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Abacavir Sulfate

Pronunciation

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
Brands: Epzicom, Trizivir, Ziagen

Warning(s)

  • Hypersensitivity Reactions
  • Serious and sometimes fatal hypersensitivity reactions reported with abacavir.1 228 229 These usually are a multiorgan syndrome characterized by manifestations from ≥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).1 228 229 (See Hypersensitivity Reactions under Cautions.)

  • Individuals carrying the human leukocyte antigen (HLA)-B*5701 allele are at high risk for abacavir hypersensitivity reactions.1 228 229 Screening for HLA-B*5701 allele recommended prior to initiation of abacavir (Ziagen) or a fixed-combination preparation containing abacavir (Epzicom, Trizivir);1 228 229 screening also recommended prior to reinitiation of these drugs in patients with unknown HLA-B*5701 status.1 228 229 (See Hypersensitivity Reactions under Cautions.)

  • Discontinue abacavir or abacavir-containing preparation as soon as a hypersensitivity reaction is suspected.1 228 229 Regardless of patient’s HLA-B*5701 status, permanently discontinue if hypersensitivity cannot be ruled out, even when other diagnoses are possible.1 228 229

  • Do not restart abacavir or any abacavir-containing preparation following a hypersensitivity reaction; more severe symptoms can recur within hours and may include potentially life-threatening hypotension and death.1 228 229 Consider that severe or fatal hypersensitivity reactions can occur within hours after reintroduction of abacavir in patients with no identified history abacavir hypersensitivity or unrecognized symptoms of hypersensitivity.1 228 229

  • Lactic Acidosis and Severe Hepatomegaly
  • Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs) alone or in conjunction with other antiretrovirals.1 228 229 (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)

  • Fixed Combinations
  • If using Epzicom or Trizivir, consider that severe, acute exacerbations of HBV reported following discontinuance of lamivudine in patients coinfected with HBV and HIV.228 229 Monitor hepatic function with both clinical and laboratory follow-up for at least several months following discontinuance of Epzicom or Trizivir in patients coinfected with HBV and HIV.228 229 If appropriate, initiation of HBV treatment may be warranted.228 229

  • If using Trizivir, consider that zidovudine has been associated with hematologic toxicity (including neutropenia and severe anemia), particularly in those with advanced HIV-1 disease,229 and that prolonged zidovudine use has been associated with symptomatic myopathy.229

Introduction

Antiretroviral; nucleoside reverse transcriptase inhibitor (NRTI).1 2 3 46 200

Uses for Abacavir Sulfate

Treatment of HIV Infection

Treatment of HIV-1 infection in conjunction with other antiretrovirals.1 200 201

Used with another NRTI (dual NRTIs) in conjunction with a nonnucleoside reverse transcriptase inhibitor (NNRTI) or HIV protease inhibitor (PI) in NNRTI- or PI-based regimens.200 201 Also used with another NRTI (dual NRTIs) in conjunction with an HIV integrase inhibitor or HIV entry or fusion inhibitor.200

Abacavir and abacavir-containing preparations not recommended in HLA-B*5701-positive individuals.1 200 201 228 229 (See Hypersensitivity Reactions under Cautions.)200 Pending additional data, some experts recommend caution in patients with plasma HIV-1 RNA levels >100,000 copies/mL and in those at high risk of cardiovascular disease.200

Slideshow: Flashback: FDA Drug Approvals 2013

For initial treatment in antiretroviral-naive adults and adolescents, some experts state that abacavir and either lamivudine or emtricitabine is an alternative (not preferred) dual NRTI option.200

When PI- or NNRTI-based regimens are used in children ≥3 months of age, some experts state that abacavir and either lamivudine or emtricitabine is a preferred dual NRTI option and abacavir and zidovudine is an alternative.201

Fixed combination containing abacavir and lamivudine (Epzicom) used when dual NRTI option of abacavir and lamivudine is indicated in conjunction with other antiretrovirals.228 Consider that Epzicom should be used with antiretrovirals from another class (not another NRTI).228

Fixed combination containing abacavir, lamivudine, and zidovudine (Trizivir) used for triple NRTI regimen;200 229 used alone or in conjunction with other antiretrovirals.200 229 Consider that Trizivir is intended only for regimens that require all 3 drugs and that data are limited regarding use of the fixed combination in patients with higher viral loads (>100,000 copies/mL) at baseline.229

Triple NRTI regimen of abacavir, lamivudine, and zidovudine not generally recommended because of inferior virologic efficacy;200 201 consider use only in special circumstances when other regimens cannot be used (e.g., because of concerns regarding drug interactions toxicity, or regimen complexity).200 201

Triple NRTI regimen of abacavir, tenofovir, and either lamivudine or emtricitabine not recommended at any time because of high rate of virologic failure.110 200 201

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.198 Used in conjunction with other antiretrovirals.198

Abacavir Sulfate Dosage and Administration

General

To reduce risk of hypersensitivity reactions, screen for HLA-B*5701 allele before initiating abacavir or fixed-combination preparation containing abacavir.1 200 201 228 229 Abacavir and abacavir-containing preparations not recommended in HLA-B*5701-positive individuals.1 200 201 228 229 (See Hypersensitivity Reactions under Cautions.)

Administration

Oral Administration

Administer single-entity preparation (Ziagen) or fixed combination containing abacavir (Epzicom, Trizivir) orally without regard to meals.1 200 201 228 229

Ziagen: Oral solution used in pediatric patients and when a solid oral dosage form is inappropriate.1 The scored 300-mg tablets may be used in children weighing ≥14 kg if they can reliably swallow tablets.1

Epzicom: Because dosages of the drugs in this fixed combination (abacavir, lamivudine) cannot be adjusted individually, do not use in patients <18 years of age, patients with impaired renal function (i.e., Clcr <50 mL/minute), patients with hepatic impairment, or others requiring dosage adjustment.228

Trizivir: Because dosages of the drugs in this fixed combination (abacavir, lamivudine, zidovudine) cannot be adjusted individually, do not use in pediatric patients, adolescents weighing <40 kg, patients with impaired renal function (i.e., Clcr <50 mL/minute), patients with hepatic impairment, or others requiring dosage adjustment.229

Dosage

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

Dosage of Epzicom and Trizivir expressed as number of tablets.228 229

Ziagen and Epzicom must be used in conjunction with other antiretrovirals;1 228 Trizivir may be used alone or in conjunction with other antiretrovirals.229

Pediatric Patients

Treatment of HIV Infection
Oral

Children and adolescents ≥3 months of age (Ziagen oral solution): 8 mg/kg (up to 300 mg) twice daily.1 201

Clinically stable children ≥3 months of age with undetectable viral load and stable CD4+ T-cell counts (Ziagen): Consider once-daily regimen of 16 mg/kg (up to 600 mg) once daily.201

Children and Adolescents Weighing ≥14 kg Able to Swallow Tablets (Ziagen 300-mg Tablets)1201

Weight (kg)

AM dose

PM dose

14–21

150 mg (half tablet)

150 mg (half tablet)

>21 to <30

150 mg (half tablet)

300 mg

≥30

300 mg

300 mg

Ziagen (adolescents ≥16 years of age): Some experts recommend 300 mg twice daily or 600 mg once daily.201

Epzicom (adolescents ≥16 years of age): 1 tablet once daily.201

Trizivir (adolescents weighing ≥40 kg): 1 tablet twice daily.200 229

Adults

Treatment of HIV Infection
Oral

Ziagen: 300 mg twice daily or 600 mg once daily.1

Epzicom: 1 tablet once daily.228

Trizivir: 1 tablet twice daily.229

Postexposure Prophylaxis of HIV
Nonoccupational Exposure
Oral

Ziagen: 300 mg twice daily or 600 mg once daily.198

Initiate postexposure prophylaxis as soon as possible following exposure (preferably ≤72 hours after exposure) and continue for 28 days.198

Prescribing Limits

Pediatric Patients

Treatment of HIV Infection
Oral

Children ≥3 months of age (Ziagen): Maximum 300 mg twice daily.1

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 Ziagen oral solution twice daily).1 Safety and efficacy not established in those with moderate to severe hepatic impairment.1

Epzicom, Trizivir: Do not use in patients with hepatic impairment.228 229

Renal Impairment

Treatment of HIV Infection

Ziagen: Dosage recommendations not available for patients with impaired renal function.1 45 46 Some experts state dosage adjustments not needed.200

Epzicom, Trizivir: Do not use in patients with Clcr <50 mL/minute.228 229

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 Abacavir Sulfate

Contraindications

  • Ziagen, Epzicom, Trizivir: Known hypersensitivity to abacavir or any ingredient in the formulation.1 228 229 Never restart abacavir or abacavir-containing preparation after an abacavir hypersensitivity reaction, regardless of patient’s HLA-B*5701 status.1 228 229 (See Hypersensitivity Reactions under Cautions.)

  • Ziagen: Moderate or severe hepatic impairment.1

  • Epzicom, Trizivir: Hepatic impairment.228 229

Warnings/Precautions

Warnings

Hypersensitivity Reactions

Serious, sometimes fatal, hypersensitivity reactions reported with abacavir (Ziagen) or fixed combination containing abacavir (Epzicom, Trizivir).1 228 229

Hypersensitivity manifestations usually involve ≥2 of the following groups: fever, rash, GI (e.g., nausea, vomiting, diarrhea, abdominal pain), constitutional (e.g., generalized malaise, fatigue, achiness), and respiratory (e.g., pharyngitis, dyspnea, cough).1 47 228 229 Lethargy, myalgia, chills, myolysis, headache, arthralgia, edema, tachycardia, abnormal chest radiographs (predominantly infiltrates, which may be localized), paresthesia, lymphadenopathy, and mucous membrane lesions (e.g., conjunctivitis, mouth ulceration) also may occur.1 47 228 229

Usually apparent within first 6 weeks of abacavir therapy, but may occur at any time during therapy.1 50 228 229 Incidence may be greater in those receiving once-daily abacavir than in those receiving twice-daily abacavir.1 80 81

Patients carrying HLA-B*5701 allele are at high risk for abacavir hypersensitivity.1 71 85 86 87 89 228 229 Screening for HLA-B*5701 allele may decrease risk;1 228 229 negative result does not absolutely rule out possibility of some form of hypersensitivity reaction,1 71 86 87 90 98 228 229 but reactions occur less frequently in HLA-B*5701-negative individuals than in HLA-B*5701-positive individuals.1 228 229

Screening for HLA-B*5701 allele recommended prior to initiating abacavir or fixed combination containing abacavir;1 200 201 228 229 also recommended prior to reinitiating abacavir or abacavir-containing preparation in patient with unknown HLA-B*5701 allele status who previously tolerated the drug.1 228 229

Abacavir and abacavir-containing preparations not recommended in patients positive for HLA-B*5701 allele.1 200 201 228 229 Consider use in such patients only under close medical supervision and under exceptional circumstances when potential benefits outweigh risks.1 228 229

Discontinue abacavir or abacavir-containing preparation as soon as a hypersensitivity reaction is first suspected.1 228 229 To minimize risk of life-threatening hypersensitivity, permanently discontinue if abacavir hypersensitivity cannot be ruled out (regardless of HLA-B*5701 allele status), even when other diagnoses are possible (e.g., acute onset respiratory disease, gastroenteritis, reactions to other drugs).1 228 229 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 69 228 229

Lactic Acidosis and Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis (sometimes fatal) reported in patients receiving NRTIs (including abacavir) alone or in conjunction with other antiretrovirals.1 228 229 Reported most frequently in women; obesity and long-term NRTI therapy also may be risk factors.1 228 229 Has been reported in patients with no known risk factors.1 228 229

Use particular caution in patients with known risk factors for liver disease.1 228 229

Interrupt abacavir 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 markedly increased serum aminotransferase concentrations).1 228 229

Other Warnings and Precautions

Cardiovascular Effects

MI has been reported in some patients receiving abacavir.1

In response to conflicting data regarding a possible association between abacavir and MI,1 102 106 108 FDA conducted a meta-analysis of 26 randomized clinical trials that evaluated use of abacavir in adults.107 109 This meta-analysis did not identify an increased risk of MI in patients receiving abacavir.107 109 FDA recommends that clinicians continue to prescribe abacavir according to approved labeling1 107 and that patients not discontinue abacavir without consulting their clinician.107

As a precaution in patients receiving antiretroviral therapy (including abacavir), consider patient’s underlying risk of CHD and minimize any modifiable risk factors (e.g., hypertension, hyperlipidemia, diabetes mellitus, smoking).1 Some experts recommend caution in patients with high risk of cardiovascular disease.200

Use of Fixed Combinations

Do not use multiple abacavir-containing preparations concomitantly.1 228 229

When fixed combination containing abacavir and lamivudine (Epzicom) used, consider cautions, precautions, and contraindications associated with both drugs.228

When fixed combination containing abacavir, lamivudine, and zidovudine (Trizivir) used, consider cautions, precautions, and contraindications associated with all 3 drugs.229

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

Mechanisms and long-term consequences of these adipogenic effects are unknown;1 causal relationship not established.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

Autoimmune disorders (e.g., Graves' disease, polymyositis, Guillain-Barré syndrome) reported in the setting of immune reconstitution; time to onset is more variable and can occur many months after initiation of antiretroviral therapy.1

Specific Populations

Pregnancy

Ziagen, Epzicom, Trizivir: Category C.1 228 229

Antiretroviral Pregnancy Registry at 800-258-4263 or .1 202 228 229

Some experts state that abacavir is an alternative (not preferred) NRTI for use in dual NRTI antiretroviral regimens in pregnant women.202

Lactation

Abacavir distributed into milk in rats;1 228 229 not known whether distributed into human milk.1 229

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.1 202

Pediatric Use

Ziagen: Safety and efficacy not established in neonates and infants <3 months of age.1

Epzicom: Do not use in pediatric patients <18 years of age.228

Trizivir: Do not use in pediatric patients or in adolescents weighing <40 kg.229

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

Geriatric Use

Ziagen, Epzicom, Trizivir: Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults.1 228 229

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1 228 229

Hepatic Impairment

Ziagen: Use caution in those with known risk factors for liver disease.1 Dosage adjustment necessary in adults with mild hepatic impairment.1 (See Hepatic Impairment under Dosage and Administration.) Safety and efficacy not established in those with moderate or severe hepatic impairment.1

Epzicom, Trizivir: Do not use in patients with impaired hepatic function.228 229

Renal Impairment

Ziagen: Abacavir pharmacokinetics not fully determined in patients with impaired renal function;1 renal excretion of unchanged abacavir only a minor route of elimination.1

Epzicom, Trizivir: Do not use in patients with Clcr <50 mL/minute.228 229

Common Adverse Effects

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

Interactions for Abacavir Sulfate

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

Specific Drugs

Drug

Interaction

Comments

Alcohol

Increased abacavir AUC and half-life; no effect on alcohol concentrations1

Although common metabolic pathways are involved, clinically important interaction not expected1

Atazanavir

No in vitro evidence of antagonistic antiretroviral effects203

Darunavir

Pharmacokinetic interactions unlikely204

No in vitro evidence of antagonistic antiretroviral effects203

Delavirdine

Pharmacokinetic interactions unlikely45 46

Didanosine

In vitro evidence of additive antiretroviral effects1

Efavirenz

Pharmacokinetic interactions unlikely45 46

In vitro evidence of additive antiretroviral effects 213

Emtricitabine

In vitro evidence of additive or synergistic antiretroviral effects 1

Etravirine

No in vitro evidence of antagonistic antiretroviral effects214

Fosamprenavir

Pharmacokinetic interaction unlikely205

In vitro evidence of synergistic antiretroviral effects205

Lamivudine

No clinically important pharmacokinetic interactions1 63 229

In vitro evidence of additive or synergistic antiretroviral effects1 2 6

Lopinavir/ritonavir

Possible decreased abacavir concentrations207

Clinical importance unknown207

Maraviroc

No in vitro evidence of antagonistic antiretroviral effects224

Methadone

Increased clearance of methadone;1 no effect on abacavir pharmacokinetics1

Some experts state dosage adjustments unnecessary;200 manufacturer of abacavir states an increase in methadone dosage may be required in a small number of patients1

Nelfinavir

In vitro evidence of synergistic antiretroviral effects208

Nevirapine

Pharmacokinetic interactions unlikely45 46

In vitro evidence of synergistic antiretroviral effects1 2 6 9

Raltegravir

In vitro evidence of additive or synergistic antiretroviral effects225

Ribavirin

No in vitro effect on antiretroviral activity of abacavir against HIV-11

Rilpivirine

Pharmacokinetic interaction not expected226

No in vitro evidence of antagonistic antiretroviral effects226

Stavudine

In vitro evidence of additive or synergistic antiretroviral effects1

Tenofovir

Pharmacokinetic interactions unlikely221

In vitro evidence of additive or synergistic antiretroviral effects1 221

Tipranavir

Ritonavir-boosted tipranavir: Decreased abacavir AUC200 211

In vitro evidence of additive antiretroviral effects211

Appropriate dosages for concomitant use with respect to safety and efficacy not established200 211

Zidovudine

No clinically important pharmacokinetic interactions1 63 229

In vitro evidence of synergistic antiretroviral effects1 2 6 9

Abacavir Sulfate Pharmacokinetics

Absorption

Bioavailability

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

Commercially available abacavir tablets and oral solution are bioequivalent.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.228

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.229 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 combinations (Epzicom, Trizivir).68 228 229

Special Populations

In pediatric patients, comparable abacavir exposure is expected with tablets or oral solution.1

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

AUC 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

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

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 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

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

Tablets

Ziagen: 20–25°C.1

Epzicom: 25°C (may be exposed to 15–30°C).228

Trizivir: 25°C (may be exposed to 15–30°C).229

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); also differs pharmacologically and structurally from other currently available antiretrovirals.1 200

  • 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 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

  • Inhibits replication of HIV by interfering with viral RNA-directed DNA polymerase (reverse transcriptase).1

  • 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

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

Advice to Patients

  • Medication guide and warning card must be provided to the patient each time abacavir or fixed combination containing abacavir is dispensed.1 228 229 Medication guide and warning card include information on symptoms of abacavir hypersensitivity reactions.1 228 229

  • Importance of patient reading the medication guide and warning card prior to initiating therapy and each time prescription is refilled;1 228 229 importance of carrying the warning card.1 228 229

  • Critical nature of compliance with HIV therapy and importance of remaining under the care of a clinician.1 228 229 Importance of taking as prescribed; do not alter or discontinue antiretroviral regimen without consulting clinician.1 228 229

  • Importance of using in conjunction with other antiretrovirals—not for monotherapy.1 228 229

  • Antiretroviral therapy is not a cure for HIV infection; opportunistic infections and other complications associated with HIV disease may still occur.1 228 229

  • Advise patients that sustained decreases in plasma HIV RNA have been associated with reduced risk of progression to AIDS and death.226

  • Advise patients that effective antiretroviral regimens can decrease HIV concentrations in blood and genital secretions and strict adherence to such regimens in conjunction with risk-reduction measures may decrease, but cannot absolutely eliminate, the risk of secondary transmission of HIV to others.200 Importance of continuing to practice safer sex (e.g., using latex or polyurethane condoms to minimize sexual contact with body fluids), never sharing personal items that can have blood or body fluids on them (e.g., toothbrushes, razor blades), and never reusing or sharing needles.1 200

  • Possibility of potentially fatal hypersensitivity reactions to abacavir.1 228 229 Discontinue the drug and consult clinicians immediately if signs or symptoms of hypersensitivity, including fever, rash, GI symptoms (nausea, vomiting, diarrhea, abdominal pain), constitutional symptoms (generalized fatigue, malaise, achiness), or respiratory symptoms (sore throat, shortness of breath, cough) occur while receiving abacavir or abacavir-containing preparation.1 228 229

  • Do not restart abacavir or abacavir-containing preparation after a hypersensitivity reaction since more severe symptoms may recur within hours and may include life-threatening hypotension and death.1 228 229

  • 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.1 228 229 Reinitiate the drug under such circumstances only if medical care is readily available.1 228 229

  • 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.228 If taking Trizivir, importance of not taking another abacavir-, lamivudine-, or zidovudine-containing preparation.229

  • Advise patients that lactic acidosis and severe hepatomegaly have been reported.1 228 229

  • Redistribution/accumulation of body fat may occur, with as yet unknown long-term health effects.1 228 229

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products, and any concomitant illnesses.1 228 229

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 228 229 Advise HIV-infected women not to breast-feed.1

  • Importance of advising patients of other important precautionary information.1 228 229 (See Cautions.)

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Abacavir Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

20 mg (of abacavir) per mL

Ziagen

ViiV

Tablets, film-coated, scored

300 mg (of abacavir)*

Abacavir Tablets

Ziagen

ViiV

Abacavir Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

600 mg (of abacavir) with Lamivudine 300 mg

Epzicom

ViiV

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

Trizivir

ViiV

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. 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/$1,031.96 or 90/$2,972.02

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

Ziagen 300MG Tablets (VIIV HEALTHCARE): 60/$608.01 or 120/$1,153.93

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions October 17, 2012. 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. ViiV Pharmaceuticals. Ziagen (abacavir sulfate) tablets and oral solution prescribing information. Research Triangle Park, NC; 2012 May.

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]

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]

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16. Van Laethem K, Witvrouw M, Balzarini J et al. Patient HIV-1 strains carrying the multiple nucleoside resistance mutations are cross-resistance to abacavir. AIDS. 2000; 14:469-71. [PubMed 10770556]

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19. Weller S, Radomski KM, Lou Y et al. Population pharmacokinetics and pharmacodynamic modeling of abacavir (1592U89) from a dose-ranging, double-blind, randomized monotherapy trial with human immunodeficiency virus-infected subjects. Antimicrob Agents Chemother. 2000; 44:2052-60. [IDIS 450048] [PubMed 10898675]

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39. McDowell JA, Chittick GE, Pilati-Stevens C et al. Pharmacokinetic interaction of abacavir (1592U89) and ethanol in human immunodeficiency virus-infected adults. Antimicrob Agents Chemother. 2000; 44:1686-90. [IDIS 450324] [PubMed 10817729]

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45. Reviewers’ comments (personal observations).

46. Glaxo Wellcome. Research Triangle Park, NC: Personal communication.

47. Saag MS, Sonnerborg A, Torres RA et al. Antiretroviral effect and safety of abacavir alone and in combination with zidovudine in HIV-infected adults. AIDS. 1998; 12:F203-9.

49. Miller V, Sturmer M, Staszewski S et al. The M184V mutation in HIV-1 reverse transcriptase (RT) conferring lamivudine resistance does not result in broad cross-resistance to nucleoside analogue RT inhibitors. AIDS. 1998; 12:705-12. [PubMed 9619801]

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51. Danehower SC, Mitchell CD, Gilbert CA et al. Correlation of phenotypic resistance and clinical efficacy of abacavir in a phase III pediatric study. Int Conf AIDS. 1998; 12:576-7.

53. Reviewers’ comments (personal observations) on Efavirenz 8:18.08.

55. Escaut L, Liotier JY, Albengres E et al. Abacavir rechallenge has to be avoided in case of hypersensitivity reaction. AIDS. 1999; 13:1419-20. [PubMed 10449301]

56. Walensky RP, Goldberg JH, Daily JP. Anaphylaxis after rechallenge with abacavir. AIDS. 1999; 13:999-1000. [PubMed 10371187]

58. Kent RS, Glaxo Wellcome. Dear health care provider letter regarding fatal hypersensitivity reactions, respiratory symptoms, and Ziagen (abacavir sulfate). Research Triangle Park, NC; 2000 Jan. From FDA web site.

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60. Harrigan PR, Stone C, Griffin P et al. Resistance profile of the human immunodeficiency virus type 1 reverse transcriptase inhibitor abacavir (1592u89) after monotherapy and combination therapy. J Infect Dis. 2000; 181:912-20. [IDIS 446773] [PubMed 10720512]

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62. McDowell JA, Chittick GE, Ravitch JR et al. Pharmacokinetics of [14C]abacavir, a human immunodeficiency virus type 1 (HIV-1) reverse transcriptase inhibitor, administered in a single oral dose to HIV-1-infected adults: a mass balance study. Antimicrob Agents Chemother. 1999; 43:2855-61. [IDIS 440000] [PubMed 10582871]

63. Wang LH, Chittick GE, McDowell JA. Single-dose pharmacokinetics and safety of abacavir (1592U89), zidovudine, and lamivudine administered alone and in combination in adults with human immunodeficiency virus infection. Antimicrob Agents Chemother. 1999; 43:1708-15. [IDIS 431224] [PubMed 10390227]

65. Rubin M. Glaxo Wellcome. Dear health care provider letter regarding severe hypersensitivity reactions following reintroduction with Ziagen (abacavir sulfate) products. Research Triangle Park, NC; 2000 Jul. From FDA web site.

68. Yuen GJ, Lou Y, Thompson NF et al. Abacavir/lamivudine/zidovudine as a combined formulation tablet: bioequivalence compared with each component administered concurrently and the effect of food on absorption. J Clin Pharmacol. 2001; 41:277-88. [PubMed 11269568]

69. Frissen PH, de Vries J, Weigel HM et al. Severe anaphylactic shock after rechallenge with abacavir without preceding hypersensitivity. AIDS. 2001; 15:289-92. [PubMed 11216946]

71. Hetherington S, Hughes AR, Mosteller M et al. Genetic variations in HLA-B region and hypersensitivity reactions to abacavir. Lancet. 2002; 359:1121-2. [IDIS 478815] [PubMed 11943262]

72. Manion DJ. Dear healthcare provider letter: early virologic non-response in patients with HIV infection treated with lamivudine, abacavir, and tenofovir. GlaxoSmithKline; 2003 Jul. From FDA website.

78. DeJesus E, Herrera G, Teofilo E for the CNA30024 Study Team. Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults. Clin Infect Dis. 2004; 39:1038-46. [PubMed 15472858]

79. Moyle GJ, DeJesus E, Cahn P for the Ziagen once-daily in Antiretroviral Combination Therapy (CNA30021) Study Team. Abacavir once or twice daily combined with once-daily lamivudine and efavirenz for the treatment of antiretroviral-naive HIV-infected adults: results of the Ziagen once daily in antiretroviral combination study. J Acquir Immune Defic Syndr. 2005; 38:417-25. [PubMed 15764958]

80. Goedken AM, Herman RA. Once-daily abacavir in place of twice-daily administration. Ann Pharmacother. 2005; 39:1302-8. [PubMed 15956231]

81. James A. Johann-Liang R. Increased rate and severity of abacavir (ABC) associated hypersensitivity reaction (HSR) in prospective clinical trials. Presented at 12th Conference on Retroviruses and Opportunistic Infections. Boston, MA: 2005 Feb 23. Poster No. 836.

82. Chappuy H, Treluyer JM, Jullien V et al. Maternal-fetal transfer and amniotic fluid accumulation of nucleoside analogue reverse transcriptase inhibitors in human immunodeficiency virus-infected pregnant women. Antimicrob Agents Chemother. 2004; 48:4332-6. [PubMed 15504861]

83. Best BM, Mirochnick M, Capparelli EV et al. Impact of pregnancy on abacavir pharmacokinetics. AIDS. 2006; 20:553-60. [PubMed 16470119]

84. Capparelli EV, Letendre SL, Ellis RJ et al. Population pharmacokinetics of abacavir in plasma and cerebrospinal fluid. Antimicrob Agents Chemother. 2005; 49:2504-6. [PubMed 15917556]

85. Martin AM, Nolan D, Gaudieri S et al. Predisposition to abacavir hypersensitivity conferred by HLA-B*5701 and a haplotypic Hsp70-Hom variant. PNAS. 2004; 101:4180-5. [PubMed 15024131]

86. Mallal S, Nolan D, Witt C et al. Association between presence of HLA-B*5701, HLA-DR7, and HLA-DQ3 and hypersensitivity to HIV-1 reverse-transcriptase inhibitor abacavir. Lancet. 2002; 359:727-32. [PubMed 11888582]

87. Hughes AR, Mosteller M, Bansal AT et al. Association of genetic variationsin HLA-B region with hypersensitivity to abacavir in some, but not all, population. Pharmacogenomics. 2004; 5:203-11. [PubMed 15016610]

89. Rauch A, Nolan D, Martin A et al. Prospective genetic screening decreases the incidence of abacavir hypersensitivity reactions in the Western Australian HIV cohort study. Clin Infect Dis. 2006; 43:99-102. [PubMed 16758424]

90. Phillips EJ. Genetic screening to prevent abacavir hypersensitivity reaction: are we there yet? Clin Infect Dis. 2006; 43:103-5.

98. Mallal S, Phillips E, Carosi G et al. HLA-B*5701 Screening for hypersensitivity to abacavir. N Engl J Med. 2008; 358:568-79. [PubMed 18256392]

99. Saag M, Balu R, Phillips E et al. High sensitivity of human leukocyte antigen-B*5701 as a marker for immunologically confirmed abacavir hypersensitivity in white and black patients. Clin Infect Dis. 2008; 46:1111-8. [PubMed 18444831]

100. Hughes S, Hughes A, Brothers C et al. PREDICT-1 (CNA 106030): the first powered, prospective trial of pharmacogenetic screening to reduce drug adverse events. Pharm Stat. 2008; 7:121-9. [PubMed 17534855]

101. Cutrell A, Brothers C, Yeo J et al. Abacavir and the potential risk of myocardial infarction. Lancet. 2008; 371:1413. Letter. [PubMed 18387668]

102. D:A:D study group. Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study; a multi-cohort collaboration. Lancet. 2008; 371:1417-26.

103. Epzicom (abacavir sulfate and lamivudine) tablets risk evaluation and mitigation strategy (REMS). From FDA website.

104. Trizivir (abacavir sulfate, lamivudine, and zidovudine) tablets risk evaluation and mitigation strategy (REMS). From FDA website.

105. Ziagen (abacavir sulfate) tablets and oral solution risk evaluation and mitigation strategy (REMS). From FDA website.

106. Food and Drug Administration. Early communication about an ongoing safety review of Ziagen (abacavir) and Videx (didanosine). 2008 July 24. From FDA website. Accessed 2011 Apr 13.

107. Food and Drug Administration. FDA drug safety communication: safety review update of abacavir and possible increased risk of heart attack. 2011 Mar 1. From FDA website. Accessed 2011 Apr 13.

108. Worm SW, Sabin C, Weber R et al. Risk of myocardial infarction in patients with HIV infection exposed to specific individual antiretroviral drugs from the 3 major drug classes: the data collection on adverse events of anti-HIV drugs (D:A:D) study. J Infect Dis. 2010; 201:318-30. [PubMed 20039804]

109. Ding X, Andraca-Carrera E, Cooper C et al. No association of myocardial infarction with ABC use: an FDA meta-analysis. Poster presented at the 18th Conference on Retroviruses and Opportunistic Infections. Boston, MA: 2011 Feb 27– Mar 2

110. Gallant JE, Rodriguez AE, Weinberg WG et al. Early virologic nonresponse to tenofovir, abacavir, and lamivudine in HIV-infected antiretroviral-naive subjects. J Infect Dis. 2005; 192:1921-30. [PubMed 16267763]

111. Eron J, Yeni P, Gathe J et al. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial. Lancet. 2006; 368:476-82. [PubMed 16890834]

112. Pulido F, Estrada V, Baril JG et al. Long-term efficacy and safety of fosamprenavir plus ritonavir versus lopinavir/ritonavir in combination with abacavir/lamivudine over 144 weeks. HIV Clin Trials. 2009 Mar-Apr; 10:76-87.

115. Post FA, Moyle GJ, Stellbrink HJ et al. Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study. J Acquir Immune Defic Syndr. 2010; 55:49-57. [PubMed 20431394]

116. Smith KY, Patel P, Fine D et al. Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment. AIDS. 2009; 23:1547-56. [PubMed 19542866]

120. Hammer SM, Ribaudo H, Bassett R et al. A randomized, placebo-controlled trial of abacavir intensification in HIV-1-infected adults with virologic suppression on a protease inhibitor-containing regimen. HIV Clin Trials. 2010 Nov-Dec; 11:312-24.

121. Moyle G, Higgs C, Teague A et al. An open-label, randomized comparative pilot study of a single-class quadruple therapy regimen versus a 2-class triple therapy regimen for individuals initiating antiretroviral therapy. Antivir Ther. 2006; 11:73-8. [PubMed 16518962]

122. Puls RL, Srasuebkul P, Petoumenos K et al. Efavirenz versus boosted atazanavir or zidovudine and abacavir in antiretroviral treatment-naive, HIV-infected subjects: week 48 data from the Altair study. Clin Infect Dis. 2010; 51:855-64. [PubMed 20735258]

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124. Sax PE, Tierney C, Collier AC et al. Abacavir-lamivudine versus tenofovir-emtricitabine for initial HIV-1 therapy. N Engl J Med. 2009; 361:2230-40. [PubMed 19952143]

125. Martínez E, Arnaiz JA, Podzamczer D et al. Substitution of nevirapine, efavirenz, or abacavir for protease inhibitors in patients with human immunodeficiency virus infection. N Engl J Med. 2003; 349:1036-46. [PubMed 12968087]

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128. Martinez E. The NEFA study: results at three years. AIDS Rev. 2007 Jan-Mar; 9:62.

129. Marcus KA. Supplemental approval release REMS requirement. Silver Spring, MD: US Food and Drug Administration; 2011 May 13. From FDA website.

198. Center for Disease Control and Prevention. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: Recommendations from the U.S. Department of Health and Human Services. MMWR Recomm Rep. 2005; 54(No. RR-2):1-19.

199. Center for Disease Control and Prevention. Updated U.S. public health service guidelines for the management of occupational exposures to HIV and recommendations for postexposure prophylaxis. MMWR Morb Mortal Wkly Rep. 2005; 54 (No. RR-9):1-17.

200. Panel on Antiretroviral Guidelines for Adults and Adolescents, US Department of Health and Human Services (HHS). Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (April 18, 2012). Updates may be available at HHS AIDS Information (AIDSinfo) website.

201. Panel on Antiretroviral Therapy and Medical Management of HIV-infected Children, US Department of Health and Human Services (HHS). Guidelines for the use of antiretroviral agents in pediatric HIV infection (August 11, 2011). Updates may be available at HHS AIDS Information (AIDSinfo) website.

202. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission, US Department of Health and Human Services (HHS). Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States (September 14, 2011). Updates may be available at HHS AIDS Information (AIDSinfo) website.

203. Bristol-Myers Squibb. Reyataz (atazanavir sulfate) capsules prescribing information. Princeton, NJ; 2012 Mar.

204. Janssen. Prezista (darunavir) oral suspension and tablets prescribing information. Titusville, NJ; 2012 Jun.

205. ViiV Healthcare. Lexiva (fosamprenavir calcium) tablets and oral suspension prescribing information. Research Triangle Park, NC; 2012 Feb.

207. Abbott Laboratories. Kaletra (lopinavir/ritonavir) tablets and oral solution prescribing information. North Chicago, IL; 2012 Feb.

208. ViiV Healthcare. Viracept (nelfinavir mesylate) tablets and oral powder prescribing information. Research Triangle Park, NC; 2012 Apr.

211. Boehringer Ingelheim. Aptivus (tipranavir) capsules and oral solution prescribing information. Ridgefield, CT; 2012 Apr.

213. Bristol-Myers Squibb. Sustiva (efavirenz) capsules and tablets prescribing information. Princeton, NJ; 2012 Jun.

214. Janssen. Intelence (etravirine) tablets prescribing information. Raritan, NJ; 2012 Mar.

220. Bristol-Myers Squibb. Zerit (stavudine) capsules and oral solution prescribing information. Princeton, NJ; 2012 Jan.

221. Gilead Sciences. Viread (tenofovir disoproxil fumarate) tablets prescribing information. Foster City, CA; 2012 Jan.

224. ViiV Healthcare. Selzentry (maraviroc) tablets prescribing information. Research Triangle Park, NC; 2011 Nov.

225. Merck Sharp & Dohme. Isentress (raltegravir) film-coated tablets and chewable tablets prescribing information. Whitehouse Station, NJ; 2012 Apr.

226. Tibotec Therapeutics. Edurant (rilpivirine) tablets prescribing information. Raritan, NJ; 2011 May.

228. ViiV Healthcare. Epzicom (abacavir sulfate and lamivudine) tablets prescribing information. Research Triangle Park, NC; 2012 May.

229. ViiV Healthcare. Trizivir (abacavir sulfate, lamivudine, and zidovudine) tablets prescribing information. Research Triangle Park, NC; 2012 May.

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