ST LOUIS (MD Consult) - On August 17, 2009, CSL Bering announced that the US Food and Drug Administration has approved Helixate FS for routine prophylaxis in children with hemophilia A aged ≤16 years who do not have preexisting joint damage. Use of Helixate FS is intended to reduce the frequency of bleeding episodes and the risk of joint damage. Helixate FS is a recombinant factor VIII product and is also indicated to control and prevent bleeding episodes in adults with hemophilia A.

For most assay sizes of Helixate FS, a 2.5-mL volume diluent is available. Albumin is not used in the formulation or purification of Helixate FS, and the manufacturing process includes a solvent/detergent viral-inactivation step. The product may be stored at room temperature (up to 25°C, 77°F) for 3 months.

The most serious adverse reactions associated with Helixate FS are systemic hypersensitivity reactions and the development of high-titer inhibitor levels, necessitating alternative treatments to antihemophilic factor. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion-site reactions, and line-associated infections in persons with central venous access devices.

圣路易斯（MD Consult）——2009年8月17日，CSL Bering公司宣布美国食品药品管理局（FDA）已批准Helixate FS作为常规预防药物用于16岁以下、无关节损伤史的甲型血友病儿童。应用Helixate FS旨在减少出血发作次数及关节损伤风险。Helixate FS是基因重组第VIII凝血因子，还适用于控制或预防甲型血友病成人患者出血发作。

在大多数Helixate FS检验规格中，2.5 ml 稀释液可购得。该药的配方或纯化过程中未使用白蛋白，生产制作过程包括有机溶剂法/清洁剂法病毒灭活步骤，可在室温（达25°C, 77°F）下储存3个月。

Helixate FS关联的最为严重的不良反应是全身超敏反应和产生高滴度抑制因子水平，因而不得不转为抗血友病因子替代治疗方案。临床试验中观察到的最常见不良反应为在无既往治疗史或极少接受治疗的患者中抑制因子的形成、皮肤相关的超敏反应、输注部位反应，以及采用中心静脉输液装置的患者发生的导管相关血流感染。

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