Taliglucerase Alfa Dosage
Medically reviewed by Drugs.com. Last updated on Nov 1, 2023.
Applies to the following strengths: 200 units
Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Gaucher Disease
Treatment-naive:
- Initial dose: 60 units/kg IV every other week
Conversion from imiglucerase:
- For patients on a stable dose of imiglucerase: Begin at same units/kg dose IV every other week
Dose adjustments should be based on individual's therapeutic goals
Comments:
- Administer as an IV infusion over 60 to 120 minutes every other week; in adult patients, an initial infusion rate of 1.2 mL/minute should be used.
- After tolerability to infusion is established, the infusion rate may be increased, but should not exceed the maximum recommended infusion rate of 2.2 mL/minute; infusion should be delivered over a minimum or 60 minutes.
Use: For long-term enzyme replacement therapy (ERT) for patients with confirmed diagnosis of type 1 Gaucher disease
Usual Pediatric Dose for Gaucher Disease
4 years or older:
Treatment-naive: Initial dose: 60 units/kg IV every other week
Conversion from imiglucerase:
- For patients on a stable dose of imiglucerase: Begin with same units/kg dose IV every other week
Dose adjustments should be based on individual's therapeutic goals
Comments:
- Administer as an IV infusion over 60 to 120 minutes every other week; in adult patients, an initial infusion rate of 1.2 mL/minute should be used.
- After tolerability to infusion is established, the infusion rate may be increased, but should not exceed the maximum recommended infusion rate of 2.2 mL/minute; infusion should be delivered over a minimum or 60 minutes.
Use: For the treatment of patients with a confirmed diagnosis of Type 1 Gaucher disease.
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
No adjustment recommended
Precautions
CONTRAINDICATIONS:
- None
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:
- For IV infusion over a minimum of 60 minutes every other week
- Due to the potential for anaphylaxis, appropriate medical support should be readily available during administration
Adults:
- Initial infusion rate: 1.2 mL/minute
- Once tolerability is established, may increase rate
- Maximum infusion rate: 2 mL/minute
- Initial infusion rate: 1 mL/minute
- Once tolerability is established, may increase
Reconstitution/preparation techniques:
- Should be prepared under the supervision of a healthcare professional; consult product labeling for additional instructions
- Reconstitute each vial with 5.1 mL of Sterile Water for Injection to yield a concentration of 40 units/mL and an extractable volume of 5 mL; upon reconstitution, mix vials gently, do not shake
- Further dilute with 0.9% sodium chloride to a final volume of 100 or 200 mL
- Following reconstitution and dilution, administer via IV infusion; filter through an in-line low-protein-binding 0.2 micrometer filter
Storage Requirements:
- Store in refrigerator at 2C to 8C (36F to 46F); protect from light
- Reconstituted product: May store for up to 24 hours when refrigerated (2C to 8C [36F to 46F]) and protected from light OR up to 4 hours at 20C to 25C (68F to 77F) without protection from light
- Diluted product: May store for up to 24 hours at 2C to 8C (36F to 46F) when protected from light
- Storage of reconstituted product and diluted products should not exceed a total of 24 hours
- Do not freeze
Monitoring:
- Hypersensitivity: Signs/symptoms of allergic reactions and/or infusion-related reactions (during and after infusion)
Patient Advice:
- Patients and caregivers should understand that infusion-related and hypersensitivity reactions including anaphylaxis may occur with therapy.
- Patients and caregivers should be informed of the signs and symptoms of anaphylaxis and hypersensitivity reactions and should be instructed to seek medical care should signs and symptoms occur.
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