agalsidase alfa (Rx)

Brand and Other Names:Replagal
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 1mg/mL
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Fabry Disease (Orphan)

0.2 mg/kg IV infusion q2Weeks over 40 minutes 

Antihistamines and corticosteroids may alleviate infusion-related reactions

Dosage Forms & Strengths

injectable solution

  • 1mg/mL
more...

Fabry Disease (Orphan)

0.2 mg/kg IV infusion q2Weeks over 40 minutes

Antihistamines and corticosteroids may alleviate infusion-related reactions

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Interactions

Interaction Checker

and agalsidase alfa

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Flushing (23.6%)

            Headache (10.9%)

            Infusion reactions (12.7%)

            Pyrexia (20%)

            Rigors (20%)

            1-10%

            Abdominal pain

            Acne

            Asthenia

            Chest pain/tightness

            Diarrhea

            Dizziness

            Dyspepsia

            Eczema

            Erythema, & other skin problems

            Edema

            Fatigue

            GI problems

            HTN

            Myalgia

            Nausea/vomiting

            Neuropathic pain

            Other pain

            Pharyngitis

            Throat irritation

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            Warnings

            Contraindications

            Hypersensitivity

            Concurrent use of chloroquine, amiodarone, benoquin or gentamicin (drugs that inhibit intracellular alpha-galactosidase activity)

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            Pregnancy & Lactation

            Pregnancy Category: no clinical data, animal studies indicate safe

            Lactation: not known whether distributed in 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

            Half-Life, Elimination: 1.5-1.8 hr

            Half-Life, tissue: 24 hr

            Metabolism: likely as other proteins

            Excretion: not significantly by renal clearance

            Mechanism of Action

            Recombinant alpha-galactosidase A, an enzyme (deficient in Fabry dz) involved in the metabolism of glycosphingolipids (e.g., GL-3); correcting abnormal glycosphingolipid metabolism resulting in reduced accumulation of glycosphingolipids and improvement of associated clinical manifestations

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            Administration

            IV Preparation

            Aseptically dilute required volume of concentrate in 100 mL NS

            Administer within 3 hr of dilution

            IV Administration

            Infuse over 40 min

            Do not administer with other drugs

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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.
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            • 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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