英文药名：EXJADE Dispersible Tablets（Deferasirox）

中文药名：地拉罗司口服悬浮片

生产厂家：诺华制药

エクジェイド懸濁用錠125mg／エクジェイド懸濁用錠500mg

治疗类别名称
铁螯合剂
商標名
EXJADE Dispersible Tablets
構造式

一般名
デフェラシロクス（Deferasirox）
化学名
4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid
分子式
C21H15N3O4
分子量
373.36
性状
白色至淡黄色粉末。微溶于丙酮，在甲醇或乙醇（95）中微溶，并且几乎不溶于水。还存在的pH依赖性溶解度，虽然在酸性侧几乎不溶，在碱性侧微溶。
适应病症：
用于因需要长期输血而引致铁质积聚的患者(如患有地中海贫血症或其他罕见的贫血症) ，适用于两岁以上儿童及成人服用。
用法用量：
建议有铁质积聚患者，例如需要长期输血人士(输血量达100毫升/公斤) 及血清铁蛋白超过1000微克/升；对应身体重量，初期建议每日服用20毫克/公斤剂量的地拉罗司，视乎血清铁蛋白指标的改善情况，患者可能需要调校或增加服用地拉罗司的剂量，一般会以5毫克/公斤或10毫克/公斤为单位作剂量调升，但服用总剂量不应超过每日30毫克/公斤。
不良反应：
常见不良反应：腹泻、呕吐、头痛、腹痛、发烧、皮疹、增加血清肌酸酐(Creatinine)等。
其他不良反应：肝酵素增加、咳嗽、喉咙发炎、荨麻疹。
不宜与含有铝质的药物(如中和胃酸药)同服。
禁忌：
对地拉罗司或当中任何成份过敏者。
包装规格
片：
125毫克*20片（PTP）
500毫克*20片（PTP）

制造商
诺华制药有限公司
EXJADE 125mg Tablets, for oral suspension（エクジェイド懸濁用錠125mg） 
Brand name : EXJADE 125mg Tablets, for oral suspension
　Active ingredient: Deferasirox
　Dosage form: white to pale-yellowish white tablet, diameter 12mm, thickness 3.6mm
　Print on wrapping: エクジェイド125mg, EXJADE, NVR J125
EXJADE 500mg Tablets, for oral suspension（エクジェイド懸濁用錠500mg） 
Brand name : EXJADE 500mg Tablets, for oral suspension
　Active ingredient: Deferasirox
　Dosage form: white to pale-yellowish white tablet, diameter 12mm, thickness 3.6mm
　Print on wrapping: エクジェイド500mg, EXJADE, NVR J500
Effects of this medicine
This medicine is an iron chelator agent which binds and excretes excessively accumulated iron from the body.
It is usually used to treat chronic iron overload due to blood transfusions (when treatment with iron chelator injection is inadequate).
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have renal disorder, malignancy or hepatic dysfunction.
If your blood platelet count is less than 50,000/mm3.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•In general, the dosage is 20 mg/kg body weight of the active ingredient. It is to be calculated and rounded to the nearest whole tablet number. Disperse the medicine by stirring in 100 mL or more water at a time, once a day and take them on an empty stomach. The dosage should be adjusted as needed basis. However, it should not exceed 30 mg/kg per day. 1 tablet contains 125 mg of the active ingredient. It may be used with tablets which has same active ingredient but has different content (500 mg). Strictly follow the instructions.
•Absorption of the medicine is susceptible to meal. Take this medicine on an empty stomach and meals should not be taken within 30 minutes after taking it.
•If there is any leftover medicine in the bottom of the cup , add water to the cup, disperse completely by stirring and drink the whole thing. The tablet should never be chewed or swallowed as whole.
•If you miss a dose, take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•This medicine may cause dizziness or visual/hearing impairment. Be aware of driving a car or operating dangerous machinery after administering this medicine.
•Deterioration of cardiac function is reported in the similar medicine when taken with 500 mg or more vitamin C (orally). Consult your doctor or pharmacist about taking supplements including vitamin C.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include diarrhea, nausea, vomiting, abdominal pain, indigestion or rash. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•hives, breathing difficulty, swelling around eyes/lips [shock, anaphylaxis]
•decrease of urine volume, edema, headache [acute renal failure, renal tubular disorder]
•decreased appetite, general malaise, jaundice [hepatitis, hepatic failure]
•nausea, severe stomachache, black stool [gastrointestinal perforation, gastric ulcer (including multiple ulcer), duodenal ulcer, gastrointestinal bleeding]
•fever, rash/bulla, red eye, sore lips/mouth [mucocutaneous ocular syndrome, erythema multiforme]
•hearing difficulty of voice or sound, blurred vision, visual disorder [hearing disorder (hearing loss), lens opacity(early cataract), optic neuritis]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
•Discard the remainder. Do not store them. Ask the pharmacist or medical institution how to discard. 
Novartis Pharma K.K.Internal
Revised: 8/2015
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
http://www.info.pmda.go.jp/go/pack/3929008X1029_1_11/