DEFERASIROX ORAL GRANULES- deferasirox granule

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

Deferasirox (UNII: V8G4MOF2V9) (Deferasirox - UNII:V8G4MOF2V9)

থেকে পাওয়া:

OAKRUM PHARMA, LLC

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Deferasirox oral granules is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. Deferasirox oral granules 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 oral granules when administered with other iron chelation therapy have not been established. Deferasirox oral granules 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 chelati

পণ্য সারাংশ:

Deferasirox Oral Granules 90 mg are white to off white granules in sachet. They are available in cartons of 30 sachets…………………………………………….(NDC 72647-371-30) Deferasirox Oral Granules 180 mg are white to off white granules in sachet. They are available in cartons of 30 sachets……………………………………………(NDC 72647-372-30) Deferasirox Oral Granules 360 mg are white to off white granules in sachet. They are available in cartons of 30 sachets……………………………………………(NDC 72647-373-30) Store Deferasirox Oral Granules 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.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

OAKRUM PHARMA, LLC
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This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Issued: February 2021
MEDICATION GUIDE
Deferasirox (dee-fer’a-si-rox) Oral Granules
What is the most important information I should know about deferasirox
oral granules?Deferasirox oral
granules can cause serious side effects, including:Kidney problems:
Deferasirox oral granules 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 oral granules 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 oral granules. Your healthcare provider should do blood
and urine tests to check your or your
child’s kidney function before and during treatment with deferasirox
oral granules. 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 oral granules . Your child may be
dehydrated. Your healthcare provider
may need to temporarily stop treatment with deferasirox oral granules
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
oral granules .
Liver problems. Deferasirox oral granules can cause liver problems,
including liver failure that can
sometimes cause death. Liver problems with deferasirox oral granules
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

পণ্য বৈশিষ্ট্য

DEFERASIROX ORAL GRANULES- DEFERASIROX GRANULE
OAKRUM PHARMA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEFERASIROX ORAL
GRANULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DEFERASIROX ORAL
GRANULES.
DEFERASIROX ORAL GRANULES, 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 ORAL GRANULES 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 ORAL GRANULES 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 oral granules 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 oral granules 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 oral granules 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 (e GFR)
greater than 60 mL/min/1.73 m is 14 mg per kg (calculated to nearest
whole sachet content for
granules) 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 sachet content for g