Imiglucerase


Concise Prescribing Info
Indications/Uses
Gaucher disease type 1 and type 3.
Dosage/Direction for Use
Adult : IV Initial: 60 units/kg once every 2 weeks via infusion over 1-2 hours. Dosage is individualised based on the severity of disease and adjusted according to response.
Dosage Details
Intravenous
Gaucher disease type 1, Gaucher disease type 3
Adult: Initially, 60 units/kg once every 2 weeks via infusion over 1-2 hours. Dosage is individualised based on the severity of disease and adjusted according to response.
Child: >2 years Same as adult dose.
Reconstitution
Add 5 ml or 10.2 mL of sterile water for inj to the vial labelled as containing 200 mg or 400 mg, respectively, to provide a solution containing 40 units/mL. Further dilute with NaCl 0.9% to a final volume of 100-200 mL.
Contraindications
Hypersensitivity.
Special Precautions
Patient with respiratory symptoms in the absence of fever. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. anaphylaxis), antibody IgG formation, pulmonary hypertension/pneumonia.
Cardiac disorders: Tachycardia, dyspnoea.
Gastrointestinal disorders: Vomiting, nausea, abdominal cramp, diarrhoea.
General disorders and administration site conditions: Fatigue, fever.
Immune system disorders: Pruritus, urticaria.
Injury, poisoning and procedural complications: Inj site reactions.
Musculoskeletal and connective tissue disorders: Arthralgia, backpain, chills.
Nervous system disorders: Dizziness, headache, paraesthesia.
Respiratory, thoracic and mediastinal disorders: Coughing.
Skin and subcutaneous tissue disorders: Rash.
Vascular disorders: Hypotension, flushing, cyanosis.
MonitoringParameters
Monitor CBC, platelets, LFT, IgG antibody formation periodically during the 1st year of treatment; chitotriosidase, ACE, acid phosphatase, Fe, iron-binding capacity, ferritin, vitamin B12; MRI or CT scan of liver and spleen, skeletal x-rays, DXA; pulmonary function tests; ECG; growth in paediatric patients.
Action
Description: Imiglucerase is a recombinant form of β-glucocerebrosidase, an enzyme that catalyses the hydrolysis of glucocerebroside to glucose and ceramide. It used to replace glucocerebrosidase enzyme that is deficient in Gaucher’s disease.
Pharmacokinetics:
Distribution: Volume of distribution: 0.09-0.15 L/kg.
Excretion: Elimination half-life: 3.6-10.4 minutes.
Storage
Store between 2-8°C.
ATC Classification
A16AB02 - imiglucerase ; Belongs to the class of enzymes. Used in the treatment of alimentary tract and metabolism problems.
References
Anon. Imiglucerase. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/01/2018.

Buckingham R (ed). Alglucerase. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/01/2018.

Cerezyme Injection (Genzyme Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/01/2018.

Joint Formulary Committee. Imiglucerase. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/01/2018.

McEvoy GK, Snow EK, Miller J et al (eds). Imiglucerase. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 02/01/2018.

Disclaimer: This information is independently developed by MIMS based on Imiglucerase from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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