据报道，礼来的副甲状腺激素Forteo(teriparatide rDNA注射剂)得到了FDA的批准上市，在美国用于治疗绝经期妇女骨质疏松症，包括原发性或性腺功能减退性骨质疏松症的男性病人。 英文藥名：Forteo 中文藥名：骨穩  預充注射器 廠商名稱：禮來製藥 成分及含量：Teriparatide(重組DNA) 3ml/支/28天 藥理作用：Teriparatide(重組DNA)含重組人體副甲狀腺荷爾蒙片段〔rhPTH(1-34)〕。ㄧ天一次投予Teriparatide，由於刺激成骨作用多於蝕骨作用，因而促進小梁骨與皮質骨表面的新骨生成。內生性84個胺基酸的副甲狀腺素(PTH)，主要調節骨骼與腎臟中鈣與磷的代謝。PTH生理作用包括調節骨骼代謝、腎小管鈣與磷的重吸收及小腸鈣的吸收。PTH與Teriparatide的生活活性皆經由與細胞表面高親和力的特異接受體結合，且於骨骼與腎臟具有相同的生理作用。Teriparatide不會在骨骼或其他組織中累積。 衛署適應症： 1.停經後婦女骨質疏鬆症具高度骨折風險者。 2.男性原發性或次發性性腺功能低下症之骨質疏鬆症且具高度骨折風險者。 用法用量： 1.Forteo應於皮下注射於大腿或腹部。建議劑量為20mcgㄧ天一次。 2.初次Forteo治療應在病患可以坐下或躺下的環境投予，以防發生姿態性低血壓症狀。 3.Forteo治療2年以上的安全性及療效尚未評估，因此不建議使用此藥超過2年。 4.Forteo為澄明無色液體，如果出現固體顆粒或混濁或變色液體，則不應使用。 5.不應使用超過使用期限的注射筆。每隻Forteo注射筆自第一次注射可以繼續使用28天，過了28天使用期，即使仍有剩餘藥液，應丟棄Forteo注射筆。不要與人共用注射筆。   副作用：頭痛、無力、噁心、關節痛、頭暈、鼻炎、投藥後4-6小時出現暫時性升高血鈣。 懷孕：C級 禁忌：Forteo不可用於對Teriparatide或其賦形劑過敏的病患。 注意事項： 臨床試驗中，Forteo與安慰劑組的尿路結石發生率相似。若病患疑似患有進行性尿路結石症或已存在高尿鈣症，應於治療期間測量其尿液鈣排泄量。Forteo應小心使用於進行性或近期曾發生尿路結石症的病患，因可能導致病情惡化。 Teriparatide偶而會發生暫時性姿勢性低血壓症狀，通常在投藥4小時內出現，在數分鐘至數小時內會自行緩解，若病患躺下可緩解症狀，這不會影響後續治療。 Forteo不會影響毛地黃對收縮時間間隔的作用。然而偶發性病例報告指出高血鈣可能使病人容易產生毛地黃中毒。因為Forteo會暫時升高血鈣濃度，應小心使用於接受毛地黃治療的病患。 藥物過量處理： 藥物過量可能的影響，包括延遲性高血鈣作用及姿態性低血壓危險、噁心、呕吐、頭暈、及頭痛。Teriparatide沒有特異性解毒劑，所以過量處理，包括停止Forteo治療、監測血鈣及血磷濃度、給予適當的支持療法。 Forteo Generic Name: teriparatide (ter i PAR a tide) Brand Names: Forteo What is Forteo? Forteo is a man-made form of a hormone called parathyroid that exists naturally in the body. Forteo increases bone density and increases bone strength to help prevent fractures. Forteo is used to treat osteoporosis in men and women who have a high risk of bone fracture. Forteo may also be used for other purposes not listed in this medication guide. What is the most important information I should know about Forteo? This medication has been found to cause an increased risk of bone cancer in animal studies. It is not known if this risk is also increased in humans treated with Forteo. Talk with your doctor about your individual risk. Forteo can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid smoking cigarettes, or try to quit smoking altogether. Smoking can reduce your bone mineral density, making fractures more likely. Avoid drinking alcohol, which also may affect your bone mineral density. What should I discuss with my healthcare provider before using Forteo? Do not use this medication if you are allergic to teriparatide. Before using Forteo, tell your doctor if you are allergic to any drugs, or if you have: Paget's disease or other bone disorders (besides osteoporosis); high levels of calcium or alkaline phosphatase in your blood; a condition called hyperparathyroidism; a bone disease other than osteoporosis; a history of bone cancer or radiation treatment involving your bones; or if you have ever had kidney stones. If you have any of these conditions, you may need a dose adjustment or special tests to safely use Forteo. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Forteo passes into breast milk. Do not use Forteo without telling your doctor if you are breast-feeding a baby. This medication has been found to cause an increased risk of bone cancer in animal studies. It is not known if this risk is also increased in humans treated with Forteo. Talk with your doctor about your individual risk. How should I use Forteo? Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label. Forteo is given as an injection under the skin of the thigh or stomach. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes. This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets. Forteo can cause you to feel dizzy or light-headed. It may help to sit or lie down for a short time after injecting the medication. Do not use Forteo for longer than 2 years unless your doctor tells you to. Forteo is only part of a complete program of treatment that also includes diet, exercise, vitamins or mineral supplements, and changing certain behaviors. Follow your diet and exercise routines very closely. It is important to use Forteo regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Forteo can be injected at any time of the day. It may be easier to remember to use Forteo if it is used at about the same time each day. Do not Forteo that is discolored or cloudy or that has particles in it. It should be clear and colorless. Do not use Forteo after the expiration date printed on the pen or pen packaging. Store the Forteo injection pen in the refrigerator but do not allow it to freeze. Take the pen out of the refrigerator only long enough to use it. After use, recap the pen and put it back into the refrigerator. Throw away the injection pen after 28 days of use, even if it still has medicine in it. What happens if I miss a dose? Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose. What happens if I overdose? Seek medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, dizziness, headache, feeling light-headed, or fainting. What should I avoid while using Forteo? Forteo can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid smoking cigarettes, or try to quit smoking altogether. Smoking can reduce your bone mineral density, making fractures more likely. Avoid drinking alcohol, which also may affect your bone mineral density. Forteo side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Forteo and call your doctor at once if you have any of these serious side effects: feeling light-headed or fainting every time you inject this medicine; fast or pounding heartbeats every time you inject this medicine; or nausea, vomiting, constipation, and muscle weakness. Less serious side effects may include: mild dizziness; pain, redness, bruising, itching, or swelling where the medicine was injected; leg cramps; joint pain; cough, sore throat, runny nose; headache or neck pain; or nausea, constipation, diarrhea. This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088. What other drugs will affect Forteo? Before using Forteo, tell your doctor if you are taking digoxin (digitalis, Lanoxin, Lanoxicaps). You may need a dose adjustment or special tests to safely use Forteo. There may be other drugs not listed that can interact with Forteo. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Where can I get more information? Your pharmacist can provide more information about Forteo. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. Forteo（副甲状腺激素）获准上市 据报道，礼来的副甲状腺激素Forteo(teriparatide rDNA注射剂)得到了FDA的批准上市，在美国用于治疗绝经期妇女骨质疏松症，包括原发性或性腺功能减退性骨质疏松症的男性病人。 在美国，受骨质疏松症折磨的人高达一千万，每年并导致一百五十万例的骨折，单是治疗骨折的费用就达一百亿美元之多；然而目前治疗骨质疏松症的药物，仅能延缓骨质流失的速度而已。 最近研究成功的新药 Forteo，却能够加倍增加新骨形成的速度。制药公司希望Forteo能够获得美国食品暨药物管理局核准，于今年底成为处方药。 新药Forteo的临床试验结果令人十分鼓舞，因为它能减少百分之六十五的脊椎骨折，优于现有的药物，其它的药物如Fosamax，减少脊椎骨折的发生率为百分之四十八，Actonel 为百分之四十一。 在最近的一项研究中，一千六百三十七名绝经后至少曾发生过一次骨折的妇女参加了随机对比试验，在使用 Forteo 十八个月后，她们的骨质密度增加了百分之十三；另在动物实验时出现骨瘤的现象，在临床试验中并未发生。 Forteo的原始名称为 teriparatide，由三十四个氨基酸组成，其功能类似于甲状旁腺激素。Forteo的主要缺点是必须每天注射一次，因此可能须像糖尿病患者注射胰岛素一样，骨质疏松症患者也要学会给自己打针。 欧洲药物评估机构（EMEA）表示支持礼来公司的骨质疏松药物Forteo（teriparatide，特立帕肽），但只限于在女性患者中使用。上个月美国FDA批准了这一药物用于治疗骨质疏松，包括男性病人和绝经后妇女。EMEA称其科学委员会推荐批准这一药物用于绝经后妇女的骨质疏松。但是没有提到男性患者。欧洲药物评估机构一般会在宣布支持后的几周内正式批准新药上市。Forteo是一种每天一次的针剂，与大多数骨质疏松药物防止和减少骨质损失不同的是，这种药物还能促进新骨形成。礼来公司在上个月公布的一项对照试验结果中说，Forteo治疗组的脊柱骨密度比默克公司的竞争产品Fosamax（alendronate，阿仑膦酸钠）高5倍。 唑来膦酸联合特立帕肽较单用更有效 ASBMR第31届年会 2009年9月14日报道：一项新的研究表明，唑来膦酸与甲状旁腺素特立帕肽（Forteo）结合使用不影响特立帕肽的作用，而且可以增加作用效果。 这项部分双盲研究涉及4个国家的35个临床中心，共包括412例首次治疗的绝经后骨质疏松症女性，入组者的年龄在45至87岁。入组女性随机分配到3组：接受5mg静脉注射唑来膦酸联合每日皮下特立帕肽20mg治疗、只使用特立帕肽20mg治疗、或只使用唑来膦酸5mg治疗。 研究人员在基线处、13周、26周、52 周时测量了入组者的腰椎和全髋骨密度，分析结果表明，腰椎骨密度在联合用药组、单用特立帕肽组、单用唑来膦酸组分别增加7.51%、7.05%、4.37%。 联合用药组与单用特立帕肽组的差异并不显著，而联合用药组较单用唑来膦酸组治疗更有效（P < .001）。与单用特立帕肽相比，联合用药显著增加13周和26周时的腰椎骨密度，并且显著增加13周、26周和52周时的全髋骨密度（P < .005），在整个实验过程中，骨转换标志物I型胶原的C-尾肽和N-末端前肽一直低与单用特立帕肽组。 联合用药组、单用特立帕肽组、单用唑来膦酸组严重副反应的总体发生率分别为9.5%、14.6% 和10.9%。 学名特立帕肽（FORTEO的） 商品名FORTEO的750MCG/3ML/PEN FORTEO的28DOSE/2.4ML/PEN 中文名骨稳注射液 主成份及含量750mcg/3mL/pen28 dose/2.4mL/pen 制造厂名称 礼来 产地法国 用法皮下注射 成人剂量为资深大律师的大腿或腹壁，连用20微克。资深大律师，20微克，连用。 副作用头晕，心跳加速，血钙过高（恶心，呕吐，便秘，倦怠无力），注射部位红斑，肿痛 异动类别药品变更 异动原因药委会决议 异动描述的FORTEO&reg;（特立帕肽）750mcg/3mL/pen因药品规格变更，业经药委会同意以新规格取代： 新品规格变更为600mcg/2.4mL/pen，因取消每次给药前“试注“步骤，每支注射笔同样可供应28剂。 自6月24日起启用新品（请改处方料号864151），同日起旧剂型将限定已开立慢性病连续处方笺患者领用。 英文药名: Forteo (Teriparatide) 中文药名: 特立帕肽注射液 生产厂家: Eli Lilly Generic Name for FORTEO Teriparatide (recombinant) 250micrograms/mL; soln for SC inj; contains m-cresol. Legal Classification: Rx Pharmacological Class for FORTEO Hormone (human parathyroid hormone, recombinant). Manufacturer of FORTEO Lilly, Eli and Company        Indications for FORTEO Postmenopausal osteoporosis in women who are at high risk for fracture. To increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. Treatment of men and women with osteoporosis associated with sustained glucocorticoid therapy at high risk for fracture (see literature).        Adult dose for FORTEO 20 micrograms SC once daily into thigh or abdominal wall; may treat for up to 2 years. Children's dosing for FORTEO Not recommended. Warnings/Precautions for FORTEO Increased baseline risk for osteosarcoma (eg, Paget's disease of bone, unexplained increased alkaline phosphatase, open epiphyses, prior skeletal radiation therapy), bone metastases, history of skeletal malignancies, metabolic bone disease, hypercalcemia or risk thereof (eg, hyperparathyroidism): not recommended. Urolithiasis. Hypercalciuria. Hepatic, renal, or cardiac disease. Pregnancy (Cat.C). Nursing mothers: not recommended. Interactions for FORTEO Caution with digoxin (teriparatide-induced hypercalcemia increases risk of toxicity). Adverse Reactions for FORTEO Arthralgia, pain, nausea; transient orthostatic hypotension, hypercalcemia, hyperuricemia, inj site reactions. How is FORTEO supplied? Multidose Pen (2.4mL, 3mL)—1 Related Disease: Bone disorders Osteoporosis~bone metabolism 英文药名：FORTEO的（Teriparatide） 中文药名：特立帕肽注射液 生产厂家：礼来公司 FORTEO的通用名称 特立帕肽（重组）250micrograms/mL;为SC已经来到溶液;含有甲酚。 法律分类： 接收 FORTEO的药理班 生长激素（人甲状旁腺激素，重组）。 制造商的FORTEO 礼来公司，礼和公司         FORTEO的适应症 绝经后骨质疏松症的妇女谁在骨折高风险。为了增加对骨质疏松症的小学或性腺机能减退谁在骨折高风险是男性的骨质。治疗男性和糖皮质激素治疗与持续关联骨折高风险（见文献）骨质疏松症的妇女。 成人剂量的FORTEO 资深大律师一旦进入20微克大腿或腹壁每日可处理多达2年。 儿童用药的使用FORTEO 不推荐。 警告/对FORTEO的注意事项 增加基线风险骨肉瘤（如Paget的骨疾病，不明原因的增加碱性磷酸酶，开放骨骺，事先骨骼放射治疗），骨转移，骨肿瘤，代谢性骨骼疾病，高血钙或风险零件（如甲状旁腺功能亢进症）的历史：不推荐。尿路结石。高钙尿症。肝，肾或心脏疾病。妊娠（Cat.C）。哺乳母亲：不推荐。 互作的FORTEO 地高辛警告（teriparatide的诱导毒性高钙血症增加风险）。 为FORTEO的不良反应 关节痛，疼痛，恶心，暂时性体位性低血压，高钙血症，高尿酸血症，已经来到现场反应。 如何FORTEO的供应？ 多剂量笔（2.4mL，3毫升）- Forteo治疗骨质疏松症的安全性 一项为期2年的大鼠动物实验显示，Forteo会增加骨肉瘤的发生率，且与剂量及疗程长短相关。尽管临床试验中并未发现Forteo所导致的骨肉瘤病例，但Forteo用于人类治疗是否也存在增加肿瘤患病率的潜在风险目前尚不明确。 专家认为，Forteo只适宜用于那些用药后获益会远大于弊的患者。而那些本身即具有发生骨肉瘤风险的高危人群（如Paget’s骨病患者、碱性磷酸酶不明原因升高者、儿童或生长期青少年及曾接受过外源性或内源性放射治疗的患者）则是Forteo的禁忌人群。此外，具有骨转移或恶性骨癌病史的、代谢性骨病（骨质疏松症除外）患者也不适宜应用Forteo治疗。由于Forteo可能会增高血钙水平，因此血钙较高的患者也不考虑该药治疗。临床试验中，20mcg治疗剂量的Forteo的治疗副反应是非常轻微的，通常不需要停药观察。腿部抽筋和眩晕是较常见的副反应。 Forteo 和Fosamax（福善美）是目前用于治疗骨质疏松症的两类常用药物，均具有增加骨密度的疗效，但作用机制有所不同。Forteo 是通过加快骨形成的速度来促进新骨的形成，Fosamax则是通过抑制骨丢失来达到增加骨密度的目的。Forteo是目前美国食品和药物管理局首次，且是唯一批准通过的具有促进骨形成功效的制剂。 补充甲状旁腺激素在应用阿仑膦酸盐治疗的骨质疏松症患者中的疗效观察 双膦酸盐类(bisphosphonates)药物已发展成为最有效的骨吸收抑制剂。阿仑膦酸钠是一种被广泛应用的有效的骨质疏松症治疗药物，并能预防绝经后骨质丢失。国外的研究人员近期进行了一项研究，评估了长期接受阿仑膦酸盐（alendronate）治疗的骨质疏松症患者是否对补充甲状旁腺激素的治疗有应答，并探讨了间断补充甲状旁腺激素的治疗方案是否同每日一次给药的方案同样有效。 研究人员随机选取了126名应用阿仑膦酸盐治疗1年以上的女性骨质疏松症患者，分为三组，一组为a阿仑膦酸盐+每日甲状旁腺激素（1-34）治疗，共15个月；一组为阿仑膦酸盐+间断性甲状旁腺激素（1-34）治疗，即每日给予甲状旁腺激素三个月后停用3个月，然后再重复3个月的激素治疗，如此交替，总疗程为15个月；另一组为单纯阿仑膦酸盐治疗，共15个月。 结果显示，给予甲状旁腺激素治疗的两组患者的骨形成指数上升明显。在间断补充甲状旁腺激素治疗组中，一旦停止激素治疗，患者的骨形成指数即会下降，随着甲状旁腺激素治疗的继续，指数会再次回升。虽然这两组患者的骨吸收都有所增加，但每日治疗组的进行性增加要较间断治疗组更显著。前组患者的脊椎骨密度增加了6.1%，而后者增加了5.4%（两组间无显著统计学差异，但与单用阿仑膦酸盐组比较，P<0.001）。每日激素治疗组、间断激素治疗组和单纯阿仑膦酸盐治疗组中分别有1人、2人和4人新发椎骨畸形。 研究人员指出，间断的甲状旁腺激素治疗会导致甲状旁腺激素的前期反应（主要表现为单纯刺激骨形成）与后期反应（表现为激活骨重建）相脱离。而前期反应对增加脊椎的骨密度更为重要。对于那些在开始阿仑膦酸盐治疗前就已存在顽固性骨质疏松的患者而言，无论是每日还是间断激素治疗都有增加脊椎骨密度的功效。