LUMIZYME- alglucosidase alfa injection, powder, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ALGLUCOSIDASE ALFA (UNII: DTI67O9503) (ALGLUCOSIDASE ALFA - UNII:DTI67O9503)

Tilgjengelig fra:

Genzyme Corporation

INN (International Name):

ALGLUCOSIDASE ALFA

Sammensetning:

ALGLUCOSIDASE ALFA 5 mg in 1 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

LUMIZYME® (alglucosidase alfa) [see Description (11)] is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (acid α-glucosidase [GAA] deficiency). None. Risk Summary Data from postmarketing reports and published case reports with alglucosidase alfa use in pregnant women have not identified a LUMIZYME-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The continuation of treatment for Pompe disease during pregnancy should be individualized to the pregnant woman. Untreated Pompe disease may result in worsening disease symptoms in pregnant women [see Clinical Considerations] . Reproduction studies performed in mice and rabbits at doses resulting in exposures up to 0.4 or 0.5 times the human steady-state AUC (area under the plasma concentration-time curve), respectively, during the period of organogenesis revealed no evidence of effects on embryo-fetal development. In mice there was an increase in pup mortality during lactation

Produkt oppsummering:

LUMIZYME 50 mg vials are supplied as a sterile, nonpyrogenic, white to off-white lyophilized cake or powder in single-dose vials. NDC 58468-0160-1 (Carton of one single-dose vial) NDC 58468-0160-2 (Carton of ten single-dose vials) Store LUMIZYME under refrigeration between 2°C and 8°C (36°F and 46°F). Do not use LUMIZYME after the expiration date on the vial.

Autorisasjon status:

Biologic Licensing Application

Preparatomtale

LUMIZYME- ALGLUCOSIDASE ALFA INJECTION, POWDER, FOR SOLUTION
GENZYME CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LUMIZYME SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LUMIZYME.
LUMIZYME (ALGLUCOSIDASE ALFA), FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2010
WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED
REACTIONS, AND RISK OF CARDIORESPIRATORY FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
LIFE-THREATENING ANAPHYLACTIC REACTIONS AND SEVERE HYPERSENSITIVITY
REACTIONS HAVE
OCCURRED IN SOME PATIENTS DURING AND AFTER ALGLUCOSIDASE ALFA
INFUSIONS. IMMUNE-
MEDIATED REACTIONS PRESENTING AS PROTEINURIA, NEPHROTIC SYNDROME, AND
NECROTIZING
SKIN LESIONS HAVE OCCURRED IN SOME PATIENTS FOLLOWING ALGLUCOSIDASE
ALFA TREATMENT.
CLOSELY OBSERVE PATIENTS DURING AND AFTER ALGLUCOSIDASE ALFA
ADMINISTRATION AND BE
PREPARED TO MANAGE ANAPHYLAXIS AND HYPERSENSITIVITY REACTIONS. INFORM
PATIENTS OF
THE SIGNS AND SYMPTOMS OF ANAPHYLAXIS, HYPERSENSITIVITY REACTIONS, AND
IMMUNE-
MEDIATED REACTIONS AND HAVE THEM SEEK IMMEDIATE MEDICAL CARE SHOULD
SIGNS AND
SYMPTOMS OCCUR. (5.1, 5.2)
INFANTILE-ONSET POMPE DISEASE PATIENTS WITH COMPROMISED CARDIAC OR
RESPIRATORY
FUNCTION MAY BE AT RISK OF SERIOUS ACUTE EXACERBATION OF THEIR CARDIAC
OR RESPIRATORY
COMPROMISE DUE TO FLUID OVERLOAD, AND REQUIRE ADDITIONAL MONITORING.
(5.3)
INDICATIONS AND USAGE
LUMIZYME (alglucosidase alfa) is a hydrolytic lysosomal
glycogen-specific enzyme indicated for patients
with Pompe disease (GAA deficiency). (1)
DOSAGE AND ADMINISTRATION
20 mg per kg body weight administered every 2 weeks as an intravenous
infusion. (2)
DOSAGE FORMS AND STRENGTHS
For injection: 50 mg of alglucosidase alfa as lyophilized powder in a
single-dose vial for reconstitution.
(3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Anaphylaxis and Hypersensitivity Reactions: Life-threatening
anaphylaxis and hypersensitivity reactions
have bee