Myozyme

Myozyme

Manufacturer:

Genzyme

Distributor:

DKSH
Concise Prescribing Info
Contents
Alglucosidase alfa
Indications/Uses
Long-term enzyme replacement therapy in adults & paed patients of all ages w/ confirmed diagnosis of Pompe disease (acid α-glucosidase deficiency).
Dosage/Direction for Use
20 mg/kg IV once every 2 wk. Infusion rate: Initially 1 mg/kg/hr, may be increased gradually by 2 mg/kg/hr every 30 min until max: 7 mg/kg/hr.
Contraindications
Special Precautions
Discontinue use if severe hypersensitivity/anaphylactic reactions occur. Infusion-associated reactions. Patients w/ compromised cardiac & resp function due to advanced Pompe disease; acute illness eg, pneumonia, sepsis. Monitor signs & symptoms of systemic immune complex-mediated reactions involving skin & other organs. Closely monitor patients who develop IgE Ab to alglucosidase alfa. Regularly monitor IgG Ab titers. Concomitant use w/ immunosuppressive agents. May affect ability to drive & use machines. Renal or hepatic impairment. Not to be used during pregnancy. Lactation.
Adverse Reactions
Infantile-onset Pompe disease Tachycardia; flushing; tachypnoea, cough; vomiting; urticaria, rash; pyrexia; decreased O2 saturation. Agitation; tremor; cyanosis; HTN, pallor; retching, nausea; erythema, maculopapular, macular & papular rash, pruritus; irritability, chills; increased heart rate, BP & body temp. Late-onset Pompe disease Hypersensitivity; dizziness, paraesthesia, headache; flushing; throat tightness; diarrhoea, vomiting, nausea; urticaria, papular rash, pruritus, hyperhidrosis; muscle spasms & twitching, myalgia; pyrexia, chest discomfort, peripheral oedema, local swelling, fatigue, feeling hot; increased BP.
MIMS Class
Other Agents Affecting Metabolism
ATC Classification
A16AB07 - alglucosidase alfa ; Belongs to the class of enzymes. Used in the treatment of alimentary tract and metabolism problems.
Presentation/Packing
Form
Myozyme powd for infusion 50 mg
Packing/Price
1's
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