Velaglucerase alfa


Concise Prescribing Info
Indications/Uses
Gaucher disease type 1.
Dosage/Direction for Use
Adult : IV As long-term ERT: Initial: 60 units/kg once every other week. Usual dosage range: 15-60 units/kg every other week. Dosage is individualised based on disease severity, achievement and maintenance of therapeutic goals and adjusted according to response.
Dosage Details
Intravenous
Gaucher disease type 1
Adult: As long-term enzyme replacement therapy (ERT): Initially, 60 units/kg every other week via infusion through an in-line low protein-binding filter (0.2 micrometre) over 60 minutes. Usual dosage range: 15-60 units/kg every other week. Dosage is individualised based on disease severity, achievement and maintenance of therapeutic goals and adjusted according to response.
Child: 4-17 years Same as adult dose.
Reconstitution
Reconstitute vial labelled as containing 400 units with 4.3 mL of sterile water for injection to provide a solution containing 100 units/mL. Gently swirl or rotate to mix. Do not shake or agitate. Further dilute with 100 mL of NaCl 0.9% solution.
Special Precautions
Patient with immune response to other ERTs. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Immunogenicity, hypersensitivity reactions (e.g. anaphylaxis).
Cardiac disorders: Tachycardia.
Gastrointestinal disorders: Abdominal pain, nausea.
General disorders and administration site conditions: Infusion-related reaction, asthenia, fatigue, weakness, fever, pyrexia, chest discomfort.
Investigations: Prolonged aPTT.
Musculoskeletal and connective tissue disorders: Arthralgia, back pain, bone pain.
Nervous system disorders: Headache, dizziness.
Vascular disorders: Hypertension, hypotension, flushing.
MonitoringParameters
Assess history of response/reactions to other ERT prior to initiation of treatment. Monitor CBC, LFT, IgG antibodies, MRI or CT scan of liver and spleen, and bone density.
Action
Description: Velaglucerase alfa is a biosynthetic form of human β-glucocerebrosidase, an enzyme that catalyses the hydrolysis of glucocerebroside to glucose and ceramide. It is used to replace glucocerebrosidase enzyme that is deficient in Gaucher’s disease.
Pharmacokinetics:
Absorption: Rapidly absorbed. Time to peak plasma concentration: Between 40-60 minutes.
Distribution: Volume of distribution: 0.08-0.11 L/kg.
Excretion: Elimination half-life: 5-12 minutes.
Storage
Store between 2-8°C. Protect from light. Do not freeze.
ATC Classification
A16AB10 - velaglucerase alfa ; Belongs to the class of enzymes. Used in the treatment of alimentary tract and metabolism problems.
References
Anon. Velaglucerase Alfa. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 06/06/2018.

Anon. Velaglucerase Alfa. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/06/2018.

Buckingham R (ed). Velaglucerase Alfa. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/06/2018.

Joint Formulary Committee. Velaglucerase alfa. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/06/2018.

Vpriv Injection, Powder, Lyophilized for Solution (Shire US Manufacturing Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 06/06/2018.

Disclaimer: This information is independently developed by MIMS based on Velaglucerase alfa 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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