Trade name
Kanuma
Strength
2 mg/mL (volume: 10 mL)
IV administration
Allow vial/s to reach room temperature prior to dilution.
Dilute to 0.1 to 1.5 mg/mL. Mix gently by slowly inverting, do not shake. Give over at least 2 hours via a 0.2 micron low protein binding in-line filter.
Doses equal to 1 mg/kg: If patient tolerates 2 hour infusion, may give subsequent doses over 1 hour.
Doses equal to 3 mg/kg: Consider further prolonging infusion time.
Patients with previous non-life-threatening hypersensitivity reaction to sebelipase alfa: Consider further prolonging infusion time.
Other routes of administration
IM: Not recommended.
SC: Not recommended.
Compatible IV fluids
Sodium chloride 0.9%
Additional information
Observe closely for anaphylactic reactions.
Most hypersensitivity reactions occur up to 4 hours after the end of the infusion and in patients who have previously tolerated sebelipase alfa.
Management of hypersensitivity may include temporary interruption of the infusion, lowering the infusion rate, and/or treatment with antihistamines, antipyretics and/or corticosteroids.
Pre-medication with corticosteroids, antipyretic agents and/or antihistamines prior to the infusion is recommended and may reduce the incidence and intensity of side effects during the infusion. Refer to relevant local guideline.
Manufactured using chicken egg whites.
Refrigerate, do not freeze.
Solution should be clear or slightly opalescent, and colourless or slightly coloured.
Discard any unused vial contents.
Protect from light during storage.