EXJADE- deferasirox tablet, for suspension

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Novartis Pharmaceuticals Corporation

INN (Algemene Internationale Benaming):

DEFERASIROX

Samenstelling:

DEFERASIROX 125 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Exjade is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. Exjade 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 Exjade when administered with other iron chelation therapy have not been established. Exjade 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 therapy) - Advanced malignancies. [see Warnings and Precautions (5.1, 5.3)]

Product samenvatting:

Exjade is provided as 125 mg, 250 mg, and 500 mg tablets for oral suspension. 125 mg Off-white, round, flat tablet with beveled edge and imprinted with “J” and “125” on one side and “NVR” on the other. Bottles of 30 tablets………………………………………………………………..(NDC 0078-0468-15) 250 mg Off-white, round, flat tablet with beveled edge and imprinted with “J” and “250” on one side and “NVR” on the other. Bottles of 30 tablets………………………………………………………………..(NDC 0078-0469-15) 500 mg Off-white, round, flat tablet with beveled edge and imprinted with “J” and “500” on one side and “NVR” on the other. Bottles of 30 tablets………………………………………………………………..(NDC 0078-0470-15) Store Exjade tablets 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.

Autorisatie-status:

New Drug Application

Bijsluiter

Novartis Pharmaceuticals Corporation
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This Medication Guide has been approved by the U.S.
Food and Drug Administration.
Revised: July 2020
MEDICATION GUIDE
EXJADE® (ex jayde)
(deferasirox)
tablets
for oral suspension
What is the most important information I should know about Exjade?
Exjade can cause serious side effects, including:
Kidney problems. Exjade 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
Exjade 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 Exjade.
Your healthcare provider should do blood and urine tests to check your
or your child’s kidney function
before and during treatment with Exjade. 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 Exjade. Your child may be dehydrated. Your child’s
healthcare provider may need to
temporarily stop treatment with Exjade 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 Exjade.
Liver problems. Exjade can cause liver problems, including liver
failure that can sometimes cause death.
Liver problems with Exjade 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

Productkenmerken

EXJADE- DEFERASIROX TABLET, FOR SUSPENSION
NOVARTIS PHARMACEUTICALS CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EXJADE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EXJADE.
EXJADE (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._
EXJADE 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)
EXJADE 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
Exjade 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)
Exjade 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 Exjade 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, as oral suspension. Calculate dose to the
nearest whole tablet. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets for oral suspension: 125 mg, 250 mg, 500