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

HIV Infection

Indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in patients who weigh at least 40 kg

1 tablet PO q12hr

<40 kg: Not recommended

Dosage modification

Renal impairment CrCl <50 mL/min: Fixed dose tablet cannot be dose adjusted

Hepatic impairment

  • Mild: Fixed dose tablet cannot be dose adjusted
  • Mild or moderate: Contraindicated

Dosage Forms & Strengths

lamivudine/zidovudine/abacavir

tablet

  • 150mg/300mg/300mg

HIV Infection

Indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection who weigh at least 40 kg

<40 kg: Not recommended

≥40 kg: 1 tablet PO q12hr

Dosage Modifications

Renal impairment (CrCl <50 mL/min): Fixed dose tablet cannot be dose adjusted

Hepatic impairment

  • Mild: Fixed dose tablet cannot be dose adjusted
  • Mild or moderate: Contraindicated
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Interactions

Interaction Checker

and lamivudine/zidovudine/abacavir

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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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

            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

            Hematologic toxicity

            • Hematologic toxicity, including neutropenia and anemia, has been associated with the use of zidovudine

            Myopathy

            • Symptomatic myopathy associated with prolonged use of zidovudine

            Lactic acidosis and severe hepatomegaly with steatosis

            • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including abacavir, lamivudine, and zidovudine
            • Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur

            Contraindications

            Hypersensitivity to any component

            Moderate or severe hepatic impairment

            Presence of HLA-B*5701 allele

            Cautions

            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

            Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with use of nucleoside analogues, including abacavir, lamivudine, and zidovudine (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 develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity

            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

            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

            Treatment with zidovudine, a component of the combination formulation, has been associated with loss of subcutaneous fat; the incidence and severity of lipoatrophy are related to cumulative exposure; this fat loss, which is most evident in the face, limbs, and buttocks, may be only partially reversible and improvement may take months to years after switching to a non-zidovudine-containing regimen; patients should be regularly assessed for signs of lipoatrophy during therapy with zidovudine-containing products, and if feasible, therapy should be switched to an alternative regimen if there is suspicion of lipoatrophy

            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

            Hyperlactatemia, which may be due to mitochondrial dysfunction, reported in infants with in utero exposure to zidovudine-containing products; causal relationship between these events and exposure to zidovudine-containing products in utero or peri-partum not established

            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, similar to those seen in adults; 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

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            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.