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:

Alembic Pharmaceuticals Limited

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. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s EXJADE® (deferasirox) tablets for oral suspension. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. The safety and efficacy of deferasirox tablets for oral suspension when administered with other iron chelation therapy have not been established. Deferasirox tablets for oral suspension 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 chelatio

Product summary:

Deferasirox Tablets for Oral Suspension 125 mg White to off-white, round, flat tablets debossed with “L461” on one side and plain on the other side. NDC 46708-324-30                Bottle of 30 tablets Deferasirox Tablets for Oral Suspension 250 mg White to off-white, round, flat tablets debossed with “L462” on one side and plain on the other side. NDC 46708-325-30                Bottle of 30 tablets Deferasirox Tablets for Oral Suspension 500 mg White to off-white, round, flat tablets debossed with “L463” on one side and plain on the other side. NDC 46708-326-30                Bottle of 30 tablets Store deferasirox tablets for oral suspension at 25°C (77°F); excursions are permitted to 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
Alembic Pharmaceuticals Limited
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MEDICATION GUIDE
Deferasirox (dee-FER-a-sir-ox)
Tablets for Oral Suspension
What is the most important information I should know about deferasirox
tablets for oral suspension?
Deferasirox tablets for oral suspension can cause serious side
effects, including:
Kidney problems. Deferasirox tablets for oral suspension 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 for oral suspension 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 for oral suspension.
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 for oral
suspension. 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 tablets for oral suspension. Your child may
be dehydrated. Your child’s
healthcare provider may need to temporarily stop treatment with
deferasirox tablets for oral
suspension 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
tablets for oral suspension.
Liver problems. Deferasirox tablets for oral suspension can cause
liver problems, including liver failure that
can sometimes cause death. Liver problems with deferasirox tablets for
oral suspension may be mo

Summary of Product characteristics

DEFERASIROX - DEFERASIROX TABLET, FOR SUSPENSION
ALEMBIC PHARMACEUTICALS LIMITED
----------
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 TABLETS FOR ORAL SUSPENSION 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 TABLETS FOR ORAL SUSPENSION THERAPY REQUIRES CLOSE PATIENT
MONITORING,
INCLUDING LABORATORY TESTS OF RENAL AND HEPATIC FUNCTION. (5)
RECENT MAJOR CHANGES
Indication 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)
Limitations of Use:
The safety and efficacy of deferasirox tablets for oral suspension
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) (2)
DOSAGE FORMS AND STRENGTHS
Tablets for oral suspension: 125 mg, 250 mg, 500 mg. (3)
CONTRAINDICATIONS
• Estimated GFR less than 40 mL/min/1.73 m . (4)
• Patients with poor performance status. (4)
• Patients with high-risk MDS. (4)
• Patients with advanced malignancies. (4)
• Patients with platelet counts less than 50 x 10 /L. (4)
• Known hypersensi