1. Prolia 曾獲選為美國時代雜誌(Time) 10 大醫療突破之一 (10 medical breakthroughs in 2009)。
2. 因為Prolia 是第一個且唯一的RANK Ligand Ihibitor，以模仿OPG(保骨素)的作用有效抑制蝕骨細胞的生成、作用與存活。不同於雙磷酸鹽的作用機轉，Prolia 也有與雙磷酸鹽不同的療效/安全性優勢。
3. 根據NEJM發表的FREEDOM study:
(1)可顯著降低68%的新脊椎骨折、40%的髖骨骨折與20%的非脊椎骨折的風險。(2)Prolia發生一般與嚴重不良反應的比例與Placebo相當。
4. 根據DECIDE及STAND study:
(1) Prolia 對骨骼強度與結構影響優於alendronate。(2) Prolia 對增加骨骼扭轉的承受力(PMI) 顯著優於alendronate。(3)而Prolia在緻密骨(cortical bone) 的骨密度、厚度都優於alendronate。
5. 任何時間皆可注射，不用考慮用餐時間，不用補充水分。
6. 對腎功能受損的患者並不需要調整劑量。
7. Prolia通過網狀內皮系統由血清排除，不經由肝臟的細胞色素P450系統代謝。
8. 每6個月皮下注射一次，簡單方便；不用躺著輸注或站著吃藥
Product Name : XGEVA SOLUTION FOR INJECTION 120MG
Registration No. : HK-61163
Certificate Holder : GLAXOSMITHKLINE LIMITED
Certificate Holder Address : UNIT 2201 2214 AND 23/F TOWER 6,
THE GATEWAY HARBOUR CITY 9 CANTON RD,TSIM SHA TSUI,KLN
Ingredients : DENOSUMAB。
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PROLIA - denosumab injection
Amgen, Inc
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Prolia safely and effectively. See full prescribing information for Prolia.
Prolia™ (denosumab)
Injection, for subcutaneous use
Initial U.S. Approval: 2010
INDICATIONS AND USAGE
Prolia is a RANK ligand (RANKL) inhibitor indicated for:
Treatment of postmenopausal women with osteoporosis at high risk for fracture (1.1)
DOSAGE AND ADMINISTRATION
Prolia should be administered by a healthcare professional (2.1)
Administer 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen (2.1)
Instruct patients to take calcium 1000 mg daily and at least 400 IU vitamin D daily (2.1)
DOSAGE FORMS AND STRENGTHS
Single-use prefilled syringe containing 60 mg in a 1 mL solution (3)
Single-use vial containing 60 mg in a 1 mL solution (3)
CONTRAINDICATIONS
Hypocalcemia (4.1, 5.1)
WARNINGS AND PRECAUTIONS
Hypocalcemia: Must be corrected before initiating Prolia. May worsen especially in patients with renal impairment. Adequately supplement patients with calcium and vitamin D (5.1)
Serious infections including skin infections: May occur, including those leading to hospitalization. Advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis (5.2)
Dermatologic reactions: Dermatitis, rashes, and eczema have been reported. Consider discontinuing Prolia if severe symptoms develop (5.3)
Osteonecrosis of the jaw: Has been reported with Prolia. Monitor for symptoms (5.4)
Suppression of bone turnover: Significant suppression has been demonstrated. Monitor for consequences of bone oversuppression (5.5))
ADVERSE REACTIONS
Most common adverse reactions (> 5% and more common than placebo): back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. Pregnancy Surveillance Program available (8.1)
Nursing mothers: May impair mammary gland development and lactation. Disco
