Esperoct: Uses, Side Effects, Dosage, and More

Esperoct is an FDA-approved injectable medicine used to treat and control bleeding episodes in people with 血友病A. It is also used to manage bleeding around surgery and to reduce the frequency of bleeding episodes in people with hemophilia A.  

介绍和用途

Esperoct is a brand-name prescription product. The active ingredient in this product is turoctocog alfa pegol. It is a lab-created form of factor VIII, also known as recombinant antihemophilic factor. 

Because the active ingredient is conjugated with a polyethylene glycol molecule, Esperoct stays in the body longer than standard half-life factor VIII products. This extends factor VIII activity in the body. 

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

A healthcare provider may prescribe Esperoct for adults and children with hemophilia A to:

• Treat and control bleeding episodes 
• Manage bleeding around surgery 
• Provide routine prophylaxis to reduce the frequency of bleeding episodes 

This medication should not be used to treat 血管性血友病 （血管性血友病）。. 

作用机制

People with hemophilia A have deficient or dysfunctional clotting factor VIII. Factor VIII is necessary for the blood-clotting process. Its deficiency can cause prolonged or spontaneous bleeding into the joints, muscles, or internal organs.

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

Esperoct 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。.

Esperoct comes as a white to off-white powder in single-dose vials. It is available in nominal dosage strengths of approximately 500, 1,000, 1500, 2,000, 3,000, 4,000, and 5,000 International Units (IU) per vial. The powder must be mixed with the provided sterile sodium chloride solution and is administered through intravenous infusion.  

Dosing of Esperoct To Control Bleeding Episodes

轻微出血: 40 IU/kg for patients 12 years or older and 65 IU/kg for patients younger than 12 years. A single dose is typically sufficient. 

中度出血: 40 IU/kg for patients 12 years or older and 65 IU/kg for patients younger than 12 years. An additional dose may be given after 24 hours. 

大出血: 50 IU/kg for patients 12 years or older and 65 IU/kg for patients younger than 12 years. Additional doses may be given approximately every 24 hours. 

手术用药 

小手术: 50 IU/kg for patients 12 years or older and 65 IU/kg for patients younger than 12 years before surgery. If required, additional doses may be given after 24 hours. 

大手术: 50 IU/kg for patients 12 years or older and 65 IU/kg for patients younger than 12 years before surgery. Additional doses may be given approximately every 24 hours for the first 7 days and then approximately every 48 hours until wound healing. 

Dosing for routine prophylaxis

Patients 12 years or older: The starting dose is 50 IU/kg every 4 days. Dosing frequency may be adjusted based on bleeding episodes.

Patients younger than 12 years: 65 IU/kg twice weekly. Dosing frequency may be adjusted based on bleeding episodes.

副作用

常见副作用

• 皮疹或瘙痒
• Swelling, pain, or redness at the injection site

Serious side effects include allergic reactions and the development of neutralizing antibodies (inhibitors) against factor VIII. Seek emergency medical care if you develop symptoms of a severe allergic reaction such as itching, hives, tightness of the chest, wheezing, or facial swelling. Call your healthcare provider immediately if your bleeding does not stop after taking Esperoct. This may be a sign that the medication is not working as intended. 

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 Esperoct. 

严重过敏反应

Seek emergency medical care if you experience any signs of an allergic reaction, such as:

• 麻疹
• 胸闷
• 哮鸣
• 头晕
• 呼吸困难
• 面部肿胀

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 this medication from working properly. Your healthcare provider will likely order tests to measure factor VIII inhibitors in your blood if:

• 开始治疗后，VIII因子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。

Before Taking Esperoct

Before using Esperoct, tell your healthcare provider if you:

• Have any known allergies 
• Have or have had any medical conditions
• 曾经或现在已开发出VIII因子抑制剂
• 正在哺乳
• 怀孕或计划怀孕

Don’t use Esperoct if you are allergic to factor VIII, any ingredients of Esperoct, or hamster 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. Ensure you are comfortable with the instructions prior to preparing the medication yourself.

• 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。
• Only take out the exact number of packages you need
• Bring the kit to room temperature
• Administer Esperoct 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。
• Your healthcare provider may order blood tests to monitor factor VIII activity and your response to treatment. 
• Check the reconstituted solution before infusion. It should be clear and colorless, with no visible particles.
• Use the reconstituted solution immediately. If you cannot, use it within 4 hours when stored at or below 86ºF (30°C) or within 24 hours when stored in a refrigerator at 36°F to 46°F (2°C to 8°C).
• If you miss a dose, infuse the missed dose as soon as you remember. Never use a double dose to make up for a missed dose. 
• Call your healthcare provider immediately if you infuse more than the prescribed dose. 

存储和搬运

• Store the unmixed vials in the original container protected from light. 
• 不要冷冻。. 
• You may store it in a refrigerator at 36°F to 46°F (2°C to 8°C) for up to 30 months until expiration. 
• Until expiration, you may store it at room temperature (don’t exceed 86°F or 30°C) for up to 12 months, or up to 3 months at temperatures not exceeding 104°F (40°C).
• If you choose to store this medication at room temperature, never put it back in the refrigerator. 

Esperco Cost and Financial Assistance 

Cost can vary depending on your prescribed dose, treatment frequency, insurance coverage, location, and pharmacy. Contact your insurance provider to find out if your plan covers Esperoct or requires prior authorization.

Manufacturer assistance programs or other financial assistance may be available to eligible patients and could help reduce out-of-pocket costs. 联系我们 if you are interested in exploring financial assistance or copay assistance for Esperoct.