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保骼麗 注射液 Prolia (denosumab) 衛署菌疫輸字第 000918 號 1 …
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1 保骼麗 注射液 Prolia ® (denosumab) 衛署菌疫輸字第 000918 號 1 適應症 治療有骨折高風險性之停經後婦女骨質疏鬆症。 說明： 有骨折高風險性之停經後婦女骨質疏鬆症，包含下列任一狀況：有骨質疏鬆症骨折病史、具有 多項骨折危險因子、先前接受其他骨質疏鬆症療法失敗或無法耐受其他骨質疏鬆症療法之病 患。 對患有骨質疏鬆症之停經後婦女，Prolia 可降低脊椎、非脊椎和髖骨骨折的發生率。 治療有高度骨折風險之骨質疏鬆症男性患者，以增加骨量 (bone mass)。 說明： Prolia 適用於治療有高度骨折風險 (定義為有骨質疏鬆症骨折病史，或具有多項骨折危險因子) 之骨質疏鬆症男性患者，或先前曾接受其他骨質疏鬆症療法失敗或無法耐受其他骨質疏鬆症療 法的患者，以增加骨量 (bone mass) [參見臨床研究 (14.2)]。 治療糖皮質類固醇引起的骨質疏鬆症。 說明： Prolia 適用於治療有高度骨折風險的糖皮質類固醇引起之骨質疏鬆症男性與女性病人，這群病 人指正開始或持續每日劑量等效於 7.5 毫克 prednisone 或以上的全身性糖皮質類固醇，並預計 維持使用糖皮質類固醇至少 6 個月。高度骨折風險的定義為發生過骨質疏鬆性骨折、具有多重 骨折風險因子、或曾接受其他骨質疏鬆症治療失敗或耐受不良的病人 [參見臨床研究 (14.3)]。 治療因為非轉移性攝護腺癌而進行雄性荷爾蒙抑制治療且具高度骨折風險之男性患者的骨質流 失現象。 說明： Prolia 亦可降低此類病人脊椎骨折的發生率。 2 劑量與用法 本藥限由醫師使用。 2.1 安全劑量或用法的重要訊息 施打 Prolia 前必須排除懷孕情形。有生育能力的女性在施打 Prolia 前皆應先驗孕。依據動物研 究發現，Prolia 用於懷孕女性可能對胎兒造成傷害 [參見特殊族群之使用 (8.1、8.3)]。 2.2 建議劑量 施打 Prolia 應由健康照護專業人員來進行。 Prolia 的建議劑量為每 6 個月一次皮下注射單劑 60 毫克。請以皮下注射的方式將 Prolia 施打於 上臂、大腿或腹部。所有的病人都應每天補充至少 1000 毫克的鈣質與至少 400 IU 的維生素 D [參見警語和注意事項 (5.3)]。 如果漏打一劑 Prolia，應於病人方便時儘快施打。之後再從最後一次注射的日期算起，排定每 6 個月一次的注射時間。
Transcript of 保骼麗 注射液 Prolia (denosumab) 衛署菌疫輸字第 000918 號 1 …
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[ (14.3)]
Prolia [ (8.18.3)]
2.2
[ (5.3)]
6
Prolia (
25°C/77°F) 15 30 Prolia [ / (16)]
4
4
Prolia
• Prolia Prolia
[ (8.1)]
(6.2)]
5.2
Prolia [ (4) (6.2)]
5.3
5
< 30 /] ) Prolia
14 ()
D /
(parathyroid
()
D
D [ (2.1) (4) (6.1) (17)]
5.4
denosumab ONJ [ (6.1)] Prolia
ONJ
Prolia
Prolia
ONJ -
Prolia
Prolia () Prolia
Prolia Prolia
9 Prolia 24
18
[ (12.2) (14.1)]
Prolia 7 ( 19 )
Prolia Prolia
5.7
[ (6.1)]
()
Prolia
[ (6.1)]
Prolia
[ (6.2)] Prolia
[ (17)]
6
Prolia
Amgen
(RMP)
Amgen [email protected]
(ADR)
7808 60 91 3
Prolia 3876
3886 6 60 Prolia
1000 400 IU D
2.3% (n = 90) Prolia 1.8% (n = 70)
24.2% Prolia 25.0%
Prolia 2.1% 2.4%
≥ 2% Prolia
Prolia
9
1.7% Prolia
10
< 7.5 mg/dL
10% 50 80 / 29%
< 30 / 29%
D 4550
Prolia 10 < 30 /
-5.5% ≥ 30 / -3.1%
RANKL ( Prolia)
7808
Prolia 0.2%
3.3% Prolia 4.0% ( 0.7%Prolia 0.9%) (
0.5%Prolia 0.7%) ( 0.0%Prolia 0.1%)
Prolia
3
( < 0.1%Prolia 0.4%)
Prolia
8.2%Prolia 10.8% (p < 0.0001)
[ (5.8)]
Prolia 2½ [ (5.5)]
10
6% 3%
Prolia 17 ( 7 43 )
[ (5.6)]
4 (0.1%) Prolia 8 (0.2%)
Prolia 8
4.3%Prolia 4.8% (
0.7%Prolia 0.9%) ( 0.2%Prolia 0.5%) (
0.6%Prolia 0.9%)
120 120 6
60 Prolia 1000 800 IU
D
0.8% (n = 1) Prolia 0.8% (n = 1)
7.5% Prolia 8.3%
Prolia 0% 2.5%
≥ 5% Prolia
( 6.7%Prolia 8.3%) (
5.8%Prolia 6.7%) ( 5.8%Prolia 6.7%)
4 (3.3%) 5 (4.2%) Prolia (
)
1 (0.8%) 1 (0.8%) Prolia
(3 1 )
11
2 1
Prolia 795 (30%
70% ) 20 94 ( 63 ) 7.5 prednisone (
) 384 5 ()394
Prolia 6 60
1000 800 IU D
0.5% (n = 2) Prolia 1.5% (n = 6)
17% Prolia 16%
Prolia 3.6% 3.8%
≥ 2% Prolia
Prolia
*
Prolia 1 Prolia 8.0
[ (5.5)]
15 (3.9%) 17 (4.3%) Prolia
16 (4.2%) 15 (3.8%) Prolia
()
Prolia
3 1468 48
97 725 731
Prolia 60
1000 400 IU D
30.6% Prolia 34.6%
Prolia 6.1% 7.0%
Prolia
2 252 35 84
120 129 Prolia
60
1000 400 IU D
9.2% Prolia 14.7%
Prolia 4.2% 0.8%
Prolia
≥ 10% ( 13.0%
Prolia 14.3%) ( 10.5%Prolia 11.5%) ( 7.7%Prolia
9.9%) ( 3.8%Prolia 6.0%)
Prolia
( 1.2%Prolia 4.7%) ( < 8.4 mg/dL) Prolia
(2.4%0%)
•
•
55 )
13
denosumab 50
) denosumab 20
denosumab 50
) 50 / denosumab 6
RANKL
[ (8.2) (13.2)]
denosumab
denosumab (NOEL) Cmax 22.9 ng/mL ( RANKL) [
(12.3)]
14
denosumab 1 denosumab (
≤ 0.5%)
RANKL [ (8.1) (13.2)]
8.3
denosumab 60 11000
NOEL 38
denosumab
[ (12.3)]
Prolia
(osteoprotegerin) Fc (OPG-Fc) (
≤ 10 /) RANKL (Prolia )
( 6 60 ) 10 50 (10
50 /) denosumab ( [/] )
denosumab
denosumab
6
[ (8.1)]
8.5
Prolia 9943 (76%) ≥ 65 3576 (27%) ≥ 75
Prolia 133 (55%) ≥ 65 39
(16%) ≥ 75 355 (47%)
≥ 65 132 (17%) ≥ 75
8.6
Prolia
()
D [ (5.3) (6.1) (12.3)]
8.7
()
Prolia
1 Prolia 60 denosumab (60 /)4.7%
17 mM 0.01% 20 (USP) pH 5.2
12
12.1
Prolia RANKL
RANK RANKL/RANK
(bone resorption)
12.2
60 Prolia 1
(C-telopeptidesCTX) 3 85% 1 Prolia 1
3 39% 68% CTX (0.049 ng/mL)
denosumab CTX
≥ 87% ≥ 45% ( 45-80%) Prolia (bone
remodeling)
(bone formation) (physiological
coupling) ( [osteocalcin] I
[P1NP]) Prolia Prolia
40% 60% 12
16
(n = 7318 64 )
( 12 ) 60 Prolia denosumab (Cmax)
6.75 mcg/mL ( [SD] = 1.89 mcg/mL) denosumab (Tmax) 10
(3 21 ) Cmax denosumab 4 5
25.4 (SD = 8.5n = 46)Denosumab 16
(AUC0-16 weeks) 316 mcg•day/mL (SD = 101 mcg•day/mL)
6 60 denosumab
12 (43-65) denosumab
60 denosumab Cmax (± SD)
6170 (± 2070) ng/mL 100 (± 81.9) ng/mL denosumab
2% Tmax 8.0 ( 7.9 21 )
21 ( 8.0 49 ) 22 denosumab
301 ng/mL ( 10 )11 9
denosumab ( 106 )5
denosumab (n = 12) (± SD) 21.1 (± 36.5) ng/mL
19 etanercept (
50 ) etanercept 7 denosumab (
60 )Etanercept
midazolam (2 )Denosumab midazolam midazolam
P450 3A4 (CYP3A4) denosumab CYP3A4
17
( 6 60 ) 13 50 ( [/]
) denosumab
( 6 60 ) 50
( [/] ) denosumab
(BMD)
) RANK/RANKL ( OPG-Fc)
denosumab RANK/RANKL
()
RANK/RANKL 2
RANKL OPG-Fc
RANKL
14
14.1
BMD T -2.5 -4.0
( Paget )
7808 60 91 72
BMD T -2.8 23%
6 (N = 3906) Prolia 60
(N = 3902) 1000 400 IU D
3 ()
X (T4-L4)
3
(p < 0.0001)3 7.2%
Prolia 2.3% 3
4.8% 68%
3Prolia
0-3 7.2 2.3 4.8 (3.9, 5.8) 68 (59, 74) + * Mantel-Haenszel
BMD
Prolia
0.7% 3 0.3%
40% (p = 0.04) ( 1)
1. 3
(N = 3906) Prolia (N = 3902)
G R
H 0328Z
H v1
(%)+
(%)
1 8.0 6.5 1.5 (0.3, 2.7) 20 (5, 33)* + 3 Kaplan-Meier 1 () * p = 0.01
(BMD)
3 Prolia BMD 3 BMD
8.8% 6.4% 5.2%/
(BMI) BMD BMD
Prolia BMD 12
266
BMD 0.5% ( mean %)
denosumab ( 1460 100 mg) BMD 5.7%6.7%
7.5% p < 0.0001 denosumab 12
BMD (p < 0.05)
BMD
92 24 () 36 115
(Prolia 53 62 )
115 (100%) 7 (6%)
38% 36
100% Prolia
2343 2207 ) 7
Prolia 6 60
Prolia ( 1 ) D ( 400 IU) 2626 (58%
34% )
Prolia BMD
21.7% 9.2% 9.0% 13.0% 1/3 2.8%
BMD T -1.3
20
6.8% 13.1%
14.2
BMD T
-2.0 -3.5 BMD T -1.0 -3.5
(
Paget )
242 31 84 65
6 (n = 121) Prolia 60 (n = 121)
1000 800 IU D
(BMD)
BMD 1
Prolia 1 BMD 1 BMD 4.8% (
+0.9%Prolia +5.7%(95% CI: 4.0, 5.6)p < 0.0001) 2.0% ( +0.3%
Prolia +2.4%) 2.2% ( 0.0%Prolia +2.1%)
BMD BMD
12 ) 29 (100%)
Prolia 6 (35%)
Prolia
Prolia 6% 12
100% Prolia
14.3
2 (NCT 01575873)
12 Prolia
795 (70% 30% ) 20 94 ( 63 ) 3
7.5 prednisone () 6
(n = 290) 3
7.5 prednisone () 6 (
n = 505) < 50
≥ 50 BMD
T-score ≤ -2.0 BMD T-score ≤ -1.0
1:1 (
risedronate 5 ) (n = 397) Prolia 60 (n = 398)
1000 800 IU
D
( 0.8%Prolia 3.8%) 2.9% (p < 0.001)
Prolia BMD (
2.3%Prolia 4.4%) 2.2% (p < 0.001)
BMD T
BMD
12 17 ( 11 Prolia 6 )
17 (100%)
100% Prolia 12
1 (33%) 2 (67%)
Prolia
3 (1:1)
70 BMD T -1.0 -
4.0 BMD T -0.4 22%
1468 48 97 ( 76 )
6 (n = 734) Prolia 60 (n = 734)
6 (< 70 ≥ 70 )
(≤ 6 > 6 ) 79%
6 1000 400 IU
D
36 X
Prolia BMD [ -1.0%
Prolia +5.6% 6.7% (95% CI: 6.2, 7.1)p < 0.0001]
62% 3 BMD 3 7.9% ( -1.2%
Prolia +6.8%) 5.7% ( -2.6%Prolia +3.2%) 4.9% (
-1.8%Prolia +3.0%)BMD
BMD
22
0-3 3.9 1.5 2.4 (0.7, 4.1) 62 (22, 81) + * Mantel-Haenszel ADT
2 (1:1)
BMD T -1.0 -2.5 25
BMD T -1.1 2.0%
252 35 84 ( 59 )
6 (n = 125) Prolia 60 (n = 127) 4
(≤ 6 vs. > 6 )
62% 6
1000 400 IU D
(BMD)
BMD 12 12
Prolia BMD [ -0.7%Prolia +4.8%
5.5% (95% CI: 4.8, 6.3)p < 0.0001]
81% 2 BMD 2 7.6% ( -1.4%
Prolia +6.2%) 4.7% ( -1.0%Prolia +3.8%) 3.6% (
-0.8%Prolia +2.8%)
60 /1 1
Prolia 2°C 8°C (36°F 46°F)
Prolia ( 25°C/77°F)
Prolia 25°C/77°F 14
14 Prolia Prolia
Prolia
Xgeva [ (5.1)]
denosumab (Prolia Xgeva) [ (5.2) (4)]
[ (5.3) (8.6)]
Prolia ()
[ (5.4)]
Prolia (MVF)
[ (5.8)]
[(5.9)]
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State Road 31, Kilometer 24.6, Juncos, Puerto Rico 00777
