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abacavir (Rx)Brand and Other Names:Ziagen

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oral solution

  • 20mg/mL

tablet

  • 300mg
more...

HIV Infection

300 mg PO q12hr, OR

600 mg PO qDay in combination with other antiretroviral agents

Dosage Modifications

Renal impairment: No dosage adjustment required

Hepatic impairment

  • Mild (Child-Pugh 5-6): Reduce dose to 200 mg q12hr (use oral solution)
  • Moderate-to severe: Contraindicated

Dosage Forms & Strengths

oral solution

  • 20mg/mL

tablet

  • 300mg
more...

HIV Infection

Neonates/Infants: Safety and efficacy not established

3 months-16 years: 8 mg/kg PO q12hr or 16 mg/kg/day; not to exceed 600 mg/day in combination with other antiretroviral agents 

≥14 kg: Available as a scored tablet; if unable to reliably swallow tablets, prescribe the oral solution

>16 years: 300 mg PO q12hr, OR 600 mg PO qDay in combination with other antiretroviral agents

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Interactions

Interaction Checker

abacavir and

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 (17-19%)

            Headache (9-13%)

            Malaise/Fatigue (12%)

            Nausea & vomiting (10%)

            1-10%

            Hypersensitivity reaction (2-8%)

            Diarrhea (5-7%)

            Musculoskelatal pain (5-7%)

            Hypertriglyceridemia (6%)

            Hepatic: AST Increased (6%)

            Depression (4-6%)

            Fever/chills (3-6%)

            Viral respiratory infections (5%)

            Ear/nose /throat infections (4-5%)

            Rash (4-5%)

            Anxiety (3-5%)

            Thrombocytopenia (1%)

            <1%

            Anaphylactoid reaction

            Pulmonary hypertension

            Erythema multiforme

            Redistribution/accumulation of body fat

            Stevens-Johnson syndrome

            Toxic epidermal necrolysis

            Pancreatitis

            GGT increased

            Hepatic steatosis

            Heptaomegaly

            Hepatotoxicity

            Lactic acidosis

            MI

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            Warnings

            Black Box Warnings

            Hypersensitivity Reactions

            • Severe and sometimes fatal hypersensitivity reactions (discontinue immediately if hypersensitivity reaction suspected); Never restart after suspected hypersensitivity reaction because 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)
            • Hypersensitivity reactions & HLA-B*5701 allele (section 2) 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

            • Lactic acidosis and hepatomegaly with steatosis (including fatal cases) reported with use of nucleoside analogues alone or in combination

            Contraindications

            Hypersensitivity;

            Presence of HLA-B*5701 allele

            do not restart abacavir following hypersensitive reaction without regard of HLA-B-5701, may cause hypotension, death

            Moderate or severe hepatic impairment

            Cautions

            (All NRTIs): Risk of potentially fatal lactic acidosis & severe hepatomegaly with steatosis when used alone or in combination with other antiretrovirals

            Risk of immune reconstitution syndrome if used in combination w/ other antiretroviral drugs

            Increased risk of serious or fatal hypersensitivity reactions in patients w/ human leukocyte antigen allele, HLA-B*5701; do not restart abacavir following hypersensitive reaction without regard of HLA-B-5701, may cause hypotension, death

            May cause redistribution of fat that may result in cushingoid appearance

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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: Nor recommended; HIV+ women are advised not to breastfeed

            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

            Mechanism of Action

            Guanosine analog that inhibits HIV-1 reverse transcriptase by competing with dGTP as substrate, which in turn inhibits viral replication

            Pharmacokinetics

            Absorption: Rapid & extensive absorption

            Vd: 0.86 L/kg

            Protein Bound: 50%

            Metabolism: hepatic via alcohol dehydrogenase & glucuronyl transferase to inactive carboxylate & glucuronide metabolites

            Bioavailability: 83%

            Half-life elimination: 1.5 hr

            Peak Plasma Time: 0.7-1.7 hr

            Excretion: Urine (80%); feces (16%)

            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)
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            Images

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            Formulary

            FormularyPatient Discounts

            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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