imiglucerase (Rx)

Brand and Other Names:Cerezyme
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 200 units
  • 400 units

Gaucher Disease

Indicated for type 1 Gaucher's disease; associated with one or more of the following: anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly

2.5 units/kg IV infused over 1-2 hr 3 times per week OR 30-60 unit/kg IV q2Weeks initially

May initiate at a higher dose/frequency based on disease severity

Up to 240 unit/kg q2Weeks has been safely used

Dosage Forms & Strengths

powder for injection

  • 200 units
  • 400 units

Gaucher Disease

<2 years: Safety and efficacy not estabilshed

>2 years: 2.5 units/kg IV (1-2 hours infusion) 3 times per week OR 30-60 unit/kg IV q2Weeks initially

May initiate at a higher dose/frequency based on disease severity

Up to 240 unit/kg q2Weeks has been safely used

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Interactions

Interaction Checker

and imiglucerase

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Hypersensitivity with infusion (6.6%)

            Nausea, abdominal pain, vomigin, diarrhea (1.5%)

            Rash (1.5%)

            Fatigue (1.5%)

            Headache (1.5%)

            Fever (1.5%)

            Dizziness (1.5%)

            Chills (1.5%)

            Backache (1.5%)

            Tachycardia (1.5%)

            <1%

            Discomfort

            Pruritus

            Burning

            Swelling

            Sterile abscess at site of venipuncture

            Pulmonary hypertension

            Pneumonia

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            Warnings

            Contraindications

            None listed in the manufacturer's label

            Cautions

            Antibodies to imiglucerase that may lead to infusion reactions reported in up to 15% of patients within 6 months from the onset of therapy; antibody formation rare after 12 months of therapy

            Most patients with infusion reactions are able to continue treatment if pre-treated with antihistamines and/or corticosteroids and infused at a lower rate

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Not known if distributed into breast milk, use caution

            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

            Analog of beta-glucocerebrosidase, lysosomal enzyme replacement that plays a role in the hydrolysis of glucocerebroside to glucose and ceramide

            Pharmacokinetics

            Half-Life: 3.6-10.4 min

            Onset: 30 min

            Vd: 0.09-0.15 L/kg

            Renal Clearance: 9.8-20.3 mL/min/kg

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            Administration

            IV Preparation

            Reconstitute with 5.1 mL SWI for 200 u vial & 10.2 mL for 400 U vial (resulting conc 40 U/mL)

            Stable for 12 hr at room temp & fridge

            IV Administration

            Dilute to a final volume 100-200 mL w/ NS

            Diluted soln stable for 24 hr in fridge

            Infuse over 1-2 hr

            Storage

            Store vials at 2-8°C (36-46°F)

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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.