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Prolia (denosumab) by Amgen: Drug Safety Communication - FDA
Investigating Risk of Severe Hypocalcemia in Patients on
Dialysis (1)
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: The FDA is investigating the risk of severe hypocalcemia with
serious outcomes, including hospitalization and death, in patients
with advanced kidney disease on dialysis treated with the
osteoporosis medicine Prolia (denosumab). FDA's review of interim
results from an ongoing safety study of Prolia suggests an increased
risk of hypocalcemia, or low calcium levels in the blood, in
patients with advanced kidney disease. Preliminary results from a
separate internal FDA study further investigating hypocalcemia in
dialysis patients treated with Prolia show a substantial risk with
serious outcomes, including hospitalization and death.
Because of the frequency and seriousness of these risks, the FDA is
alerting health care professionals and patients about them and is
continuing to evaluate this potential safety issue with Prolia use
in patients with advanced kidney disease, particularly those on
dialysis. The FDA will communicate the final conclusions and
recommendations when the review is completed and there is more
information to share.
For more information about this alert, click on the red button "Read
Alert" below.
BACKGROUND: Prolia is a prescription medicine approved in June 2010
to treat postmenopausal women with osteoporosis at high risk for
bone fracture. Prolia was later approved to treat men with
osteoporosis, glucocorticoid induced osteoporosis, bone loss in men
receiving androgen deprivation therapy for prostate cancer and in
women receiving aromatase inhibitor therapy for breast cancer.
Prolia works by blocking a protein called RANK (receptor activator
of nuclear factor kappa beta) and helps prevent bone cells called
osteoclasts from breaking down bone in the body. A health care
professional administers Prolia by injection once every six months.
美國FDA正在調查接受骨質疏鬆症藥物Prolia(denosumab)治療的透析患者，其發生嚴重低血鈣症伴隨其他嚴重後果(包括住院和死亡)的風險。美國FDA根據一項正在進行中的Prolia安全性研究的期中分析結果，其研究顯示患有晚期腎病的患者發生低血鈣症或血液中鈣含量較低的風險增加。另一項美國FDA內部研究的初步結果，進一步調查接受Prolia治療的透析患者之低血鈣情形，結果顯示存在有嚴重後果(包括住院和死亡)的重大風險。
Prolia為一處方藥，於2010年6月經美國FDA核准上市，用於治療有骨折高風險之停經後婦女骨質疏鬆症。Prolia也核准用於治療男性骨質疏鬆症、糖皮質類固醇引起的骨質疏鬆症、因攝護腺癌進行雄性荷爾蒙抑制治療之男性患者的骨質流失現象，和接受芳香環轉化酶抑制劑治療的女性乳癌患者。其作用機轉為透過阻斷RANK，因而防止破骨細胞分解骨骼。一般建議每六個月注射一次。
相關訊息與連結請參考FDA網址：https://reurl.cc/GXv2A3
（待續）
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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