lamivudine/abacavir (Rx)

Brand and Other Names:Epzicom
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lamivudine/abacavir

tablet

  • 300mg/600mg

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 dosage adjustment (eg, CrCl <50 mL/min, hepatic impairment)

Dosage Forms & Strengths

lamivudine/abacavir

tablet

  • 300mg/600mg

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 dosage adjustment (eg, CrCl <50 mL/min, hepatic impairment)

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Interactions

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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

            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

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            Pregnancy & Lactation

            Pregnancy

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

            Available data from antiretroviral pregnancy registry show no difference in overall risk of birth defects for abacavir or lamivudine compared with background rate for birth defects of 2.7% in Metropolitan Atlanta Congenital Defects Program (MACDP) reference population

            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

            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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.