近日，美国FDA批准其治疗更年期骨质酥松症的新药Reclast上市。Reclast 一年仅用一次，每次静脉输注仅用15分钟，是同类药物中最方便的，具有较强的治疗药品。 Reclast（唑来膦酸 zoledronic acid）注射液 最初美国批准：2001 适应症和用法 密固是双膦酸盐的指示： 治疗和预防绝经后骨质疏松 治疗以增加骨量男性骨质疏松症 治疗和预防糖皮质激素诱导的骨质疏松症 在男性和女性骨佩吉特氏病的治疗 使用限制 处理不当使用最佳期限截至开采。对于患者骨折的风险较低，可以考虑经过3至5年的使用停药。 作用机理 密固是一个双膦酸酯和主要作用于骨。它是破骨细胞介导的骨吸收的抑制剂。 骨二膦酸盐的选择性作用是基于他们对矿化骨高亲和力。静脉注射唑来膦酸快速分区骨和高骨转换优先的网站本地化。在破骨细胞唑来膦酸的主要分子目标是酶法尼基焦磷酸合酶。唑来膦酸的作用持续时间比较长是能够将其高结合亲和力归因于骨矿物质 用法用量 在没有少于15分钟静脉注射输液： 绝经后骨质疏松治疗;处理以增加在人与骨质疏松的骨量：治疗和预防糖皮质激素诱导的骨质疏松症：5毫克每年一次 预防绝经后骨质疏松：5毫克每2年一次 骨佩吉特氏病治疗：单5毫克静滴。患者shoulderstand接受1500mg的元素钙和800国际单位的维生素D每天 剂型和规格 5毫克在100毫升现成注入溶液 禁忌症 低钙血症 患者肌酐清除率小于35毫升/分钟，并在那些具有的急性肾损伤的证据 过敏密固的任何部件 警告和注意事项 产品含有相同的活性成分：患者在接受择泰shoulderstand没有收到密固 低钙血症治疗期间可能会恶化。患者一定要充分履行补充钙和维生素D 肾损害：单剂量shoulderstand不超过5毫克和输液的持续时间shoulderstand不超过15分钟不到。肾毒性可能更大患者的潜在肾功能不全或与其他危险因素包括高龄或脱水。监控肌酐清除率beforeeach剂量 有报道颚（ONJ）坏死。所有患者在治疗之前shouldhave由处方日常口语考试 非典型股骨骨折havebeen报道。患者大腿或腹股沟疼痛shoulderstand进行评估，以排除股骨骨折 怀孕：密固可致胎儿危害。生育潜力shoulderstand妇女被告知 严重的骨骼，可能会出现关节和肌肉疼痛。密固扣压未来的剂量，如果症状严重发生 不良反应 最常见的不良反应（大于10％）是发热，肌痛，头痛，关节痛，肢体疼痛。其他重要的不良反应是流感样疾病，恶心，呕吐，腹泻和眼睛发炎。 药物相互作用 氨基糖苷类抗生素：可降​​低长时间血钙 袢利尿剂：可以增加低钙血症的风险 肾毒性药物：应谨慎使用 药物主要通过肾脏排泄：接触可能有肾损害增加。检测患者血清肌酐处于危险之中， 在使用特定人群 哺乳期的母亲：密固不应给哺乳期妇女 儿童用药：在儿童患者未标明 老年用药：特别注意监测肾功能 完整处方资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3c79ff9c-a6f4-405d-b19c-7e473a61dedc FDA approves Reclast (zoledronic acid) for osteoporosis in postmenopausal women Reclast (zoledronic acid) Injection has been approved by the US Food and Drug Administration (FDA) as the first and only therapy to prevent postmenopausal osteoporosis for two years with a single dose. Reclast is already approved as a once-yearly infusion for the treatment of postmenopausal osteoporosis. The FDA decision is based on a study involving more than 500 postmenopausal women with osteopenia, or low bone mass, showing that a single infusion of Reclast significantly increased bone mineral density (BMD) at two years compared to placebo. Approximately 22 million women in the US have osteopenia, putting them at increased risk of osteoporosis, a disease that causes bones to break more easily. Osteoporosis is a major public health threat affecting an estimated 10 million men and women in the US. Although low bone mass is less severe in people with osteopenia than those with osteoporosis, they are still at increased risk of fractures. In fact, research shows that approximately half of women who experience a fragility fracture, or a broken bone due to a fall from standing height or less, have osteopenia, highlighting the importance of treating and preventing further bone loss. "It is very important to treat postmenopausal women with low bone mass to help prevent them from progressing to osteoporosis," said Mone Zaidi, MD, PhD, Professor of Medicine, Geriatrics, and Physiology and Director of the Mount Sinai Bone Program at Mount Sinai School of Medicine in New York, USA. "The dosing of Reclast for the prevention of postmenopausal osteoporosis offers an advance over existing therapies since it can be given once every two years, instead of daily, weekly or monthly." Reclast is already approved as a once-yearly infusion to treat postmenopausal osteoporosis, to increase bone mass in men with osteoporosis, and to treat and prevent osteoporosis caused by glucocorticoids, commonly known as steroids. Reclast is also approved for the treatment of Paget's disease of bone, the second most common metabolic bone disorder, in men and women. "We are very pleased that this latest US approval recognizes the large body of safety and efficacy data for Reclast and underlines its potential to protect patients with a number of bone disorders," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "Women with low bone mass in the US now have an important new option that is proven to strengthen their bones, and therefore help prevent the onset of osteoporosis, for a full two years with only one infusion." The new indication to prevent bone loss in postmenopausal women with osteopenia was based on a two-year randomized, multi-center, double-blind, placebo-controlled study of 581 postmenopausal women older than 45 years of age. The primary endpoint was the change in BMD at two years relative to baseline. This study included women in early menopause (i.e. within five years of menopause) and late menopause (i.e. more than five years from menopause). Patients were divided into three groups and received either Reclast at the beginning of the study and again at one year, Reclast at the beginning of the study and placebo at one year, or placebo at the beginning of the study and again at one year. Reclast significantly increased lumbar spine BMD relative to placebo at the end of the two-year study . Treatment with Reclast given as a single dose at the beginning of the study increased lumbar spine BMD by 6.3% in the early menopause group and by 5.4% in the late menopause group at two years (both p<0.0001). You should not take Reclast if you're on Zometa (zoledronic acid) Injection because it contains the same active ingredient. Additionally, you should not take Reclast if you have low blood calcium, kidney problems, or are allergic to Reclast. If you are pregnant, plan to become pregnant, or are nursing, you should not take Reclast. It's important to drink fluids before getting Reclast to help prevent kidney problems. The most common side effects include flu-like symptoms, fever, muscle or joint pain, headache, nausea, vomiting and diarrhea. Tell your doctor if you have dental problems because rarely, problems with the jaw have been reported with Reclast. Discuss all medicines you are taking, including prescription and non-prescription drugs, vitamins, and herbal supplements. If you develop severe bone, joint, or muscle pain, numbness, tingling or muscle spasms, contact your doctor. Aclasta/Reclast has been used in nearly 500,000 patients worldwide, including more than 238,000 in the US, to help prevent fractures. It is available in all 50 US states and reimbursed by all Medicare Part B carriers and virtually all health insurance plans. Reclast can be administered in physicians' offices or at one of more than 5,600 infusion centers located throughout the US. The active ingredient in Reclast is zoledronic acid 5 mg administered once a year when treating postmenopausal osteoporosis. Reclast contains the same active ingredient found in Zometa (zoledronic acid) Injection. -------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: RECLAST SOLUTION 5MG/100ML/BTL 原产地英文药品名: ZOLEDRONIC ACID 中文参考商品译名: 密固达溶液 5毫克/100毫升/瓶 中文参考药品译名: 唑来膦酸 生产厂家中文参考译名: 诺华 生产厂家英文名: NOVARTIS