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pegloticase (Rx)Brand and Other Names:Krystexxa

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 8mg/mL
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Gout

Indicated for treatment of chronic gout in adult patients refractory to conventional treatment

8 mg IV infusion q2wk (see Administration)

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

pegloticase 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%

            Gout flares (77%)

            Infusion reactions (26%)

            Nausea (12%)

            Urticaria (10.6%)

            1-10%

            Chest discomfort (9.5%)

            Chest pain (9.5%)

            Erythema (9.5%)

            Pruritus (9.5%)

            Nasopharyngitis (7%)

            Anaphylaxis (5%)

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            Warnings

            Black Box Warnings

            Anaphylaxis and infusion reactions have been reported; these reactions may occur with any infusion, including the first, and typically manifest within 2 h of infusion (although delayed-type hypersensitivity has also been reported)

            Only administer in a healthcare setting, and monitor for appropriate period following infusion

            Premedicate with antihistamines and corticosteroids

            Risk for anaphylaxis is higher if serum uric acid level >6 mg/dL, monitor serum uric acid levels before infusion and consider discontinuing if levels increase to >6 mg/dL (particularly if 2 consecutive levels of >6 mg/dL are observed)

            Contraindications

            Hypersensitivity

            G6PD-deficiency (increased risk of hemolysis and methemoglobinemia)

            Cautions

            Gout flare frequently observed (initiate gout flare prophylaxis with NSAID or colchicine at least 1 wk before starting pegloticase); gout flare prophylaxis recommended for at least first 6 months

            Screen patients at higher risk of G6PD deficiency, especially those of African and Mediterranean ancestry

            Caution with congestive heart failure (not formally studied in patients with CHF); congestive heart failure exacerbation may occur; monitor patients closely following infusion

            Unknown if retreatment after stopping for longer than 4 wk increases risk of anaphylaxis, infusion reactions, or immunogenicity

            Risk of infusion reaction is increased in patients whose uric acid is >6 mg/dL; if less than severe infusion reactions occur, may slow infusion or infusion stopped and restarted at lower rate at physician's discretion

            Discontinue use of oral antihyperuricemic agents prior to therapy; do not initiate during course of therapy; agents may delay interpretation of ineffective pegloticase treatment

            Patients may be at increased risk for anaphylaxis and infusion reactions, when treatment is discontinued for >4 weeks, due to potential to immunogenicity

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Unknown whether distributed in breast milk; if it is distributed into breast milk, the potential for serious adverse reactions exist, therefore breastfeeding is not recommended

            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

            Recombinant, pegylated uric acid specific enzyme; achieves its therapeutic effect by catalyzing oxidation of uric acid to allantoin, thereby lowering serum uric acid levels

            Pharmacokinetics

            Onset of action: 24 hr

            Duration: 12.5 days

            Half-life: 14 days

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            Administration

            IV Compatibilities

            Solution: 0.9% NaCl, 0.45% NaCl

            IV Preparation

            IV infusion

            • Withdraw 1 mL from vial (discard any unused portion) and add to a single 250 mL bag of 0.9% or 0.45% NaCl
            • Invert infusion bag a number of times to ensure thorough mixing
            • DO NOT SHAKE
            • Stability: Admixture is stable for 4 hr at 2-8 degrees C (36-46 degrees F) or at room temperature (20-25 degrees C, 68-77 degrees F)

            IV Administration

            Do NOT administer as IV push or bolus

            Premedicate with antihistamines and corticosteroids

            Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to >6 mg/dL (especially if 2 consecutive levels > 6 mg/dL observed)

            Administer IV infusion over at least 2 hr via gravity feed or volumetric infusion pump

            Storage

            Store refrigerated in original carton (do not freeze)

            Protect from light

            Do not shake

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            Images

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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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