Novoeight 全面概述：利用重组技术治疗血友病 A

Novoeight (Turoctocog alfa) is an antihemophilic factor VIII produced via recombinant technology. This medication is generally prescribed to treat or prevent bleeding episodes in patients with 血友病A. 

Patients with hemophilia A lack clotting factor VIII (a blood clotting protein), and Novoeight replaces the missing clotting factor VIII, thereby helping the blood to clot. 

Novoeight was first approved by the US Food and Drug Administration (FDA) in February 2013 due to its effective results in one of the largest 临床试验 to date.

This medication can only be obtained via a doctor’s prescription and is self-administered after training is received from a healthcare professional. 

What Is Novoeight Used To Treat?

Novoeight is used to treat hemophilia A in children and adults. It is used to:

• Control bleeding episodes in hemophilia A patients
• Reduce the frequency (number) of bleeding episodes in hemophilia A patients
• Prevent bleeding during minor or major surgery in patients with hemophilia A 

Novoeight cannot be used for the treatment of 血管性血友病 在患者中。

How Does Novoeight Work?

In patients with hemophilia A, clotting Factor VIII is either missing or does not work properly, which causes bleeding in joints, muscles, or internal organs. 

Novoeight contains an active substance, “Turoctocog alfa,” which mimics the function of naturally occurring coagulation factor VIII and helps the blood to form a clot. 

The recombinant Novoeight corrects the factor VIII deficiency by replacing the missing clotting factor VIII, thereby temporarily controlling the bleeding disorder.

有哪些剂型和强度？

Novoeight is available in lyophilized powder form in a single-dose vial with the following concentrations (strengths): 250, 500, 1000, 1500, 2000, and 3000 IU per vial. 

The powder is reconstituted with 4 ml of 0.9% sodium chloride solution. Each ml of reconstituted solution contains:

• 250 IU (62.5 IU/ml)
• 500国际单位（125国际单位/毫升） 
• 1,000 国际单位（250 国际单位/毫升）
• 1,500 IU (375 IU/ml)
• 2,000 国际单位（500 国际单位/毫升）
• 3,000 国际单位（750 国际单位/毫升）

What Is the Usual Dose for Patients With Hemophilia A?

剂量信息

The dosage of Novoeight is adjusted according to the patient’s body weight, frequency of bleeding episodes, severity of factor VIII deficiency, and the type of bleeding they are experiencing. 

For Minor-To-Moderate Bleeding or Minor Surgery

Maintain a plasma factor VIII activity level of 20% – 40% of normal IU in cases of minor bleeding, such as minor muscle or oral bleeding, and 30% – 60% of normal IU in cases of moderate bleeding, such as bleeding into the oral cavity or mild head trauma. Additional units of Novoeight are given every 12 – 24 hours until the bleeding is resolved.

For minor surgery such as tooth extraction, 30% – 60% of normal IU factor VIII activity level is administered every 24 hours for at least 1 day until healing is achieved. 

对于大出血或外科手术：

If a patient has major bleeding, maintain a plasma factor VIII activity level of 60% – 80% of normal IU, followed by a repeat dosage given every 8 to 24 hours until bleeding has resolved.

In major surgeries like joint replacement, trauma, or tonsillectomy, 60% – 80% of normal IU factor VIII activity level is given every 8 to 24 hours until adequate wound healing is achieved. 

Dosing for Routine Prophylaxis

The following are the recommended dosages of Novoeight to reduce the number (frequency) of bleeding episodes in children and adult patients with hemophilia A:

• For adults: 20 – 50 IU/kg of Novoeight three times a week or 20 – 40 IU/kg of Novoeight every other day.
• For children (under 12 years of age): 25 – 60 IU/kg of Novoeight three times a week or 25 – 50 IU/kg of Novoeight every other day.

How Is Novoeight Given?

Novoeight is given as an intravenous (via a vein) infusion (slowly over 2 to 5 minutes) directly into the bloodstream. 

What Are the Common Side Effects of Novoeight?

Along with its promising results in hemophilia A patients, Novoeight can cause some adverse effects. The most common side effects observed during clinical trials (≥ 1% of patients) are:

• Injection site reaction, such as swelling, itching, pain, or redness 
• 发热 (high fever)

Novoeight rarely causes hypersensitivity (allergic) reactions, and in some cases, they can progress into severe 过敏反应 (including anaphylactic shock). The early signs of allergic reactions, which can progress to anaphylaxis, may include:

• Rashes or hives
• 呼吸困难或吞咽困难
• Swelling of the lips and tongue
• Light-headedness
• Dizziness or loss of consciousness
• Pale and cold skin
• 心跳加快 
• Red or swollen face or hands 

If you experience these symptoms, discontinue use and consult your healthcare provider immediately to seek appropriate treatment. 

An allergic reaction could occur due to Factor VIII inhibitors — a type of antibody produced by the immune system against Factor VIII. Factor VIII inhibitors stop Novoeight from working properly, which results in the loss of bleeding control. 

Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.

What Precautions Should You Take While Taking Novoeight?

Always consult your healthcare provider before taking this medication. Tell your doctor if you:

• 怀孕或计划怀孕
• 正在哺乳
• Are allergic to any component of Novoeight recombinant product
• 对仓鼠蛋白过敏
• 正在服用任何药物，包括非处方药（草药）和膳食补充剂
• Have tested positive for Factor VIII inhibitors 

Does Novoeight Remain Stable at High Temperatures?

Yes, Novoeight has the longest duration of stability and can be stored at up to 104˚F for up to 3 months. It can also be stored for up to 12 months at 86˚F (room temperature). 

After reconstitution, you can store the medication for 2 hours at 104˚F and 4 hours at up to 86˚F.

成本

Novoeight (recombinant) intravenous powder costs around $12 for a supply of one lyophilized powder vial for injection. However, the cost can differ depending on the pharmacy you visit.