ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

• Peripheral neuropathy (PN): ADCETRIS causes PN that is predominantly sensory. Cases of motor PN have also been reported. ADCETRIS-induced PN is cumulative. Monitor for symptoms such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Institute dose modifications accordingly.
• Anaphylaxis and infusion reactions: 注射相关反应(IRR)，包括过敏反应，已发生与ADCETRIS. Monitor patients during infusion. 如果发生IRR，中断输液并采取适当的医疗管理. If anaphylaxis occurs, 立即永久停止输液并给予适当的药物治疗. Premedicate patients with a prior IRR before subsequent infusions. 前用药可能包括扑热息痛，抗组胺药和皮质类固醇.
• Hematologic toxicities: 使用ADCETRIS可导致致命和严重的发热性中性粒细胞减少症. ADCETRIS可发生长时间(≥1周)严重的中性粒细胞减少和3或4级血小板减少或贫血. 对既往未治疗的III/IV期cHL或PTCL患者，在接受ADCETRIS联合化疗的同时，从第1周期开始给予G-CSF一级预防. Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.
• Serious infections and opportunistic infections: Infections such as pneumonia, bacteremia, 以及脓毒症或脓毒症休克(包括致命结局)在adcetris治疗的患者中已经有报道. 在治疗细菌、真菌或病毒感染期间密切监测患者.
• Tumor lysis syndrome: 密切监测肿瘤快速增殖、肿瘤负担高的患者.
• Increased toxicity in the presence of severe renal impairment: 严重肾功能损害患者发生≥3级不良反应和死亡的频率高于肾功能正常患者. Avoid use in patients with severe renal impairment.
• 中度或重度肝损伤时毒性增加: 与肝功能正常的患者相比，中、重度肝损害患者发生≥3级不良反应和死亡的频率更高. Avoid use in patients with moderate or severe hepatic impairment.
• Hepatotoxicity: Fatal and serious cases have occurred in ADCETRIS-treated patients. Cases were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after the first ADCETRIS dose or rechallenge. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Monitor liver enzymes and bilirubin. Patients with new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of ADCETRIS.
• PML: 在adcetris治疗的患者中，有报告JC病毒感染导致PML的致命病例. 首次出现症状发生在ADCETRIS启动后的不同时间, with some cases occurring within 3 months of initial exposure. In addition to ADCETRIS therapy, 其他可能的致病因素包括以前的治疗方法和可能导致免疫抑制的潜在疾病. 在有新发中枢神经系统异常体征和症状的患者中考虑PML的诊断. 如果怀疑为PML，请持有ADCETRIS，如果确认为PML，请停止ADCETRIS.
• Pulmonary toxicity: Fatal and serious events of noninfectious pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome have been reported. 监测患者的体征和症状，包括咳嗽和呼吸困难. In the event of new or worsening pulmonary symptoms, 在评估期间保持ADCETRIS的剂量，直到症状改善.
• Serious dermatologic reactions: 使用ADCETRIS治疗Stevens-Johnson综合征(SJS)和中毒性表皮坏死松解症(TEN)的致命和严重病例已有报道. 如果发生SJS或TEN，停止ADCETRIS并给予适当的药物治疗.
• Gastrointestinal (GI) complications: Fatal and serious cases of acute pancreatitis have been reported. Other fatal and serious GI complications include perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus. 既往胃肠道受累的淋巴瘤可能增加穿孔的风险. In the event of new or worsening GI symptoms, including severe abdominal pain, perform a prompt diagnostic evaluation and treat appropriately.
• Hyperglycemia: Serious cases, such as new-onset hyperglycemia, exacerbation of pre-existing diabetes mellitus, 酮症酸中毒(包括致死性结局)均有报道. 高血糖多发生于高体重指数或糖尿病患者. Monitor serum glucose and if hyperglycemia develops, administer anti-hyperglycemic medications as clinically indicated.
• Embryo-fetal toxicity: 基于作用机制和动物实验，ADCETRIS可对胎儿造成危害. 告知女性生殖能力及对胎儿的潜在风险, 在ADCETRIS治疗期间和最后剂量ADCETRIS后至少6个月内避免怀孕. 

Most Common (≥20% in any study) Adverse Reactions

Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, and mucositis.

同时使用强CYP3A4抑制剂或诱导物有可能影响单甲基auristatin E (MMAE)的暴露.

中度或重度肝损害或严重肾功能损害:MMAE暴露和不良反应增加. Avoid use.

建议有生育潜力的女性性伴侣的男性在ADCETRIS治疗期间和最后剂量ADCETRIS后至少6个月使用有效避孕措施.

建议患者立即报告怀孕，并避免在接受ADCETRIS时母乳喂养.