HERCEPTIN(trastuzumab) kit - America[美国药品]

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HERCEPTIN(trastuzumab) kit(二十八)

2013-09-23 11:52:32 来源: 作者: 【大中小】浏览:15769次评论:0条

ssion (IHC) testing is summarized in Table 12.

Table 12: Exploratory Analyses by HER2 Status using Updated Overall Survival Results
	FC (N=296)*	FC + H (N=298)†
Two patients on the FC arm who were FISH+ but IHC status unknown were excluded from the exploratory subgroup analyses. Five patients on the Herceptin-containing arm who were FISH+, but IHC status unknown were excluded from the exploratory subgroup analyses. Includes 6 patients on chemotherapy arm, 10 patients on Herceptin arm with FISH-, IHC3+ and 8 patients on chemotherapy arm, 8 patients on Herceptin arm with FISH status unknown, IHC 3+.
FISH+ / IHC 0, 1+ subgroup (N=133)
No. Deaths / n (%)	57/71 (80%)	56/62 (90%)
Median OS Duration (mos.)	8.8	8.3
95% CI (mos.)	(6.4, 11.7)	(6.2, 10.7)
Hazard ratio (95% CI)	1.33 (0.92, 1.92)
FISH+ / IHC2+ subgroup (N=160)
No. Deaths / n (%)	65/80 (81%)	64/80 (80%)
Median OS Duration (mos.)	10.8	12.3
95% CI (mos.)	(6.8, 12.8)	(9.5, 15.7)
Hazard ratio (95% CI)	0.78 (0.55, 1.10)
FISH+ or FISH /IHC3+‡ subgroup (N=294)
No. Deaths / n (%)	104/143 (73%)	96/151 (64%)
Median OS Duration (mos.)	13.2	18.0
95% CI (mos.)	(11.5. 15.2)	(15.5, 21.2)
Hazard ratio (95% CI)	0.66 (0.50, 0.87)

16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied

Herceptin is supplied in a multi‑use vial containing 440mg trastuzumab as a lyophilized sterile powder, under vacuum. Each carton contains one vial Herceptin® and one vial (20mL) of Bacteriostatic Water for Injection (BWFI), USP, containing 1.1% benzyl alcohol as a preservative. NDC 50242‑134‑68.
16.2 Stability and Storage

Vials of Herceptin are stable at 2–8°C (36–46°F) prior to reconstitution.

Do not use beyond the expiration date stamped on the vial. A vial of Herceptin reconstituted with BWFI, as supplied, is stable for 28days after reconstitution when stored refrigerated at 2–8°C (36–46°F). Discard any remaining multi‑dose reconstituted solution after 28days. A vial of Herceptin reconstituted with unpreserved SWFI (not supplied) should be used immediately and any unused portion discarded. Do Not Freeze Herceptin following reconstitution or dilution.

The solution of Herceptin for infusion diluted in polyvinylchloride or polyethylene bags containing 0.9% Sodium Chloride Injection, USP, should be stored at 2–8°C (36–46°F) for no more than 24hours prior to use.
17 PATIENT COUNSELING INFORMATION