FERRIPROX- deferiprone tablet, film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

DEFERIPRONE (UNII: 2BTY8KH53L) (DEFERIPRONE - UNII:2BTY8KH53L)

Disponibbli minn:

Chiesi USA, Inc.

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

FERRIPROX Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes. FERRIPROX Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with sickle cell disease or other anemias. - Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia. FERRIPROX is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation. The following reactions have been reported in association with the administration of deferiprone: Henoch-Schönlein purpura; urticaria; and periorbital edema with skin rash [see Adverse Reactions (6.2)]. Risk Summary In animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%,

Sommarju tal-prodott:

FERRIPROX® Tablets (deferiprone) are white to off-white capsule-shaped tablets, film-coated, and have a functional score imprinted with “APO” score “500” on one side and are plain on the other. They are provided in HDPE bottles. 500 mg film-coated tablets, 100 tablets NDC 10122-100-10 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Fuljett ta 'informazzjoni

Chiesi USA, Inc.
----------
This Medication Guide has been
approved by the U.S. Food and Drug
Administration.
Revised: 04/2021
CTFD-011-0620-01-SPL-1
Medication Guide
FERRIPROX (Feh' ri prox) Tablets
(deferiprone)
tablets, for oral use
500 mg
What is the most important information I should know
about FERRIPROX Tablets?
FERRIPROX Tablets can cause serious side effects,
including a very low white blood cell count. One type of
white blood cell that is important for fighting infections is
called a neutrophil. If your neutrophil count is low
(neutropenia), you may be at risk of developing a serious
infection that can lead to death. Neutropenia is common
with FERRIPROX Tablets and can become severe in some
people. Severe neutropenia is known as agranulocytosis. If
you develop agranulocytosis, you will be at risk of
developing serious infections that can lead to death.
Your healthcare provider should do a blood test before you
start FERRIPROX Tablets and weekly during treatment to
check your neutrophil count. If you develop neutropenia,
your healthcare provider should check your blood counts
every day until your white blood cell count improves. Your
healthcare provider may temporarily stop treatment with
FERRIPROX Tablets if you develop neutropenia or
infection.
Stop taking FERRIPROX Tablets and get medical help right
away if you develop any of these symptoms of infection:
•
fever
•
sore throat or mouth sores
•
flu-like symptoms
•
chills and severe shaking
See “What are the possible side effects of FERRIPROX
Tablets?” for more information about side effects.
What is FERRIPROX Tablets?
FERRIPROX Tablets is a prescription medicine used to
treat iron overload from blood transfusions in adults and
children 8 years of age and older with:
•
thalassemia syndromes.
•
sickle cell disease or other anemias.
It is not known if FERRIPROX Tablets is safe and effective
to treat iron overload due to blood transfusions:
•
in people with myelodysplastic syndrome or
Diamond Blackfan anemia
•
in children less than 8 yea

Karatteristiċi tal-prodott

FERRIPROX- DEFERIPRONE TABLET, FILM COATED
CHIESI USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FERRIPROX TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FERRIPROX
TABLETS.
FERRIPROX (DEFERIPRONE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
WARNING: AGRANULOCYTOSIS AND NEUTROPENIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FERRIPROX CAN CAUSE AGRANULOCYTOSIS THAT CAN LEAD TO SERIOUS
INFECTIONS AND DEATH.
NEUTROPENIA MAY PRECEDE THE DEVELOPMENT OF AGRANULOCYTOSIS. (5.1)
MEASURE THE ABSOLUTE NEUTROPHIL COUNT (ANC) BEFORE STARTING FERRIPROX
AND
MONITOR WEEKLY WHILE ON THERAPY. (5.1)
INTERRUPT FERRIPROX IF INFECTION DEVELOPS AND MONITOR THE ANC MORE
FREQUENTLY.
(5.1)
ADVISE PATIENTS TAKING FERRIPROX TO REPORT IMMEDIATELY ANY SYMPTOMS
INDICATIVE
OF INFECTION. (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1)
04/2021
INDICATIONS AND USAGE
FERRIPROX Tablets are an iron chelator indicated for the treatment of
transfusional iron overload in adult
and pediatric patients 8 years of age and older with thalassemia
syndromes. (1.1)
FERRIPROX Tablets are an iron chelator indicated for the treatment of
transfusional iron overload in adult
and pediatric patients 8 years of age and older with sickle cell
disease or other anemias. (1.2)
Limitations of Use
Safety and effectiveness have not been established for the treatment
of transfusional iron overload in
patients with myelodysplastic syndrome or in patients with Diamond
Blackfan anemia. (1.3)
DOSAGE AND ADMINISTRATION
25 mg/kg to 33 mg/kg actual body weight, orally, three times per day,
for a total daily dose of 75 mg/kg to
99 mg/kg body weight. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 500 mg film-coated, with functional scoring. (3)
CONTRAINDICATIONS
Hypersensitivity to deferiprone or to any of the excipients in the
formulation. (4)
WARNINGS AND PRECAUTIONS
Liver Enzyme Elevations: Monitor monthly and discontinue for
persistent elevations. (5.2)
Zinc