Whats Hot?

Amgen舉行圓桌會談探討亞裔美國人骨質疏鬆問題

| January 7, 2019 | 0 Comments

Prolia® (denosumab)可幫助罹患停經後骨質疏鬆症有高度骨折風險的婦女強化骨質 

領先全球的生物科技公司之一Amgen在El Monte(艾爾蒙地)的LA Web為華裔社區舉辦活動,加強社區民眾對骨質疏鬆症(osteoporosis)的了解。這是一個不僅嚴重而且未受到包括華裔社區在內足夠關注的疾病。

Nora Tee醫師分享了和這個疾病有關的信息,也提供了亞裔民眾必須的知識,以便進一步了解他們的風險,同時談到獲得食品藥物管理局(FDA)批准,必須經由醫師處方的藥物Prolia® (denosumab)如何能夠治療有高度骨折風險之停經後婦女的骨質疏鬆症。

Amgen Prolia Event held in El Monte, CA at the LA Web Community Center on December 8, 2018. Photography by Steven Lam.
Instagram @stevenlamphoto

骨質疏鬆症是在人體流失過多骨質或是無法製造足夠骨質,或兩者同時存在時發生的疾病。1骨質疏鬆症令骨頭變得脆弱,容易因為跌倒而斷裂。患有嚴重骨質疏鬆症的人甚至打噴嚏或輕微碰撞就有可能發生骨頭斷裂的情形。1

亞裔民眾有發生骨質疏鬆的危險,因為許多亞裔民眾骨架小,骨質密度低。2許多傳統亞洲飲食無法充分提供維持骨頭強健所需的鈣,更增加發生骨質疏鬆的風險。2,3

所幸民眾可以通過調整生活方式和治療選擇來幫助他們的骨質疏鬆症。治療選擇中的一種,獲得食品和藥物管理局(FDA)批准,名為Prolia® (denosumab)的處方藥可以幫助罹患停經後骨質疏鬆症,有高度骨折風險的婦女降低骨折風險。4許多停經後婦女罹患骨質疏鬆症,因為她們的身體製造新骨質的速度無法趕上在停經期間和停經期後因為荷爾蒙改變而流失的骨質。5

每兩位超過50歲的美國婦女中就有一位在一生中至少發生一次因為骨質疏鬆症導致的骨折。1以全世界而言,曾經因為骨質疏鬆症發生骨折的人如果未經診斷和適當的治療,日後再度發生骨折的機率是其他人的兩倍。6

“罹患停經後骨質疏鬆症的婦女因為有大量令骨質流失的細胞,骨頭因此變得脆弱疏鬆,“7 Amgen全球開發執行醫學總監Rachel Wagman表示。“Prolia® 可以通過阻止令骨質流失細胞的開發,不讓它們接觸和傷害骨頭而有助於上述症狀。4患有停經後骨質疏鬆症的婦女應該和她們的醫師談談,了解Prolia® 是否適合她們。”

請登入www.myprolia.com/chinese/了解有關骨質疏鬆症,骨質強壯的重要性,以及Prolia®作為停經後骨質疏鬆症之治療選擇的進一步詳情。

Amgen Prolia Event held in El Monte, CA at the LA Web Community Center on December 8, 2018. Photography by Steven Lam.
Instagram @stevenlamphoto

 

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.

Amgen Prolia Event held in El Monte, CA at the LA Web Community Center on December 8, 2018. Photography by Steven Lam.
Instagram @stevenlamphoto

重要安全資訊

請勿使用Prolia® ,如果您: 有低血鈣;已懷孕或準備懷孕,因為Prolia® 可能會傷害您的胎兒;或者對狄諾塞麥(denosumab)或Prolia® 的任何成分過敏。

對於 Prolia® 我應該要知道的最重要資訊是什麼?

如果您接受 Prolia® ,就不應該接受 XGEVA® 。Prolia® 與 XGEVA® 含有相同的藥物(denosumab)。

Prolia® 會引起嚴重副作用:

有 Prolia® 使用者出現過嚴重的過敏反應。如果您有嚴重過敏反應的任何症狀,包括低血壓;呼吸困難;喉嚨緊繃;面部、嘴脣或舌頭腫脹;皮疹;瘙癢;或蕁麻疹,應立即致電醫生或到就近的急診室。

低血鈣症。Prolia® 會降低您血液中的鈣水平。如果您有低血鈣症,可能會在治療期間惡化。在接受 Prolia® 以前,必須先治療您的低血鈣症。

按醫生囑咐服用鈣和維他命 D 能有助預防低血鈣症。

可能會發生嚴重的下顎骨問題(骨壞死)。在您開始 Prolia® 治療以前,醫生應該檢查您的口腔,並可能會讓您去看牙醫。您在接受 Prolia® 治療期間,務必保持良好的口腔護理。

不尋常的大腿骨折。有些人的大腿骨會出現不尋常的骨折。骨折的症狀包括髖部、腹股溝或大腿出現新的或不尋常的疼痛。

停止使用 Prolia® 後的骨骼斷折風險增加,包括脊柱骨折。 在您的 Prolia® 治療停止後,您發生骨骼斷折,包括脊柱骨折的風險會增加。如果您的脊柱已經有過骨折,脊柱發生超過一處骨折的風險則會增加。在未諮詢醫生以前,請勿停用 Prolia® 。如果您的 Prolia® 治療已經停止,請諮詢醫生您可以服用哪些其他藥物。

嚴重感染 可能會發生在您的皮膚、下腹部、膀胱或耳部。使用 Prolia® 者也可能會更常發生因感染引起的心臟內膜炎症。您可能要到醫院接受治療。

Prolia® 是一種會影響您身體抵抗感染的能力的藥物。免疫系統減弱或服用了影響免疫系統的藥物的人,會有更大風險發生嚴重感染。

有患者報告出現皮膚問題如皮膚發炎、皮疹和濕疹。

骨骼、關節或肌肉疼痛。部分 Prolia® 使用者出現嚴重骨骼、關節或肌肉疼痛。

在接受 Prolia® 以前,應告訴醫生您的所有健康狀況,包括如果您:

  • 正在服用 XGEVA® 藥物(denosumab)
  • 有低血鈣症
  • 不能每天攝取鈣和維他命 D
  • 做過副甲狀腺或甲狀腺(位於頸部的內分泌腺)手術
  • 被告知您的胃或腸道吸收礦物質時有困難(吸收不良症候群)
  • 有腎臟問題或正在洗腎
  • 準備進行牙科手術或拔牙
  • 已懷孕或準備懷孕

針對育齡女性:

    • 開始使用 Prolia® 前,您的醫療保健提供者應該對您進行妊娠試驗。
    • 您應該在 Prolia® 治療期間,並在接受最後一劑 Prolia® 後至少 5 個月內使用有效的避孕方法。
    • 如果您在使用 Prolia® 期間懷孕,請立即告訴您的醫生。
  • 正在授乳或準備授乳

Prolia® 可能會有哪些副作用?

尚未知道長時間使用 Prolia® 會否引致骨折的癒合緩慢。對於接受停經後骨質疏鬆症治療的女性,Prolia® 最常見的副作用為背部疼痛、手臂和腿部疼痛、高膽固醇,肌肉疼痛,以及膀胱感染。Prolia® 在男性身上最常見的副作用為背部疼痛、關節疼痛和普通感冒(流鼻水或喉嚨痛)。

上述並非 Prolia® 的全部副作用。請致電您的醫生徵求有關副作用的醫療建議。

我們鼓勵您向 FDA 報告處方藥的不良副作用。請瀏覽 www.fda.gov/medwatch,或致電1‑800‑FDA‑1088

適應症

Prolia® 是一種用於治療女性停經後骨質疏鬆症的處方藥,適用於有高骨折風險的女性,或她們不能使用另一種骨質疏鬆症藥物,或者其他骨質疏鬆症藥物效果不佳。

Prolia® 是一種增加骨量的處方藥,用於治療患有骨質疏鬆症,並有高骨折風險的男性。

請參閱 Prolia® 完整處方資訊用藥指南

Amgen Prolia Event held in El Monte, CA at the LA Web Community Center on December 8, 2018. Photography by Steven Lam.
Instagram @stevenlamphoto

Comments

comments

Tags:

Category: News 新聞

About the Author (Author Profile)