VIMIZIM- elosulfase alfa injection, solution, concentrate

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

ELOSULFASE ALFA (UNII: ODJ69JZG85) (ELOSULFASE ALFA - UNII:ODJ69JZG85)

Disponibil de la:

BioMarin Pharmaceutical Inc.

INN (nume internaţional):

ELOSULFASE ALFA

Compoziție:

ELOSULFASE ALFA 5 mg in 5 mL

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Vimizim (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). None Pregnancy Exposure Registry There is a Morquio A Registry that collects data on pregnant women with MPS IVA who are treated with Vimizim.  Contact [e-mail] or call 1-800-983-4587 for information and enrollment. Risk Summary Available data from published case reports and postmarketing experience with Vimizim use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, no effects on embryo-fetal development were observed in rats given daily administration of elosulfase alfa up to 33 times the human steady-state AUC (area under the concentration-time curve) at the recommended human weekly dose premating and through the period of organogenesis. No effects on embryo-fetal development were observed in rabbits given daily administration of elosulfase alfa at doses up

Rezumat produs:

Vimizim is supplied as a concentrated solution for infusion (1 mg per mL) requiring dilution. One vial of 5 mL contains 5 mg Vimizim. NDC 68135-100-01, 5 mL single-dose vial Store Vimizim under refrigeration at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light. Diluted Vimizim should be used immediately. If immediate use is not possible, diluted Vimizim may be stored for up to 24 hours at 2°C to 8°C (36°F to 46°F) followed by up to 24 hours at 23°C to 27°C (73°F to 81°F) during administration.

Statutul autorizaţiei:

Biologic Licensing Application

Caracteristicilor produsului

VIMIZIM- ELOSULFASE ALFA INJECTION, SOLUTION, CONCENTRATE
BIOMARIN PHARMACEUTICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIMIZIM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VIMIZIM.
VIMIZIM (ELOSULFASE ALFA) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2014
WARNING: RISK OF ANAPHYLAXIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
LIFE-THREATENING ANAPHYLACTIC REACTIONS HAVE OCCURRED IN SOME PATIENTS
DURING
VIMIZIM INFUSIONS. ANAPHYLAXIS, PRESENTING AS COUGH, ERYTHEMA, THROAT
TIGHTNESS,
URTICARIA, FLUSHING, CYANOSIS, HYPOTENSION, RASH, DYSPNEA, CHEST
DISCOMFORT, AND
GASTROINTESTINAL SYMPTOMS IN CONJUNCTION WITH URTICARIA, HAVE BEEN
REPORTED TO OCCUR
DURING INFUSIONS, REGARDLESS OF DURATION OF THE COURSE OF TREATMENT.
CLOSELY OBSERVE PATIENTS DURING AND AFTER VIMIZIM ADMINISTRATION AND
BE PREPARED
TO MANAGE ANAPHYLAXIS. INFORM PATIENTS OF THE SIGNS AND SYMPTOMS OF
ANAPHYLAXIS
AND HAVE THEM SEEK IMMEDIATE MEDICAL CARE SHOULD SYMPTOMS OCCUR.
PATIENTS WITH ACUTE RESPIRATORY ILLNESS MAY BE AT RISK OF SERIOUS
ACUTE EXACERBATION
OF THEIR RESPIRATORY COMPROMISE DUE TO HYPERSENSITIVITY REACTIONS, AND
REQUIRE
ADDITIONAL MONITORING (5.1, 5.2, 6).
INDICATIONS AND USAGE
Vimizim is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific
enzyme indicated for patients with
Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome) (1).
DOSAGE AND ADMINISTRATION
2 mg per kg body weight administered once every week as an intravenous
infusion over a minimum of 3.5
to 4.5 hours, based on infusion volume (2.1, 2.3).
DOSAGE FORMS AND STRENGTHS
Injection: 5 mg/5 mL (1 mg/mL) in single-dose vials (3).
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
· Anaphylaxis and Hypersensitivity Reactions: Life-threatening
anaphylaxis and hypersensitivity reactions
have been observed in some patients during treatment with Vimizim. If
anaphylaxis or severe
hypersensitivity reactions occur, immediately stop the infusion an