lamivudine/abacavir (Rx)

Brand and Other Names:Epzicom
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lamivudine/abacavir

tablet

  • 300mg/600mg
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HIV Infection

Indicated to treat HIV infection in combination with other antiretroviral drugs

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

Dosage Modifications

Fixed-dose combination product; do not prescribe for patients requiring a dosage adjustment (eg, CrCl <50 mL/min, hepatic impairment)

Dosage Forms & Strengths

lamivudine/abacavir

tablet

  • 300mg/600mg
more...

HIV Infection

Indicated to treat HIV infection in combination with other antiretroviral drugs

<25 kg: Safety and efficacy not established

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

Assess child's ability to swallow the tablet whole

Dosage Modifications

Fixed-dose combination product; do not prescribe for patients requiring a dosage adjustment (eg, CrCl <50 mL/min, hepatic impairment)

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Interactions

Interaction Checker

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            Warnings

            Black Box Warnings

            Severe acute exacerbations of hepatitis B reported in patients co-infected 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 anti-hepatitis B treatment

            abacavir

            • Severe and sometimes fatal hypersensitivity reactions (discontinue immediately if hypersensitivity reaction suspected)
            • Never restart after suspected hypersensitivity reaction as more severe symptoms can occur within hours and may include life-threatening hypotension and death
            • 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
            • Hypersensitivity reaction to this drug is a multiorgan clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups: 1) fever, 2) rash, 3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain, 4) constitutional (eg, generalized malaise, fatigue, achiness), and 5) respiratory (eg, pharyngitis, dyspnea, cough); HLA-B*5701 allele carriers at high risk for hypersensitivity reaction, Prior to initiating therapy, screen for the HLA-B*5701 allele; this approach decreases risk of hypersensitivity reaction
            • Screening also recommended prior to reinitiation in patients of unknown HLA-B*5701 status who have previously tolerated abacavir therapy
            • HLA-B*5701 allele negative patients may develop hypersensitivity reaction; although frequency significantly less than in HLA-B*5701 positive patients
            • Regardless of HLA-B*5701 status, permanently discontinue if hypersensitivity cannot be ruled out, even when other diagnoses are possible
            • Lactic acidosis and hepatomegaly with steatosis (including fatal cases) reported with nucleoside analogues alone or in combination

            lamivudine

            • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals
            • Not FDA approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of this drug have not been established in patients coinfected with HBV and HIV
            • Tablets and oral solution formulations used to treat HIV infection contain a higher dose of lamivudine than formulations indicated for chronic hepatitis B infection; HIV patients should receive only formulation specific for HIV

            Contraindications

            Hypersensitivity (hypersensitivity reaction to abacavir is potentially lethal)

            CrCl <50 mL/min; may use adjusted doses of abacavir & lamivudine instead

            Patients requiring individual dose adjustments for each drug component

            Hepatic impairment

            Cautions

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

            (All NRTIs): Risk of potentially fatal lactic acidosis & severe hepatomegaly with steatosis

            Exacerbation of hepatitis B may occur on discontinuation

            Risk of immune reconstitution syndrome

            May cause redistribution of fat (cushingoid appearance)

            Use caution in patients with risks for coronary heart disease

            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

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            Pregnancy & Lactation

            Pregnancy Category: C

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

            Lactation: do not nurse if taking this drug

            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

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            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.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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