Abcertin® 400 Units

Imiglucerase for Injection

Rx/ Orphan Drug
Therapeutic Area
Gaucher Disease
Active Substance
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Product Appearance
White to off white lyophilized cake in colorless and transparent vial; After reconstitution, colorless and clear liquid
Quantitative Composition
(per 1 vial)
Active ingredient: Imiglucerase (in-house) 424 Units
Stabilizer: D-mannitol 340 mg, Polysorbate 80 1.06 mg
Inactive ingredients: Trisodium Citrate, Disodium Citrate, Citric Acid Hydrate, Sodium Hydroxide
Indications and Usage
Abcertin (imiglucerase for injection) is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Type 1 Gaucher disease who show symptom in one or more of the following conditions.
· anemia after exclusion of other causes, such as iron deficiency
· thrombocytopenia
· bone disease after exclusion of other causes such as Vitamin D deficiency
· hepatomegaly or splenomegaly
Dosage and Administration
Abcertin (imiglucerase for injection) is administered by intravenous infusion over 1-2 hours. Dosage should be individualized to each patient. Initial dosages range from 2.5U/kg of body weight 3 times a week to 60 U/kg once every 2 weeks. 60 U/kg every 2 weeks is the dosage for which the most data are available. Disease severity may dictate that treatment is initiated at a relatively high dose or relatively frequent administration. Dosage adjustments should be made on an individual basis and may increase or decrease, based on achievement of therapeutic goals as assessed by routine comprehensive evaluations of the patient's clinical manifestations. On the day of use, after the correct amount of Abcertin to be administered to the patient has been determined, the appropriate numbers of vials are each reconstituted with Sterile Water for Injection, USP. The final concentrations and administration volumes are provided in the following table:
400 Unit Vial
Sterile water for reconstitution 10.2 mL
Final volume of reconstituted product 10.6 mL
Concentration after reconstitution 40 U/mL
Withdrawal volume 10.0 mL
Units of enzyme within final volume 400 unit

A nominal 10.0 mL for the 400 unit vial is withdrawn from each vial. The appropriate amount of Abcertin for each patient is diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of 100-200 mL. Abcertin is administered by intravenous infusion over 1-2 hours. Aseptic techniques should be used when diluting the dose. Since Abcertin does not contain any preservative, after reconstitution, vials should be promptly diluted and not stored for subsequent use. Abcertin, after reconstitution, has been shown to be stable for up to 12 hours when stored at room temperature (25°C) and at 2-8°C. Abcertin, when diluted, has been shown to be stable for up to 24 hours when stored at 2-8°C. Relatively low toxicity, combined with the extended time course of response, allows small dosage adjustments to be made occasionally to avoid discarding partially used bottles. Thus, the dosage administered in individual infusions may be slightly increased or decreased to utilize fully each vial as long as the monthly administered dosage remains substantially unaltered.
Storage Condition
Hermetic containers, refrigeration (2~8°C)
Package Unit
400 Units/vial
Reporting Adverse Events
If you have experienced an adverse event or adverse drug reaction from Abcertin, please report to ISU ABXIS by phone +82-31-696-4631 (limited to South Korea) or email to

*The information provided in this product page of ISU ABXIS’s corporate website is for general information purposes only and does not constitute product advertising or medical advice. The material contained herein is not intended to be a source of prevention, diagnosis, and treatment without consulting healthcare professionals. Please discuss it with your doctor for any medical advice and medication guide for the product.