Drug Detail:Velaglucerase alfa (Velaglucerase alfa [ vel-a-gloo-ser-ase-al-fa ])
Drug Class: Lysosomal enzymes
Usual Adult Dose for Gaucher Disease
Starting dose for patients naive to enzyme replacement therapy (ERT): 60 units/kg IV every other week
Switching from imiglucerase to velaglucerase alfa: Patients currently being treated with stable doses of imiglucerase may switch by starting this drug at the previous imiglucerase dose 2 weeks after the last imiglucerase dose.
Comments:
- This drug should be administered as a 60-minute IV infusion under the supervision of a healthcare professional.
Use: For long-term ERT for patients with type 1 Gaucher disease
Usual Pediatric Dose for Gaucher Disease
4 years or older:
- Starting dose for patients naive to ERT: 60 units/kg IV every other week
- Switching from imiglucerase to velaglucerase alfa: Patients currently being treated with stable doses of imiglucerase may switch by starting this drug at the previous imiglucerase dose 2 weeks after the last imiglucerase dose.
Comments:
- This drug should be administered as a 60-minute IV infusion under the supervision of a healthcare professional.
Use: For long-term ERT for patients with type 1 Gaucher disease
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
Dose can be adjusted based on achievement and maintenance of each patient's therapeutic goals.
Precautions
Safety and efficacy have not been established in patients younger than 4 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Administer diluted solution through an in-line low protein-binding 0.2 micrometer filter over 60 minutes; appropriate medical support should be readily available during administration.
- Consider pretreatment with antihistamines and/or corticosteroids in patients who had hypersensitivity symptoms associated with prior infusions.
- Complete the infusion within 24 hours after the vials are reconstituted.
Storage requirements:
- Do not freeze.
- Protect from light.
- Lyophilized powder: Store at 2C to 8C (36F to 46F).
- Reconstituted solution, diluted solution: If cannot use immediately, may store for up to 24 hours at 2C to 8C (36F to 46F)
Reconstitution/preparation techniques:
- The manufacturer product information should be consulted.
IV compatibility:
- This drug should not be infused with other products in the same infusion tubing; compatibility with other products has not been evaluated.