Aldurazyme

Aldurazyme

Manufacturer:

Genzyme
/
Sanofi-Aventis

Distributor:

DKSH
Concise Prescribing Info
Contents
Laronidase
Indications/Uses
Hurler & Hurler-Scheie forms of mucopolysaccharidosis I & Scheie form w/ moderate to severe symptoms.
Dosage/Direction for Use
Recommended dose: 0.58 mg/kg body wt IV infusion once wkly over approx 3-4 hr. Infusion rate: Initially 10 mcg/kg/hr, may be incrementally increased every 15 min during the 1st hr until max of 200 mcg/kg/hr maintained for 2-3 hr. Pre-treatment is recommended 60 min prior to start of the infusion & may include antihistamines, anti-pyretics or both. Patient >20 kg body wt Total vol: 250 mL, ≤20 kg body wt Total vol: 100 mL.
Special Precautions
Discontinue if anaphylaxis or other severe allergic reactions occur. Acute febrile or resp illness. Patients susceptible to fluid overload, w/ acute underlying resp illness or compromised cardiac &/or resp function. Patients should receive antipyretics &/or antihistamines 60 min prior to infusion. Pregnancy & lactation. Childn. Elderly ≥65 yr.
Adverse Reactions
Flushing, pyrexia, headache, rash, abdominal pain or discomfort & inj site reaction; otitis media, chills, increased BP, decreased oxygen saturation. Angioedema, hypotension, paresthesia, feeling hot, hyperhidrosis, tachycardia, vomiting, back pain, & cough.
ATC Classification
A16AB05 - laronidase ; Belongs to the class of enzymes. Used in the treatment of alimentary tract and metabolism problems.
Presentation/Packing
Form
Aldurazyme infusion 2.9 mg/5 mL
Packing/Price
1's
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