博纳吐单抗冻干粉注射剂Blincyto Injection 35mcg(Blinatumomab)

药店国别:

产地国家:美国

处方药:

所属类别: 35微克/瓶

包装规格: 35微克/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:AMGEN USA, INC

原产地英文商品名:BLINCYTO 35MCG LYO PWD SDV 1/EA

原产地英文药品名:Blinatumomab

中文参考商品译名:BLINCYTO注射剂 35微克/瓶

中文参考药品译名:博纳吐单抗

曾用名:

简介:近日,BiTE免疫疗法Blincyto(blinatumomab)获欧美批准上市,用于费城染色体阴性(Ph-)复发性或难治性前体B细胞急性淋巴细胞白血病(ALL)成人患者的治疗。此次批准,使 Blincyto成为欧洲批准的首个双特异性T细胞衔接器(BiTE)抗体药物。Blincyto(blinatumomab)是全球首个BiTE免疫疗法,基于安进最先进的双特异性T细胞衔接系统(BiTE)开发,这是一种双特异性抗体,能够通过将肿瘤细胞上的CD19蛋白呈递给T细胞特异表达的CD3蛋白,进而激活免疫系统识别并杀灭肿瘤细胞。批准日期:2014年3月12日;公司:Amgen Inc.BLINCYTO(blinatumomab)注射用,为静脉使用在美国初次批准:2014

作用机制

Blinatumomab是一个双特异性指向CD19 CD3 T-细胞衔接器结合至B-系来源细胞表面上表达的CD19和在T细胞的表面上表达CD3。通过在T-细胞受体(TCR)复合物上CD3与良性和恶性B细胞上CD19连接激活内源性T细胞。Blinatumomab介导T细胞和肿瘤细胞间突触的形成,细胞粘附分子的上调,细胞溶解蛋白的生产,炎性细胞因子的释放,和T细胞的增殖,导致CD19+细胞重新定向溶解。

适应证和用途

BLINCYTO是一种圣特异性指向CD19 CD3 T-细胞衔接器适用为费城染色体-阴性复发性或难治性B-细胞前体急性淋巴母细胞白血病(ALL)的治疗。这个适应证是在加速批准下被批准的。继续批准这个适应证可能取决于在随后试验中临床获益的确证。

剂量和给药方法

⑴ 剂量–建议对第一个疗程的头9天和第二个疗程的头2天住院。⒈治疗的单个疗程由连续静脉输注4周接着自由间隔2周治疗组成。⒉ 对体重至少45 kg患者,在疗程1中,在第1–7天给予BLINCYTO在9g/day和在第8–28天28g/day。对随后疗程,在第1–28天给予BLINCYTO在28 ?g/day。

⑵ 给药⒈在每个疗程BLINCYTO的首次剂量前1小时,前一步剂量前(例如疗程1第8天),或一次4或更多小时的中断后重新开始输注,静脉用地塞米松[dexamethasone]20 mg预先给药。⒉利用一个输注泵在恒速连续静脉输注给予。⒊静脉IV袋应被历时24小时或48小时输注。⒋BLINCYTO应通过一个专门的管腔输注。

⑶ 制备 – 提供静脉溶液稳定剂和加入重建的BLINCYTO前用于涂层预充液IV袋。⒈只用注射用无菌注射用水,USP重建BLINCYTO。⒉当制备为输注溶液时必须严格无菌术观察因为BLINCYTO不含抗微生物防腐剂。⒊ 使用在混合指导中描述的专门容积。剂型和规格注射用:为重建35 ?g冻干粉在一次性使用小瓶中。禁忌证对blinatumomab或对产品剂型的任何组分已知超敏性。

警告和注意事项

⑴感染:监视患者体征或症状并适当地治疗。

⑵ 对驾驶和使用机械能力的影响:忠告患者避免驾驶和当正在给予BLINCYTO时从事危险性职业或活动例如操作重型或潜在危险机械。制备和给药错误:严格遵循为制备(包括混合)和给药指导。

不良反应

最常见不良反应(≥ 20%)为发热,头痛,周边水肿,发热性中性粒细胞减少,恶心,低钾血症,颤抖,皮疹,和便秘。

特殊人群中使用

在儿童患者中经验有限。

博纳吐单抗冻干粉注射剂英文版说明书

Immunotherapy for the Treatment of Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic LeukemiaInformation contained on this page is provided by an independent third-party content provider. WorldNow and this Station make no warranties or representations in connection therewith. If you have any questions or comments about this page please contact pressreleases@worldnow.com.SOURCE AmgenBLINCYTO is the First-and-Only Bispecific CD19-Directed CD3 T-Cell Engager (BiTE®) Immunotherapy to be Approved by the FDABLINCYTO (Blinatumomab) for Injection Will be Available as a 35 mcg Single use VialTHOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Dec. 3, 2014 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of BLINCYTO™ (blinatumomab) for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials. With this approval, BLINCYTO becomes the first FDA-approved bispecific CD19-directed CD3 T-cell engager (BiTE®) antibody construct product, and the first single-agent immunotherapy to be approved for the treatment of patients with Ph- relapsed or refractory B-cell precursor ALL, a rare and rapidly progressing cancer of the blood and bone marrow.1-3″The FDA’s breakthrough therapy designation and accelerated approval of BLINCYTO underscores the critical need for new treatment options for patients with relapsed or refractory B-cell precursor ALL, who are often young adults,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “BLINCYTO is the first clinical and regulatory validation of the BiTE® platform, a new and innovative approach that helps the body’s own immune system fight cancer.”The BLINCYTO approval is based on results of Amgen’s ‘211 trial, a Phase 2, multicenter, single-arm open-label study. Eligible patients were > 18 years of age with Ph- relapsed or refractory B-cell precursor ALL. Relapsed or refractory was defined as relapsed with first remission duration of < 12 months in the first salvage, or relapsed or refractory after first salvage therapy, or relapsed within 12 months of allogeneic hematopoietic stem cell transplantation (HSCT), and had > 10 percent blasts in bone marrow. Of the 185 patients eva luated in the trial, 41.6 percent (77/185; 95 percent CI: 34.4-49.1) achieved complete remission or complete remission with partial hematologic recovery (CR/CRh*) within two cycles of treatment with BLINCYTO, which was the primary endpoint of the study. The majority of responses (81 percent [62/77]) occurred within the first cycle of treatment. Among patients who achieved CR/CRh*, 39 percent (30/77) went on to HSCT, and 75.3 percent (58/77 95 percent CI: 64.2-84.4) achieved minimal residual disease (MRD) response, a measure of eradication of residual disease at the molecular level.”The approval of BLINCYTO represents a significant milestone in immunotherapy research, providing clinicians the opportunity to offer a new single-agent therapy to patients fighting this highly aggressive cancer with previously limited options,” said Anthony S. Stein, M.D., clinical professor, Hematology/Oncology at City of Hope.BLINCYTO has a BOXED WARNING in its product label regarding Cytokine Release Syndrome (CRS) and Neurological Toxicities.Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinune BLINCYTO as recommended. Neurological toxicities, which may be severe, life-threatening, or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended.BLINCYTO is contraindicated to patients with known hypersensitivity to blinatumomab or to any component of the product formulation.Monitor patients for signs and symptoms of infection and treat appropriately.Advise patients to refrain from driving and engaging in hazardous occupations or activities such as driving, operating heavy or potentially dangerous machinery while BLINCYTO is being administered.It is important to strictly follow instructions for preparation (including admixing) and administration to prevent overdose and underdose.The most common adverse reactions (= 20 percent) were pyrexia (62 percent), headache (36 percent), peripheral edema (25 percent), febrile neutropenia (25 percent), nausea (25 percent), hypokalaemia (23 percent), rash (21 percent), tremor (20 percent) and constipation (20 percent). Serious adverse reactions were reported in 65 percent of patients. The most common serious adverse reactions (= 2 percent) included febrile neutropenia, pyrexia, pneumonia, sepsis, neutropenia, device-related infection, tremor, encephalopathy, infection, overdose, confusion, Staphylococcal bacteremia and headache.The FDA has also approved a risk eva luation and mitigation strategy (REMS) for BLINCYTO. The purpose of the BLINCYTO REMS is to inform healthcare providers of the serious risks of CRS, neurological toxicities, and preparation and administration errors. Additional information about the BLINCYTO REMS program can be found at http://www.BLINCYTOREMS.com.Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436) regarding BLINCYTO availability.Amgen and its subsidiary Onyx Pharmaceuticals, Inc., which will commercialize BLINCYTO in the U.S., have announced the availability of Onyx Pharmaceuticals 360™ (Onyx 360), to patients receiving BLINCYTO in the U.S. Onyx 360 is a comprehensive patient and caregiver support and services program designed to help patients navigate the treatment journey, including reimbursement and payment support, treatment support and referrals to third-party organizations for day-to-day needs and emotional support. Dedicated Oncology Nurse Advocates are available Monday through Friday from 9 a.m. to 8 p.m. Eastern Standard Time at 1-855-ONYX-360 (1-855-669-9360) to assist patients, caregivers and healthcare providers.Patients diagnosed with adult ALL are often young adults, with a median age at diagnosis of 34-39.4 In adult patients with relapsed or refractory ALL, median overall survival is just three to five months.5About BLINCYTO™ (blinatumomab)BLINCYTO is the first BiTE® antibody construct and the first single-agent immunotherapy to be approved by the U.S. Food and Drug Administration (FDA).3 BLINCYTO was granted breakthrough therapy and priority review designations by the FDA, and is now approved in the U.S. for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).About BiTE® TechnologyBispecific T cell engager (BiTE®) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE® antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers. For more information, visit www.biteantibodies.com.Important U.S. Product InformationBLINCYTO is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.IMPORTANT SAFETY INFORMATIONWARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES•Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO™. Interrupt or discontinue BLINCYTO™ as recommended.•Neurological toxicities, which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO™. Interrupt or discontinue BLINCYTO™ as recommended.ContraindicationsBLINCYTO™ is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.Warnings and Precautions•Cytokine Release Syndrome (CRS): Life-threatening or fatal CRS occurred in patients receiving BLINCYTO™. Infusion reactions have occurred and may be clinically indistinguishable from manifestations of CRS. Closely monitor patients for signs and symptoms of serious events such as pyrexia, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), disseminated intravascular coagulation (DIC), capillary leak syndrome (CLS), and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Interrupt or discontinue BLINCYTO™ as outlined in the Prescribing Information (PI).•Neurological Toxicities: Approximately 50% of patients receiving BLINCYTO™ in clinical trials experienced neurological toxicities. Severe, life-threatening, or fatal neurological toxicities occurred in approximately 15% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. The median time to onset of any neurological toxicity was 7 days. Monitor patients for signs or symptoms and interrupt or discontinue BLINCYTO™ as outlined in the PI.•Infections: Approximately 25% of patients receiving BLINCYTO™ experienced serious infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment. Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO™ as needed.•Tumor Lysis Syndrome (TLS): Life-threatening or fatal TLS has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on treatment hydration, should be used during BLINCYTO™ treatment. Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO™ as needed to manage these events.•Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate laboratory parameters during BLINCYTO™ infusion and interrupt BLINCYTO™ if prolonged neutropenia occurs.•Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures, patients receiving BLINCYTO™ are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO™ is being administered.•Elevated Liver Enzymes: Transient elevations in liver enzymes are associated with BLINCYTO™ treatment. The majority of these events were observed in the setting of CRS. The median time to onset was 15 days. Grade 3 or greater elevations in liver enzymes occurred in 6% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase (GGT), and TBILI prior to the start of and during BLINCYTO™ treatment. BLINCYTO™ treatment should be interrupted if transaminases rise to > 5 times the upper limit of normal (ULN) or if TBILI rises to > 3 times ULN.•Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO™, especially in patients previously treated with cranial irradiation and anti-leukemic chemotherapy.•Preparation and administration errors have occurred. Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose).Adverse Events•The most commonly reported adverse reactions (= 20%) in clinical trials were pyrexia (62%), headache (36%), peripheral edema (26%), febrile neutropenia (26%), nausea (25%), hypokalemia (23%), rash (21%), tremor (20%) and constipation (20%).Dosage and Administration Guidelines•BLINCYTO™ is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm.•It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).Please see full Prescribing Information and medication guide for BLINCYTO at www.BLINCYTO.com.About AmgenAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be the world’s largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.About Onyx Pharmaceuticals, Inc.Based in South San Francisco, California, Onyx Pharmaceuticals, Inc., an Amgen subsidiary, is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company’s website at www.onyx.com. Onyx Pharmaceuticals is on Twitter. Sign up to follow our Twitter feed @OnyxPharm at http://twitter.com/OnyxPharm.Forward-Looking StatementsThis news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen, we or us) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen Inc., including Amgen Inc.’s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Dec. 3, 2014, and expressly disclaims any duty to update information contained in this news release.No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us and our partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.In addition, sales of our products (including products of our wholly-owned subsidiaries) are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we and our partners routinely obtain patents for our and their products and technology, the protection of our products offered by patents and patent applications may be challenged, invalidated or circumvented by our or our partners’ competitors and there can be no guarantee of our or our partners’ ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to integrate the operations of companies we have acquired may not be successful. Cost savings initiatives may result in us incurring impairment or other related charges on our assets. We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings from our recently announced restructuring plans. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase common stock.

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