Aldurazyme

Aldurazyme

Manufacturer:

Sanofi

Distributor:

DCH Auriga - Healthcare
Concise Prescribing Info
Contents
Laronidase
Indications/Uses
Hurler & Hurler-Scheie forms of mucopolysaccharidosis I & Scheie form w/ moderate to severe symptoms in adults & ped patients.
Dosage/Direction for Use
IV infusion Recommended dose: 0.58 mg/kg once wkly. Infusion rate: Initially 10 mcg/kg/hr, may be increased every 15 min during the 1st hr until max of 200 mcg/kg/hr for 2-3 hr. Patient >20 kg Total infusion vol: 250 mL. ≤20 kg Total infusion vol: 100 mL. Patient w/ compromised cardiac/resp function & weighing up to 30 kg Total infusion vol: 100 mL.
Special Precautions
Discontinue immediately if anaphylactic or other serious hypersensitivity reactions occur. Greater risk for infusion reactions in patients w/ acute febrile or resp illness. Consider airway patency evaluation prior to treatment initiation. Risk of acute cardiorespiratory failure in patients susceptible to fluid overload, or patients w/ acute underlying resp illness or compromised cardiac &/or resp function for whom fluid restriction is indicated. Potential for infusion reactions. Patients should receive antipyretics &/or antihistamines prior to infusion. Pregnancy & lactation. Not known whether patients ≥65 yr respond differently from younger patients.
Adverse Reactions
Anaphylactic & hypersensitivity reactions. Infusion reactions (flushing, pyrexia, headache, rash, abdominal pain or discomfort, inj site reactions, chills, increased BP, tachycardia, decreased O2 saturation), back or musculoskeletal pain, otitis media, central venous catheterization. Pallor, tremor, resp distress, wheezing, crepitations (pulmonary), pruritus. Potential for immunogenicity.
MIMS Class
Other Agents Affecting Metabolism
ATC Classification
A16AB05 - laronidase ; Belongs to the class of enzymes. Used in the treatment of alimentary tract and metabolism problems.
Presentation/Packing
Form
Aldurazyme conc soln for IV infusion 2.9 mg/5 mL
Packing/Price
1's
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