DEFERASIROX tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Aurobindo Pharma Limited

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. Deferasirox tablets are 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 concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L. The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. Deferasirox tablets are contraindicated in patients with: - Estimated GFR less than 40 mL/min/1.73 m2 [see Dosage and Administration (2.5), Warnings and Precautions (5.1)] ; - Poor performance status [see Warnings and Precautions (5.1, 5.3)] ; - High-risk myelodysplastic syndromes (this patient population was not studied and is not expected to benefit from chelation therapy) ; - Advance

उत्पाद समीक्षा:

Deferasirox Tablets 90 mg are light blue, oval biconvex, film-coated tablets with beveled edges, debossed with ‘DF’ on one side and ‘90’ on other side. They are available in:                   Bottles of 30                                           NDC 59651-410-30 Deferasirox Tablets 180 mg are medium blue, oval biconvex, film-coated tablets with beveled edges, debossed with ‘DF’ on one side and ‘180’ on other side. They are available in:                   Bottles of 30                                           NDC 59651-411-30                   Deferasirox Tablets 360 mg are dark blue, oval biconvex, film-coated tablets with beveled edges, debossed with ‘DF’ on one side and ‘360’ on other side. They are available in:                   Bottles of 30                                           NDC 59651-412-30                   Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

Aurobindo Pharma Limited
----------
MEDICATION GUIDE
Deferasirox Tablets
(dee fer' a sir ox)
What
is
the
most
important
information
I
should
know
about
deferasirox
tablets?
Deferasirox
tablets
can
cause
serious
side
effects,
including:
Kidney problems: Deferasirox tablets can cause sudden (acute) kidney
problems, including kidney failure
that may require treatment with dialysis, and may cause death. Deaths
have happened mostly in people
who also have other health problems and had a blood disorder that was
in an advanced stage. Adults and
children who already have kidney problems and are taking certain
medicines with deferasirox tablets may
also have an increased risk of sudden kidney problems. Be sure to tell
your healthcare provider about all
the
medicines
you
take
during
treatment
with
deferasirox
tablets.
Your healthcare provider should do blood and urine tests to check your
or your child’s kidney function
before and during treatment with deferasirox tablets. Call your
healthcare provider right away if:
•
your child becomes sick with fever, vomiting, or diarrhea and cannot
drink fluids normally during
treatment with deferasirox tablets. Your child may be dehydrated. Your
healthcare provider may
need to temporarily stop treatment with deferasirox tablets and treat
your child for dehydration to
help prevent kidney problems. Your healthcare provider may monitor
your child’s kidney function
more closely.
•
you notice that you or your child are passing less urine than usual
during treatment with
deferasirox tablets.
Liver problems. Deferasirox tablets can cause liver problems,
including liver failure that can sometimes
cause death. Liver problems with deferasirox tablets may be more
common in people who are over 55
years of age but can also happen in children. Liver failure has
happened more often in people with
cirrhosis of the liver and failure of other organs. Liver failure has
also happened along with kidney
problems
in
certain
children
who
become
dehydrated.
See
“Kidney
problems”
above.
Your health

उत्पाद विशेषताएं

DEFERASIROX - DEFERASIROX TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEFERASIROX TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DEFERASIROX TABLETS.
DEFERASIROX TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2005
WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL
HEMORRHAGE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DEFERASIROX MAY CAUSE SERIOUS AND FATAL:
ACUTE KIDNEY INJURY, INCLUDING ACUTE RENAL FAILURE REQUIRING DIALYSIS
AND RENAL TUBULAR
TOXICITY INCLUDING FANCONI SYNDROME (5.1)
HEPATIC TOXICITY, INCLUDING FAILURE (5.2)
GASTROINTESTINAL HEMORRHAGE (5.3)
DEFERASIROX THERAPY REQUIRES CLOSE PATIENT MONITORING, INCLUDING
LABORATORY TESTS OF
RENAL AND HEPATIC FUNCTION. (5)
INDICATIONS AND USAGE
Deferasirox tablets are an iron chelator indicated for the treatment
of chronic iron overload due to blood
transfusions in patients 2 years of age and older. (1.1)
Deferasirox tablets are 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. (1.2)
Limitations of Use:
The safety and efficacy of deferasirox tablets when administered with
other iron chelation therapy have not
been established. (1.3)
DOSAGE AND ADMINISTRATION
Transfusional Iron Overload: Initial dose for patients with estimated
glomerular filtration rate (eGFR)
greater than 60 mL/min/1.73 m is 14 mg per kg (calculated to nearest
whole tablet) once daily. (2.1)
NTDT Syndromes: Initial dose for patients with eGFR greater than 60
mL/min/1.73 m is 7 mg per kg
(calculated to nearest whole tablet) once daily. (2.2)
See full prescribing information for information regarding monitoring,
administration, and dose-
reductions for organ impairment. (2.1, 2.2, 2.3, 2.4)