lamivudine/zidovudine/abacavir (Rx)

Brand and Other Names:Trizivir
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lamivudine/zidovudine/abacavir

tablet

  • 150mg/300mg/300mg
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HIV Infection

1 tablet PO q12hr

<40 kg: Not recommended

Renal Impairment

CrCl <50 mL/min: Not recommended

Hepatic Impairment

Contraindicated

Dosage Forms & Strengths

lamivudine/zidovudine/abacavir

tablet

  • 150mg/300mg/300mg
more...

HIV Infection

<12 years or <40 kg: Not recommended

>12 years or >40 kg: 1 tablet PO q12hr

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Interactions

Interaction Checker

and lamivudine/zidovudine/abacavir

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Nausea

            Headache

            Fatigue

            Malaise

            Vomiting

            1-10%

            Rash

            Fever/chills

            Anxiety

            Depression

            Increased triglyceride levels

            Diarrhea

            Increased amylase

            Neutropenia

            Increased ALT

            Increased CPK

            Ear infection

            Nose/throat infection

            Viral infection

            Frequency Not Defined

            Immune reconstitution syndrome

            GGT increased

            Fat redistribution

            Pancreatitis

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            Warnings

            Black Box Warnings

            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
            • Exacerbations of hepatitis reported after discontinuation of lamivudine; monitor patients closely with both clinical and laboratory follow-up for at least several months after stopping treatment; if appropriate, initiate anti-hepatitis B therapy
            • 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

            zidovudine

            • Neutropenia and severe anemia reported, particularly in patients with advanced HIV disease
            • Myopathy associated with prolonged use
            • Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) reported with nucleoside analogues alone or in combination

            Contraindications

            Hypersensitivity

            CrCl <50 mL/min

            Hepatic impairment

            Patients requiring individual dose adjustments for each drug component

            Presence of HLA-B*5701 allele

            Cautions

            Risk of immune reconstitution syndrome

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

            Use caution in patients with risks for coronary heart disease

            Use caution when treating in combination with interferon alfa with or without ribavirin in HIV/HBV; monitor for hepatic decompensation, neutropenia, or anemia and reduce interferon dose and or ribavirin or discontinue if toxicity occurs

            Discontinue therapy as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both in co-infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin

            Exacerbation of anemia reported in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine; coadministration of ribavirin and zidovudine not advised

            Immune reconstitution syndrome and redistribution/accumulation of body fat reported in patients treated with combination antiretroviral therapy

            Not for administration with other products containing abacavir, lamivudine, or zidovudine; or emtricitabine-containing products

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            Pregnancy & Lactation

            Pregnancy

            There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the drug during pregnancy; healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263

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

            Lactation

            The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection; abacavir, lamivudine and zidovudine are present in human milk; there is no information on effects of abacavir, lamivudine and zidovudine 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 beind treated with the drug combination

            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

            Zidovudine: NRTI; interferes with HIV viral RNA-dependent DNA polymerase (inhibits viral replication); thymidine 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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