DEFERASIROX tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Zydus Pharmaceuticals USA Inc.

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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); -   Adv

Termék összefoglaló:

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 70710-1275-3 in bottles of 30 tablets with child-resistant closure. NDC 70710-1275-1 in bottles of 100 tablets. 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 70710-1276-3 in bottles of 30 tablets with child-resistant closure. NDC 70710-1276-1 in bottles of 100 tablets. 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 70710-1277-3 in bottles of 30 tablets with child-resistant closure. NDC 70710-1277-1 in bottles of 100 tablets. 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.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

Zydus Pharmaceuticals USA Inc.
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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.
Y

Termékjellemzők

DEFERASIROX- DEFERASIROX TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA 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 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,