近日，美国FDA批准其新药ILUMYA™（tildrakizumab-asmn）上市，治疗适合接受全身治疗或光疗的中度至重度斑块型银屑病成人患者。
银屑病是皮肤上出现的慢性免疫性疾病。它是一种非传染性疾病，可加速皮肤细胞的生长周期，并导致皮肤出现厚厚的鳞屑区域。最常见的银屑病形式为斑块型银屑病，影响了大约80%至90%的银屑病患者。斑块型银屑病通常表现为红色、凸起的皮肤区域覆盖有片状白色鳞片，可能会发痒、疼痛，并可能导致裂开和流血。许多患者需要持续生活在这种疾病带来的痛苦中，他们急需有效的治疗来缓解疾病，提高生活质量。
ILUMYA正是这样一款疗法。它可以选择性结合IL-23的p19亚基，并抑制其与IL-23受体作用，从而抑制促炎细胞因子和趋化因子的释放。在完成初始剂量的第0周和第4周，ILUMYA每12周通过皮下注射以100 mg的剂量施用。ILUMYA不适合对tildrakizumab严重过敏的患者。
批准日期：2018年3月22日 公司：Sun Pharma
ILUMYA™(tildrakizumab-asmn)注射液，为皮下使用
美国初次批准：2018
作用机制
Tildrakizumab是一种人源化IgG1/k单克隆抗体选择性地结合至IL-23的p19亚单位和抑制它与IL-23受体的相互作用。IL-23是一种天然存在的细胞因子涉及在炎症和免疫反应。Tildrakizumab抑制促炎性细胞因子和趋化因子的释放。
适应证和用途
ILUMYA是一种白介素-23拮抗剂适用为成年有中度-至-严重斑块银屑病患者对全身治疗或光治疗为被选者的治疗。
剂量和给药方法
● 通过皮下注射给药。
● 推荐剂量为100mg在周 0，4，和每12周其后.
剂型和规格
注射液：100mg/mL 溶液在一个单-剂量预装注射器.
禁忌证
严重的超敏性反应对tildrakizumab或对赋形剂的任何。
警告和注意事项
● 超敏性：如发生一种严重的过敏反应，终止ILUMYA立即地和开始适当治疗。
● 感染：ILUMYA可能增加 的风险感染. 指导患者寻求医学建议为临床上重要慢性或急性感染体征或症状的发生。如一个严重的感染发生考虑终止ILUMYA直至感染解决。
● 结核(TB)：
治疗开始前评价TB.
不良反应
伴随ILUMYA治疗最常见(≥ 1%)不良反应为上呼吸道感染，注射部位反应，和腹泻。
药物相互作用
活疫苗：避免使用活疫苗在用ILUMYA治疗患者中。
包装供应/贮存和处置
供应
ILUMYA(tildrakizumab-asmn)注射液是一种无菌，无防腐剂，透明至略微不透明，无色至略微黄色溶液。ILUMYA是供应如单-剂量预装注射器每纸盒输送1mL的100mg/mL溶液。
● NDC 0006-4241-00
每个预装注射器装备有一个护装置和一个针盖。
贮存和处置
冰箱贮存在2°C至8°C(36°F至46°F)在原始纸盒避光保护直至使用。不同冻结。不要摇晃。 ILUMYA可被保持在室温在 25°C(77°F)共至30天在原始纸盒避光保护。一旦贮存在室温，不要放回冰箱。.
如在30天内不使用，遗弃ILUMYA。不要贮存ILUMYA在25°C(77°F)以上。
ILUMYA™ (tildrakizumab-asmn) injection, for subcutaneous use
Initial U.S. Approval: 2018
Ilumya Now Available for the Treatment of Plaque Psoriasis
Ilumya (tildrakizumab-asmn) has been made available by Sun Pharma for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Ilumya, an interleukin-23 antagonist, acts by selectively binding to the p19 subunit of IL-23 and inhibiting its interaction with the IL-23 receptor, blocking the release of pro-inflammatory cytokines and chemokines.
“Ilumya offers a new, safe and effective treatment option for people who are still struggling to manage their moderate-to-severe plaque psoriasis,” said Abhay Gandhi, Chief Executive Officer, Sun Pharma, North America. “We understand the importance of patient and physician choice, and are committed to making Ilumya among the most cost-effective treatments on the market today.” Analyses presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2018 meeting showed that compared with non-targeted treatments like apremilast, Ilumya was found to be the most cost-effective; results also demonstrated that Ilumya was more cost-effective than other biologic therapies indicated for plaque psoriasis.
Ilumya is supplied as a 100mg/mL strength solution for subcutaneous injection in single-dose prefilled syringes. Treatment should only be administered by a healthcare provider. Prior to initiating therapy, patients should be eva luated for tuberculosis infection. The most common adverse reactions associated with Ilumya include upper respiratory infections, injection site reactions, and diarrhea.
https://www.ilumya.com/pdfs/Sun_Pharma_ILUMYA_US_Prescribing_Information.pdf