ELAPRASE- idursulfase solution, concentrate

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

idursulfase (UNII: 5W8JGG2651) (idursulfase - UNII:5W8JGG2651)

Beszerezhető a:

Takeda Pharmaceuticals America, Inc.

INN (nemzetközi neve):

IDURSULFASE

Összetétel:

IDURSULFASE 6 mg in 3 mL

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

ELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking capacity in patients 5 years and older. In patients 16 months to 5 years of age, no data are available to demonstrate improvement in disease-related symptoms or long term clinical outcome; however, treatment with ELAPRASE has reduced spleen volume similarly to that of adults and children 5 years of age and older. The safety and efficacy of ELAPRASE have not been established in pediatric patients less than 16 months of age [see Use in Specific Populations (8.4)]. None. Risk Summary There are no adequate and well-controlled studies with ELAPRASE use in pregnant women. Available data from a small number of postmarketing cases with ELAPRASE use in pregnancy are insufficient to inform drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In an animal reproduction study, no evidence of adverse effects on pre- and post-natal development wa

Termék összefoglaló:

ELAPRASE is supplied as a sterile injection in a 5 mL Type I glass vial. The vials are closed with a butyl rubber stopper with fluororesin coating and an aluminum overseal with a blue flip-off plastic cap. Each carton contains a single vial             NDC 54092-700-01 Store ELAPRASE vials in the carton at 2°C to 8°C (36°F to 46°F) to protect from light. Do not freeze or shake. Do not use ELAPRASE after the expiration date on the vial.

Engedélyezési státusz:

Biologic Licensing Application

Termékjellemzők

ELAPRASE- IDURSULFASE SOLUTION, CONCENTRATE
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ELAPRASE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ELAPRASE.
ELAPRASE (IDURSULFASE) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2006
WARNING: RISK OF ANAPHYLAXIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
LIFE-THREATENING ANAPHYLACTIC REACTIONS, PRESENTING AS RESPIRATORY
DISTRESS, HYPOXIA,
HYPOTENSION, URTICARIA AND/OR ANGIOEDEMA OF THROAT OR TONGUE HAVE
OCCURRED IN SOME
PATIENTS DURING AND UP TO 24 HOURS AFTER ELAPRASE INFUSIONS. CLOSELY
OBSERVE PATIENTS
DURING AND AFTER ELAPRASE 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
COMPROMISED
RESPIRATORY FUNCTION OR ACUTE RESPIRATORY DISEASE MAY BE AT RISK OF
SERIOUS ACUTE
EXACERBATION OF THEIR RESPIRATORY COMPROMISE DUE TO HYPERSENSITIVITY
REACTIONS, AND
REQUIRE ADDITIONAL MONITORING. (5.1, 5.3, 6)
INDICATIONS AND USAGE
ELAPRASE is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific
enzyme indicated for patients with
Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been
shown to improve walking
capacity in patients 5 years and older. In patients 16 months to 5
years of age, no data are available to
demonstrate improvement in disease-related symptoms or long term
clinical outcome; however,
treatment with ELAPRASE has reduced spleen volume similarly to that of
adults and children 5 years of
age and older. The safety and efficacy of ELAPRASE have not been
established in pediatric patients less
than 16 months of age (1).
DOSAGE AND ADMINISTRATION
The recommended dosage is 0.5 mg per kg of body weight administered
once every week as an
intravenous infusion (2).
DOSAGE FORMS AND STRENGTHS
Injection: 6 mg/3 mL (2 mg/mL) in single-use vial (3)
CONTRAINDICATIONS
None. (4)
WA