Alprolix: A Comprehensive Guide to Uses, Dosage, Side Effects, and Safety

Alprolix injection is a long-acting coagulation factor IX (recombinant) used to treat bệnh máu khó đông B in children and adults. In this article, you will learn about its mechanism of action, dosage, side effects, cost, and more.

Before Using Alprolix

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

• Are pregnant or planning to get pregnant
• Đang cho con bú
• Have proteins called inhibitors, which can stop this medication from working well

Cảnh báo và Phòng ngừa

Phản ứng dị ứng

Alprolix injections may cause allergic reactions, which can be fatal. Seek emergency medical care if you experience:

• Nổi mề đay
• Khó thở
• Sưng ở mặt hoặc cổ họng

Sản xuất chất ức chế (kháng thể)

In some cases, your body can produce proteins called “inhibitors” or antibodies, which can prevent this medication from working as intended.

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

• Factor IX level does not increase as expected after starting treatment
• Bleeding does not stop with an appropriate dose

Complications Due to Blocked Blood Vessels

Factor IX products may increase the risk of a blood vessel being blocked by a circulating blood clot. The risk may be higher if you receive continuous infusions through a large vein. 

Thus, Alprolix is administered as a bolus infusion (rapid injection) over several minutes. 

Alprolix Introduction and Uses

Alprolix injection is a brand-name prescription product. It contains the active ingredient “recombinant coagulation factor IX”, also called eftrenonacog alfa. 

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

A healthcare provider may prescribe this medication for children and adults with hemophilia B to:

• Kiểm soát và ngăn ngừa các đợt chảy máu
• Ngăn ngừa chảy máu trong khi phẫu thuật
• Giảm tần suất chảy máu

In people with hemophilia B, blood doesn’t clot properly, as they have a coagulation factor IX deficiency. Factor IX deficiency causes abnormal bleeding after injuries or surgery. Severe hemophilia B may cause spontaneous joint or muscle bleeds. 

Alprolix should not be used to remove inhibitors in people with hemophilia B. 

The US FDA approved Alprolix (then made by Biogen Idec) to treat hemophilia B in 2014. Currently, Bioverativ Therapeutics Inc., a Sanofi Company, makes this medication. 

This medication comes as a sterile white to off-white powder that must be reconstituted into a solution for intravenous (IV) injection. There are three components in an Alprolix kit:

• One single-dose glass vial, which contains powder of factor IX and the Fc molecule
• One prefilled syringe containing 5 ml liquid, also called a diluent
• One reconstitution device (which is used to mix the powder and liquid before administration)

Các loại thuốc sau đây hiện có tại Hoa Kỳ:

• 250 IU
• 500 IU
• 1.000 IU 
• 2.000 IU
• 3.000 IU 
• 4.000 IU

Alprolix Mechanism of Action

This medication works by replacing missing coagulation factor IX in people with hemophilia B. It comprises two components:

1. Factor IX (helps stop bleeds)
2. Fc Molecule (helps factor IX recirculate in the bloodstream)

This fusion extends Alprolix’s half-life, allowing for less frequent administration. 

Alprolix Dosing 

Before administering Alprolix for hemophilia, your healthcare provider will use a specific formula to determine the dose. Then they will prepare the medication according to the instructions in the package insert.

The dose and duration of the treatment depend on:

• Tuổi
• Cân nặng cơ thể
• Mức độ nghiêm trọng của tình trạng thiếu hụt yếu tố IX
• Desired factor IX level
• Patient’s condition
• Vị trí và mức độ chảy máu

Alprolix Dosing for Control of Bleeding Episodes

Minor and moderate bleeding: The dose is calculated to achieve a factor IX level of 30% – 60% of normal. May be repeated every 48 hours if there is evidence of bleeding. 

Major bleeding: The dose is calculated to achieve a factor IX level of 80% – 100% of normal. May be repeated after 6 – 10 hours, then every 24 hours for 3 days, then every 48 hours until bleeding is resolved.

Alprolix Dosing for Preventing Bleeding During Surgery

Minor surgery: A single infusion to achieve a factor IX level of 50 – 80 IU/dL. Repeat after 24 – 48 hours until bleeding stops.

Major surgery: Initial infusion to achieve a factor IX level of 60 – 100 IU/dL. May be repeated after 6 – 10 hours and then every 24 hours for the first 3 days, then every 48 hours until bleeding stops.

Alprolix Dosing for Routine Prevention of Bleeding Episodes

The typical starting doses are:

• For individuals 12 years or older: 50 IU/kg once weekly or 100 IU/kg every 10 days
• For individuals up to 11 years: 60 IU/kg once weekly

Children younger than 12 years may need more frequent or higher doses. For individuals 12 years or older, dose adjustment is not usually necessary.

Alprolix Proper Use

• Use this or any medication exactly as directed. 
• You will likely receive your first dose in a hospital or clinic setting. 
• Then, your healthcare provider will teach you how to prepare and self-administer this medication. 
• Ask your doctor or pharmacist if you have problems understanding any part of “Instruction for Use.”

Alprolix Storage and Handling

Before Preparing the Solution

• Bảo quản trong bao bì gốc để tránh tiếp xúc với ánh nắng mặt trời.
• Duy trì nhiệt độ bảo quản từ 2°C đến 8°C (36°F đến 46°F). Tránh đông lạnh.
• You may store this medication at room temperature (maximum temperature of 30°C or 86°F) for up to 6 months. The expiration date should be printed on the label.
• Nếu bạn bảo quản thuốc này ở nhiệt độ phòng, hãy ghi lại ngày lấy thuốc ra khỏi tủ lạnh.
• Khi sản phẩm đã đạt đến nhiệt độ phòng, tránh để sản phẩm trở lại tủ lạnh.
• Never use Alprolix beyond the expiration date printed on the vial or 6 months after storage at room temperature.

After Preparing the Solution

• Bạn có thể bảo quản dung dịch ở nhiệt độ phòng (nhiệt độ tối đa 30°C hoặc 86°F) trong tối đa 3 giờ. Tránh tiếp xúc trực tiếp với ánh nắng mặt trời.
• Bỏ dung dịch nếu không sử dụng trong vòng 3 giờ sau khi pha.
• Không bao giờ sử dụng dung dịch có cặn hoặc có vật chất dạng hạt.
• Vứt bỏ bất kỳ sản phẩm nào không sử dụng.

Alprolix Side Effects

Tác dụng phụ có thể nhẹ hoặc nặng. 

Các tác dụng phụ phổ biến nhất ở những người đã được điều trị trước đó có thể bao gồm:

• Đau đầu
• Tingling or burning in the mouth
• Chóng mặt
• Mệt mỏi
• Giảm cảm giác thèm ăn
• Huyết áp thấp
• Obstructed urine flow

Các tác dụng phụ phổ biến nhất ở những người chưa được điều trị trước đó có thể bao gồm:

• Sản xuất chất ức chế (kháng thể)
• Pain, redness, or itching at the injection site
• Dị ứng

Alprolix Cost

Chi phí có thể thay đổi tùy thuộc vào gói bảo hiểm, địa điểm và hiệu thuốc của bạn. Liên hệ với nhà cung cấp bảo hiểm của bạn để tìm hiểu xem gói bảo hiểm của bạn có chi trả cho loại thuốc này hay bạn cần được chấp thuận trước.

Sanofi, the manufacturer of Alprolix, offers three financial assistance programs to help you access treatment:

Alprolix Free Trial Plus Program: With this program, you may be able to get a FREE 30-day supply with a valid prescription from your healthcare provider.

Alprolix Factor Access Program: This program can help you access treatment even if your insurance is interrupted.

Alprolix Sanofi Copay Program: Contact a Sanofi case manager at 1-833-723-5463.

To explore these programs or apply for copay assistance, contact our team at AmeriPharma for financial assistance.