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:

Teva Pharmaceuticals USA, 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 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 malign

Product summary:

Deferasirox 90 mg tablets are light blue, film-coated, modified oval shape tablets, debossed with “TV” on one side and “D22” on the other side. Tablets are available in bottles of 30 (NDC 0093-3517-56). Deferasirox 180 mg tablets are medium blue, film-coated, modified oval shape tablets, debossed with “TV” on one side and “D17” on the other side. Tablets are available in bottles of 30 (NDC 0093-3516-56). Deferasirox 360 mg tablets are dark blue, film-coated, modified oval shape tablets, debossed with “TV” on one side and “D21” on the other side. Tablets are available in bottles of 30 (NDC 0093-3515-56). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Teva 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 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
TEVA 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,