DEFERIPRONE tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. Limitations of Use: Pediatric use information is approved for Chiesi USA, Inc.’s FERRIPROX® (deferiprone) tablets. However, due to Chiesi USA, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Deferiprone tablets are 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%, respectively, of the maximum recommended human dose (MRHD) resulted in structural abnormalities, embryo-fetal mor

Product summary:

Deferiprone Tablets (three times a day), 1,000 mg: Deferiprone Tablets (three times a day) are white to off-white, modified capsule shaped, biconvex, film coated tablets, debossed with 54 [score] 23 on one side and plain on the other. They are provided in a 50 count, 150 count, and 300 count HDPE bottle with a child-resistant cap. NDC 0054-0711-19: Bottle of 50 Tablets NDC 0054-0711-23: Bottle of 150 Tablets NDC 0054-0711-28: Bottle of 300 Tablets Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep the bottle tightly closed to protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Hikma Pharmaceuticals USA Inc.
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Medication Guide
Deferiprone (de fer’ i prone) Tablets
What is the most important information I should know about deferiprone
tablets?
Deferiprone 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 deferiprone 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 will do a blood test before you start
deferiprone tablets and regularly 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 deferiprone tablets if you develop
neutropenia or infection.
Stop taking deferiprone tablets and call your healthcare provider or
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
It is important for you to have your white blood cell count checked
within 24 hours of developing
symptoms of an infection to see if you have severe neutropenia
(agranulocytosis). Do not delay getting
medical care if you are unable to reach your healthcare provider.
See “What are the possible side effects of deferiprone tablets?”
for more information about side effects.
What are deferiprone tablets?
Deferiprone tablets are a prescription medicine used to treat iron
overload from blood transfusions in
adults with thalassemia syndromes when current iron removal
(chelation) therapy does not work well
enough.
It is not known if deferiprone tablets are safe

Summary of Product characteristics

DEFERIPRONE- DEFERIPRONE TABLET, COATED
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEFERIPRONE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DEFERIPRONE TABLETS.
DEFERIPRONE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
WARNING: AGRANULOCYTOSIS AND NEUTROPENIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
•
INDICATIONS AND USAGE
Deferipronetablets are an iron chelator indicated for the treatment of
transfusional iron overload in adult
patients with thalassemia syndromes when current chelation therapy is
inadequate. (1)
_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.
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Hypersensitivity to deferiprone or to any of the excipients in the
formulations. (4)
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HIKMA PHARMACEUTICALS
USA INC. AT 1-
800-962-8364 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
DEFERIPRONE TABLETS 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
DEFERIPRONE TABLETS
AND MONITOR REGULARLY WHILE ON THERAPY. (5.1)
INTERRUPT DEFERIPRONE TABLETS THERAPY IF NEUTROPENIA DEVELOPS. (5.1)
INTERRUPT DEFERIPRONE TABLETS IF INFECTION DEVELOPS AND MONITOR THE
ANC MORE
FREQUENTLY. (5.1)
ADVISE PATIENTS TAKING DEFERIPRONE TABLETS TO REPORT IMMEDIATELY ANY
SYMPTOMS
INDICATIVE OF INFECTION. (5.1)
Deferiprone Tablets are available in a 1,000 mg formulation. (2.1)
To prevent medication errors, before prescribing and dispensing,
ensure that the tablet formulation is
appropriate for the dosin