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Erelzi(etanercept-szzs Injection)

2018-09-07 14:45:22 作者：新特药房来源：互联网浏览次数：0 文字大小：【大】【中】【小】

简介： 近日，由诺华（Novartis）旗下仿制药单元山德士（Sandoz）开发的依那西普生物类似药Erelzi（etanercept-szzs）美国食品和药物管理局（FDA）批准，该药是安进超级重磅产品Enbrel（etanercept，依那西普，一 ...

关键字：依那西普生物类似药 etanercept-szzs 商品名Erelzi 类风湿性关节炎、银屑病、强直性脊柱炎幼年特发性关节炎

近日，由诺华（Novartis）旗下仿制药单元山德士（Sandoz）开发的依那西普生物类似药Erelzi（etanercept-szzs）美国食品和药物管理局（FDA）批准，该药是安进超级重磅产品Enbrel（etanercept，依那西普，一种TNF抑制剂）的生物类似药，适应症与Enbrel相同，包括：类风湿性关节炎（RA）、斑块型银屑病（PsO）、银屑病关节炎（PsA）、强直性脊柱炎（AS）及幼年特发性关节炎（JIA）。
Erelzi是FDA批准的首个依那西普生物类似药，也是诺华山德士在美国市场继Zarxio（安进Neupogen[gilgrastim，非格司亭]的生物类似药）之后获批的第二款生物类似药，同时也是FDA批准的美国市场的第三款生物类似药。
批准日期：2016年9月1日 开发公司：山德士（Sandoz）
ERELZI（依那西普[etanercept-szzs]）注射液，用于皮下使用
美国最初批准：2016年
ERELZI（依那西普-szzs）与ENBREL®（依那西普）生物相似。
警告：
严重的感染和恶意
查看完整的盒装警告的完整处方信息。
严重的感染
导致住院或死亡的严重感染的风险增加，包括结核病（TB），细菌性败血症，侵入性真菌感染（表面细胞病）以及由其他机会病原体引起的感染。
如果患者在治疗期间出现严重感染或败血症，应停用ERELZI。
进行潜伏性结核病的检测;如果是阳性，在开始ERELZI之前开始治疗结核病。
在治疗期间监测所有患者的活动性结核病，即使是最初的潜伏性结核病检测结果为阴性。
恶性肿瘤的一些致命的淋巴瘤和其他恶性肿瘤已经报道用TNF阻滞剂治疗的儿童和青少年患者，包括依那西普产品。
作用机制
TNF是一种天然存在的细胞因子，参与正常的炎症和免疫反应。它在RA的炎症过程，多关节型JIA，AS和另一种适应症以及由此产生的关节病理学中起重要作用。在RA，JIA，AS和其他两种适应症患者的相关组织和体液中发现TNF水平升高。
TNF（TNFRs）的两种不同受体，55千道尔顿蛋白质（p55）和75千道尔顿蛋白质（p75），作为细胞表面和可溶形式的单体分子自然存在。
TNF的生物活性取决于与细胞表面TNFR的结合。
依那西普产品是可以结合TNF分子的p75TNF受体的二聚体可溶形式。依那西普产品抑制TNF-α和TNF-β（淋巴毒素α[LT-α]）与细胞表面TNFR的结合，使TNF在生物学上无活性。在体外研究中，没有检测到依那西普与TNF-α的大复合物，并且在存在或不存在补体的情况下，表达跨膜TNF（结合安非他酮产物）的细胞不被裂解。
适应症和用法
ERELZI是一种肿瘤坏死因子（TNF）阻滞剂，适用于治疗：类风湿性关节炎（RA）多发性幼年特发性关节炎（JIA）2岁或以上的患者。
强直性脊柱炎（AS）。
剂量和给药
ERELZI通过皮下注射给药。
成人RA：每周一次50mg，含有或不含甲氨蝶呤（MTX）。
AS：每周一次50毫克。
JIA（体重> 63 kg的患者）：每周0.8mg/kg，每周最多50mg。
剂量形式和强度
注射：25mg/0.5mL和50mg/mL溶液在单剂量预填充注射器中使用BDUltraSafeCassive®针头护套。
注射：50mg/mL单剂量预填充Sensoready®笔溶液。
禁忌症
败血症。
警告和注意事项
在活动性感染期间不要启动ERELZI。如果感染发展，如果感染严重，请仔细监测并停止ERELZI。
考虑对有侵袭性真菌风险的患者进行经验性抗真菌治疗在ERELZI上发生严重全身性疾病的感染（那些妓女或前往真菌病流行地区的人）。
可能发生脱髓鞘疾病，恶化或新发作。
在接受TNF阻断剂的患者中观察到淋巴瘤病例。
可能发生充血性心力衰竭，恶化或新发作。
如果出现全血细胞减少症或再生障碍性贫血的症状，建议患者立即就医，并考虑停止ERELZI。
监测先前感染乙型肝炎病毒的患者再次活化治疗期间和治疗后数月。如果发生重新激活，请考虑停止ERELZI并开始抗病毒治疗。
可能发生过敏反应或严重过敏反应。
如果出现狼疮样综合征或自身免疫性肝炎，请停止ERELZI。
不良反应
最常见的不良反应（发生率> 5％）：感染和注射现场反应。
要报告疑似不良反应，请致电1-800-525-8747联系Sandoz Inc.或致电1-800-FDA-1088或www.fda.gov/medwatch联系FDA
药物相互作用
活疫苗-不应该与ERELZI一起使用。阿那金拉增加了严重感染的风险。
阿巴西普增加严重不良事件（包括感染）的风险。
不推荐使用环磷酰胺-与ERELZI一起使用。
有关患者咨询信息和药物指南，请参阅17。生物仿制药是指基于数据批准生物制品证明它与FDA批准的生物制品高度相似，被称为参考产品，并且没有临床意义生物仿制药产品和参考产品之间的差异。
已经证明了ERELZI的生物相似性用于使用条件（例如，适应症，给药方案），强度，剂型和其完整处方信息中描述的管理路线。
包装提供/存储和处理
使用BD UltraSafe无源针头保护器给予一个50mg ERELZI预充式注射器一个ERELZI Sensoready Pen提供的剂量相当于两个25mg ERELZI预充式注射器配有BD UltraSafe无源针护罩。
ERELZI预充式注射器配有BD UltraSafe无源针护罩和ERELZI PrefilledSensoready笔
每个ERELZI（依那西普-szzs）注射单剂量预充式注射器配有BD UltraSafe被动针护罩和ERELZI单剂量预填充Sensoready笔包含清晰和无色至微黄色溶液，含有25mg/0.5mL或50mg/ mL依那西普-szzs带有27号1/2英寸针头的单剂量注射器。
ERELZI应在36°F至46°F（2°C至8°C）的温度下冷藏。不要使用ERELZI有效期限印在纸箱或桶标签上。不要摇晃将ERELZI存放在原装纸箱，以防光或物理损坏。
为方便起见，在室温下储存各个注射器或Sensoready笔在68°F至77°F（20°C至25°C）之间允许的最长单个周期为28天，具有防光和热源保护。一旦注射器或Sensoready笔被存储
在室温下，不应放回冰箱。如果28天内未使用在室温下，应丢弃注射器或Sensoready笔。不要存放ERELZI在极热或极冷。不要冻结。放在儿童接触不到的地方。
完整说明资料附件：http://erelzi.com/globalassets/erelzi2/erelzi-label-jan-2018.pdf
Erelzi (etanercept-szzs Injection)
Brand name: Erelzi
Generic name: etanercept-szzs
Dosage form: Injection
Company: Sandoz Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis
Erelzi (etanercept-szzs) is a tumor necrosis factor (TNF) blocker biosimilar to Enbrel indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
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INDICATIONS
ERELZI is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ERELZI can be initiated in combination with methotrexate (MTX) or used alone.
ERELZI is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older.
ERELZI is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).
IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS
Patients treated with etanercept products are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. ERELZI should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before ERELZI use and during therapy. Treatment for latent infection should be initiated prior to ERELZI use, 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness, and 3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with ERELZI should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ERELZI, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis prior to initiating therapy.
MALIGNANCIES
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including etanercept products.
In adult clinical trials of all TNF blockers, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA patients. The role of TNF blocker therapy in the development of malignancies is unknown.
Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in RA and other indications. The risk of leukemia may be higher in patients with RA (approximately 2-fold) than the general population.
Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ERELZI. Periodic skin examinations should be considered for all patients at increased risk for skin cancer.
Pediatric Patients
In patients who initiated therapy at ≤ 18 years of age, approximately half of the reported malignancies were lymphomas (Hodgkin's and non-Hodgkin's lymphoma). Other cases included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.
NEUROLOGIC REACTIONS
Treatment with TNF-blocking agents, including etanercept products, has been associated with rare (< 0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability, and with peripheral nervous system demyelinating disorders. Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with etanercept products therapy. Prescribers should exercise caution in considering the use of ERELZI in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.
CONGESTIVE HEART FAILURE
Cases of worsening congestive heart failure (CHF) and, rarely, new-onset cases have been reported in patients taking etanercept products. Caution should be used when using ERELZI in patients with CHF. These patients should be carefully monitored.
HEMATOLOGIC REACTIONS
Rare cases of pancytopenia, including aplastic anemia, some fatal, have been reported. The causal relationship to ERELZI therapy remains unclear. Exercise caution when considering ERELZI in patients who have a previous history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection. Consider discontinuing ERELZI if significant hematologic abnormalities are confirmed.
HEPATITIS B REACTIVATION
Reactivation of hepatitis B has been reported in patients who were previously infected with hepatitis B virus (HBV) and received concomitant TNF-blocking agents, including ERELZI. Most reports occurred in patients also taking immunosuppressive agents, which may contribute to hepatitis B reactivation. Exercise caution when considering ERELZI in these patients.
ALLERGIC REACTIONS
Allergic reactions associated with administration of ERELZI during clinical trials have been reported in < 2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of ERELZI should be discontinued immediately and appropriate therapy initiated.
IMMUNIZATIONS
Live vaccines should not be administered to patients on ERELZI. Pediatric patients, if possible, should be brought up to date with all immunizations prior to initiating ERELZI. In patients with exposure to varicella virus, temporarily discontinue ERELZI and consider prophylactic treatment with Varicella Zoster Immune Globulin.
AUTOIMMUNITY
Autoantibodies may develop with ERELZI and rarely lupus-like syndrome or autoimmune hepatitis may occur. These may resolve upon withdrawal of ERELZI. Stop ERELZI if lupus-like syndrome or autoimmune hepatitis develops.
WEGENER'S GRANULOMATOSIS PATIENTS
The use of ERELZI in patients with Wegener's granulomatosis receiving immunosuppressive agents (eg, cyclophosphamide) is not recommended.
MODERATE TO SEVERE ALCOHOLIC HEPATITIS
Based on a study of patients treated for alcoholic hepatitis, exercise caution when using ERELZI in patients with moderate to severe alcoholic hepatitis.
ADVERSE REACTIONS
The most commonly reported adverse reactions in RA clinical trials were injection site reaction and infection. In clinical trials of all other adult indications, adverse reactions were similar to those reported in RA clinical trials.
In general, the adverse reactions in pediatric patients were similar in frequency and type as those seen in adult patients. The types of infections reported in pediatric patients were generally mild and consistent with those commonly seen in the general pediatric population.
DRUG INTERACTIONS
The use of ERELZI in patients receiving concurrent cyclophosphamide therapy is not recommended. The risk of serious infection may increase with concomitant use of abatacept therapy. Concurrent therapy with ERELZI and anakinra is not recommended. Hypoglycemia has been reported following initiation of ERELZI therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.