JADENU deferasirox granule

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

DEFERASIROX (UNII: V8G4MOF2V9) (DEFERASIROX - UNII:V8G4MOF2V9)

MAH:

Catalent Germany Schorndorf GmbH

INN:

DEFERASIROX

composition:

DEFERASIROX 90 mg

prescription_type:

PRESCRIPTION DRUG

authorization_status:

APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT

SPC

JADENU- DEFERASIROX GRANULE
CATALENT GERMANY SCHORNDORF GMBH
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JADENU SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR JADENU.
JADENU (DEFERASIROX) TABLETS, FOR ORAL USE
JADENU SPRINKLE (DEFERASIROX) GRANULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2005
WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL
HEMORRHAGE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
JADENU MAY CAUSE SERIOUS AND FATAL:
RENAL TOXICITY, INCLUDING FAILURE ( 5.1)
HEPATIC TOXICITY, INCLUDING FAILURE ( 5.2)
GASTROINTESTINAL HEMORRHAGE ( 5.3)
JADENU THERAPY REQUIRES CLOSE PATIENT MONITORING, INCLUDING LABORATORY
TESTS OF RENAL AND HEPATIC
FUNCTION. ( 5)
RECENT MAJOR CHANGES
Dosage and Administration, Administration ( 2.3)
5/2017
Warnings and Precautions, Hypersensitivity ( 5.6)
8/2016
Warnings and Precautions, Severe Skin Reactions ( 5.7)
8/2016
INDICATIONS AND USAGE
JADENU is an iron chelator indicated for the treatment of chronic iron
overload due to blood transfusions in patients 2
years of age and older. This indication is approved under accelerated
approval based on a reduction of liver iron
concentrations and serum ferritin levels. Continued approval for this
indication may be contingent upon verification and
description of clinical benefit in confirmatory trials. ( 1.1)
JADENU is indicated for the treatment of chronic iron overload in
patients 10 years of age and older with non-transfusion-
dependent thalassemia (NTDT) syndromes and with a liver iron (Fe)
concentration (LIC) of at least 5 mg Fe per gram of
dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. This
indication is approved under accelerated approval
based on a reduction of liver iron concentrations (to less than 5 mg
Fe/g dw) and serum ferritin levels. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trials. ( 1.2)
Limitations of Use
Cont