudine / zidovudine. Periodic blood counts are recommended for HIV-1-infected individuals and patients with asymptomatic or early HIV-1 disease.[Ref]
In one zidovudine study, myalgias and elevated creatine phosphokinase occurred in 8% of treated patients with a CD4 cell count less than 200/mm3, and in none of the patients with higher CD4 cell counts. Dosage reduction has not affected the course of myopathy, although drug discontinuation sometimes resulted in improvement of symptoms, generally within a month. Muscle biopsy has shown atrophic and sometimes necrotic fibers, ragged-red fibers, and large accumulations of mitochondrial and fibrillar sarcoplasmic inclusions.[Ref]
Musculoskeletal side effects of at least moderate intensity have included musculoskeletal pain (5%) when abacavir was administered with lamivudine and zidovudine. Myopathy and myositis, with pathological changes similar to that produced by HIV-1 disease, have been associated with prolonged use of zidovudine. Myalgia, arthralgia, muscle weakness, creatine phosphokinase elevation, and rhabdomyolysis have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Psychiatric side effects of at least moderate intensity have included depressive disorders (6%), anxiety (5%), and worsening of preexisting depression when abacavir was administered with lamivudine and zidovudine. Other psychiatric side effects reported with the use of zidovudine have included isolated cases of mania, anxiety, and grandiosity.[Ref]
Immunologic side effects of at least moderate intensity have included ear/nose/throat infections (5%) and viral respiratory infections (5%) when abacavir was administered with lamivudine and zidovudine. Immune reconstitution syndrome has been reported. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution. The emergence of lamivudine-resistant hepatitis B virus (HBV) has been reported in HIV-1-infected patients who were treated with lamivudine-containing regimens in the presence of coinfection with HBV.
Cardiovascular side effects have included rare cases of reversible congestive heart failure, syncope, and vasodilation with zidovudine. Myocardial infarction has been reported during postmarketing experience with abacavir. Cardiomyopathy and vasculitis have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
A study investigating the frequency of myocardial infarction (MI) in patients taking combination antiretroviral treatment showed an increased risk of MI with the use of abacavir within the previous 6 months; however, these results are not conclusive. The manufacturer reviewed its own clinical study databases and although the results of the analysis are inconclusive, they did not show an excess risk of MI. A meta-analysis conducted by the FDA showed no statistically significant difference in MI events between patients who received abacavir and those who did not.[Ref]
Respiratory side effects have included nasal symptoms and cough in patients treated with lamivudine and zidovudine simultaneously. Abnormal breath sounds/wheezing have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Genitourinary side effects have included gynecomastia during postmarketing experience with abacavir, lamivudine, and/or zidovudine.
Renal side effects of at least moderate intensity have included renal signs/symptoms (not specified) in less than 1% of patients when abacavir was administered with lamivudine and zidovudine.
Ocular side effects have included a case of macular edema deemed definitively associated with zidovudine in a patient with a history of anterior uveitis secondary to syphilis.[Ref]
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