NEXVIAZYME NGPT- avalglucosidase alfa injection, powder, lyophilized, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

AVALGLUCOSIDASE ALFA (UNII: EO144CP0X9) (AVALGLUCOSIDASE ALFA - UNII:EO144CP0X9)

Tilgjengelig fra:

Genzyme Corporation

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

NEXVIAZYME is indicated for the treatment of patients 1 year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency). None. Risk Summary Available data from case reports of NEXVIAZYME use in pregnant women are insufficient to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, available data from postmarketing reports and published case reports on alglucosidase alfa (another hydrolytic lysosomal glycogen-specific enzyme replacement therapy) use in pregnant women have not identified a drug-associated risk of adverse pregnancy 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) . Embryo-fetal toxicity studies performed in pregnant mice resulted in maternal toxicity related to an immunologic response (including an anaphyl

Produkt oppsummering:

How Supplied NEXVIAZYME (avalglucosidase alfa-ngpt) for injection is supplied as a sterile, white to pale-yellow lyophilized powder in a single-dose vial. Each vial contains 100 mg of avalglucosidase alfa-ngpt. NEXVIAZYME is available as: One single-dose vial in a carton (NDC 58468-0426-1) Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not use NEXVIAZYME after the expiration date on the vial.

Autorisasjon status:

Biologic Licensing Application

Preparatomtale

NEXVIAZYME NGPT- AVALGLUCOSIDASE ALFA INJECTION, POWDER, LYOPHILIZED,
FOR
SOLUTION
GENZYME CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEXVIAZYME SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEXVIAZYME.
NEXVIAZYME (AVALGLUCOSIDASE ALFA-NGPT) FOR INJECTION, FOR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 2021
WARNING: SEVERE HYPERSENSITIVITY REACTIONS, INFUSION-ASSOCIATED
REACTIONS,
AND RISK OF ACUTE CARDIORESPIRATORY FAILURE IN SUSCEPTIBLE PATIENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS
APPROPRIATE MEDICAL MONITORING AND SUPPORT MEASURES, INCLUDING
CARDIOPULMONARY
RESUSCITATION EQUIPMENT, SHOULD BE READILY AVAILABLE. IF A SEVERE
HYPERSENSITIVITY
REACTION OCCURS, DISCONTINUE NEXVIAZYME IMMEDIATELY AND INITIATE
APPROPRIATE
MEDICAL TREATMENT. (5.1)
INFUSION-ASSOCIATED REACTIONS (IARS)
IF SEVERE IARS OCCUR, CONSIDER IMMEDIATE DISCONTINUATION AND
INITIATION OF
APPROPRIATE MEDICAL TREATMENT. (5.2)
RISK OF ACUTE CARDIORESPIRATORY FAILURE IN SUSCEPTIBLE PATIENTS
PATIENTS SUSCEPTIBLE TO FLUID VOLUME OVERLOAD, OR THOSE WITH ACUTE
UNDERLYING
RESPIRATORY ILLNESS OR COMPROMISED CARDIAC OR RESPIRATORY FUNCTION,
MAY BE AT RISK OF
SERIOUS EXACERBATION OF THEIR CARDIAC OR RESPIRATORY STATUS DURING
NEXVIAZYME
INFUSION. (5.3)
RECENT MAJOR CHANGES
Dosage and Administration (2.1, 2.2)
9/2023
Warnings and Precautions (5.1, 5.2)
9/2023
INDICATIONS AND USAGE
NEXVIAZYME is a hydrolytic lysosomal glycogen-specific enzyme
indicated for the treatment of patients 1
year of age and older with late-onset Pompe disease (lysosomal acid
alpha-glucosidase [GAA] deficiency).
(1)
DOSAGE AND ADMINISTRATION
Consider administering antihistamines, antipyretics, and/or
corticosteroids prior to NEXVIAZYME
administration to reduce the risk of IARs. (2.1)
NEXVIAZYME is administered as intravenous infusion. For patients
weighing (2.2):
≥30 kg, the recommended dosage is 20 mg/kg (of actual bod