Alprolix

Pronunciation: al-pro-lix
Generic name: Coagulation Factor IX (Recombinant), Fc Fusion Protein
Dosage form: lyophilized powder for solution for intravenous injection
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 13, 2024.

What is Alprolix?

Alprolix is used to help control and prevent bleeding in people with hemophilia B (congenital Factor IX deficiency). Alprolix is a coagulation Factor IX concentrate that replaces the missing or low levels of Factor IX; this helps control bleeding episodes, manage bleeding in surgery, and can be used regularly to prevent bleeding episodes. Coagulation Factor IX is sometimes written as coagulation Factor 9.

Alprolix is a recombinant Factor product, which means it is developed in a laboratory and is not human plasma derived from donor-sourced plasma.

Hemophilia B is a genetic disorder that causes low levels of a clotting protein called Factor IX, this causes individuals to bleed for a longer time than other people. External bleeding can be due to dental procedures, minor cuts, or trauma and can also involve internal bleeding into joints and muscles.

Alprolix FDA approval was received on March 28, 2014, for the company Biogen Idec. It is now manufactured for Bioverativ Therapeutics Inc. which is a Sanofi Company.

Alprolix side effects

Common side effects of Alprolix

Common Alprolix side effects may include nausea, headache, dizziness, altered sense of taste, mild skin rash, or pain, redness, itching, stinging, or other irritation where the medicine was injected.

Serious side effects of Alprolix

Get emergency medical help if you have signs of an allergic reaction: hives, itching; wheezing, tightness in your chest, difficult breathing, fast heartbeats, blue lips, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Alprolix may cause other serious side effects. Call your doctor at once if you have:

weight gain, swelling in your waist, hands, or lower legs;
loss of appetite;
fever or chills;
continued bleeding after treatment;
new or worsened bleeding; or
signs of excessive blood clotting--sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance, chest pain, coughing up blood, or pain, swelling, warmth, and redness in one or both legs.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warnings

You should not use Alprolix if you are allergic to Alprolix or any of the other ingredients. Tell your healthcare provider if you have had an allergic reaction to any Factor IX product prior to using Alprolix.

Before using this medicine

Tell your doctor about all of your medical conditions, including if you:

have been told that you have inhibitors to Factor IX (because Alprolix may not work for you).

Pregnancy

Tell you healthcare provider if you are pregnant or planning to become pregnant. It is not known if Alprolix may harm your unborn baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. It is not known if Alprolix passes into breast milk or if it can harm your baby.

How should I use Alprolix?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may receive your first dose in a hospital or clinic setting to quickly treat any serious side effects.

Alprolix is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Alprolix Administration

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Alprolix must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.

The mixture should appear clear, yellow, or colorless. Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Gently swirl but do not shake the medicine while mixing or you may ruin the medicine. Use the injection within 3 hours after mixing your dose.

You may need frequent blood tests.

In case of emergency, wear or carry medical identification to let others know you have a bleeding disorder.

Alprolix Dosing information

On-demand treatment and control of bleeding episodes:

Initial Dose: Type of Bleeding	Target Circulating FIX (IU/dL)	Dosing Interval (hours)
Minor and Moderate	30–60	Repeat every 48 hours as needed if there is further evidence of bleeding.
Major	80–100	Consider repeat dose after 6–10 hours, then every 24 hours for 3 days, then every 48 hours until healing achieved.

Perioperative management:

Minor surgery: a single infusion to reach FIX level of 50–80 IU/dL may be sufficient. Repeat as needed after 24–48 hours until bleeding stops and healing is achieved.
Major surgery: initial infusion to reach FIX level of 60–100 IU/dL. Consider a repeat dose after 6–10 hours and then every 24 hours for the first 3 days, then every 48 hours until bleeding stops and healing is achieved.

Routine prophylaxis:

For adults and adolescents ≥12 years of age, start at 50 IU/kg once weekly or 100 IU/kg once every 10 days.
For children <12 years of age, start at 60 IU/kg once weekly.
Adjust dosing regimen based on individual response. More frequent or higher doses may be needed in children <12 years of age.

Use: adults and children with hemophilia B for:

On-demand treatment and control of bleeding episodes,
Perioperative management of bleeding,
Routine prophylaxis to reduce the frequency of bleeding episodes.

What other drugs will affect Alprolix?

Tell your healthcare provider about all of the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal medicines.

There are no known drugs interactions with Alprolix.

Storage

Store Alprolix vials at 2°C to 8°C (36°F to 46°F). Do not freeze.

Alprolix vials may also be stored at room temperature up to 30°C (86°F) for a single 6-month period.

If you choose to store Alprolix at room temperature:

Note on the carton the date on which the product was removed from refrigeration.
Use the product before the end of this 6-month period or discard it.
Do not return the product to the refrigerator.

Do not use product or diluent after the expiration date printed on the carton, vial, or syringe.

After Reconstitution:

Use the reconstituted product as soon as possible; however, you may store the reconstituted product at room temperature up to 30°C (86°F) for up to 3 hours. Protect the reconstituted product from direct sunlight. Discard any product not used within 3 hours after reconstitution.
Do not use Alprolix if the reconstituted solution is cloudy, contains particles or is not colorless.

What else should I know about Alprolix?

Medicines are sometimes prescribed for purposes other than those listed here. Do not use Alprolix for a condition for which it was not prescribed. Do not share it with other people, even if they have the same symptoms that you have.

Alprolix Instructions for Use

Read the Instructions for Use before you start using Alprolix and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Your healthcare provider should show you or your caregiver how to reconstitute and administer Alprolix the first time Alprolix is used.

Check the expiration date on the Alprolix kit.

Do not use the product if past the expiration date.

Allow the Alprolix vial and the diluent to come to room temperature.

Do not use external heat sources such as putting the vial and/or diluent in hot water.

Find a clean, flat work surface and collect all the supplies you will need to reconstitute and administer Alprolix.

Wash your hands with soap and water. Aseptic technique (clean and germ free) should be used.

Alprolix Reconstitution

Step 1: Remove the plastic cap from the Alprolix vial. Wipe the rubber stopper of the vial with an alcohol wipe and allow it to dry.
After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.

Step 2: Completely remove the backing from the vial adapter package by peeling back the lid.
Do not remove the vial adapter from the package or touch the inside of the vial adapter.

Step 3: Keep the vial on a flat surface. Hold the vial adapter package with one hand and using the other hand, place the vial adapter over the vial.
The spike should be placed directly above the center of the rubber stopper.
Push the vial adapter straight down until the adapter spike punctures the center of the vial stopper and is fully inserted.

Step 4: Lift the package cover away from the vial adapter and discard the cover.

Step 5: Only use the diluent syringe provided to reconstitute the drug product.
Hold the plunger rod at the circular disk.
Place the tip of the plunger rod into the end of the syringe.
Turn in a clockwise motion until it is securely attached.

Step 6: With one hand, hold the diluent syringe right under the cap, and with the cap pointing up.
Make sure you are holding the diluent syringe by the ridged part directly under the cap.
Do not use if the cap has been removed or is not securely attached.

Step 7: With your other hand, grasp the cap and bend it at a 90° angle until it snaps off.
After the cap snaps off, you will see the glass tip of the syringe.
Do not touch the glass tip of the syringe or inside of the cap.

Step 8: Be sure the vial is sitting on a flat surface.
Insert the tip of the syringe into the adapter opening.
Turn the syringe in a clockwise motion until it is securely attached to the adapter.

Step 9: Slowly depress the plunger rod to inject all of the diluent into the vial.
The plunger rod may rise slightly after this process. This is normal.

Step 10: With the syringe still connected to the adapter, gently swirl the vial until the product is completely dissolved.
The appearance of the solution should be clear to slightly opalescent and colorless.
Do not shake.
Do not use the reconstituted Alprolix if it contains visible particles or is cloudy.

If you are using more than one vial, stop here and proceed to the Pooling Instructions on the back.

Step 11: Make sure the plunger rod is completely depressed.
Turn the vial upside-down.
Slowly pull on the plunger rod to draw the solution into the syringe.
Be careful not to pull the plunger rod completely out of the syringe.

Step 12: Gently unscrew the syringe from the vial adapter and dispose of the vial with the adapter still attached.
Do not touch the syringe tip or the inside of the cap.
Reconstituted Alprolix should be administered as soon as possible. Figure

Alprolix Pooling

Pooling is the process of combining two or more reconstituted vials into a larger syringe (not into the diluent syringe) prior to intravenous administration.

If you are using two or more vials, follow these pooling steps.

Be sure to leave the vial adapter attached to the vial as you will need it for attaching a large luer lock syringe.

Do not detach the diluent syringe or the large luer syringe until you are ready to attach the large luer lock syringe to the next vial (with vial adapter attached).

Step 1: Remove the diluent syringe from the vial adapter by turning it counterclockwise until it is completely detached.

Step 2: Attach a separate large luer lock syringe by turning clockwise until it is securely attached.

Step 3: Slowly pull on the plunger rod to draw the solution into the syringe.
Repeat this pooling procedure with each vial you will be using.
Once you have pooled the required dose, proceed to administration using the large luer lock syringe.

Alprolix Administration (Intravenous Injection)

Alprolix is administered by intravenous infusion after reconstitution of the drug powder with the diluent.

Your healthcare provider should teach you how to infuse Alprolix. Once you have been taught to self-infuse, you can follow these instructions.

Do not administer reconstituted Alprolix if it contains particulate matter, is discolored, or is cloudy.

Step 1: Attach the syringe to the connector end of the infusion set tubing by turning clockwise until it is securely attached.
Do not administer reconstituted Alprolix in the same tubing or container with other medicinal products.

Step 2: Apply a tourniquet and clean the skin area where you will perform the infusion using an alcohol wipe.

Step 3: Depress the plunger until all air is removed from the syringe and Alprolix has reached the end of the infusion set tubing.
Do not push Alprolix through the needle.

Step 4: Remove the protective needle cover from the infusion set tubing.
Insert the needle on the infusion set tubing into the vein.
Remove the tourniquet.
Always verify proper needle placement when performing intravenous administration.

Step 5: Slowly depress the plunger on the syringe to administer Alprolix.
Alprolix should be injected intravenously over several minutes.
The rate of administration should be determined by your comfort level.
The small amount of drug product left in the infusion set will not affect treatment.

Step 6: After infusing Alprolix, remove the infusion set and use a sterile gauze to put pressure on the infusion site for several minutes.
Apply an adhesive bandage if necessary.