Ferriprox® (deferiprone) Prescribing Information

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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/NEUTROPENIA
See full prescribing information for complete boxed warning.
INDICATIONS AND USAGE
FERRIPROX® (deferiprone) 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)
Limitation 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)
DOSAGE FORMS AND STRENGTHS
• 500 mg film-coated tablets with a functional score. (3)
CONTRAINDICATIONS
• Hypersensitivity to deferiprone or to any of the excipients in the
formulation. (4)
WARNINGS AND PRECAUTIONS
• If infection occurs while on Ferriprox, interrupt therapy and monitor the
ANC more frequently. (5.1)
• Ferriprox can cause fetal harm. Women should be advised of the
potential hazard to the fetus and to avoid pregnancy while on this drug.
(5.2)
ADVERSE REACTIONS
• The most common adverse reactions are (incidence ≥ 5%)
chromaturia, nausea, vomiting and abdominal pain, alanine
aminotransferase increased, arthralgia and neutropenia. (5.1, 6)
To report SUSPECTED ADVERSE REACTIONS, contact ApoPharma Inc.
at: Telephone: 1-866-949-0995 Email: medicalsafety@apopharma.com
or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
• Avoid concomitant use with other drugs known to be associated with
neutropenia or agranulocytosis; however, if this is not possible, closely
monitor the absolute neutrophil count. (7.1)
• Allow at least a 4-hour interval between Ferriprox and mineral
supplements, and antacids that contain polyvalent cations (e.g., iron,
aluminum, and zinc). (7.3)
USE IN SPECIFIC POPULATIONS
• Safety and efficacy of Ferriprox has not been evaluated in patients with
severe hepatic impairment. (8.7)
• Nursing mothers: Discontinue the use of Ferriprox or discontinue
nursing. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and
Medication Guide.
Revised: 05/2017
1
• 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 the ANC weekly on therapy. (5.1)
• Interrupt Ferriprox if infection develops and monitor the ANC

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