Velaglucerase alfaPronunciation: VEL-a-GLOO-ser-ase AL-fa
Class: Enzyme replacement
- Injection, lyophilized powder for solution 200 units
- Injection, lyophilized powder for solution 400 units
Velaglucerase alfa catalyzes the hydrolysis of glucocerebroside to glucose and ceramide.
Vd is 82 to 108 mL/kg.
The half-life is 11 to 12 min. Plasma Cl ranges from 6.72 to 7.56 mL/min/kg.
Indications and Usage
Long-term enzyme replacement therapy for children and adults with type I Gaucher disease.
None well documented.
Dosage and AdministrationAdults and Children older than 4 yr of age
IV 60 units/kg every other week. Dosage adjustments are based on achievement and maintenance of each patient's therapeutic goals. Clinical studies have evaluated doses ranging from 15 units/kg to 60 units/kg every other week.
- For IV infusion only. Not for intradermal, subcutaneous, IM, IV bolus, or intra-arterial administration.
- Reconstitute powder with sterile water for injection: 2.2 mL for 200 unit vial; 4.3 mL for 400 unit vial.
- Upon reconstitution, mix vial gently. Do not shake.
- Do not use if reconstituted solution is cloudy or discolored, or contains opaque particles.
- Withdraw prescribed dose from vial(s) and dilute in 100 mL of sodium chloride 0.9% injection.
- Administer diluted solution by 60-min IV infusion.
- Do not infuse with other products in the same infusion tubing because the compatibility in solution with other products has not been evaluated.
- Diluted solution may be filtered through an in-line, low protein-binding 0.2 mcm filter during administration.
- Consider pretreatment with antihistamines and/or corticosteroids if hypersensitivity symptoms developed during previous infusion.
Store vials at 36° to 46°F. Reconstituted or diluted solution is stable for up to 24 h when stored at 36° to 46°F. The infusion should be completed within 24 h of reconstitution. Do not freeze. Protect from light. Discard any unused reconstituted solution. Do not save for future use.
None well documented.
Hypertension, hypotension, tachycardia (more than 3%).
Headache (36%); dizziness (22%); asthenia/fatigue (13%).
Flushing, rash, urticaria (more than 3%).
Abdominal pain (19%); nausea (10%).
Back pain (18%); joint (knee) pain (15%); bone pain (more than 3%).
Infusion-related reaction (52%); upper respiratory tract infection (32%); pyrexia (22%); APTT prolonged (11%).
Periodically monitor for immunoglobulin G (IgG) antibody formation during first year of treatment.
Category B .
Safety and efficacy in patients younger than 4 yr of age are not established.
Approach dose selection for an elderly patient cautiously; consider potential comorbid conditions.
Has been reported in clinical studies. Use with caution in patients who have exhibited symptoms of hypersensitivity to velaglucerase alfa, excipients in the drug product, or to other enzyme replacement therapies.
IgG antibodies to velaglucerase alfa may occur.
Infusion-related reactions (eg, dizziness, fatigue/asthenia, headache, hypertension, hypotension, nausea, pyrexia) may occur.
No data available.
- Advise patient or caregiver that medication will be prepared and administered by a health care provider in a health care setting.
- Advise patient or caregiver that reactions during or shortly after infusion occur commonly and that medications may be given before the infusion in an effort to prevent or reduce the severity of these reactions.
- Advise patient or caregiver to notify health care provider if any of the following occur: pain, redness, or burning at infusion site; persistent or intolerable nausea, vomiting, stomach pain, diarrhea, or dizziness; any other unexplained symptom or sign.
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