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Ziagen

Generic Name: Abacavir Sulfate
Class: Nucleoside and Nucleotide Reverse Transcriptase Inhibitors
VA Class: AM800
Chemical Name: (1S-cis)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1)
Molecular Formula: (C14H18N6O)2 • H2SO4
CAS Number: 188062-50-2

Special Alerts:

[Posted 03/01/2011] ISSUE: FDA updated the public about an ongoing safety review of abacavir and a possible increased risk of heart attack. There has been conflicting information on the potential increased risk of heart attack with abacavir (Ziagen) treatment. An increased risk of heart attack (myocardial infarction or MI) has been seen in several observational studies and one randomized controlled trial (RCT) with abacavir. However, an increased risk of heart attack has not been seen in other RCTs and the safety database maintained by the drug manufacturer.

FDA conducted a meta-analysis of 26 randomized clinical trials that evaluated abacavir. This meta-analysis did not show an increased risk of MI associated with the use of abacavir. FDA will continue to communicate any new safety information to the public as it becomes available.

BACKGROUND: Abacavir is an antiviral medication used in combination with other antiretroviral drugs [abacavir and lamivudine (Epzicom); abacavir, lamivudine, and zidovudine (Trizivir)] for the treatment of HIV-1 infection.

RECOMMENDATION: Healthcare professionals should continue to prescribe abacavir according to the professional label. Patients should not stop taking their abacavir without first talking to their healthcare professional. For more information visit the FDA website at: and .

REMS:

FDA approved a REMS for abacavir to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

  • Serious and sometimes fatal hypersensitivity reactions reported.1 66 74 These hypersensitivity reactions are a multiorgan syndrome usually characterized by a sign or symptom in ?2 of the following groups: fever, rash, GI (including nausea, vomiting, diarrhea, abdominal pain), constitutional (including generalized malaise, fatigue, aching), and respiratory (including dyspnea, cough, pharyngitis).66 74 (See Hypersensitivity Reactions under Cautions.)

  • Individuals who carry the human leukocyte antigen (HLA)-B*5701 allele are at high risk for a hypersensitivity reaction.1 98 Prior to initiation of abacavir therapy, screening for the HLA-B*5701 allele is recommended.1 13 Screening also is recommended prior to reinitiation of abacavir therapy in patients who previously tolerated the drug whose HLA-B*5701 status is unknown.1 (See Hypersensitivity Reactions under Cautions.)

  • Discontinue abacavir as soon as a hypersensitivity reaction is suspected.1 66 74 Permanently discontinue if hypersensitivity cannot be ruled out regardless of the patient’s HLA-B*5701 status, even when other diagnoses are possible.1 66 74

  • Do not restart abacavir or any abacavir-containing preparation following a hypersensitivity reaction because more severe symptoms can recur within hours and have included potentially life-threatening hypotension and death.1 66 74 Severe or fatal hypersensitivity reactions can occur within hours after reintroduction of abacavir in patients with no identified history or unrecognized symptoms of abacavir hypersensitivity.1 66 74

  • Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported rarely in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs) alone or in conjunction with other antiretrovirals.1 66 74 (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)

  • The fixed-combination preparation Epzicom contains 2 NRTIs (abacavir and lamivudine) and the fixed-combination preparation Trizivir contains 3 NRTIs (abacavir, lamivudine, zidovudine); these are intended only for patients whose regimen would otherwise include abacavir and the other components.66 74

  • If using Epzicom or Trizivir, consider that severe, acute exacerbations of hepatitis B virus (HBV) infection have been reported when lamivudine was discontinued in patients coinfected with HBV and HIV.66 74 Closely monitor hepatic function for at least several months following discontinuance of Epzicom or Trizivir in patients coinfected with HBV and HIV.66 74 If appropriate, initiation of therapy for HBV infection may be warranted.66 74

  • If using Trizivir, consider that zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in those with advanced HIV infection,66 and that prolonged zidovudine use has been associated with symptomatic myopathy.66

Introduction

Antiretroviral; nucleoside reverse transcriptase inhibitor (NRTI).1 2 3 4 13 46

Uses for Ziagen

Treatment of HIV Infection

Treatment of HIV-1 infection in conjunction with other antiretrovirals in adults, adolescents, and pediatric patients.1 13

An alternative (not a preferred) NRTI for use in multiple-drug antiretroviral regimens for initial therapy in adults who test negative for the human leukocyte antigen (HLA)-B*5701 allele.13 (See Hypersensitivity Reactions under Cautions.)

Fixed-combination preparation containing abacavir and lamivudine (Epzicom) used in conjunction with other antiretrovirals in adults.74

Fixed-combination preparation containing abacavir, lamivudine, and zidovudine (Trizivir) used for triple NRTI treatment of HIV-1 infection in adults and adolescents;13 66 can be used alone or in conjunction with other antiretrovirals.13 66 If using Trizivir, consider that data are limited regarding use of the fixed combination in patients with higher viral loads (>100,000 copies/mL) at baseline.66

Because of inferior antiretroviral activity, a triple NRTI regimen of abacavir, lamivudine, and zidovudine is not recommended for initial therapy.13

Because of a high rate of virologic failure, a triple NRTI regimen of abacavir, lamivudine, and tenofovir is not recommended in treatment-naive or previously treated patients.13 72

Postexposure Prophylaxis of HIV

Postexposure prophylaxis of HIV infection in individuals who have had nonoccupational exposure to blood, genital secretions, or other potentially infectious body fluids of a person known to be infected with HIV when that exposure represents a substantial risk for HIV transmission.75 Used in conjunction with other antiretrovirals.75

Ziagen Dosage and Administration

General

To reduce the risk of a hypersensitivity reaction, screen for HLA-B*5701 before initiating abacavir.13 36 (See Hypersensitivity Reactions under Cautions.)

Administration

Oral Administration

Administer single-entity preparation (Ziagen) or fixed-combination preparations (Epzicom, Trizivir) orally without regard to meals.1 13 36 66 74

Since dosage of abacavir and lamivudine cannot be adjusted individually, the fixed-combination preparation containing abacavir and lamivudine (Epzicom) should not be used in pediatric patients; patients with impaired renal function (i.e., Clcr <50 mL/minute); patients with hepatic impairment; or patients who experience dose-limiting adverse effects.74

Since dosage of the drugs cannot be adjusted individually, the fixed-combination preparation containing abacavir, lamivudine, and zidovudine (Trizivir) should not be used in pediatric patients; adolescents or adults with low body weight (i.e., <40 kg); patients with impaired renal function (i.e., Clcr <50 mL/minute); patients with hepatic impairment; or patients who experience dose-limiting adverse effects.66

A copy of the manufacturer’s Medication Guide and Warning Card should be dispensed to individuals receiving abacavir each time they are given a new or refill prescription of the drug; patients should be instructed to carry the warning card with them.1 66 74 The guide and warning card provide information on potentially life-threatening hypersensitivity reactions, including information on how to recognize such reactions.1 66 74

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as abacavir sulfate; dosage expressed in terms of abacavir.1

Dosage of Epzicom or Trizivir expressed as number of tablets.66 74

Abacavir must be used in conjunction with other antiretrovirals.1 13 The fixed-combination preparation containing abacavir and lamivudine (Epzicom) is used with other antiretrovirals;74 the fixed-combination preparation containing abacavir, lamivudine, and zidovudine (Trizivir) may be used alone or in conjunction with other antiretrovirals.13 66

Pediatric Patients

Treatment of HIV Infection
Oral

Children and adolescents1 36 3 months to 16 years of age: 8 mg/kg (up to 300 mg) twice daily.1

Trizivir: 1 tablet twice daily in adolescents weighing ?40 kg.13 66

Adults

Treatment of HIV Infection
Oral

300 mg twice daily or 600 mg once daily.1 13

Epzicom: 1 tablet once daily.13 74

Trizivir: 1 tablet twice daily in adults weighing ?40 kg.13 66

Postexposure Prophylaxis of HIV
Nonoccupational Exposure
Oral

300 mg twice daily or 600 mg once daily.75

Initiate postexposure prophylaxis as soon as possible following exposure (preferably ?72 hours after exposure) and continue for 28 days.75

Special Populations

Hepatic Impairment

Treatment of HIV Infection
Oral

Adults with mild hepatic impairment (Child-Pugh score 5–6): 200 mg twice daily (i.e., 10 mL of oral solution twice daily).1 Safety and efficacy not established in those with moderate to severe hepatic impairment.1

Epzicom and Trizivir not recommended in those with impaired hepatic function.66 74

Renal Impairment

Treatment of HIV Infection

No dosage recommendations available for patients with impaired renal function.1 45 46 Some experts state dosage adjustments not needed.13

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1

Cautions for Ziagen

Contraindications

  • Known hypersensitivity to abacavir or any ingredient in the formulation.1 Never restart abacavir after a hypersensitivity reaction regardless of the patient’s HLA-B*5701 status.1 Reinitiation of abacavir in patients with history of hypersensitivity to the drug has been associated with fatal rechallenge reactions.1

  • Patients with moderate or severe hepatic impairment.1

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Lactic Acidosis and Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis (sometimes fatal) reported in patients receiving NRTIs.1 13 Reported most frequently in women; obesity and long-term NRTI therapy also may be risk factors.1 Has been reported in patients with no known risk factors.1

Cautious use recommended in patients with known risk factors for liver disease.1

Interrupt therapy if there are clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (e.g., hepatomegaly and steatosis even in the absence of marked increases in serum aminotransferase concentrations).1

Sensitivity Reactions

Hypersensitivity Reactions

Potentially life-threatening hypersensitivity reactions are the major toxicity reported with abacavir.1 Hypersensitivity reactions (including anaphylaxis) and urticaria also reported in patients receiving fixed-combination preparations containing abacavir (Epzicom, Trizivir).66 74

An association between abacavir hypersensitivity reactions and presence of the HLA-B*5701 allele has been reported.1 13 71 85 86 87 89 Experts recommend that all patients be screened for HLA-B*5701 before starting abacavir.13 36 Individuals who test positive for HLA-B*5701 should not receive abacavir.1 13 36 Testing should not be considered a substitute for close clinical observation; a negative test result does not absolutely rule out the possibility of some form of hypersensitivity reaction.1 13 If HLA-B*5701 screening is not available, experts consider abacavir a reasonable option: careful monitoring is recommended.13

Hypersensitivity reactions may involve multiple organ and body systems.1 Most frequent manifestations are fever, rash, fatigue, GI symptoms (e.g., nausea, vomiting, diarrhea, abdominal pain), and respiratory symptoms (e.g., pharyngitis, dyspnea, cough).1 5 13 47

Other signs and symptoms include malaise, lethargy, myalgia, myolysis, headache, arthralgia, edema, pharyngitis, cough, abnormal radiographs (predominantly infiltrates, which may be localized), dyspnea, paresthesia, lymphadenopathy, and mucous membrane lesions (e.g., conjunctivitis, mouth ulceration).1 5 13 47

Some patients with fatal hypersensitivity reactions were initially diagnosed as having acute respiratory disease (pneumonia, bronchitis, flu-like illness).58

Manifestations of hypersensitivity usually are apparent within the first 6 weeks of abacavir therapy, but may occur at any time during therapy.1 5 50 Incidence of severe hypersensitivity reactions may be greater in those receiving a once-daily abacavir regimen than in those receiving a twice-daily regimen.1 80 81

Discontinue abacavir as soon as a hypersensitivity reaction is first suspected.1 To avoid a delay in diagnosis and minimize risk of life-threatening hypersensitivity, abacavir should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible (e.g., acute onset respiratory disease, gastroenteritis, reactions to other drugs).1

Do not reinitiate abacavir in any patient who experienced a hypersensitivity reaction since more severe symptoms will recur within hours and may include life-threatening hypotension and death.1 13 Severe or fatal hypersensitivity reactions can occur within hours after reintroduction of the drug in patients with no identified history of abacavir hypersensitivity or with unrecognized manifestations of hypersensitivity to the drug.1 65 69

Abacavir Hypersensitivity Registry at 800-270-0425.1

General Precautions

Do not use multiple abacavir-containing preparations concomitantly.1 66 74

Use of Fixed Combinations

When used in fixed combination with lamivudine (Epzicom), consider the cautions, precautions, and contraindications associated with lamivudine.74

When used in fixed combination with lamivudine and zidovudine (Trizivir), consider the cautions, precautions, and contraindications associated with the concomitant agents.66

Cardiovascular Effects

Recent use of abacavir (within 6 months) may increase the risk of MI; risk may be increased in patients with cardiac risk factors (10-year predicted CHD risk >20%).1 97 102

HIV Resistance

Possibility of HIV-1 resistant to abacavir and cross-resistance to other NRTIs, especially in those who received prolonged prior NRTI therapy.1 May result in limited response to abacavir.1

Adipogenic Effects

Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, breast enlargement, and general cushingoid appearance.1

Immune Reconstitution Syndrome

During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jiroveci [formerly P. carinii]); this may necessitate further evaluation and treatment.1

Specific Populations

Pregnancy

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Category C.1 66

Antiretroviral Pregnancy Registry at 800-258-4263.1 64 66

An alternative (not a preferred) NRTI for use in multiple-drug regimens in pregnant women.64

Lactation

Abacavir distributed into milk in rats;1 66 not known whether distributed into human milk.1 66

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.1 64

Pediatric Use

Safety and efficacy of abacavir tablets or oral solution not established in neonates and infants <3 months of age.1

Epzicom should not be used in pediatric patients since dosages of the drugs cannot be adjusted individually.74

Trizivir should not be used in pediatric patients or in adolescents weighing <40 kg since dosages of the drugs cannot be adjusted individually.66

Adverse effects reported in children similar to those reported in adults (e.g., hypersensitivity reactions, GI effects).1 5 6 23 34 36

Geriatric Use

Insufficient experience in those ?65 years of age to determine whether they respond differently than younger adults.1 66

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1 66

Trizivir and Epzicom should not be used in those with Clcr <50 mL/minute.66 74

Hepatic Impairment

Abacavir dosage adjustment necessary in adults with mild hepatic impairment.1 (See Hepatic Impairment under Dosage and Administration.) Safety and efficacy of abacavir not established in those with moderate or severe hepatic impairment.1

Use abacavir with caution in those with known risk factors for liver disease.1

Epzicom and Trizivir should not be used in patients with impaired hepatic function.66 74

Renal Impairment

Pharmacokinetics of abacavir have not been fully determined in patients with impaired renal function;1 renal excretion of unchanged abacavir is only a minor route of elimination.1

Epzicom and Trizivir should not be used in those with Clcr <50 mL/minute.66

Common Adverse Effects

Hypersensitivity reactions, GI effects (nausea, vomiting, diarrhea, anorexia), insomnia, fever and/or chills, headache, malaise, fatigue.1

Interactions for Ziagen

Abacavir not metabolized by CYP isoenzymes1 and does not inhibit CYP3A4, 2C9, or 2D6.1 24 Interactions with drugs metabolized by these CYP isoenzymes unlikely.1

Specific Drugs

Drug

Interaction

Comments

Alcohol

Increased abacavir AUC; no effect on alcohol concentrations1 66

Darunavir

Pharmacokinetic interactions unlikely96

Delavirdine

Pharmacokinetic interactions unlikely45 46

Didanosine

In vitro evidence of additive antiretroviral effects1

Efavirenz

Pharmacokinetic interactions unlikely45 46

In vitro evidence of synergistic antiretroviral effects 92

Emtricitabine

In vitro evidence of additive or synergistic antiretroviral effects 94

Fosamprenavir

Pharmacokinetic interaction unlikely77

In vitro evidence of synergistic antiretroviral effects77

Lamivudine

No clinically important pharmacokinetic interactions1 63 66

In vitro evidence of additive antiretroviral effects1 2 6

Lopinavir

Possible decreased abacavir plasma concentrations76

Clinical importance unknown76

Methadone

Increased clearance of methadone;1 no effect on abacavir pharmacokinetics1

An increase in methadone dosage may be required in some patients; most patients will not need modification of methadone dosage1

Nelfinavir

In vitro evidence of synergistic antiretroviral effects95

Nevirapine

Pharmacokinetic interactions unlikely45 46

In vitro evidence of synergistic antiretroviral effects1 2 6 9

Stavudine

In vitro evidence of additive or synergistic antiretroviral effects1

Tenofovir

Pharmacokinetic interactions unlikely77

In vitro evidence of additive or synergistic antiretroviral effects77

Tipranavir

Ritonavir-boosted tipranavir: Decreased abacavir AUCs13 93

In vitro evidence of additive antiretroviral effects93

Appropriate dosages for concomitant use with respect to safety and efficacy not established13 93

Zidovudine

No clinically important pharmacokinetic interactions1 63 66

In vitro evidence of synergistic antiretroviral effects1 2 6 9

Ziagen Pharmacokinetics

Absorption

Bioavailability

Mean absolute oral bioavailability of abacavir is 83%.1 46 Well absorbed following oral administration.1 2 6 19 23 43

Commercially available abacavir tablets and oral solution are bioequivalent.1 46

Fixed-combination tablet containing abacavir 600 mg and lamivudine 300 (Epzicom) is bioequivalent to two 300-mg tablets of abacavir and two 150-mg tablets of lamivudine given simultaneously.74

Fixed-combination tablet containing abacavir 300 mg, lamivudine 150 mg, and zidovudine 300 mg (Trizivir) is bioequivalent to a 300-mg abacavir tablet, a 150-mg lamivudine tablet, and a 300-mg zidovudine tablet given simultaneously.66 68

Food

Food does not have a clinically important effect on bioavailability of abacavir.1 46 68

Food does not affect AUC of abacavir, lamivudine, or zidovudine when the drugs are given as fixed-combination preparations (Epzicom, Trizivir).66 68 74

Special Populations

AUC of abacavir is 89% higher in patients with mild hepatic impairment (Child-Pugh score 5–6) than in those with normal hepatic function.1

AUC of abacavir is similar in pregnant and nonpregnant women; peak plasma concentrations may be slightly decreased and there is greater variability in AUC and oral clearance during pregnancy.83

Distribution

Extent

Distributed into CSF following oral administration.1 6 20 46 62 84

Plasma Protein Binding

50% bound to plasma proteins; binding independent of drug concentrations.1

Abacavir crosses the placenta.82 83 Concentrations in cord blood at time of delivery generally similar to maternal serum concentrations.82

Abacavir distributed into milk in rats; not known whether distributed into human milk.1

Elimination

Metabolism

Metabolized in the liver by alcohol dehydrogenase and glucuronyltransferase to inactive metabolites.1

Intracellularly, abacavir is phosphorylated and then converted to the active carbovir triphosphate by cellular kinases.1 3 6 Intracellular (host cell) conversion to carbovir triphosphate is necessary for the antiviral activity of the drug.1 2 3 4 5 6 7 8 9

Elimination Route

82.2% of an oral dose excreted in urine and 16% excreted in feces.1 46

Half-life

About 1.5 hours.1 6 7 46

Special Populations

Half-life is increased 58% in patients with mild hepatic impairment (Child-Pugh score 5–6).1

Half-life was 1.33 hours in 1 patient with renal failure (GFR <10 mL/minute) undergoing peritoneal dialysis.18

Stability

Storage

Oral

Solution

20–25°C.1 May be refrigerated;1 do not freeze.1

Tablets, Film-coated

Ziagen: 20–25°C.1

Epzicom: 25°C (may be exposed to 15–30°C).74

Trizivir: 25°C (may be exposed to 15–30°C).66

Actions and Spectrum

  • Abacavir is a carbocyclic NRTI.1 2 3 4 46

  • Pharmacologically related to, but structurally different from, other NRTIs (e.g., didanosine, emtricitabine, lamivudine, stavudine, zidovudine) and other currently available antiretrovirals.1 13

  • A prodrug that is inactive until converted intracellularly to carbovir triphosphate.1 2 3 4

  • Active in vitro against HIV-1 and HIV-2.1 2 Has some in vitro activity against hepatitis B virus (HBV) and cytomegalovirus (CMV), but is inactive against other human viruses tested, including herpes simplex virus (HSV) types 1 and 2, varicella-zoster virus, and influenza virus type A.2

  • Strains of HIV-1 with reduced susceptibility to abacavir have been produced in vitro1 2 4 6 and have emerged during therapy with the drug.1 2 6 16 60 61

  • Cross-resistance between abacavir and other NRTIs (e.g., didanosine, emtricitabine, lamivudine, stavudine) and cross-resistance between abacavir and tenofovir reported.1 4 6 16 49 94 HIV isolates highly resistant to multiple NRTIs also have reduced susceptibility to abacavir.6 16 21

  • Cross-resistance between abacavir and PIs or NNRTIs highly unlikely since the drugs have different targets and mechanisms of action.13

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Critical nature of compliance with HIV therapy.1 Importance of using abacavir in conjunction with other antiretrovirals—not for monotherapy.1

  • Antiretroviral therapy is not a cure for HIV infection, and opportunistic infections still may occur.1 HIV transmission via sexual contact or sharing needles is not prevented by antiretrovirals.1

  • Possibility of potentially fatal hypersensitivity reactions to abacavir.1 Discontinue the drug and consult clinicians immediately if signs or symptoms of hypersensitivity occur, including fever, rash, fatigue, GI symptoms (nausea, vomiting, diarrhea, abdominal pain), or respiratory symptoms (sore throat, shortness of breath, cough).1

  • Do not restart abacavir after a hypersensitivity reaction since more severe symptoms will recur within hours and may include life-threatening hypotension and death.1

  • Advise patients that if abacavir therapy is interrupted for reasons other than hypersensitivity (e.g., interruption in drug supply), it should not be reinitiated without consulting clinicians since a severe or fatal hypersensitivity reaction can occur when the drug is reintroduced.1 Reinitiate the drug under such circumstances only if medical care is readily available.1

  • If taking Ziagen, importance of not taking another abacavir-containing preparation.1 If taking Epzicom, importance of not taking another abacavir- or lamivudine-containing preparation.74 If taking Trizivir, importance of not taking another abacavir-, lamivudine-, or zidovudine-containing preparation.66

  • Importance of patient reading the Medication Guide and Warning Card that should be provided each time a new and refill prescription is dispensed and importance of carrying the card at all times.1 The card summarizes the symptoms of abacavir hypersensitivity reactions.1

  • Redistribution/accumulation of body fat may occur, with as yet unknown long-term health effects.1

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Abacavir Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

20 mg (of abacavir) per mL

Ziagen (with parabens)

GlaxoSmithKline

Tablets, film-coated

300 mg (of abacavir)

Ziagen

GlaxoSmithKline

Abacavir Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

600 mg (of abacavir) with Lamivudine 300 mg

Epzicom

GlaxoSmithKline

300 mg (of abacavir) with Lamivudine 150 mg and Zidovudine 300 mg

Trizivir

GlaxoSmithKline

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Epzicom 600-300MG Tablets (VIIV HEALTHCARE): 30/$979.94 or 90/$2,819.83

Ziagen 20MG/ML Solution (VIIV HEALTHCARE): 240/$143.99 or 720/$419.97

Ziagen 300MG Tablets (VIIV HEALTHCARE): 60/$579.99 or 120/$1,099.92

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. GlaxoSmithKline. Ziagen (abacavir sulfate) tablets and oral solution prescribing information. Research Triangle Park, NC; 2008 Jun.

2. Daluge SM, Good SS, Faletto MB et al. 1592U89, a novel carbocyclic nucleoside analog with potent, selective anti-human immunodeficiency virus activity. Antimicrob Agents Chemother. 1998; 41:1082-93.

3. Faletto MB, Miller WH, Garvey EP et al. Unique intracellular activation of the potent anti-human immunodeficiency virus agent 1592U89. Antimicrob Agents Chemother. 1997; 41:1099-107. [PubMed 9145876]

4. Tisdale M, Alnadaf T, Cousens D. Combination of mutations in human immunodeficiency virus type 1 reverse transcriptase required for resistance to the carbocyclic nucleoside 1592U89. Antimicrob Agents Chemother. 1997; 41:1094-8. [PubMed 9145875]

5. Anon. Three new drugs for HIV infection. Med Lett. 1998; 40:114-6.

6. Foster RH, Faulds D. Abacavir. Drugs. 1998; 55:729-36. [PubMed 9585869]

7. Kumar PN, Sweet DE, McDowell JA et al. Safety and pharmacokinetics of abacavir (1592U89) following oral administration of escalating single doses in human immunodeficiency virus type 1-infected adults. Antimicrob Agents Chemother. 1999; 43:603-8. [IDIS 424134] [PubMed 10049274]

8. Hughes W, McDowell JA, Shenep J et al. Safety and single-dose pharmacokinetics of abacavir (1592U89) in human immunodeficiency virus type 1-infected children. Antimicrob Agents Chemother. 1999; 43:609-15. [IDIS 424135] [PubMed 10049275]

9. Drusano GL, D’Argenio DZ, Symonds W et al. Nucleoside analog 1592U89 and human immunodeficiency virus protease inhibitor 141W94 are synergistic in vitro. Antimicrob Agents Chemother. 1998; 42:2153-9. [PubMed 9736527]

10. Hirsch MS, Conway B, D’Aquila RT et al. Antiretroviral drug resistance testing in adults with HIV infection. Implications for clinical management. JAMA. 1998; 279:1984-91. [IDIS 406338] [PubMed 9643863]

11. Hammer SM, Saag MS, Schechter M, et al. Treatment of adult HIV infection: 2006 recommendations of the International AIDS Society–USA panel. JAMA. 2006; 296:827-43. [PubMed 16905788]

12. Gazzard B, for the BHIVA Guidelines Writing Committee. British HIV association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy (2005). HIV Med. 2005; 6(Suppl 2):1-61.

13. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (November 3, 2008). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

14. Notermans DW. Abacavir: a viewpoi





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