FERRIPROX- deferiprone tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ApoPharma USA, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FERRIPROX® is indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. Approval is based on a reduction in serum ferritin levels. There are no controlled trials demonstrating a direct treatment benefit, such as improvement in disease-related symptoms, functioning, or increased survival [see Clinical Studies (14)] . Limitations of Use - Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with other chronic anemias. 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 o

Product summary:

FERRIPROX® (deferiprone) tablets are white to off-white, capsule-shaped tablets, film-coated, and have a functional score imprinted with “APO” score “1000” on one side and are plain on the other. They are provided in HDPE bottles. 1,000 mg film-coated tablets, 50 tablets NDC 52609-0007-5 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]. Keep the bottle tightly closed to protect from moisture.

Authorization status:

New Drug Application

Patient Information leaflet

ApoPharma USA, Inc.
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MEDICATION GUIDE
FERRIPROX® (Feh’ ri prox)
(deferiprone)
tablets
What is the most important information I should know about FERRIPROX?
FERRIPROX 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 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 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 if you develop
neutropenia or infection.
Stop taking FERRIPROX 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?” for more
information about side effects.
What is FERRIPROX?
FERRIPROX is a prescription medicine used to treat people with
thalassemia syndromes who have iron
overload from blood transfusions, when current iron removal
(chelation) therapy does not work well
enough.
It is not known if FERRIPROX is safe and effective:
•
to treat iron overload due to blood transfusions in people with any
other type of anemia that is
long lasting (chronic)
•
in children
Do not take FERRIPROX if you are allergic to deferiprone or any of the
ingredients in FERRIPROX.
See the end of this Medication Guide for a complete list of
ingredients in FERRIPROX.
Before you take FERRIPROX, tell your healthcare provider

Summary of Product characteristics

FERRIPROX- DEFERIPRONE TABLET, FILM COATED
APOPHARMA USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FERRIPROX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FERRIPROX.
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
Dosage and Administration, Recommended Dosage (2.1) 08/2019
INDICATIONS AND USAGE
FERRIPROX is an iron chelator indicated for the treatment of patients
with transfusional iron overload due to thalassemia
syndromes when current chelation therapy is inadequate. (1)
Approval is based on a reduction in serum ferritin levels. There are
no controlled trials demonstrating a direct treatment
benefit, such as improvement in disease-related symptoms, functioning,
or increased survival. (1)
Limitations of Use
Safety and effectiveness have not been established for the treatment
of transfusional iron overload in patients with other
chronic anemias. (1)
DOSAGE AND ADMINISTRATION
25 mg/kg to 33 mg/kg 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: 1,000 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 Deficiency: Monitor during ther