DEFERASIROX tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 m 2 [see Dosage and Administration (2.5), Warnings and Precautions (5.1)]; - Poor performance status [see Warnings and Precautions (5.1, 5.3)] ; - High-risk myelodyspl

Product summary:

Deferasirox tablets 90 mg are light blue oval biconvex film-coated tablets with beveled edges, debossed with ‘S102’ on one side and plain on the other side. They are available in bottles of 30 tablets (NDC 57664-768-83). Deferasirox tablets 180 mg are medium blue oval biconvex film-coated tablets with beveled edges, debossed with ‘S103’ on one side and plain on the other side. They are available in bottles of 30 tablets (NDC 57664-769-83). Deferasirox tablets 360 mg are dark blue oval biconvex film-coated tablets with beveled edges, debossed with ‘S104’ on one side and plain on the other side. They are available in bottles of 30 tablets (NDC 57664-770-83). Store deferasirox tablets at 20°C-25°C (68°F-77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Deferasirox Tablets
(def-era-si-rox)
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. You

Summary of Product characteristics

DEFERASIROX- DEFERASIROX TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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 TABLETS 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 TABLETS THERAPY REQUIRES CLOSE PATIENT MONITORING,
INCLUDING LABORATORY
TESTS OF RENAL AND HEPATIC FUNCTION. (5)
RECENT MAJOR CHANGES
Indications and Usage, Limitations of Use (1.3) 7/2019
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/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/kg
(calculated to nearest whole tablet) once daily. (2.2)
See full prescribing information for information regar