Amgen举行圆桌会谈探讨亚裔美国人骨质疏松问题

Prolia® (denosumab)可帮助罹患停经后骨质疏松症有高度骨折风险的妇女强化骨质 

领先全球的生物科技公司之一Amgen在El Monte(艾尔蒙地)的LA Web为华裔社区举办活动，加强社区民众对骨质疏松症（osteoporosis）的了解。这是一个不仅严重而且未受到包括华裔社区在内足够关注的疾病。

Nora Tee医师分享了和这个疾病有关的信息，也提供了亚裔民众必须的知识，以便进一步了解他们的风险，同时谈到获得食品药物管理局（FDA）批准，必须经由医师处方的药物Prolia® (denosumab)如何能够治疗有高度骨折风险之停经后妇女的骨质疏松症。

骨质疏松症是在人体流失过多骨质或是无法制造足够骨质，或两者同时存在时发生的疾病。¹骨质疏松症令骨头变得脆弱，容易因为跌倒而断裂。患有严重骨质疏松症的人甚至打喷嚏或轻微碰撞就有可能发生骨头断裂的情形。¹

亚裔民众有发生骨质疏松的危险，因为许多亚裔民众骨架小，骨质密度低。²许多传统亚洲饮食无法充分提供维持骨头强健所需的钙，更增加发生骨质疏松的风险。^2,3

所幸民众可以通过调整生活方式和治疗选择来帮助他们的骨质疏松症。治疗选择中的一种，获得食品和药物管理局（FDA）批准，名为Prolia® (denosumab)的处方药可以帮助罹患停经后骨质疏松症，有高度骨折风险的妇女降低骨折风险。⁴许多停经后妇女罹患骨质疏松症，因为她们的身体制造新骨质的速度无法赶上在停经期间和停经期后因为荷尔蒙改变而流失的骨质。⁵

每两位超过50岁的美国妇女中就有一位在一生中至少发生一次因为骨质疏松症导致的骨折。¹以全世界而言，曾经因为骨质疏松症发生骨折的人如果未经诊断和适当的治疗，日后再度发生骨折的机率是其他人的两倍。⁶

“罹患停经后骨质疏松症的妇女因为有大量令骨质流失的细胞，骨头因此变得脆弱疏松，“7 Amgen全球开发执行医学总监Rachel Wagman表示。“Prolia® 可以通过阻止令骨质流失细胞的开发，不让它们接触和伤害骨头而有助于上述症状。⁴患有停经后骨质疏松症的妇女应该和她们的医师谈谈，了解Prolia® 是否适合她们。”

请登入www.myprolia.com/chinese/了解有关骨质疏松症，骨质强壮的重要性，以及Prolia®作为停经后骨质疏松症之治疗选择的进一步详情。

 

Indication

Prolia® is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.

 

Important Safety Information

 

Do not take Prolia® if you: have low blood calcium; or are pregnant or plan to become pregnant, as Prolia® may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia®.

 

What is the most important information I should know about Prolia®?

 

If you receive Prolia®, you should not receive XGEVA®. Prolia® contains the same medicine as XGEVA® (denosumab).

 

Prolia® cancauseserioussideeffects:

 

Serious allergic reactions have happened in people whotakeProlia®.             Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of your face, lips, or tongue; rash; itching; orhives.

 

Low blood calcium (hypocalcemia). Prolia® may lower the calcium levels in your blood. If you have low blood calcium, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia®.

 

Take calcium and vitamin D as your doctor tells you to help prevent low blood calcium.

 

Severe jaw bone problems (osteonecrosis) may occur. Your doctor should examine your mouth before you start Prolia® and may tell you to see your dentist. It is important for you to practice good mouth care during treatment with Prolia®.

 

Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.

 

Increased risk of broken bones, including broken bones in the spine, after stopping Prolia®. After your treatment with Prolia® is stopped, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop taking Prolia® without first talking with your doctor. If your Prolia® treatment is stopped, talk to your doctor about other medicine that you can take.

 

Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen. Inflammation of the inner lining of the heart (endocarditis) due to an infection may also happen more often in people who take Prolia®. You may need to go to the hospital for treatment.

 

Prolia® is a medicine that may affect the ability of your body to fight infections. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections.

 

Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported.

 

Bone, joint, or muscle pain. Some people who take Prolia® develop severe bone, joint, or muscle pain.

 

Before taking Prolia®, tell your doctor about all of your medical conditions, including if you:

• Take the medicine XGEVA®(denosumab)
• Have low bloodcalcium
• Cannot take daily calcium and vitamin D
• Had parathyroid or thyroid surgery (glands located in yourneck)
• Have been told you have trouble absorbing minerals in your stomach orintestines (malabsorptionsyndrome)
• Have kidney problems or are on kidneydialysis
• Plan to have dental surgery or teethremoved
• Are pregnant or plan to becomepregnant

Females who are able to become pregnant:

• Your healthcare provider should do a pregnancy test before you starttreatment withProlia®.
• You should use an effective method of birth control (contraception) during treatment with Prolia® and for at least 5 months after your last dose ofProlia®.
• Tell your doctor right away if you become pregnant while takingProlia®.

• Are breast-feeding or plan tobreast-feed

 

What are the possible side effects of Prolia®?

 

It is not known if the use of Prolia® over a long period of time may cause slow healing of broken bones. The most common side effects of Prolia® are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.

 

These are not all the possible side effects of Prolia®. Call your doctor for medical advice about side effects.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

 

Please see Prolia® full Prescribing Information, including Medication Guide.

重要安全资讯

请勿使用Prolia^® ，如果您： 有低血钙；已怀孕或准备怀孕，因为Prolia^® 可能会伤害您的胎儿；或者对狄诺塞麦（denosumab）或Prolia^® 的任何成分过敏。

对于 Prolia^® 我应该要知道的最重要资讯是什么？

如果您接受 Prolia^® ，就不应该接受 XGEVA^® 。Prolia^® 与 XGEVA^® 含有相同的药物（denosumab）。

Prolia^® 会引起严重副作用：

有 Prolia^® 使用者出现过严重的过敏反应。如果您有严重过敏反应的任何症状，包括低血压；呼吸困难；喉咙紧绷；面部、嘴唇或舌头肿胀；皮疹；瘙痒；或荨麻疹，应立即致电医生或到就近的急诊室。

低血钙症。Prolia^® 会降低您血液中的钙水平。如果您有低血钙症，可能会在治疗期间恶化。在接受 Prolia^® 以前，必须先治疗您的低血钙症。

按医生嘱咐服用钙和维他命 D 能有助预防低血钙症。

可能会发生严重的下颚骨问题（骨坏死）。在您开始 Prolia^® 治疗以前，医生应该检查您的口腔，并可能会让您去看牙医。您在接受 Prolia^® 治疗期间，务必保持良好的口腔护理。

不寻常的大腿骨折。有些人的大腿骨会出现不寻常的骨折。骨折的症状包括髋部、腹股沟或大腿出现新的或不寻常的疼痛。

停止使用 Prolia^® 后的骨骼断折风险增加，包括脊柱骨折。 在您的 Prolia^® 治疗停止后，您发生骨骼断折，包括脊柱骨折的风险会增加。如果您的脊柱已经有过骨折，脊柱发生超过一处骨折的风险则会增加。在未咨询医生以前，请勿停用 Prolia^® 。如果您的 Prolia^® 治疗已经停止，请咨询医生您可以服用哪些其他药物。

严重感染 可能会发生在您的皮肤、下腹部、膀胱或耳部。使用 Prolia^® 者也可能会更常发生因感染引起的心脏内膜炎症。您可能要到医院接受治疗。

Prolia^® 是一种会影响您身体抵抗感染的能力的药物。免疫系统减弱或服用了影响免疫系统的药物的人，会有更大风险发生严重感染。

有患者报告出现皮肤问题如皮肤发炎、皮疹和湿疹。

骨骼、关节或肌肉疼痛。部分 Prolia^® 使用者出现严重骨骼、关节或肌肉疼痛。

在接受 Prolia^® 以前，应告诉医生您的所有健康状况，包括如果您：

• 正在服用 XGEVA^® 药物（denosumab）
• 有低血钙症
• 不能每天摄取钙和维他命 D
• 做过副甲状腺或甲状腺（位于颈部的内分泌腺）手术
• 被告知您的胃或肠道吸收矿物质时有困难（吸收不良症候群）
• 有肾脏问题或正在洗肾
• 准备进行牙科手术或拔牙
• 已怀孕或准备怀孕

针对育龄女性：

• • 开始使用 Prolia^® 前，您的医疗保健提供者应该对您进行妊娠试验。
  • 您应该在 Prolia^® 治疗期间，并在接受最后一剂 Prolia^® 后至少 5 个月内使用有效的避孕方法。
  • 如果您在使用 Prolia^® 期间怀孕，请立即告诉您的医生。
• 正在授乳或准备授乳

Prolia^® 可能会有哪些副作用？

尚未知道长时间使用 Prolia^® 会否引致骨折的愈合缓慢。对于接受停经后骨质疏松症治疗的女性，Prolia^® 最常见的副作用为背部疼痛、手臂和腿部疼痛、高胆固醇，肌肉疼痛，以及膀胱感染。Prolia^® 在男性身上最常见的副作用为背部疼痛、关节疼痛和普通感冒（流鼻水或喉咙痛）。

上述并非 Prolia^® 的全部副作用。请致电您的医生征求有关副作用的医疗建议。

我们鼓励您向 FDA 报告处方药的不良副作用。请浏览 www.fda.gov/medwatch，或致电1‑800‑FDA‑1088。

适应症

Prolia^® 是一种用于治疗女性停经后骨质疏松症的处方药，适用于有高骨折风险的女性，或她们不能使用另一种骨质疏松症药物，或者其他骨质疏松症药物效果不佳。

Prolia^® 是一种增加骨量的处方药，用于治疗患有骨质疏松症，并有高骨折风险的男性。

请参阅 Prolia^® 完整处方资讯及用药指南。

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