DEFERASIROX ORAL granule

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Ascend Laboratories, LLC

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Deferasirox oral granules are 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. This indication is approved under accelerated approval based on a reduction of liver iron concentrations (to less than 5 mg Fe/g dw) and serum ferritin levels [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. Deferasirox is contraindicated in patients with: - Estimated GF

Tuoteyhteenveto:

Deferasirox oral granules 90 mg are Off white to yellowish granular powder in sachet. They are available in cartons of 30 sachets. (NDC 67877-675-84). Deferasirox oral granules 180 mg are Off white to yellowish granular powder in sachet. They are available in cartons of 30 sachets. (NDC 67877-676-84). Deferasirox oral granules 360 mg are Off white to yellowish granular powder in sachet. They are available in cartons of 30 sachets. (NDC 67877-677-84). 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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

Ascend Laboratories, LLC
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MEDICATION GUIDE
DEFERASIROX
(de FER a sir ox)
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
child’s healthcare provider may need to
temporarily stop treatment with deferasirox oral granules 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 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 failure of other organs. Liver failure
has also happened along with kidney
proble

Valmisteyhteenveto

DEFERASIROX ORAL - DEFERASIROX ORAL GRANULE
ASCEND LABORATORIES, 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 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 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 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.
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 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 m2 is 7 mg per kg
(calculated to nearest whole sachet content for granules) once daily.
(2.2)
See full prescribing information for