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. Improvement of pulmonary function & walking capacity.
Dosage/Direction for Use
Recommended dose: 0.58 mg/kg body wt IV 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 body wt Total vol: 250 mL. ≤20 kg body wt Total vol: 100 mL. Patient w/ compromised cardiac/resp function ≤30 kg body wt Total vol: 100 mL.
Special Precautions
Discontinue in case of anaphylaxis & severe allergic reactions. Acute febrile or resp illness. Evaluate airway patency. Risk of acute cardiorespiratory failure. Infusion reactions. Patients should receive antipyretics &/or antihistamines prior to infusion. Pregnancy & lactation. Elderly >65 yr.
Adverse Reactions
Anaphylactic & allergic reactions. Infusion reactions (flushing, pyrexia, headache, rash, abdominal pain or discomfort, inj site reactions, chills, increased BP, tachycardia, decreased oxygen saturation), back or musculoskeletal pain, otitis media, central venous catheterization. Pallor, tremor, resp distress/failure, wheezing, crepitations (pulmonary), pruritus. Potential for immunogenicity. Cough, diarrhea, vomiting, rhinitis, otorrhea.
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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