Velaglucerase Beta For Injection Application Scope

Velaglucerase beta for injection is indicated for the long-term enzyme replacement therapy (ERT) of patients with Type 1 Gaucher disease. It helps reduce symptoms such as anemia, thrombocytopenia, hepatosplenomegaly, and bone disease caused by deficient glucocerebrosidase activity.

Velaglucerase Beta For Injection Characteristics

Ingredients: Velaglucerase beta (a recombinant form of human β-glucocerebrosidase).
Properties: White to off-white lyophilized powder for reconstitution and intravenous infusion.
Packaging Specification: 400 U/vial.
Storage: Store at 2–8 °C. Do not freeze. Protect from light.
Expiry Date: As indicated on packaging
Executive Standard: According to pharmacopoeia/regulatory filing
Approval Number: As indicated on packaging
Date of Revision: As indicated on packaging
Manufacturer: CANbridge

Guidelines for the Use of Velaglucerase Beta For Injection

Dosage and Administration: Treatment should be initiated and supervised by a physician experienced in Gaucher disease or enzyme replacement therapy.
- Recommended Dose:
  - 60 units/kg of body weight administered every 2 weeks via intravenous infusion.
  - Dose may be adjusted based on patient response and clinical goals.
- Administration:
  - Reconstitute and dilute before use.
  - Administer by intravenous infusion over 60 minutes.
  - Use aseptic technique.
- Missed Dose: Administer the missed infusion as soon as possible. Resume the regular schedule thereafter.
Adverse Reactions:
- Common Adverse Reactions:
  - Headache
  - Dizziness
  - Fatigue
  - Nausea
  - Infusion-related reactions (fever, chills, rash, pruritus, urticaria)
- Serious Adverse Reactions:
  - Hypersensitivity reactions, including anaphylaxis
  - Severe infusion-related reactions (bronchospasm, hypotension)
Contraindications: Known severe hypersensitivity to velaglucerase beta or any excipients.
Precautions:
- Monitor patients for infusion-related reactions; premedication may be considered.
- Use with caution in patients with a history of allergic reactions to enzyme therapies.
- Safety in pregnancy and lactation has not been fully established.

Velaglucerase Beta For Injection Interactions

No significant drug–drug interactions reported to date.
Concomitant use with immunosuppressive therapies may increase risk of infections or alter immune response to velaglucerase beta.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.