DEFERASIROX tablet, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ascend Laboratories, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. Deferasirox 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 th

Product summary:

Deferasirox is provided as 125 mg, 250 mg, and 500 mg tablets for oral suspension. 125 mg White to off white, round, flat tablet with beveled edge and debossed with 'DS' on the one side and '125' on other side. Tablets are provided as follows: Bottle of 30:                                             NDC 67877-549-30 250 mg White to off white, round, flat tablet with beveled edge and debossed with 'DS' on the one side and '250' on other side. Tablets are provided as follows: Bottle of 30:                                             NDC 67877-550-30 500 mg White to off white, round, flat tablet with beveled edge and debossed with 'DS' on the one side and '500' on other side. Tablets are provided as follows: Bottle of 30:                                             NDC 67877-551-30 Store deferasirox tablets for oral suspension 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DEFERASIROX - DEFERASIROX TABLET, FOR SUSPENSION
Ascend Laboratories, LLC
----------
MEDICATION GUIDE
DEFERASIROX
(de FER a sir ox)
tablets
for oral suspension
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 with
deferasirox. Call your or your child’s
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
child’s healthcare provider may need
to temporarily stop treatment with deferasirox and treat your child
for dehydration to help prevent
kidney problems. Your child’s 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 with deferasirox 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” a

Summary of Product characteristics

DEFERASIROX - DEFERASIROX TABLET, FOR SUSPENSION
ASCEND LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEFERASIROX TABLETS
FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DEFERASIROX TABLETS FOR ORAL SUSPENSION.
DEFERASIROX TABLETS, FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2005
WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL
HEMORRHAGE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DEFERASIROX MAY CAUSE:
• 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 for oral suspension 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 for oral suspension 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 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 m is 20 mg per kg body weight once daily,
as oral suspension. Calculate
dose to the nearest whole tablet. (2.1)
NTDT Syndromes: Initial dose for patients with eGFR greater than 60
mL/min/1.73 m is 10 mg per kg
body weight once daily,