国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
DEFERIPRONE (UNII: 2BTY8KH53L) (DEFERIPRONE - UNII:2BTY8KH53L)
ApoPharma USA, Inc.
DEFERIPRONE
DEFERIPRONE 500 mg
ORAL
PRESCRIPTION DRUG
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 or
FERRIPROX® (deferiprone) tablets 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 52609-0006-1 Store at 20 ºC to 25 ºC (68 ºF to 77 ºF); excursions permitted to 15 ºC to 30 ºC (59 ºF to 86 ºF) [see USP Controlled Room Temperature].
New Drug Application
ApoPharma USA, Inc. ---------- 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 阅读完整的文件
FERRIPROX- DEFERIPRONE TABLET, FILM COATED APOPHARMA USA, INC. ---------- 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) 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 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 Deficiency: Monitor during therapy and supplement for deficiency. (5.3) Embryo-Fetal Toxicity: Can cause fe 阅读完整的文件