纳武单抗,纳武单抗注射溶液nivolumab(Opdivo solution infusion)

药店国别:

产地国家:德国

处方药:

所属类别: 10毫升(10毫克/1毫升)/瓶

包装规格: 10毫升(10毫克/1毫升)/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Bristol-Myers Squibb

原产地英文商品名:Opdivo solution for infusion 10ml(10mg/1ml)/VIAL

原产地英文药品名:nivolumab

中文参考商品译名:Opdivo注射液 10毫升(10毫克/1毫升)/瓶

中文参考药品译名:纳武单抗

曾用名:

简介

抗癌免疫疗法PD-1抑制剂Opdivo(nivolumab获欧洲药品管理局(EMA)批准治疗晚期黑色素瘤和转移鳞状非小细胞肺癌

上市批准日期: 2014年12月22日;

公司:施贵宝公司OPDIVO(nivolumab)注射液,供静脉使用

初次批准:2014

最近重大改变:(红色是新版)

适应证和用途: 3/2015

警告和注意事项: 3/2015

适应证和用途

OPDIVO是一个人程序死亡受体-1(PD-1)适用为阻断抗体治疗有以下患者:

⑴有不能切除货转移黑色素瘤和易普利姆玛[ipilimumab]和,如BRAF V600突变阳性,一种BRAF抑制剂后疾病进展患者的治疗。这个适应症是根据肿瘤反应率和反应的持久性加速批准下被批准。

对这个适应证的继续批准可能取决于验证和在验证试验中临床获益的描述。

⑵用基于铂化疗或后有进展的转移鳞状非小细胞肺癌。

剂量和给药方法

每2周历时60分钟静脉输注给予3mg/kg。

剂型和规格注射液:40 mg/4mL和100mg/10 mL溶液在一次性小瓶中。

禁忌证:无。

警告和注意事项

免疫介导不良反应:根据反应严重程度给予糖皮质激素。

⑴ 免疫介导肺炎:对中度不给和对严重或危及生命肺炎永久终止。

⑵ 免疫介导结肠炎:不给对中度或严重和对危及生命结肠炎永久终止。

⑶ 免疫介导肝炎:监视对肝功能中变化。对中度不给和对严重或危及生命转氨酶或总胆红素升高永久终止。

⑷ 免疫介导肾炎和肾功能不全:监视在肾功能中变化。对中度不给和对严重或危及生命血清肌酐升高永久终止。

⑸ 免疫介导甲状腺功能减退和甲状腺功能亢进:监视甲状腺功能变化。需要时开始甲状腺激素替代。

⑹ 胚胎胎儿毒性:可能致胎儿危害。忠告对胎儿潜在风险和使用有效避孕。

不良反应

有黑色素瘤患者中最常见不良反应(≥20%)是皮疹。在有晚期鳞状非小细胞肺癌患者中最常见不良反应(≥20%)是疲乏,呼吸困难,肌肉骨骼痛,食欲减退,咳嗽,恶心,和便秘。

在特殊人群中使用⑴ 哺乳:终止哺乳。

英文版说明

OPDIVO (nivolumab) injection, for intravenous useInitial U.S. Approval: 2014Indication and Important Safety Information for OPDIVO® (nivolumab)INDICATIONOPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.IMPORTANT SAFETY INFORMATIONImmune-Mediated Pneumonitis•Severe pneumonitis or interstitial lung disease, including fatal cases, occurred with OPDIVO treatment. Across the clinical trial experience in 691 patients with solid tumors, fatal immune-mediated pneumonitis occurred in 0.7% (5/691) of patients receiving OPDIVO; no cases occurred in Trial 3. In Trial 3, immune-mediated pneumonitis occurred in 6% (7/117) of patients receiving OPDIVO including five Grade 3 and two Grade 2 cases. Monitor patients for signs and symptoms of pneumonitis. Administer corticosteroids for Grade 2 or greater pneumonitis. Permanently discontinue OPDIVO for Grade 3 or 4 and withhold OPDIVO until resolution for Grade 2.Immune-Mediated Colitis•In Trial 3, diarrhea occurred in 21% (24/117) of patients receiving OPDIVO. Grade 3 immune-mediated colitis occurred in 0.9% (1/117) of patients. Monitor patients for immune-mediated colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO for Grade 2 or 3. Permanently discontinue OPDIVO for Grade 4 colitis or recurrent colitis upon restarting OPDIVO.Immune-Mediated Hepatitis•In Trial 3, the incidences of increased liver test values were AST (16%), alkaline phosphatase (14%), ALT (12%), and total bilirubin (2.7%). Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4 immune-mediated hepatitis.Immune-Mediated Nephritis and Renal Dysfunction•In Trial 3, the incidence of elevated creatinine was 22%. Immune-mediated renal dysfunction (Grade 2) occurred in 0.9% (1/117) of patients. Monitor patients for elevated serum creatinine prior to and periodically during treatment. For Grade 2 or 3 serum creatinine elevation, withhold OPDIVO and administer corticosteroids; if worsening or no improvement occurs, permanently discontinue OPDIVO. Administer corticosteroids for Grade 4 serum creatinine elevation and permanently discontinue OPDIVO.Immune-Mediated Hypothyroidism and Hyperthyroidism•In Trial 3, hypothyroidism occurred in 4.3% (5/117) of patients receiving OPDIVO. Hyperthyroidism occurred in 1.7% (2/117) of patients including one Grade 2 case. Monitor thyroid function prior to and periodically during treatment. Administer hormone replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism.Other Immune-Mediated Adverse Reactions•The following clinically significant immune-mediated adverse reactions occurred in <2% of OPDIVO-treated patients: adrenal insufficiency, uveitis, pancreatitis, facial and abducens nerve paresis, demyeliniation, autoimmune neuropathy, motor dysfunction and vasculitis. Across clinical trials of OPDIVO administered at doses 3 mg/kg and 10 mg/kg, additional clinically significant, immune-mediated adverse reactions were identified: hypophysitis, diabetic ketoacidosis, hypopituitarism, Guillain-Barré syndrome, and myasthenic syndrome. Based on the severity of adverse reaction, withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone- replacement therapy.Embryofetal Toxicity•Based on its mechanism of action, OPDIVO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and for at least 5 months after the last dose of OPDIVO.Lactation•It is not known whether OPDIVO is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from OPDIVO, advise women to discontinue breastfeeding during treatment.Serious Adverse Reactions•In Trial 3, serious adverse reactions occurred in 59% of patients receiving OPDIVO. The most frequent serious adverse drug reactions reported in ≥2% of patients were dyspnea, pneumonia, chronic obstructive pulmonary disease exacerbation, pneumonitis, hypercalcemia, pleural effusion, hemoptysis, and pain.Common Adverse Reactions•The most common adverse reactions (≥20%) reported with OPDIVO in Trial 3 were fatigue (50%), dyspnea (38%), musculoskeletal pain (36%), decreased appetite (35%), cough (32%), nausea (29%), and constipation (24%).http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394

 

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