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Cerezyme(Imiglucerase)

Acetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine Injection

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Formulation:

INJECTION

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Reminder: The outer packaging is for reference only, please purchase and use under the guidance of a pharmacist. For read by medical and pharmaceutical professionals only.

Cerezyme (imiglucerase) is a recombinant enzyme therapy used to treat Gaucher disease, a rare lysosomal storage disorder caused by β-glucocerebrosidase deficiency. By replacing the missing enzyme, Cerezyme facilitates the breakdown of accumulated glucocerebroside, alleviating symptoms such as hepatosplenomegaly, anemia, and bone abnormalities.

This medication is administered through intravenous infusion and is tailored to individual patient needs. It has demonstrated efficacy in improving hematological and visceral symptoms, providing a crucial therapeutic option for managing the disease long-term. Due to its specialized nature, Cerezyme is typically used under the supervision of healthcare professionals in hospital or clinical settings.

Generic name

Cerezyme(Imiglucerase)

English name

Imiglucerase

Alternative Names

Cerezyme

Drug prices

Indications

Cerezyme is indicated for the treatment of Type 1 Gaucher disease in adults and pediatric patients ≥2 years of age, manifesting as one or more of the following:

Anemia
Thrombocytopenia
Bone disease (e.g., osteopenia, osteonecrosis)
Hepatomegaly
Splenomegal

Therapeutic Target

Mechanism: Targets β-glucocerebrosidase deficiency in lysosomes, hydrolyzing accumulated glucocerebroside into glucose and ceramide.

Active Ingredients

Active Ingredient: Imiglucerase (recombinant human β-glucocerebrosidase analog).

Dosage form

INJECTION

specifications

400 units/vial.

Description

1.Molecular Characteristics: Monomeric glycoprotein (497 amino acids; Mr=60,430) with 4 N-linked glycosylation sites.

2.Formulation: Contains 424 units imiglucerase, mannitol (340 mg), polysorbate 80 (1.06 mg), and sodium citrates.

3.Reconstitution: Yields 40 units/mL in Sterile Water for Injection

Dosage and Administration

Dosing

Range: 2.5 units/kg thrice weekly to 60 units/kg every 2 weeks.

Titration: Adjust based on disease severity and therapeutic goals.

Administration Protocol

Reconstitution:

Add 10.2 mL Sterile Water to each 400-unit vial; roll/tilt to dissolve (avoid shaking).

Final concentration: 40 units/mL.

Dilution:

Dilute with 0.9% NaCl to 100–200 mL (100 mL for patients <18 kg).

Infusion:

≥18 kg: 1–2 hours.

<18 kg: 2 hours.

Filtration: Use in-line 0.2 μm filter if needed.

Premedication

For hypersensitivity-prone patients: Antihistamines/corticosteroids.

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