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Elosulfase Alfa Dosage

Applies to the following strength(s): 1 mg/mL

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 Mucopolysaccharidosis Type IV

2 mg/kg via IV infusion once a week

Comments:
-Should be infused over 3.5 to 4.5 hours, depending on infusion volume
-Pretreatment with antihistamines with or without antipyretics is recommended 30 to 60 minutes before starting the infusion.

Use: For patients with mucopolysaccharidosis IVA (MPS IVA; Morquio A syndrome)

Usual Pediatric Dose for Mucopolysaccharidosis Type IV

5 years or older: 2 mg/kg via IV infusion once a week

Comments:
-Should be infused over 3.5 to 4.5 hours, depending on infusion volume
-Pretreatment with antihistamines with or without antipyretics is recommended 30 to 60 minutes before starting the infusion.

Use: For patients with MPS IVA

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:
-Risk of Anaphylaxis: Life-threatening anaphylactic reactions reported in some patients during infusions of this drug. Anaphylaxis occurred during infusions, regardless of treatment duration. Patients should be observed closely during and after infusion and healthcare providers should be prepared to manage anaphylaxis. Patients should be advised of the signs/symptoms of anaphylaxis and should seek medical care at once if symptoms occur. Patients with acute respiratory illness may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions and require additional monitoring.

Safety and efficacy have not been established in patients younger than 5 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Administer the diluted solution using a low-protein-binding infusion set with a low-protein-binding 0.2 micrometer in-line filter.
-Consult the manufacturer product information for instructions regarding infusion rate.
-Infuse total volume over at least 3.5 hours for patients weighing less than 25 kg.
-Infuse total volume over at least 4.5 hours for patients weighing at least 25 kg.
-Complete the infusion within 48 hours from the time of dilution.

Storage requirements:
-Do not freeze or shake.
-Protect from light.
-Concentrated solution: Store at 2C to 8C (36F to 46F).
-Diluted solution: If cannot use immediately, may store for up to 24 hours at 2C to 8C (36F to 46F) followed by up to 24 hours at 23C to 27C (73F to 81F).

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.
-Final volume for patients weighing less than 25 kg: 100 mL
-Final volume for patients weighing at least 25 kg: 250 mL

IV compatibility:
-Compatible with 0.9% Sodium Chloride Injection, USP
-Should not be infused with other products in the infusion tubing; compatibility not evaluated

Patient advice:
-A voluntary Morquio A Registry has been established. For additional information and enrollment: MARS@bmrn.com

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