Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ALGLUCOSIDASE ALFA (UNII: DTI67O9503) (ALGLUCOSIDASE ALFA - UNII:DTI67O9503)
Genzyme Corporation
ALGLUCOSIDASE ALFA
ALGLUCOSIDASE ALFA 5 mg in 1 mL
PRESCRIPTION DRUG
Biologic Licensing Application
MYOZYME- ALGLUCOSIDASE ALFA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GENZYME CORPORATION ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MYOZYME SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MYOZYME. MYOZYME (ALGLUCOSIDASE ALFA) INJECTABLE FOR INTRAVENOUS INFUSION INITIAL U.S. APPROVAL: 2006 WARNING: ANAPHYLAXIS, SEVERE ALLERGIC AND IMMUNE MEDIATED REACTIONS AND RISK OF CARDIORESPIRATORY FAILURE LIFE-THREATENING ANAPHYLACTIC, SEVERE ALLERGIC AND IMMUNE MEDIATED REACTIONS HAVE BEEN OBSERVED IN SOME PATIENTS DURING MYOZYME INFUSIONS. THEREFORE, APPROPRIATE MEDICAL SUPPORT SHOULD BE READILY AVAILABLE WHEN MYOZYME IS ADMINISTERED. RISK OF CARDIORESPIRATORY FAILURE PATIENTS WITH COMPROMISED CARDIAC OR RESPIRATORY FUNCTION MAY BE AT RISK OF SERIOUS ACUTE EXACERBATION OF THEIR CARDIAC OR RESPIRATORY COMPROMISE DUE TO INFUSION REACTIONS, AND REQUIRE ADDITIONAL MONITORING. _See WARNINGS AND PRECAUTIONS (5) _ INDICATIONS AND USAGE MYOZYME (alglucosidase alfa) is a lysosomal glycogen-specific enzyme indicated for use in patients with Pompe disease (GAA deficiency). MYOZYME has been shown to improve ventilator-free survival in patients with infantile-onset Pompe disease as compared to an untreated historical control, whereas use of MYOZYME in patients with other forms of Pompe disease has not been adequately studied to assure safety and efficacy. (1) DOSAGE AND ADMINISTRATION The recommended dosage of MYOZYME is 20 mg/kg body weight administered every 2 weeks as an intravenous infusion. (2) DOSAGE FORMS AND STRENGTHS Dosage form: Lyophilized powder for solution for intravenous infusion. Dosage strength: 5 mg/mL. (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Life-threatening anaphylactic, severe allergic and immune mediated reactions: Ensure that appropriate medical support is readily available. If severe allergic or anaphylactic reactions occur, consider immediate discontinuation of MYOZYME and initiate appropriate medical treatm read_full_document