How do you administer Lumizyme?
The recommended dosage of Lumizyme ® (alglucosidase alfa) is 20 mg per kg of body weight, administered every two weeks as an intravenous infusion. The total volume of infusion is determined by the patient’s body weight and should be administered over approximately 4 hours.
How do you dilute Lumizyme?
LUMIZYME should be diluted in 0.9% Sodium Chloride for Injection, USP, immediately after reconstitution, to a final LUMIZYME concentration of 0.5 to 4 mg/mL. See Table 1 for the recommended total infusion volume based on patient weight. f. Slowly withdraw the reconstituted solution from each vial.
What is Lumizyme infusion?
Lumizyme is administered by intravenous infusion, and should be reconstituted, diluted, and administered by a health care professional. Lumizyme is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (acid α-glucosidase (GAA) deficiency).
Can Lumizyme be reconstituted with normal saline?
Lumizyme ® (alglucosidase alfa) is supplied as a sterile, nonpyrogenic, white to off-white lyophilized cake or powder that must be reconstituted for intravenous administration….This Lumizyme website is for U.S. healthcare professionals only.
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What is the difference between Lumizyme and Myozyme?
Myozyme is indicated for infantile-onset Pompe disease; Lumizyme is indicated for patients aged ≥8 years. Although both drugs have been shown to improve patient survival rates, they both also have a boxed warning, because of the possibility of life-threatening allergic reactions.
Where is Lumizyme manufactured?
–(BUSINESS WIRE)–Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA has granted U.S. marketing approval for LumizymeTM (alglucosidase alfa), produced at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium.
What is Lumizyme used to treat?
LUMIZYME® (alglucosidase alfa) is an enzyme replacement therapy for patients with Pompe disease (acid α-glucosidase (GAA) deficiency).
What is Lumizyme used for?
Lumizyme (alglucosidase alfa) is an enzyme replacement therapy (ERT) for patients with Pompe disease. Pompe disease is a rare lysosomal storage disorder in which people do not have an enzyme called acid alpha-glucosidase (GAA). A lack of this enzyme causes a buildup of complex sugars (glycogen) in the body.
Is lumizyme an orphan drug?
Alglucosidase alfa was designated as an orphan drug for the treatment of Pompe disease in 1997; alglucosidase alfa (Myozyme) was approved by the FDA for the treatment of infantile-onset Pompe disease in April 2006.
Is lumizyme a biologic?
Genzyme will launch the same biologic under two different names in the US after the FDA decided the drug produced at 2000L was considerably different to the 160L version.
What is lumizyme made of?
The manufacture of Lumizyme ® (alglucosidase alfa) employs recombinant DNA technology to produce the human GAA enzyme using Chinese hamster ovary (CHO) cells. Production begins with genetic modification of host CHO cells to express the human GAA gene.