比卡鲁胺片BICALUTAMIDE(Casodex Table 50mg)

产地国家加拿大

处方药

所属类别 50毫克/片 30片/盒

包装规格 50毫克/片 30片/盒

计价单位

生产厂家英文名AstraZeneca

原产地英文商品名Casodex -50mg/Tablet 30Tablets

原产地英文药品名BICALUTAMIDE

中文参考商品译名Casodex -50毫克/片 30片/盒

中文参考药品译名:比卡鲁胺

简介

部份中文比卡鲁胺处方资料(仅供参参考)

通用名:比鲁卡胺片

商品名:康士得/Casodex

英文名:Bicalutamide tablet

生产厂家: AstraZeneca(阿斯利康)

CASODEX(bicalutamide,比卡鲁胺)是种非甾体雄激素受体抑制剂,于1995年在欧美国家上市。已在全球80多个国家上市销售,是前期应用最广泛的前列腺癌治疗药物。由于其出色的安全性和有效性,一般来说有良好的耐药性,且少有因不良反应而停药的情况,但是专家并不建议长期使用比卡鲁胺片。具体的耐药时间要视情况而定。

批准日期:2002年06月04日 公司:阿斯利康

CASODEX(比卡鲁胺[bicalutamide])片剂,口服

美国初次批准:1995年

作用机理

CASODEX是一种非甾体雄激素受体抑制剂。

它通过与靶组织中的细胞溶质雄激素受体结合而竞争性地抑制雄激素的作用。 已知前列腺癌对雄激素敏感并且对治疗有反应,抵消了雄激素的作用和/或去除了雄激素的来源。

当CASODEX与黄体生成激素释放激素(LHRH)类似物疗法联合使用时,不能抑制LHRH类似物诱导的血清睾丸激素

受到影响。 但是,在以CASODEX为单一药物治疗前列腺癌的临床试验中,已经注意到血清睾丸激素和雌二醇的升高。

在已经接受CASODEX和LHRH激动剂治疗并且由于进行性晚期前列腺癌而终止CASODEX治疗的部分患者中,可能会观察到前列腺特异性抗原(PSA)降低和/或临床改善(抗雄激素戒断现象)。

适应症和用途

•CASODEX 50mg是一种雄激素受体抑制剂,可与黄体生成素释放激素(LHRH)类似物联合治疗,用于治疗D2期转移性前列腺癌。

•CASODEX 150mg每天不被允许单独使用或与其他治疗一起使用。

剂量和给药

CASODEX疗法与LHRH类似物联合使用的推荐剂量为每天一次(早晨或晚上)一次50毫克片剂。

剂量形式和强度

50毫克片剂

禁忌症

•过敏症

•妇女。

•怀孕

警告和注意事项

•已观察到严重的肝损伤和致命的肝衰竭。在开始用CASODEX治疗之前,应在治疗的前四个月中定期监测血清转氨酶水平,此后应定期监测其症状或体征,提示肝功能异常。患有肝功能不全的住院患者请谨慎使用CASODEX。

•据报道,CASODEX 150 mg单药治疗期间,女性乳房发育和乳房疼痛。

•CASODEX与LHRH激动剂结合使用。

LHRH激动剂已显示可导致男性的葡萄糖耐量降低。应考虑监测接受CASODEX并结合LHRH激动剂的患者的血糖。

•建议监测前列腺特异性抗原(PSA)。如果PSA增加,则评估临床进展。

不良反应

接受CASODEX加LHRH-A的患者中有10%以上发生不良反应:潮热,疼痛(包括全身,背部,骨盆和腹部),乏力,便秘,感染,恶心,周围水肿,呼吸困难,腹泻,血尿,夜尿和贫血。

药物相互作用

•R-比卡鲁胺是CYP 3A4的抑制剂;因此,当CASODEX与CYP 3A4底物并用时应谨慎。

•对于已经接受从CASODEX开始使用的香豆素抗凝剂的患者,应严密监测凝血酶原时间。

在特定人群中的使用

•小儿患者:尚未证明该疗法可治疗家族性男性有限性早熟(睾丸中毒)。

包装供应/存储和处理方式

白色薄膜衣片(一侧标识为“ CDX50”,反面标识为“ CASODEX徽标”)以每箱30片的单位剂量起泡剂提供。

英文版说明书

GENERIC NAME: BICALUTAMIDE – ORALBRAND NAME(S): CasodexUSES:Bicalutamide is used to treat prostate cancer that has spread to other areas of the body. It is used in combination with hormone treatment. This medication works by blocking the action of male hormones in the prostate, slowing growth of the tumors.This medication should not be used in women or children.HOW TO USE:Take this medication by mouth, usually once a day in the morning or evening, with or without food, or as directed by your doctor.Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. The dosage is based on your medical condition and response to therapy.Do not increase your dose or take this medication more often without your doctor’s approval. Your condition will not improve any faster, and the risk of serious side effects may be increased.Since this drug can be absorbed through the skin, women who are pregnant or who may become pregnant should not handle this medication.SIDE EFFECTS:Flushing and sweating (hot flashes), body aches and pains, breast swelling/tenderness/pain, headache, dizziness, drowsiness, trouble sleeping, weakness, hair loss, weight changes, constipation, diarrhea, stomach upset, gas, nausea, vomiting, and loss of appetite may occur.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects.Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: decreased sexual ability/desire, vision changes, numbness/tingling of the hands or feet, swelling of the arms/legs, unusual or easy bleeding/bruising, change in the amount of urine, painful urination, signs of infection (e.g., fever, chills, persistent sore throat), trouble breathing, persistent cough, mental/mood changes (e.g., anxiety, depression).Seek immediate medical attention if any of these very serious side effects occur: chest pain, jaw/left arm pain.Rarely, bicalutamide may cause growth of other types of tumors. Consult your doctor immediately if new lumps or growths occur.This medication may rarely cause serious (possibly fatal) liver disease. Seek immediate medical attention if any of these side effects occur: dark urine, yellowing of the eyes/skin, unusual tiredness, severe stomach/abdominal pain, persistent nausea/vomiting.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs.Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects.If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health

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