alglucerase (Rx)

Brand and Other Names:Ceredase
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Dosing & Uses

AdultPediatric

Dosing Form & Strengths

injectable solution

  • 80 units/mL (400 units/vial)

Gaucher Disease

Indicated for long-term enzyme replacement therapy for type I Gaucher disease in patients with signs and symptoms severe enough to result in anemia, thrombocytopenia, bone disease, or hepatomegaly/splenomegaly

Individualize dose: Initial dose may be as little at 2.5 units/kg IV 3 times/week up to as much as 60 units/kg IV as frequent as qWeek, or as infrequently as q4weeks

60 Units/kg IV q2weeks is the dose for which the most data are available

Disease severity may dictate that drug be initiated with relatively high doses or relatively frequent administration; after patient response is well-established, a reduction in dosage may be attempted for maintenance therapy; progressive reductions can be made at intervals of 3-6 months while carefully monitoring response parameters

Administration

Pretreat with antihistamine before administration to reduce risk of infusion related reactions

Infuse IV over 1-2 hr

Dosing Considerations

Derived from human placenta tissue donors

Has been largely replaced by the recombinant product, imiglucerase (Cerezyme)

Prepared on a batch-by-batch basis for a few patients unable to tolerate or do not respond well to the newer product

Dosing Form & Strengths

injectable solution

  • 80 units/mL (400 units/vial)

Gaucher Disease

Indicated for long-term enzyme replacement therapy for type I Gaucher disease in patients with signs and symptoms severe enough to result in anemia, thrombocytopenia, bone disease, or hepatomegaly/splenomegaly

Individualize dose: Initial dose may be as little at 2.5 units/kg IV 3 times/week up to as much as 60 units/kg IV as frequent as qWeek, or as infrequently as q4weeks

60 Units/kg IV q2weeks is the dose for which the most data are available

Disease severity may dictate that drug be initiated with relatively high doses or relatively frequent administration; after patient response is well-established, a reduction in dosage may be attempted for maintenance therapy; progressive reductions can be made at intervals of 3-6 months while carefully monitoring response parameters

Administration

Pretreat with antihistamine before administration to reduce risk of infusion related reactions

Infuse IV over 1-2 hr

Other Information

Derived from human placenta tissue donors

Has been largely replaced by the recombinant product, imiglucerase (Cerezyme)

Prepared on a batch-by-batch basis for a few patients unable to tolerate or do not respond well to the newer product

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Adverse Effects

Frequency Not Defined

Discomfort, pruritus, burning, swelling, sterile abscess at venipuncture site

Mild fever

Chills

Abdominal discomfort

Nausea

Vomiting

Hypersensitivity symptoms during or shortly following infusion (eg, pruritus, flushing, urticaria, respiratory symptoms, nausea, abdominal cramping, hypotension)

Postmarketing Reports

Severe and serious infusion reactions including anaphylactic shock

Acute cardiorespiratory failure, possibly associated with fluid overload (in patients with pre-existing hypertrophic cardiomyopathy

Cardiac/respiratory arrest

Apnea

Stridor

Pharyngeal edema

Peripheral edema

Chest pain/discomfort

Muscle spasm

Fatigue

Conjunctivitis

Proteinuria and nephrotic syndrome

Systemic and cutaneous immune mediated reactions, including ulcerative and necrotizing skin lesions, and nephrotic syndrome secondary to membranous glomerulonephritis

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Warnings

Contraindications

None known

Cautions

IgG antibodies develop in about 13% during first year of treatment

Approximately 25% of patients with detectable IgG antibodies experience hypersensitivity

Derived from pooled human placental tissue that may contain viral agents; manufacturing steps are designed to reduce viral transmission risk

Monitor for signs of early virilization in males younger than 10 years since hCG has been detected in alglucerase

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: May be excreted in breast milk, caution advised

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

Catalyzes the hydrolysis of the glycolipid, glucocerebroside, to glucose and ceramide as part of the normal degradation pathway for membrane lipids; enzyme replacement for conditions with functional deficiency in beta-glucocerebrosidase enzymatic activity to prevent accumulation of lipid glucocerebroside

Pharmacokinetics

Half-Life: 3.6-10.4 minutes

Vd: 49.4-282.1 mL/kg

Clearance: Variable; 6.23-25.39 mL/min/kg

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Administration

IV Compatibilities

Solution: 0.9% NaCl

IV Preparation

Do NOT shake vial

Inspect bottle for particulate matter and discoloration before use; do not use if particulate matter or discoloration exhibited

IV infusion: Dilute injectable solution further with 0.9% NaCl; not to exceed volume of 200 mL

IV Administration

Use an inline particulate filter during infusion

Infuse IV over 1-2 hours

Storage

May store diluted solution for up to 18 hr at 2-8 degrees C

Does not contain any preservative; after opening, bottles should not be stored for subsequent use

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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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