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(alglucosidase alfa) for Injection, for Intravenous Use
Life-threatening anaphylactic reactions, severe allergic reactions and immune mediated reactions have been observed in some patients during LUMIZYME (alglucosidase alfa) ™ infusions. Therefore, appropriate medical support should be readily available when LUMIZYME is administered [see WARNINGS AND PRECAUTIONS].
Because of the potential risk of rapid disease progression in Pompe disease patients less than 8 years of age, LUMIZYME (alglucosidase alfa) is available only through a restricted distribution program called the LUMIZYME (alglucosidase alfa) ACE ProgramSM. Only prescribers and healthcare facilities enrolled in the program may prescribe, dispense or administer LUMIZYME (alglucosidase alfa) . LUMIZYME (alglucosidase alfa) may be administered only to patients who are enrolled in and meet all the conditions of the LUMIZYME (alglucosidase alfa) ACE Program. To enroll in the LUMIZYME (alglucosidase alfa) ACE Program call 1-800-745-4447 [see WARNINGS AND PRECAUTIONS].
LUMIZYME (alglucosidase alfa) consists of the human enzyme acid α-glucosidase (GAA), encoded by the most predominant of nine observed haplotypes of this gene. LUMIZYME (alglucosidase alfa) is produced by recombinant DNA technology in a Chinese hamster ovary cell line. The LUMIZYME (alglucosidase alfa) manufacturing process differs from that for MYOZYME, resulting in differences in some product attributes. Alglucosidase alfa degrades glycogen by catalyzing the hydrolysis of α-1,4- and α-1,6 glycosidic linkages of lysosomal glycogen.
Alglucosidase alfa is a glycoprotein with a calculated mass of 99,377 daltons for the polypeptide chain, and a total mass of approximately 109,000 daltons, including carbohydrates. Alglucosidase alfa has a specific activity of 3 to 5 Units/mg (one unit is defined as that amount of activity that results in the hydrolysis of 1 micromole of synthetic substrate per minute under specified assay conditions). LUMIZYME (alglucosidase alfa) is intended for intravenous infusion. It is supplied as a sterile, nonpyrogenic, white to off-white, lyophilized cake or powder for reconstitution with 10.3 mL Sterile Water for Injection, USP. Each 50 mg vial contains 52.5 mg alglucosidase alfa, 210 mg mannitol, 0.5 mg polysorbate 80, 9.9 mg sodium phosphate dibasic heptahydrate, 31.2 mg sodium phosphate monobasic monohydrate. Following reconstitution as directed, each vial contains 10.5 mL reconstituted solution and a total extractable volume of 10 mL at 5 mg/mL alglucosidase alfa. LUMIZYME (alglucosidase alfa) does not contain preservatives; each vial is for single use only.
Last reviewed on RxList: 6/18/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Lumizyme Information
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