abacavir (Rx)

Brand and Other Names:Epzicom
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

abacavir/lamivudine

tablet

  • 600mg/300mg

HIV Infection

Indicated to treat HIV infection in combination with other antiretroviral drugs

1 tablet (600 mg abacavir/300 mg lamivudine) PO qDay

Dosage Modifications

Renal impairment

  • CrCl ≥50 mL/min: No dosage adjustment required
  • CrCl 30-49 mL/min

    • Monitor for hematologic toxicities; if new or worsening neutropenia or anemia develops, dose adjustment of lamivudine, per lamivudine prescribing information, recommended; if lamivudine dose adjustment indicated, the drug combination should be discontinued and individual components used to construct the treatment regimen

  • CrCl <30 mL/min
    • Not recommended; fixed-dose tablet and cannot be dose adjusted
    • Consider using lamivudine oral solution or tablets plus abacavir oral solution

Hepatic impairment

  • Moderate or severe (Child-Pugh Class B or C): Contraindicated
  • Mild (Child-Pugh Class A)
    • Not recommended; fixed-dose tablet and cannot be dose adjusted
    • Consider using lamivudine oral solution or tablets plus abacavir oral solution

Dosage Forms & Strengths

abacavir/lamivudine

tablet

  • 600mg/300mg

HIV Infection

Indicated to treat HIV infection in combination with other antiretroviral drugs

<25 kg: Safety and efficacy not established

≥25 kg: 1 tablet (600 mg abacavir/300 mg lamivudine) PO qDay

Assess child's ability to swallow the tablet whole

Dosage Modifications

Renal impairment

  • CrCl ≥30 mL/min: No dosage adjustment required
  • CrCl 30-49 mL/min

    • Monitor for hematologic toxicities; if new or worsening neutropenia or anemia develops, dose adjustment of lamivudine, per lamivudine prescribing information, recommended; if lamivudine dose adjustment indicated, the drug combination should be discontinued and individual components used to construct the treatment regimen

  • CrCl <30 mL/min
    • Not recommended; fixed-dose tablet and cannot be dose adjusted
    • Consider using lamivudine oral solution or tablets plus abacavir oral solution

Hepatic impairment

  • Moderate or severe (Child-Pugh Class B or C): Contraindicated
  • Mild (Child-Pugh Class A)
    • Not recommended; fixed-dose tablet and cannot be dose adjusted
    • Consider using lamivudine oral solution or tablets plus abacavir oral solution

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Interactions

Interaction Checker

and abacavir

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (1)

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              abacavir, elvitegravir/cobicistat/emtricitabine/tenofovir DF. Other (see comment). Contraindicated. Comment: Elvitegravir/cobicistat/emtricitabine/tenofovir is a complete regimen for HIV and should not be administered with other antiretrovirals.

            Serious - Use Alternative (6)

            • betibeglogene autotemcel

              abacavir, betibeglogene autotemcel. Other (see comment). Avoid or Use Alternate Drug. Comment: Do not take antiretroviral medications for at least 1 month before mobilization or expected duration for elimination of the medications, and until all cycles of apheresis are completed. Antiretroviral medications may interfere with manufacturing of apheresed cells.

            • cabotegravir

              abacavir, cabotegravir. Other (see comment). Avoid or Use Alternate Drug. Comment: Cabotegravir plus rilpivirine is a complete regimen. Coadministration with other antiretroviral medications for treating HIV-1 infection is not recommended.

            • elivaldogene autotemcel

              elivaldogene autotemcel, abacavir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.

            • ganciclovir

              ganciclovir, abacavir. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Increased risk of hematologic toxicity.

            • ribavirin

              ribavirin increases toxicity of abacavir by Other (see comment). Avoid or Use Alternate Drug. Comment: Increased risk of lactic acidosis and hepatic decompensation.

            • valganciclovir

              valganciclovir, abacavir. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Increased risk of hematologic toxicity.

            Monitor Closely (20)

            • atazanavir

              atazanavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • cabozantinib

              abacavir will increase the level or effect of cabozantinib by Other (see comment). Use Caution/Monitor. MRP2 inhibitors increase cabozantinib toxicity

            • didanosine

              abacavir and didanosine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • efavirenz

              abacavir and efavirenz both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • emtricitabine

              abacavir and emtricitabine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • enfuvirtide

              abacavir and enfuvirtide both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • fosamprenavir

              fosamprenavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • indinavir

              indinavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • lamivudine

              abacavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • methadone

              abacavir will decrease the level or effect of methadone by unknown mechanism. Use Caution/Monitor. Monitor for opioid withdrawal symptoms.

            • nelfinavir

              nelfinavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • nevirapine

              abacavir and nevirapine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • orlistat

              orlistat will decrease the level or effect of abacavir by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

            • riociguat

              abacavir will increase the level or effect of riociguat by unknown mechanism. Modify Therapy/Monitor Closely. Riociguat dose reduction may be necessary

            • ritonavir

              ritonavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • saquinavir

              saquinavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • stavudine

              abacavir and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • tenofovir DF

              abacavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • tipranavir

              tipranavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

              tipranavir decreases levels of abacavir by unspecified interaction mechanism. Use Caution/Monitor.

            • zidovudine

              abacavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            Minor (1)

            • ethanol

              ethanol increases levels of abacavir by decreasing metabolism. Minor/Significance Unknown. Interaction usually not clinically significant.

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            Warnings

            Black Box Warnings

            Hypersensitivity reactions

            • Severe and sometimes fatal hypersensitivity reaction, with multiple organ involvement, have occurred
            • Reintroduction of abacavir or any other abacavir-containing product, even in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy, can result (within hours) in serious or fatal hypersensitivity reactions
            • Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele
            • Contraindicated with history of prior hypersensitivity reaction to abacavir and in patients who are HLA-B*5701-positive
            • All patients should be screened for the HLA-B*5701 allele before initiating or reinitiating abacavir, unless patients have a previously documented HLA-B*5701 allele assessment
            • If hypersensitivity is suspected, discontinue abacavir immediately, regardless of HLA-B*5701 status and even when other diagnoses are possible

            Exacerbations of hepatitis B

            • Severe acute exacerbations of hepatitis B reported in patients who are coinfected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine
            • Monitor hepatic function closely in these patients and, if appropriate, initiate antihepatitis B treatment

            Contraindications

            Patients who have the HLA-B*5701 allele

            Prior hypersensitivity to abacavir or lamivudine

            Moderate or severe hepatic impairment

            Cautions

            Review medical history for hypersensitivity to abacavir before administration; discontinue at first signs of hypersensitivity

            Patients with creatinine clearance between 30-49 mL/min receiving drug combination may experience a 1.6-3.3-fold higher lamivudine exposure (AUC) than patients with a creatinine clearance ≥50 mL/min; monitor for hematologic toxicities

            Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with nucleoside analogues, including abacavir and lamivudine (components of the combination product); a majority of these cases have been in women; female gender and obesity may be risk factors; suspend dosing in those who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity

            Exacerbation of hepatitis B may occur on discontinuation

            Immune reconstitution syndrome reported with combination ART; during the initial treatment phase, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis); autoimmune disorders (eg, Grave disease, polymyositis, and Guillain-Barré syndrome) have also been reported

            Use has been associated with increased risk of myocardial infarction in observational studies, but not in a meta-analysis of 26 randomized trials; caution with risks for coronary heart disease and minimizing modifiable risk factors, including smoking, hypertension, and hyperlipidemia, prior to use

            Concomitant administration of emtricitabine with lamivudine-containing products not recommended

            Hepatic decompensation, some fatal, reported in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin; discontinue therapy as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both

            Patients with hepatitis B virus co-infection

            • Posttreatment exacerbation of hepatitis
              • Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine; patients should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment
            • Emergence of lamivudine resistant HBV
              • Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in subjects dually infected with HIV-1 and HBV; emergence of hepatitis B virus variants associated with resistance to lamivudine has been reported in HIV-1-infected subjects who have received lamivudine-containing antiretroviral regimens in presence of concurrent infection with hepatitis B virus

            Due to the potential for severe, serious, and possibly fatal hypersensitivity reactions with abacavir:

            • All patients should be screened for the HLA-B*5701 allele prior to initiating or reinitiating therapy, unless patients have a previously documented HLA-B*5701 allele assessment
            • Therapy is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients
            • Before starting therapy, review medical history for prior exposure to any abacavir­ containing product; never restart treatment or any other abacavir-containing product following a hypersensitivity reaction to abacavir, regardless of HLA-B*5701 status
            • To reduce risk of a life-threatening hypersensitivity reaction, regardless of HLA-B*5701 status, discontinue therapy immediately if a hypersensitivity reaction is suspected, even when other diagnoses are possible (eg, acute onset respiratory diseases such as pneumonia, bronchitis, pharyngitis, or influenza; gastroenteritis; or reactions to other medications)
            • If a hypersensitivity reaction cannot be ruled out, do not restart treatment or any other abacavir-containing products because more severe symptoms, which may include life-threatening hypotension and death, can occur within hours
            • If a hypersensitivity reaction is ruled out, patients may restart therapy; rarely, patients who have stopped abacavir for reasons other than symptoms of hypersensitivity have also experienced life-threatening reactions within hours of reinitiating abacavir therapy; therefore, reintroduction to drug combination or any other abacavir-containing product is recommended only if medical care can be readily accessed
            • A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill
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            Pregnancy & Lactation

            Pregnancy

            If pregnant woman exposed to abacavir, report to the Antiretroviral Pregnancy Registry 1-800-258-4263

            Abacavir

            • Based on prospective reports to APR of exposures to abacavir during pregnancy resulting in live births (including over 1,300 exposed in the first trimester and over 1,300 exposed in the second/third trimester), there was no difference between overall risk of birth defects for abacavir compared with the background birth defect rate of 2.7% in the U.S. reference population of the MACDP
            • The prevalence of defects in live births was 3.2% (95% CI: 2.3% to 4.3%) following first-trimester exposure to abacavir-containing regimens and 2.9% (95% CI: 2.1% to 4.0%) following second/third trimester exposure to abacavir-containing regimens

            Lamivudine

            • Based on prospective reports to APR of exposures to lamivudine during pregnancy resulting in live births (including over 5,300 exposed in first trimester and over 7,400 exposed in second/third trimester), there was no difference between overall risk of birth defects for lamivudine compared with background birth defect rate of 2.7% in U.S. reference population of MACDP
            • The prevalence of birth defects in live births was 3.1% (95% CI: 2.7% to 3.6%) following first-trimester exposure to lamivudine-containing regimens and 2.9% (95% CI: 2.5%, 3.3%) following second/third-trimester exposure to lamivudine- containing regimens

            Lactation

            Abacavir and lamivudine are present in human milk; there is no information on effects of abacavir and lamivudine on breastfed infant or effects of drug on milk production; because of potential for (1) HIV-1 transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive infants), and (3) serious adverse reactions in breastfed infant, instruct mothers not to breastfeed if they are receiving therapy

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Pharmacogenomics

            Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction

            Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended

            For HLA-B*5701-positive patients, treatment with an abacavir-containing regimen is not recommended

            Genetic testing laboratories

            • The following companies provide genetic testing for HLA variants
            • Kashi Clinical Laboratories (www.kashilab.com)
            • LabCorp (http://www.labcorp.com/)
            • Specialty Laboratories (http://www.specialtylabs.com)
            • Quest (http://www.questdialgnotics.com)

            Mechanism of Action

            Lamivudine: NRTI; following phosphorylation, inhibits HIV reverse transcriptase by viral DNA chain termination; cytosine analog

            Abacavir: NRTI; following phosphorylation, inhibits HIV reverse transcriptase by inhibiting viral replication; guanosine analogue

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.