给药说明
1.用药前须明确诊断，尽可能找到缺铁的原因。
2.本药缓释片应整片服用，不得掰开或研碎服用。
3.服用本药的糖浆或溶液剂时宜使用吸管，以防牙齿变黑。
4.在妊娠中、后期铁摄入量减少而需要量增加，故此时补..
不同适应症和各年龄组别患者的用法用量 口服给药
治疗地中海贫血引起的铁超负荷
成人: 25 mg/kg tid。剂量不应超过>100 mg/kg/天。
儿童: 6岁以上：同成人剂量。
服药与进食 服药不受进食影响
 
禁忌 禁用于粒细胞缺乏症患者，孕妇和哺乳期妇女。
不良反应 肌肉骨骼疼痛、关节疼痛、胃肠道不适、红褐色尿、一过性肝酶异常、缺锌。粒细胞减少和中性白细胞减少。
贮藏/有效期 口服给药: 存于30°C以下。
药理作用 去铁酮为口服的高效铁离子螯合剂，一般在去铁胺不适合或有禁忌症时使用。
吸收: 口服后胃肠道吸收快。
代谢: 代谢为无活性的葡萄糖醛酸化合物。
排泄: 主要经尿液清除。清除半衰期：约2-3小时

Drug Details
Ferriprox 100 mg/ml oral solution
Presentation
Oral solution
Description
Each ml of oral solution contains 100 mg deferiprone. Excipient: Each ml of oral solution contains 0.4 mg Sunset Yellow (E110).
Indications
Ferriprox is indicated for the treatment of iron overload in patients with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.
Adult Dosage
For oral use.
Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of patients with thalassaemia.
Deferiprone is usually given as 25 mg/kg body weight, orally, three times a day for a total daily dose of 75 mg/kg body weight. Dose per kilogram body weight should be calculated to the nearest 2.5 ml. See table below for recommended doses for body weights at 10 kg increments.
Doses above 100 mg/kg/day are not recommended because of the potentially increased risk of adverse reactions; chronic administration of more than 2.5 times the maximum recommended dose has been associated with neurological disorders.
There are limited data available on the use of deferiprone in children between 6 and 10 years of age, and no data on deferiprone use in children under 6 years of age.
Due to the serious nature of agranulocytosis, that can occur with the use of deferiprone, special monitoring is required for all patients. Caution must be used when the patients' absolute neutrophil count (ANC) is low, as well as when treating patients with renal insufficiency or hepatic dysfunction.
Dose table
To obtain a dose of about 75 mg/kg/day, use the volume of oral solution suggested in the following table for the body weight of the patient.
Sample body weights at 10 kg increments are listed.

Body weight(kg) Total daily dose(mg) Dose(mg, three times/day) ml of oral solution(three times/day)
20 1500  500 5
30  2250  750 7.5
40 3000  1000 10
50  3750  1250 12.5
60 4500  1500 15
70 5250  1750 17.5
80 6000  2000 20
90 6750  2250 22.5

Child Dosage
Under six years, no data on use; six to 10 years, limited data six to 10 years, limited data available.
Contra Indications

System organ class Very common
(1/10) Common (1/100 to <1/10) Uncommon (1/1,000 to <1/100)
Investigations   Increased liver enzymes  
Blood and lymphatic system disorders   Neutropenia Agranulocytosis  
Nervous system disorders   Headache  
Gastrointestinal disorders Nausea
Abdominal Pain Vomiting Diarrhoea  
Renal and urinary disorders Chromaturia    
Musculoskeletal and connective tissue disorders   Arthralgia  
Metabolism and nutrition disorders   Increased Appetite  
General disorders and administration site conditions   Fatigue  

The most serious adverse reaction reported in clinical trials with
deferiprone is agranulocytosis (neutrophils <0.5x109/l), with an incidence of 1.1% (0.6 cases per 100 patientyears of treatment). The observed incidence of the less severe form of neutropenia (neutrophils <1.5x109/l) is 4.9% (2.5 cases per 100 patientyears). This rate should be considered in the context of the underlying elevated incidence of neutropenia in thalassaemia patients, particularly in those with hypersplenism.
Episodes of diarrhoea, mostly mild and transient, have been reported in patients treated with deferiprone. Gastrointestinal effects are more frequent at the beginning of therapy and resolve in most patients within a few weeks without the discontinuation of treatment. In some patients it may be beneficial to reduce the dose of deferiprone and then scale it back up to the former dose. Arthropathy events, which ranged from mild pain in one or more joints to severe arthritis with effusion and significant disability, have also been reported in patients treated with deferiprone.
Mild arthropathies are generally transient.
Increased levels of serum liver enzymes have been reported in patients taking deferiprone. In the majority of these patients, the increase was asymptomatic and transient, and returned to baseline without discontinuation or decreasing the dose of deferiprone.
Some patients experienced progression of fibrosis associated with an
increase in iron overload or hepatitis C.
Low plasma zinc levels have been associated with deferiprone, in a
minority of patients. The levels normalised with oral zinc
supplementation.
Neurological disorders (such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia) have been observed in children who had been voluntarily prescribed more than 2.5 times the maximum recommended dose of 100 mg/kg/day for several years.
The neurological disorders progressively regressed after deferiprone
discontinuation.
Adverse reaction frequencies: Very common (1/10), Common (1/100 to <1/10), Uncommon (1/1,000 to <1/100).
Special Precautions
Neutropenia/Agranulocytosis
Deferiprone has been shown to cause neutropenia, including
agranulocytosis. The patient's neutrophil count should be monitored every week.
In clinical trials, weekly monitoring of the neutrophil count has been effective in identifying cases of neutropenia and agranulocytosis.
Neutropenia and agranulocytosis resolved once therapy was withdrawn. If the patient develops an infection while on deferiprone, therapy should be interrupted and the neutrophil count monitored more frequently. Patients should be advised to report immediately to their physician any symptoms indicative of infection such as fever, sore throat and flulike symptoms.
Suggested management of cases of neutropenia is outlined below. It is recommended that such a management protocol be in place prior to
initiating any patient on deferiprone treatment.
Treatment with deferiprone should not be initiated if the patient is
neutropenic. The risk of agranulocytosis and neutropenia is higher, if the baseline absolute neutrophil count (ANC) is less than 1.5x109/l.
In the event of neutropenia:
Instruct the patient to immediately discontinue deferiprone and all other medicinal products with a potential to cause neutropenia. The patient should be advised to limit contact with other individuals in order to reduce the risk of infection. Obtain a complete blood cell (CBC) count, with a white blood cell (WBC) count, corrected for the presence of nucleated red blood cells, a neutrophil count, and a platelet count immediately upon diagnosing the event and then repeat daily. It is recommended that following recovery from neutropenia, weekly CBC, WBC, neutrophil and platelet counts continue to be obtained for three consecutive weeks, to ensure that the patient recovers fully. Should any evidence of infection develop concurrently with the neutropenia, the appropriate cultures and diagnostic procedures should be performed and an appropriate therapeutic regimen instituted.
In the event of severe neutropenia or agranulocytosis:
Follow the guidelines above and administer appropriate therapy such as granulocyte colony stimulating factor, beginning the same day that the event is identified; administer daily until the condition resolves.
Provide protective isolation and if clinically indicated, admit patient to the hospital.
Limited information is available regarding rechallenge. Therefore, in the event of neutropenia, rechallenge is not recommended. In the event of agranulocytosis, a rechallenge is contraindicated.
Carcinogenicity/mutagenicity/effects on fertility
In view of the genotoxicity results, a carcinogenic potential of
deferiprone cannot be excluded. No animal studies to evaluate the
potential effects of deferiprone on fertility have been reported.
Serum ferritin concentration/plasma Zn2+ concentrationIt is recommended that serum ferritin concentrations, or other indicators
of body iron load, be monitored every two to three months to assess the longterm effectiveness of the chelation regimen in controlling the body iron load. Interruption of therapy with deferiprone should be considered if serum ferritin measurements fall below 500 μg/l.
Monitoring of plasma Zn2+ concentration, and supplementation in case of a deficiency, is recommended.
HIV positive or other immune compromised patients
No data are available on the use of deferiprone in HIV positive or in other immune compromised patients. Given that deferiprone can be
associated with neutropenia and agranulocytosis, therapy in immune
compromised patients should not be initiated unless potential benefits outweigh potential risks.
Renal or hepatic impairment and liver fibrosis
There are no data available on the use of deferiprone in patients with renal or hepatic impairment. Since deferiprone is eliminated mainly via the kidneys, there may be an increasedriskofcomplications in patients with impaired renal function. Similarly, as deferiprone is metabolised in the liver, caution must be exercised in patients with hepatic dysfunction.
Renal and hepatic function should be monitored in this patient population during deferiprone therapy. If there is a persistent increase in serum alanine aminotransferase (ALT), interruption of deferiprone therapy should be considered.
In thalassaemia patients there is an association between liver fibrosis and iron overload and/or hepatitis C. Special care must be taken to ensure that iron chelation in patients with hepatitis C is optimal. In these patients careful monitoring of liver histology is recommended.
Discoloration of urine
Patients should be informed that their urine may show areddish/brown
discoloration due to the excretion of the iron-deferiprone complex.
Chronic overdose and neurological disorders
Neurological disorders have been observed in children treated with 2.5 to 3 times the recommended dose for several years. Prescribers are reminded that the use of doses above 100 mg/kg/day are not recommended.
Excipients
Ferriprox oral solution contains the colouring agent Sunset Yellow (E110) which may cause allergic reactions.
Interactions
between deferiprone and other medicinal products have not been reported.
However, since this compound binds to metallic cations, the potential exists for interactions between deferiprone and trivalent cation- dependent medicinal products such as aluminium-based antacids. Caution should be used when administering deferiprone and vitamin C concurrently.
Adverse Drug Reactions
Agranulocytosis, neutropenia. Reddish/brown discolouration of urine.
Nausea, vomiting, appetite. Also, arthropathies, increased ALT values, low plasma zinc levels. Some patients experienced progression of fibrosis associated with an increase in iron overload or hepatitis C.
注册证号 H20110352
原注册证号 
产品名称（中文） 去铁酮口服溶液
产品名称（英文） Deferiprone Oral Solution
商品名（中文） 
商品名（英文） 
剂型（中文） 口服溶液剂
规格（中文） 1ml:100mg
注册证号备注 
包装规格（中文） 250ml/瓶，500ml/瓶
生产厂商（中文） 
生产厂商（英文） Apotex Inc.-Richmond Hill site
厂商地址（中文） 
厂商地址（英文） 380 Elgin Mills Road East, Richmond Hill, Ontario, L4C 5H2 Canada

厂商国家（中文） 加拿大
厂商国家（英文） Canada
分包装批准文号 
发证日期 2011-08-15
有效期截止日 2016-08-14
分包装企业名称 
分包装企业地址 
分包装文号批准日期 
分包装文号有效期截止日 
产品类别 化学药品
药品本位码 86978225000108
药品本位码备注 
公司名称（中文） 
公司名称（英文） Apotex Inc.
地址（中文） 
地址（英文） 150 Signet Drive Western Toronto, Ontario M9L 1T9, Canada
国家（中文） 加拿大
国家（英文） Canada