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--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201162218473514.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文FUSILEV处方资料(仅供参考)
FUSILEV (levoleucovorin)注射剂用于转移性结直肠癌新药 Levoleucovorin注射剂。该药用于使用高剂量甲氨蝶呤治疗之后的骨肉瘤患者的药物治疗,可以减少高剂量甲氨蝶呤和过量叶酸拮抗剂类药物的毒性,增强这些药物的疗效。该药是唯一获FDA批准销售的含甲酰四氢叶酸异构体[Levoleucovorin或(6S)-leucovorin]药品, 向美国FDA提交新药上市申请(NDA)补件,以注射剂FUSILEV合并5-FU containing regimens,治疗恶性直肠大肠癌病患。 FDA已批准其Levoleucovorin注射剂。骨肉瘤患者用高剂量甲氨蝶呤之后进而用这种药物进行治疗,可以减少高剂量甲氨蝶呤和过量叶酸拮抗剂类药物的毒性,增强这些药物的疗效。Levoleucovorin是Spectrum制药公司近日宣布,FDA已批准其Levoleucovorin注射剂。骨肉瘤患者用高剂量甲氨蝶呤之后进而用这种药物进行治疗,可以减少高剂量甲氨蝶呤和过量叶酸拮抗剂类药物的毒性,增强这些药物的疗效。Levoleucovorin是唯一获准销售的含甲酰四氢叶酸异构体(Levoleucovorin或(6S)-leucovorin)药品,它有望于今年6月份上市。 Spectrum公司负责人称,Levoleucovorin是2008年通过FDA批准的第一种癌症治疗药。这给患者带来了一种全新的选择,有了这种药物,正在接受化疗的患者无需再使用非活性右旋异构体药物进行治疗。前临床实验结果显示,若同时使用非活性异构体药物和活性异构体药物,则两者在进入细胞过程中会互相竞争。 Levoleucovorin:骨肉瘤治疗药物 Spectrum制药公司近日宣布,美国FDA批准了该公司的Levoleucovorin注射剂上市销售。该药用于使用高剂量甲氨蝶呤治疗之后的骨肉瘤患者的药物治疗,可以减少高剂量甲氨蝶呤和过量叶酸拮抗剂类药物的毒性,增强这些药物的疗效。该药是唯一获FDA批准销售的含甲酰四氢叶酸异构体[Levoleucovorin或(6S)-leucovorin]药品,该公司希望可以在今年6月份完成该药的上市工作。 Levoleucovorin不能用于之前有对叶酸或者甲酰四氢叶酸过敏经历的患者。由于该药含钙,因此在静脉注射时,每分钟不能超过16mL(160 mg)。该药会增加氟脲嘧啶的毒性。在安慰剂对照试验中发现,甲酰四氢叶酸和甲氧苄氨嘧啶-磺胺甲异噁唑同时用于HIV患者中卡氏肺囊虫肺炎的治疗时,可能会增加治疗的失败率。在接受该药注射的患者中有过敏反应发生。在高剂量甲氨蝶呤治疗之后注射该药的患者报告有呕吐(38%)、口腔炎(38%)和恶心(19%)发生。注射该药可能会抵消镇静安眠剂、苯妥英和扑米酮的抗癫痫作用,有癫痫史或存在癫痫风险的患者需要注意。
INDICATIONS AND USAGE FUSILEV is a folate analog indicated for: • Rescue after high-dose methotrexate therapy in osteosarcoma. • Diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. • Use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.
LIMITATIONS OF USE FUSILEV is not approved for pernicious anemia and megaloblastic anemias. Improper use may cause a hematologic remission while neurologic manifestations continue to progress.
IMPORTANT SAFETY INFORMATION Contraindications • FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid.
Warnings and Precautions • Due to Ca++ content, no more than 16 mL (160 mg) of levoleucovorin solution should be injected intravenously per minute • FUSILEV enhances the toxicity of fluorouracil. • Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in HIV patients
was associated with increased rates of treatment failure in a placebo-controlled study.
Adverse Reactions Allergic reactions were reported in patients receiving FUSILEV. Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy. The most common adverse reactions (>50%) in patients with advanced colorectal cancer receiving Fusilev in combination with 5-FU were diarrhea, nausea and stomatitis.
Drug Interactions FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.
Reporting of Suspected Adverse Reactions You are encouraged to report side effects of prescription drugs to the FDA.
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