Recombinate：用途、剂量、副作用、储存和给药

Recombinate is an FDA-approved intravenous (IV) factor VIII replacement therapy used to control bleeding episodes in people with 血友病A. It is also used to manage bleeding before, during, and after surgery in people with hemophilia A. 

Recombinate Introduction and Uses

Recombinate is a brand-name prescription product. The active ingredient is a lab-made form of factor VIII, also known as antihemophilic factor, a natural clotting protein found in blood. Recombinate does not contain any human blood products. 

Recombinate belongs to the drug class called coagulation factors or hemostatics. 

A healthcare provider may prescribe Recombinate for people with hemophilia A to control bleeding episodes or manage bleeding around surgery. 

Recombinate is not indicated for the treatment of 血管性血友病 （血管性血友病）。.  

Availability note: Takeda has announced the global discontinuation of Recombinate and previously stated that it intended to continue supplying the medication to existing patients until inventory was depleted or expired in mid-2026. Patients currently using Recombinate should speak with their healthcare provider about product availability and whether a transition to another factor VIII therapy is needed. 

Recombinate Mechanism of Action

患有血友病 A 的人体内凝血因子 VIII 缺乏或功能异常。因子 VIII 是血液凝固过程所必需的，缺乏因子 VIII 会导致关节、肌肉或内脏器官出现持续性或自发性出血。.

Recombinate works by temporarily replacing the missing clotting factor VIII in the blood, helping the blood form clots and control bleeding.

Recombinate Dosing

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。.

Recombinate comes as an off-white to faint yellow powder in single-dose vials. It is available in nominal dosage strengths of approximately 250, 500, 1,000, 1,500, and 2,000 International Units (IU) per vial. The powder must be mixed with an appropriate volume of Sterile Water for Injection before intravenous (IV) infusion. Your provider will use a vial size that is appropriate for your calculated dose.

Dosing for Treatment of Bleeding Episodes 

Mild bleeding: The dose is individualized to achieve a post-infusion factor VIII activity level of approximately 20% to 40% of normal. It is administered every 12 to 24 hours for 1 to 3 days until healing is achieved or the bleeding is adequately resolved. 

中度出血: The dose is individualized to achieve a post-infusion factor VIII activity level of approximately 30% to 60% of normal. Treatment may be repeated every 12 to 24 hours for 3 days or more until pain or disability is resolved. 

危及生命的出血: The dose is individualized to achieve a post-infusion factor VIII activity level of approximately 60% to 100% of normal. Treatment may be repeated every 8 to 24 hours until the threat no longer exists. 

Dosing for Surgery

小手术: The dose is individualized to achieve a post-infusion factor VIII activity level of approximately 60% to 80% of normal. According to the prescribing information, a single infusion plus oral antifibrinolytic therapy within 1 hour is sufficient in approximately 70% of cases. 

大手术: The dose is individualized to achieve a factor VIII activity level of 80% to 100% of normal (pre- and post-operative). Treatment may be repeated every 8 to 24 hours. 

Recombinate Side Effects

常见副作用

In clinical studies, the most commonly reported side effects included:

• 发冷
• 冲洗
• 皮疹
• 流鼻血

Other side effects reported during clinical trials included nausea, fatigue, fever, dizziness, itching, pain in an extremity, and low blood pressure.

Serious risks include severe allergic reactions and the development of factor VIII inhibitors. Contact your healthcare provider right away if bleeding does not stop after using Recombinate, as this may be a sign that the medication is not working as expected. Seek immediate medical care if you develop symptoms of a severe allergic reaction. 

Recombinate Important Information and Warnings

Never attempt to inject this medication on your own unless you know how to safely administer it. Carefully follow your healthcare provider’s instructions about the dose and schedule for administering Recombinate. 

严重过敏反应

Recombinate may cause serious allergic reactions, including 过敏反应. Anaphylaxis is a potentially life-threatening allergic reaction that can cause difficulty breathing, swelling, chest tightness, wheezing, or low blood pressure.

Stop using Recombinate and seek immediate medical care if you develop symptoms of a severe allergic reaction, such as:

• 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

抑制剂（抗体）的产生

In some cases, your body can develop proteins called inhibitors (antibodies) against factor VIII, which can prevent Recombinate from working well to treat or prevent bleeding. Inhibitor development is an important concern, particularly in previously untreated patients. 

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

• Factor VIII level doesn’t increase as expected after starting treatment
• Bleeding doesn’t stop with an appropriate dose

Before Taking Recombinate

Before using Recombinate, tell your healthcare provider if you:

• Are allergic to Recombinate, any of its ingredients, or mouse, hamster, or bovine proteins
• Have or have previously developed factor VIII inhibitors
• 怀孕或计划怀孕
• 正在哺乳或计划哺乳 

Don’t use Recombinate if you have a known hypersensitivity to Recombinate, any of its ingredients, or mouse, hamster, or bovine proteins. 

正确使用

Use this or any medication exactly as directed. 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。
• Administer Recombinate at room temperature and follow your healthcare provider’s instructions for the infusion rate. Do not infuse faster than instructed. 
• 请仅使用医疗保健提供者提供或特别推荐的用品。
• You may need blood tests after receiving Recombinate to help determine if the blood level of factor VIII is enough for clot formation. 
• Check the reconstituted solution before infusion. It should be colorless to faint yellow and substantially free of visible particles.
• Do not use the solution if it is discolored or contains visible particles.
• If you miss a scheduled dose, contact your healthcare provider for instructions. Do not change your dose or treatment schedule unless instructed to do so. 

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

Recombinate Storage and Handling

• Store unopened Recombinate in a refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature up to 30°C (86°F). Keep the vials in their original box and protect them from extreme exposure to light. 
• Don’t freeze. 
• If you choose to store this medication at room temperature, keep it at room temperature until infusion and never put it back in the refrigerator. 
• Use the reconstituted solution within 3 hours. Don’t store or refrigerate the reconstituted solution. 
• Safely throw away any drug left in the vial at the end of the infusion. 

Recombinate Cost and Financial Assistance

费用可能因您的保险计划、所在地区和药房而异。请联系您的保险公司，了解您的计划是否涵盖此药物，或者您是否需要事先获得授权。如果您担心费用问题，, 联系我们 to explore financial assistance and copay assistance for Recombinate.