Generic name: Coagulation Factor IX (Recombinant), Fc Fusion Protein
Dosage form: lyophilized powder for solution for intravenous injection
Drug class: Miscellaneous coagulation modifiers
What is Alprolix?
Alprolix is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia B. Hemophilia B is also called congenital Factor IX deficiency.
Your healthcare provider may give you Alprolix when you have surgery.
Who should not use Alprolix?
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 Alprolix
Tell your doctor about all of your medical conditions, including if you:
- are pregnant or planning to become pregnant. It is not known if Alprolix may harm your unborn baby.
- are breastfeeding. It is not known if Alprolix passes into breast milk or if it can harm your baby.
- have been told that you have inhibitors to Factor IX (because Alprolix may not work for you).
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.
How should I use Alprolix?
Alprolix should be administered as ordered by your healthcare provider. You should be trained on how to do infusions by your healthcare provider. Many people with hemophilia B learn to infuse their Alprolix by themselves or with the help of a family member.
See the Instructions for Use for directions on infusing Alprolix. The steps in the Instructions for Use are general guidelines for using Alprolix. Always follow any specific instructions from your healthcare provider. If you are unsure of the procedure, please ask your healthcare provider. Do not use Alprolix as a continuous intravenous infusion.
Contact your healthcare provider immediately if bleeding is not controlled after using Alprolix.
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.|
- 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.
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.
Alprolix side effects
Common side effects include headache, abnormal sensation in the mouth, and pain in your side with blood in your urine, which may be a sign of clot formation in the urinary collecting system.
Allergic reactions may occur. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: hives, chest tightness, wheezing, difficulty breathing, or swelling of the face.
Redness to the skin at the injection site may also occur.
Alprolix may increase the risk of forming abnormal blood clots in your body, especially if you have risk factors for developing blood clots. Call your healthcare provider or seek emergency care if you have symptoms of a possible abnormal blood clot, which may include: chest pain, difficulty breathing, unexpected swelling of an arm or leg with or without pain or tenderness.
Your body can also make antibodies called "inhibitors" against Alprolix, which may stop Alprolix from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time.
These are not all the possible side effects.
Talk to your healthcare provider about any side effect that bothers you or that does not go away.
How should I store Alprolix?
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.
- 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.
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.
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
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.
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.
Dispose of all unused solution, empty vial(s), and other used medical supplies in an appropriate medical waste container.
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