TIVDAK caused changes in the corneal epithelium and conjunctiva resulting in changes in vision, 包括严重的视力丧失, 和角膜溃疡. Conduct an ophthalmic exam at baseline, 在每次剂量之前, 正如临床所示. Adhere to premedication and required eye care before, during, and after infusion. 保留TIVDAK直到改进和恢复, 减少剂量, 或永久停止, 根据严重程度.
眼部不良反应 occurred in 60% of patients with cervical cancer treated with TIVDAK across clinical trials. 最常见的是结膜不良反应(40%)。, 干眼病(29%), 角膜不良反应(21%), 和睑缘炎(8%). 3例发生3级眼部不良反应.其中严重溃疡性角膜炎3例.2%的病人. One patient experienced ulcerative keratitis with perforation requiring corneal transplantation. Cases of symblepharon were reported in patients with other tumor types treated with TIVDAK at the recommended dose.
204年innovaTV, 4% of patients experienced visual acuity changes to 20/50 or worse including 1% of patients who experienced a visual acuity change to 20/200. Of the patients who experienced decreased visual acuity to 20/50 or worse, 75%的解决, including the patient who experienced decreased visual acuity to 20/200.
Refer patients to an eye care provider for an ophthalmic exam including visual acuity and slit lamp exam at baseline, 在每次剂量之前, 正如临床所示. Adhere to premedication and required eye care to reduce the risk of ocular adverse reactions. Promptly refer patients to an eye care provider for any new or worsening ocular signs and symptoms. 保留剂量, 减少剂量, 或永久停止 TIVDAK based on the severity of the adverse reaction.
周围神经病变(PN) occurred in 42% of cervical cancer patients treated with TIVDAK across clinical trials; 8% of patients experienced Grade 3 PN. PN不良反应包括周围神经病变(20%), 周围感觉神经病变(11%), 周围感觉运动神经病(5%), 运动神经病变(3%), 肌肉无力(3%), 脱髓鞘性周围多发性神经病变(1%). One patient with another tumor type treated with TIVDAK at the recommended dose developed Guillain- Barre syndrome. 监测患者神经病变的体征和症状. 新的或恶化的PN, 保留, 剂量减少, 或永久停止 TIVDAK based on the severity of PN.
出血 occurred in 62% of cervical cancer patients treated with TIVDAK across clinical trials. The most common all grade hemorrhage adverse reactions were epistaxis (44%), 血尿(10%), 阴道出血(10%). 5%的患者发生3级出血.
肺炎: 严重的, 威胁生命的, or fatal 肺炎 can occur in patients treated with antibody-drug conjugates containing vedotin, 包括TIVDAK. Among patients with cervical cancer treated with TIVDAK across clinical trials, 2 patients (1.3%) experienced 肺炎, including 1 patient who had a fatal outcome.
Embyro-Fetal毒性: TIVDAK can cause fetal harm when administered to a pregnant woman. 告知病人对胎儿的潜在危险. Advise females of reproductive potential to use effective contraception during treatment with TIVDAK and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TIVDAK and for 4 months after the last dose.
强大的CYP3A4抑制剂: Concomitant use with strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E (MMAE) exposure, 哪些可能增加TIVDAK不良反应的风险. 密切监测患者的TIVDAK不良反应.
中度或重度肝损伤: MMAE暴露和不良反应增加. 避免使用.
哺乳期: Advise lactating women not to breastfeed during TIVDAK treatment and for at least 3 weeks after the last dose.