DEFERASIROX tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Ascend Laboratories, LLC

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 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 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 when administered with other iron chelation therapy have not been established. Deferasirox is 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) ; - Advanced malignancies [se

Ringkasan produk:

90 mg tablets - Light blue color, film coated, oval shaped, biconvex tablets, debossed with 'DFX' on the one side and '90' on other side. Tablets are provided as follows: Bottle of 30:                                                    NDC 67877-552-30 Bottle of 90:                                                    NDC 67877-552-90 180 mg tablets - Blue color, film coated, oval shaped, biconvex tablets, debossed with 'DFX' on the one side and '180' on other side. Tablets are provided as follows: Bottle of 30:                                                    NDC 67877-553-30 Bottle of 90:                                                    NDC 67877-553-90   360 mg tablets - Dark blue color, film coated, oval shaped, biconvex tablets, debossed with 'DFX' on the one side and '360' on other side. Tablets are provided as follows: Bottle of 30:                                                    NDC 67877-554-30 Bottle of 90:                                                    NDC 67877-554-90 Store Deferasirox tablets at 20°C to 25°C (68°F to 77°F); excursions are permitted between  15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

DEFERASIROX - DEFERASIROX TABLET, FILM COATED
Ascend Laboratories, LLC
----------
MEDICATION GUIDE
DEFERASIROX
(de FER a sir ox)
Tablets
What is the most important information I should know about
deferasirox?
Deferasirox can cause serious side effects, including:
Kidney problems. Deferasirox 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 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.
Your healthcare provider should do blood and urine tests to check your
or your child’s kidney function
before and during treatment withdeferasirox. 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. Your child may be dehydrated. Your
healthcare provider may need to
temporarily stop treatment with deferasirox 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.
Liver problems. Deferasirox can cause liver problems, including liver
failure that can sometimes cause death.
Liver problems withdeferasirox 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 healthcare provider should do blood tests to check y

Ciri produk

DEFERASIROX - DEFERASIROX TABLET, FILM COATED
ASCEND LABORATORIES, LLC
----------
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 is 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 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. (1.2)
Limitations of Use:
The safety and efficacy of deferasirox 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 m2 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 m2 is 7 mg per kg
(calculated to nearest whole tablet once daily. (2.2)
• See full prescribing information for information regarding
monitoring, admi