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Taliglucerase Alfa Dosage

Applies to the following strength(s): 200 units

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Gaucher Disease

Therapy-naive patients: 60 units/kg via IV infusion (administered over 60 to 120 minutes) every other week

Patients switching from imiglucerase:
-Patients currently being treated with imiglucerase for type 1 Gaucher disease can be switched to this drug.
-Patients previously receiving a stable dose of imiglucerase should begin this drug at that same dose when they switch from imiglucerase to taliglucerase alfa.
-Dose adjustments can be made based on achievement and maintenance of each patient's therapeutic goals.
-A clinical study evaluated doses ranging from 9.5 to 60 units/kg IV every other week.

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:
Therapy-naive patients: 60 units/kg via IV infusion (administered over 60 to 120 minutes) every other week

Patients switching from imiglucerase:
-Patients currently being treated with imiglucerase for type 1 Gaucher disease can be switched to this drug.
-Patients previously receiving a stable dose of imiglucerase should begin this drug at that same dose when they switch from imiglucerase to taliglucerase alfa.
-Dose adjustments can be made based on achievement and maintenance of each patient's therapeutic goals.
-A clinical study evaluated doses ranging from 9.5 to 60 units/kg IV every other week.

Use: For long-term enzyme ERT for patients with confirmed diagnosis of type 1 Gaucher disease

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

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 the diluted solution via IV infusion and filter through an in-line low-protein-binding 0.2 micrometer filter.
-Infuse over 60 to 120 minutes.
-Administer under supervision of a healthcare professional.

Pediatric Patients:
-Initial infusion rate of 1 mL/min; once tolerability is established, may increase, but not exceed maximum recommended infusion rate of 2 mL/min; total volume of infusion should be delivered over a minimum of 60 minutes.

Adult Patients:
-Initial infusion rate of 1.2 mL/min; once tolerability is established, may increase, but not exceed maximum recommended infusion rate of 2.2 mL/min; total volume of infusion should be delivered over a minimum of 60 minutes.

Storage Requirements:
-Lyophilized powder in vials: Store in refrigerator at 2C to 8C (36F to 46F) under protection from light; do not leave at room temperature beyond 24 hours before reconstitution; do not heat or microwave.
-Reconstituted product: If cannot use immediately, may store for up to 24 hours at 2C to 8C (36F to 46F) under protection 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) under protection from light.
-Storage of reconstituted and diluted products should not exceed 24 hours total.
-Do not freeze.

Reconstitution/Preparation Techniques:
-This drug should be reconstituted and diluted under supervision of a healthcare professional.
-The manufacturer product information should be consulted.
-Final volume for pediatric patients: 100 to 120 mL
-Final volume for adult patients: 130 to 150 mL; should not exceed 200 mL

General:
-Clinical studies did not include sufficient numbers of patients 65 years and older and it is therefore unknown if they respond differently than younger patients.

Monitoring:
-Hypersensitivity: Signs/symptoms of allergic reactions and/or infusion-related reactions (during and after infusion)

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