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:

Alembic Pharmaceuticals Limited

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. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s JADENU® (deferasirox) tablets. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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); • Advanced malignancies [see Warnings and Precautions (5

Product summary:

Deferasirox tablets 90 mg are light blue, oval, biconvex, film-coated tablet with beveled edges, debossed with “L” on one side and “663” on the other side. They are available as follows: NDC 46708-410-30                Bottle of 30 tablets NDC 46708-410-91                Bottle of 1000 tablets Deferasirox tablets 180 mg are medium blue, oval, biconvex, film-coated tablet with beveled edges, debossed with “L” on one side and “664” on the other side. They are available as follows: NDC 46708-411-30                Bottle of 30 tablets NDC 46708-411-91                Bottle of 1000 tablets Deferasirox tablets 360 mg are dark blue, oval, biconvex, film-coated tablet with beveled edges, debossed with “L” on one side and “665” on the other side. They are available as follows: NDC 46708-412-30                Bottle of 30 tablets NDC 46708-412-91                Bottle of 1000 tablets Store deferasirox tablets at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DEFERASIROX - DEFERASIROX TABLET, FILM COATED
Alembic Pharmaceuticals Limited
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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 b

Summary of Product characteristics

DEFERASIROX - DEFERASIROX TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS 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 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)
Limitations of Use: (1)
The safety and efficacy of deferasirox tablets when administered with
other iron chelation therapy have not
been established. (1.3) (1)
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)
See Full Prescribing information for information regarding monitoring,
administration, and dose-
reductions for organ impairment. (2.1, 2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 90 mg, 180 mg, 360 mg. (3) (3)
CONTRAINDICATIONS
Estimated GFR less than 40 mL/min/1.73 m (4)
Patients with poor performance status. (4)
Patients with high-risk MDS. (4)
Patients with advanced malignancies. (4)
Patients with platelet counts less than 50 x 10 /L. (4)
Known hypersensitivity to deferasirox or any component of deferasirox
table