BeneFIX：用途、剂量、副作用和安全性

BeneFIX injection is used to control active bleeding episodes, manage bleeding around surgery, and reduce the frequency of bleeding episodes in people with 血友病B. 

BeneFIX Introduction and Uses

BeneFIX is a brand-name prescription product. It contains the active ingredient recombinant coagulation factor IX. 

This medication belongs to the drug class known as coagulation factors or hemostatics.

医疗保健提供者可能会为患有B型血友病的儿童和成人开具此药，以：

• 治疗和控制出血事件 
• 处理手术周围出血 
• 减少出血频率

患有乙型血友病的人由于缺乏凝血因子IX，血液无法正常凝固。凝血因子IX缺乏会导致受伤或手术后出现异常出血。重度乙型血友病可能导致自发性关节或肌肉出血。. 

BeneFIX is not indicated for immune tolerance induction in people with hemophilia B. 

BeneFIX comes as a white powder in single-use vials. The powder must be mixed with the provided liquid (diluent) before infusion into a vein. 

Each BeneFIX kit contains:

• Single-use vial
• Sterile pre-filled diluent syringe
• Vial adapter reconstitution device
• Sterile infusion set
• 两份酒精棉片
• Bandage
• Gauze pad

美国具有以下优势：

• 250国际单位
• 500国际单位
• 1,000 国际单位
• 2,000 国际单位
• 3,000 国际单位

BeneFIX Mechanism of Action

BeneFIX temporarily replaces the missing clotting factor IX. This helps restore the clotting process and control bleeding. 

Before Taking BeneFIX

Before you receive your first dose of BeneFIX for hemophilia B, inform your healthcare provider if you:

• Are allergic to any factor IX product or hamster proteins
• 是否有或曾经患有任何疾病
• Have or have previously developed factor IX inhibitors
• 正在哺乳
• 怀孕或计划怀孕

Don’t use BeneFIX if you are allergic to factor IX, any ingredients of this product, or hamster proteins. 

BeneFIX Dosing

Before administering BeneFIX, your healthcare provider will use a specific formula to determine the initial dose. The dose and duration of the treatment depend on:

• 年龄
• 体重
• IX因子缺乏的严重程度
• 期望的因子IX水平
• 患者病情
• 出血部位和程度

Dosing of BeneFIX to Control Bleeding Episodes and Manage Bleeding Around Surgery

轻微出血: The dose is calculated to achieve a factor IX activity of 20% to 30% of normal. May be repeated every 12 to 24 hours. Treatment lasts 1 to 2 days. 

中度出血: The dose is calculated to achieve a factor IX activity of 25% to 50% of normal. May be repeated every 12 to 24 hours. Treatment lasts until bleeding stops or healing occurs. This is typically 2 to 7 days. 

大出血: The dose is calculated to achieve a factor IX activity of 50% to 100% of normal. May be repeated every 12 to 24 hours. Treatment lasts 7 to 10 days. 

预防出血发作的常规用药剂量

For long-term protection against bleeding, the recommended dose is 100 IU/kg once weekly. Your healthcare provider may adjust the dose or frequency based on your clinical response. 

正确使用

• 请务必按照说明使用此药或任何其他药物。. 
• Your healthcare provider may administer BeneFIX or teach you how to prepare and self-administer the medication. 
• Ask your doctor or pharmacist if you have problems understanding any part of the Instructions for Use. 
• The reconstituted solution should be clear and colorless. If it is not, don’t use it. 
• Use the reconstituted solution immediately or within 3 hours of mixing. 
• If you miss a scheduled dose, contact your healthcare provider for instructions. 
• Call your healthcare provider immediately if you take more than the prescribed dose. 
• Call your healthcare provider immediately if your bleeding does not stop after taking this medication. This may be a sign that the medication is not working as intended.

BeneFIX Storage and Handling

• Store BeneFIX at room temperature or in a refrigerator, between 2 and 30°C (36 and 86°F).
• 不要冷冻。.
• Don’t use BeneFIX after the expiration date stated on the label.

BeneFIX Side Effects

常见副作用

• 发烧
• 咳嗽
• 恶心
• Pain, swelling, or redness at the injection site
• 头痛
• 头晕 
• 皮疹

过敏反应

如果您有以下情况，请寻求紧急医疗护理：

• 哮鸣
• 呼吸困难
• 胸闷
• Bluish lips and gums
• 心跳加快
• 面部肿胀
• 皮疹
• 麻疹

抑制剂（抗体）的产生

Your healthcare provider will likely order tests to measure factor IX inhibitors in your blood if:

• 开始治疗后，因子IX水平并未如预期般升高。
• 即使服用适当剂量，出血也无法停止。

血管阻塞引起的并发症

凝血因子IX产品可能会增加血管被循环血栓阻塞的风险。如果您通过大静脉接受持续输注，风险可能会更高。. 

Contact your healthcare provider immediately if you have:

• 胸痛
• 呼吸困难
• Leg tenderness
• 肿胀

BeneFIX Cost and Financial Assistance 

The amount you pay for BeneFIX can vary depending on your prescribed dose, treatment frequency, insurance coverage, pharmacy, and location. Because BeneFIX dosing is individualized, treatment costs can vary between patients.

Contact your insurance provider to find out if your plan covers BeneFIX or requires prior authorization. Insurance coverage and patient assistance programs may help reduce your out-of-pocket costs. 联系我们 如果您有兴趣了解经济援助或 copay assistance for BeneFIX.