英文药名: Xyntha(Antihemophilic Factor Injection)

中文药名: 抗血友病因子注射剂

药品介绍

Xyntha(抗血友病因子(重组),无血浆/白蛋白)
批准日期：2008年2月21日；
公司：Wyeth Pharmaceuticals Inc.

一般描述：
 
抗血友病因子(重组)，无血浆/白蛋白，XYNTHA中的活性成分。是一种用重组DNA技术生产的重组第VIII凝血因子，为第VIII凝血因子缺乏症治疗中使用。XYNTHA中的抗血友病因子(重组)，无血浆/白蛋白是已知纯化的糖蛋白，分子质量接近170 kDa，由1438个氨基酸组成，不含B-结构区。XYNTHA抗血友病因子(重组)无血浆/白蛋白的氨基酸序列与人第VIII凝血因子的型式有可比性，分子质量90 80 kDa。XYNTHA中抗血友病因子(重组)无血浆/白蛋白，被遗传工程中国仓鼠卵巢血浆(CHO)细胞株分泌。细胞株 is grown in a 化学上确定含重组胰岛素细胞培养介质中生长，但不含任何从人或动物来源任何材料。用一种工艺纯化XYNTHA中抗血友病因子(重组)无血浆/白蛋白， 其中包括一系列层析步骤，其中一步用基于专利合成多肽亲和配基的亲和层析。工艺还包括溶剂-去垢剂病毒灭活步骤和保留病毒毫微米过滤步骤。

适应症：
XYNTHA是一种抗血友病因子适用于：
1. 在血友病A患者中控制和预防出血发作。
2. 在血友病A患者中手术预防。

用法用量：
用下列公式确定需要的剂量：
*需要的单位 = 体重(kg) × 需要第VIII凝血因子升高(IU/dL或正常的%) × 0.5 (IU/kg / IU/dL)
静脉注射配制产品的频数决定于出血发作的类型和推荐的治疗医生。

剂型和规格： XYNTHA粉为在单次使用小瓶中250、500、1000、或2000 IU。

注意事项：
1. 可能有过敏反应和严重超过敏反应。这类反应发生时，应中断治疗和应给予适当治疗。
2. 接受含第VIII凝血因子产品患者中曾检测到发生活性-中和抗体。如未达到期望的血浆第VIII凝血因子活性水平，或如用适当剂量出血未被控制，应进行用一种测定第VIII凝血因子抑制剂浓度的分析。
3. 患者可能发生对产品中存在含量的仓鼠蛋白超敏。

不良反应
最常见不良反应在研究1中(24%受试者)是头痛和在研究2是发热 (41%受试者)。
研究过程期间2/89例受试者(完成50天暴露)发生抑制剂。89例受试者完成50天暴露观察到2例抑制剂与用XYNTHA抑制剂形成率的概率95%一致，低于用贝叶斯分析4.17%。

Xyntha prefilled dual-chamber syringe approved for hemophilia A treatment
Pfizer announced that the FDA has approved a prefilled dual-chamber syringe for administration of Xyntha (antihemophilic factor [recombinant]). The device will be used to deliver Xyntha by intravenous infusion after reconstitution of a freeze-dried powder with the diluent (0.9% sodium chloride), which are both supplied within the prefilled dual-chamber syringe.

The first prefilled dual-chamber syringe to be available will provide 3000 IU of Xyntha in 4mL. Other dosages of Xyntha will be available in the prefilled dual-chamber syringes in 2011.

Xyntha is a recombinant factor VIII product indicated for both the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A.

XYNTHA
Generic Name for XYNTHA
Antihemophilic Factor (recombinant): nominally 250 IU, 500 IU, 1000 IU, or 2000 IU per vial; pwd for IV infusion after reconstitution; plasma/ albumin-free; preservative-free; contains polysorbate 80. Actual factor VIII activity noted on each vial.

Legal Classification:
Rx

Pharmacological Class for XYNTHA
Clotting factor.

Manufacturer of XYNTHA
Pfizer Labs
Indications for XYNTHA
In Hemophilia A: to control bleeding episodes, and for surgical prophylaxis.

Adult dose for XYNTHA
Individualize and titrate. Give by IV infusion over several minutes. One IU of factor VIII per kg raises the plasma factor VIII activity by about 2 IU/dL. Minor bleeds: factor VIII level required is 20–40 IU/dL or % of normal, repeat infusion every 12–24 hours as needed for at least 1 day, until resolution. Moderate bleeds: 30–60 IU/dL or % of normal; repeat infusion every 12–24 hours for 3–4 days or until hemostasis. Major bleeds: 60–100 IU/dL or % of normal, repeat infusion every 8–24 hours until resolution. Minor surgical procedures: 30–60 IU/dL or % of normal, repeat infusion every 12–24 hours for 3–4 days or until hemostasis. Major surgery: 60–100 IU/dL or % of normal; repeat infusion every 8–24 hours until hemostasis and wound healing occurs.

Children's dosing for XYNTHA
Consult manufacturer (limited pharmacokinetic data available; studies are ongoing).

Warnings/Precautions for XYNTHA
Monitor for development of Factor VIII inhibitors; may need dose adjustment. Pregnancy (Cat.C). Labor & delivery. Nursing mothers.

Adverse Reactions for XYNTHA
Hypersensitivity reactions/anaphylaxis, pyrexia, headache, GI upset, asthenia.

How is XYNTHA supplied?
Kit—1 (w. diluent, supplies)

Related Disease:
Hemophilia A