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Evenity injection subcutaneous 105mg/1.17mL(romosozumab-aqqg)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 105毫克/17毫升/支 2支/盒 
包装规格 105毫克/17毫升/支 2支/盒 
计价单位: 盒 
生产厂家中文参考译名:
安进公司
生产厂家英文名:
Amgen Inc.
该药品相关信息网址1:
https://www.drugs.com/history/evenity.html
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
Evenity injection subcutaneous 105mg/1.17mL/syringes 2syringes/box
原产地英文药品名:
romosozumab-aqqg
中文参考商品译名:
Evenity预装注射器 105毫克/17毫升/支 2支/盒
中文参考药品译名:
romosozumab-aqqg
曾用名:
简介:

 

EVENITY(romosozumab-aqqg)是第一个也是唯一一个具有双重效果的骨骼生成器,可以增加骨骼训练并减少骨质流失的新药。
近日,美国食品和药物管理局(FDA)批准EVENITY(romosozumab-aqqg)治疗骨质疏松症 绝经后妇女骨折风险高。EVENITY是骨形成的两个原因中的第一个也是唯一一个。EVENITY治疗的全部疗程是由医疗保健提供者每月服用12次.由于骨质疏松症是一种慢性疾病,因此应考虑使用抗再吸收剂继续治疗EVENITY治疗。
批准日期:2019年4月9日 公司:安进公司
EVENITY(romosozumab-aqqg)注射液,用于皮下使用
美国最初批准:2019年
警告:心肌病的潜在风险
梗塞,中风和心血管疾病死亡
查看完整的盒装警告的完整处方信息。
•EVENITY可能会增加心肌梗塞,中风和心血管死亡的风险。
•对于在前一年内患有心肌梗塞或卒中的患者,不应启动EVENITY。考虑其他心血管危险因素患者的益处是否超过其风险。
•如果患者在治疗期间出现心肌梗塞或中风,应停止使用EVENITY。
作用机制
EVENITY抑制骨质素的作用,硬化素是骨代谢的调节因子。EVENITY增加骨形成,并在较小程度上减少骨吸收。动物研究表明,thatromosozumab-aqqg通过成骨细胞成骨细胞活动刺激骨小梁和皮质骨表面的骨形成,导致骨生长和皮质骨质量以及骨结构和强度的改善[见非临床毒理学和临床研究]。
适应症和用法
硬化蛋白抑制剂适用于治疗骨折高风险的绝经后骨质疏松症,定义为骨质疏松性骨折史或多种骨折危险因素;黄金患者已经失败或对其他可用的骨质疏松症治疗不耐受。
使用限制:限制使用12个月剂量的使用时间。如果仍然需要骨质疏松症治疗,应考虑使用抗再吸收剂继续治疗。
剂量和用量
•需要两次单独的皮下注射才能使总剂量达到210mg。一个接一个地注射两个注射器。
•应由医疗保健提供者管理。
每月一次皮下注射210毫克,在腹部,大腿或上臂进行12次剂量。
•治疗期间充分补充钙和维生素D.
剂量形式和强度
注射:在一次性预装注射器中使用105mg/1.17mL溶液。全新的EVENITY需要两个一次性使用的预充式注射器。
禁忌症
•低钙血症。
•已知对EVENITY过敏。
警告和注意事项
•主要不良心脏事件(MACE):监测MI和中风的症状。
•过敏症:过敏反应,包括血管性水肿,多形性红斑,皮炎,皮疹和荨麻疹。如果发生临床显着的过敏反应,则停止使用。
低钙血症:在使用EVENITY治疗期间充分补充钙和维生素D.
•下颌骨坏死:监测症状。考虑基于利益风险评估的治疗。
•非典型股骨骨折:评估新的或不寻常的大腿,臀部或腹股沟疼痛,以排除不完全的股骨骨折。
不良反应
据报道,最常见的不良反应(≥5%)伴有关节痛和头痛。
用于特定人群
肾功能损害:严重肾功能不全或发生低钙血症风险较高的患者。监测血清钙,补充钙和维生素D.
包装如何提供/存储和处理
如何提供
EVENITY(romosozumab-aqqg)注射液是一种透明的乳白色,无色至浅黄色的皮下注射溶液,由一次性预装注射器提供。
每个一次性使用的预装注射器含有105毫克EVENITY,可输送体积为1.17毫升。Todeliver有一个全剂量,两剂105mg/1.17ml.EVENEN预充式注射器,一个接一个,总剂量为210mg。
•NDC 55513-880-02:两个105mg/1.17 mL一次性预充式注射器的纸箱。
预装注射器不是用天然橡胶胶乳制成的。
存储和处理
•在原始纸箱中将EVENITY冷却至2°C至8°C(36°F至46°F),以防止光线照射。
不要冻结。 别摇了。
•如果从冰箱中取出,可以将其保存在原始纸箱中最高25°C(77°F)的室温下,并且必须在30天内使用。如果在30天内未使用,请丢弃。
•请勿将EVENITY暴露在高于25°C(77°F)的温度下。
FDA Approves EVENITY(romosozumab-aqqg) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture
U.S. Food and Drug Administration (FDA) has approved EVENITY™ (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY is the first and only bone builder with a unique dual effect that both increases bone formation and to a lesser extent reduces bone resorption (or bone loss) to rapidly reduce the risk of fracture. A full course of EVENITY therapy is 12 monthly doses administered by a healthcare provider.2 Since osteoporosis is a chronic disease, continued therapy with an anti-resorptive agent should be considered once EVENITY therapy is completed.
About EVENITY™ (romosozumab-aqqg)
EVENITY is a bone-building humanized monoclonal antibody. It is designed to work by inhibiting the activity of sclerostin, which simultaneously results in increased bone formation and to a lesser extent decreased bone resorption. The EVENITY development program includes 19 clinical studies that enrolled more than 14,000 patients. EVENITY has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program that included two large fracture trials comparing EVENITY to either placebo or active comparator in nearly 12,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing EVENITY.
About the Pivotal EVENITY Clinical Trials
FRAME (Fracture study in postmenopausal women with osteoporosis) is a randomized, double-blind, placebo-controlled study (Study 1) that eva luated 7,180 postmenopausal women with osteoporosis. The study eva luated the efficacy of EVENITY treatment (210 mg administered monthly), compared with placebo, in reducing the incidence of new vertebral fractures through 12 months. The study also eva luated the efficacy of treating with EVENITY for 12 months followed by denosumab for 12 months, compared with placebo followed by denosumab, in reducing the incidence of new vertebral fractures through 24 months.
ARCH (Active-controlled fracture study in postmenopausal women with osteoporosis at high risk of fracture) is a randomized, double-blind, alendronate-controlled study (Study 2) of EVENITY in 4,093 postmenopausal women with osteoporosis and previous fracture history. This event-driven study eva luated 12 months of EVENITY treatment (210 mg administered monthly) followed by at least 12 months of alendronate treatment (70mg), compared with alendronate treatment alone, to assess its efficacy in reducing the risk of clinical fracture (non-vertebral fracture and symptomatic vertebral fracture) through the primary analysis period and the incidence of new vertebral fracture at 24 months.
About Osteoporosis-related Fractures
Worldwide, one in three women and one in five men, over the age of 50, will suffer a fracture due to osteoporosis.8 Similarly, in the U.S. one in two women will fracture in her lifetime due to osteoporosis.1 With an aging population these numbers will rise, yet despite this, there is a large gap in the management and treatment of osteoporosis, especially in the post-fracture setting, with an estimated four out of five patients remaining undiagnosed and untreated after a fracture.8 Without proper care or access to effective intervention options, they remain at risk of painful and disabling fractures in the future.
Important U.S. Product Information
EVENITY™ is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
The anabolic effect of EVENITY wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered.
Important U.S. Safety Information
POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH
EVENITY™ may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY™ should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY™ should be discontinued.
In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY™ compared to those treated with alendronate.
Contraindications: EVENITY™ is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY™. EVENITY™ is contraindicated in patients with a history of systemic hypersensitivity to romosozumab or to any component of the product formulation. Reactions have included angioedema, erythema multiforme and urticaria.
Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash and urticaria have occurred in EVENITY™-treated patients. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of EVENITY™.
Hypocalcemia: Hypocalcemia has occurred in patients receiving EVENITY™. Correct hypocalcemia prior to initiating EVENITY™. Monitor patients for signs and symptoms of hypocalcemia, particularly in patients with severe renal impairment or receiving dialysis. Adequately supplement patients with calcium and vitamin D while on EVENITY™.
Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving EVENITY™. A routine oral exam should be performed by the prescriber prior to initiation of EVENITY™. Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, and corticosteroids) may increase the risk of developing ONJ. Other risk factors for ONJ include cancer, radiotherapy, poor oral hygiene, pre-existing dental disease or infection, anemia and coagulopathy.
For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. In these patients, dental surgery to treat ONJ may exacerbate the condition. Discontinuation of EVENITY™ should be considered based on benefit-risk assessment.
Atypical Femoral Fractures: Atypical low-energy or low trauma fractures of the femoral shaft have been reported in patients receiving EVENITY™. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated.
During EVENITY™ treatment, patients should be advised to report new or unusual thigh, hip or groin pain. Any patient who presents with thigh or groin pain should be eva luated to rule out an incomplete femur fracture. Interruption of EVENITY™ therapy should be considered based on benefit-risk assessment.
Adverse Reactions: The most common adverse reactions (≥ 5%) reported with EVENITY™ were arthralgia and headache.
EVENITY™ is a humanized monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.

https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/evenity/evenity_pi_hcp_english.ashx 

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