Xyntha is an FDA-approved prescription medication for adults and children with 血友病A that replaces clotting factor VIII to help prevent and control bleeding. Hemophilia A (经典血友病) is an inherited bleeding disorder caused by a deficiency or dysfunction of clotting factor VIII.
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Xyntha Introduction and Uses
Xyntha is a brand-name prescription product. The active ingredient in this product is recombinant antihemophilic factor (rAHF), which is also known as coagulation factor VIII or moroctocog alfa.
Xyntha belongs to a drug class called coagulation factors.
医疗保健提供者可能会为患有A型血友病的儿童和成人开具此药物，以：
- 出血发生时应立即进行治疗和控制。
- 术前、术中和术后出血管理
- 通过常规预防性治疗减少出血发作的频率
Xyntha is not indicated for the treatment of von Willebrand disease (VWD).
Xyntha comes as a white to off-white powder in single-use vials. Each vial contains 250, 500, 1,000, or 2,000 International Units (IU) of the active drug.
Each Xyntha vial kit contains:
- 4 ml 0.9% Sodium Chloride with plunger rod for assembly
- One vial adapter
- 一套无菌输液装置
- 两份酒精棉片
- 一块绷带
- 一块纱布垫
- 一份包装说明书
The powder must be mixed with the sodium chloride solution before intravenous (IV) infusion.
作用机制
People with hemophilia A have deficient or dysfunctional clotting factor VIII. Factor VIII plays an important role in the blood-clotting process, and a deficiency can lead to prolonged or spontaneous bleeding, including bleeding into the joints and muscles.
Xyntha works by temporarily replacing the missing clotting factor VIII in the blood, helping the blood form clots and control bleeding.
Before Using Xyntha
Before you receive your first dose of Xyntha, inform your healthcare provider if you are:
- Allergic to Xyntha, any of its ingredients, or hamster proteins, which may be present in trace amounts
- Pregnant or planning to become pregnant
- 母乳喂养或计划母乳喂养
Important Xyntha Warnings
过敏反应
This medicine may cause serious allergic reactions, including 过敏反应. Anaphylaxis is a potentially life-threatening allergic reaction that can cause breathing problems, swelling, a rapid heartbeat, faintness, or low blood pressure.
Stop using this medication and seek immediate medical care if you develop the following symptoms after receiving Xyntha:
- 皮疹和瘙痒
- 嘶哑
- 呼吸困难
- 吞咽困难
- 手、脸或嘴肿胀
- 胸闷
- 低血压
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Factor VIII Inhibitor Development
Some people can develop antibodies called factor VIII inhibitors, which may reduce or prevent Xyntha from working effectively.
Your healthcare provider may order blood tests to check for factor VIII inhibitors if:
- Your factor VIII levels do not increase as expected after treatment
- 即使使用适当剂量，出血也无法控制。
剂量
您的医疗保健提供者会根据您的体重、您希望增加的VIII因子活性、临床反应和治疗需求来计算您的剂量。请务必使用专门为您开具的剂量。.
治疗剂量和持续时间取决于：
- VIII因子缺乏症的严重程度
- 出血的部位和程度
- 出血事件或手术的类型
- 您的临床状况和治疗反应
Dosing for On-Demand Treatment and Control of Bleeding Episodes
轻微出血: The dose is individualized to achieve a factor VIII activity level of approximately 20% to 40% of normal. Treatment may be repeated every 12 to 24 hours for at least 1 day, depending on the severity of bleeding.
中度出血: The dose is individualized to achieve a factor VIII activity level of approximately 30% to 60% of normal. Treatment may be repeated every 12 to 24 hours for 3 to 4 days or until bleeding is adequately controlled.
大出血: The dose is individualized to achieve a factor VIII activity level of approximately 60% to 100% of normal. Treatment may be repeated every 8 to 24 hours until the bleeding is controlled.
术中预防出血的用药
小手术: The dose is individualized to achieve a factor VIII activity level of approximately 30% to 60% of normal. Treatment may be repeated every 12 to 24 hours as directed by the healthcare provider.
大手术: The dose is individualized to achieve a factor VIII activity level of approximately 60% to 100% of normal. Treatment may be repeated every 8 to 14 hours until adequate wound healing is achieved.
Dosing for Routine Prevention of Bleeding Episodes
建议的起始治疗方案包括：
- Adults and adolescents 12 years or older: 30 IU/kg IV three times weekly
- Children younger than 12 years: 25 IU/kg IV every other day
12 岁以下的儿童可能需要更高剂量或更频繁的用药，因为药物可能更快地从他们体内清除。.
您的医疗保健提供者将根据您的出血模式、VIII 因子水平和临床反应调整剂量或频率。.
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关于共付额援助副作用
Xyntha常见的副作用包括：
- Nausea, vomiting, diarrhea
- 头痛
- 头晕
- 关节疼痛
- 皮疹
- 咽喉痛
- 咳嗽
- 鼻塞
- 弱点
- 疲劳
- 发烧
- Pain, swelling, or itching at the injection site
Serious risks of Xyntha include severe allergic reactions and the development of factor VIII inhibitors. Contact your healthcare provider if bleeding is not adequately controlled after receiving Xyntha or if you experience an increase in bleeding episodes. These may be signs that factor VIII inhibitors have developed.
Seek immediate medical attention if you experience symptoms of a serious allergic reaction, such as difficulty breathing, chest tightness, swelling of the face or mouth, or severe dizziness or fainting.
Xyntha Administration and Proper Use
Use Xyntha exactly as prescribed by your healthcare provider. You may receive your first dose in a hospital, clinic, or treatment center. If home treatment is appropriate, your healthcare provider will teach you how to prepare and administer the medication safely.
- 请阅读并遵循产品随附的使用说明。
- 洗手后在干净的表面上操作。
- 让试剂盒达到室温。
- Use only the supplies provided with Xyntha or recommended by your healthcare provider
- Inspect the reconstituted solution before infusion; it should be clear to slightly opalescent and colorless
- 如果溶液中含有颗粒或出现变色，请勿使用。
如果出现以下情况，请立即联系您的医疗保健提供者：
- 治疗后出血情况未得到控制
- 你服用的剂量超过了规定的剂量。
- 您在配制或输注药物时遇到困难
出行前，请咨询您的医疗保健提供者，并携带足够整个旅程所需的药品和输液用品。.
Xyntha Storage and Handling
- Store unopened Xyntha in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 36 months from the date of manufacture, but not beyond the labeled expiration date.
- 在标签所示的有效期内，该药物可在室温（不超过 25°C (77°F)）下保存长达 3 个月。.
- 在纸箱提供的空白处记录室温储存的开始日期。.
- 药物在室温下存放 3 个月后，请立即使用或丢弃。.
- 药物在室温下保存后，请勿再放回冰箱。.
- 请勿在药品标签所示的有效期后或在室温下存放 3 个月后使用，以先到者为准。.
- Do not freeze Xyntha.
- 避免长时间暴露在光线下。.
- 复溶后，将注射器直立放置于室温下，直至使用。.
- 配制后的溶液应在 3 小时内或取下灰色橡胶尖端帽后注入。.
- Discard the reconstituted solution if it has not been used within 3 hours.
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Cost and Financial Assistance
Cost can vary depending on your insurance plan, location, and pharmacy. Contact your insurance provider to find out if your plan covers this medication or if you need prior authorization. If cost is a concern, 联系我们 to learn more about financial or copay assistance for Xyntha.
