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:

Northstar Rx LLC.

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. 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 [see Clinical Studies (14)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. 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: -   Esti

Product summary:

Deferasirox tablets, 90 mg are white to off-white-colored, oval-shaped, biconvex, film-coated tablets, debossed with "1275" on one side and plain on other side and are supplied as follows: NDC 16714-993-01 in bottles of 30 tablets with child-resistant closure. Deferasirox tablets, 180 mg are light blue-colored, oval-shaped, biconvex, film-coated tablets, debossed with "1276" on one side and plain on other side and are supplied as follows: NDC 16714-994-01 in bottles of 30 tablets with child-resistant closure. Deferasirox tablets, 360 mg are blue-colored, oval-shaped, biconvex, film-coated tablets, debossed with "1277" on one side and plain on other side and are supplied as follows: NDC 16714-995-01 in bottles of 30 tablets with child-resistant closure. Storage Store deferasirox tablets at 25°C (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

Northstar Rx LLC.
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MEDICATION GUIDE
Deferasirox (dee fer' a sir ox) Tablets
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 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 healthcar

Summary of Product characteristics

DEFERASIROX - DEFERASIROX TABLET, FILM COATED
NORTHSTAR RX LLC.
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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 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)
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. 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_
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 p