It's common to have questions when you're learning about something for the first time. Here are some answers to questions that you may have about ALPROLIX. Remember, speaking with your healthcare provider is always a good way to get the information you need when you're considering transitioning to a new factor.
What is ALPROLIX?ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is a recombinant DNA derived coagulation Factor IX concentrate indicated in 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
Limitation of Use
ALPROLIX is not indicated for induction of immune tolerance in patients with hemophilia B.
What prophylaxis dosing options does ALPROLIX offer?The recommended starting prophy regimens are either 50 IU/kg once weekly, or 100 IU/kg once every 10 days. Dosing regimens can be adjusted up or down based on individual response.
The amount of time that ALPROLIX is active may be different in children. Children under 12 may have a shorter half-life and lower recovery. Therefore, higher doses or more frequent infusions may be needed. Talk to your child's healthcare provider to find out the dosing regimen of ALPROLIX that's right for your child.
What is Fc Fusion and how does it help prolong ALPROLIX's half-life ?Fc Fusion is the process by which ALPROLIX, a recombinant Factor IX protein, joins, or fuses, to Fc1, which is normally found as part of a common protein in your body.2 This joining of Factor IX to Fc results in factor with a long half-life.3 It is believed Fc Fusion allows ALPROLIX to use your body's natural pathway to recycle and recirculate in the bloodstream longer.
How effective was ALPROLIX in treating bleeds?Out of 636 bleeds, 90.4% of bleeds were treated with a single infusion of ALPROLIX; 6.9% of bleeds were treated with 2 infusions of ALPROLIX; and 2.7% of bleeds were treated with 3 infusions of ALPROLIX.3
What were the most common drug-related side effects of ALPROLIX?The most common drug-related side effects of ALPROLIX are headache and abnormal sensation of the mouth.
- Learn more about side effects of ALPROLIX
Did prophylaxis treatment with ALPROLIX provide effective protection* from bleeds?Yes. In a clinical study of 123 people ages 12 to 71 with severe† hemophilia B, people who infused once-weekly with ALPROLIX experienced a median annual bleed rate of 2.95 overall bleed rate of 2.95 overall bleeds and a median annual bleed rate of 1.04 spontaneous bleeds.
Additionally, people on every 10-day‡ prophylaxis experienced a median annual overall bleed rate of 1.38 bleeds and a median annual spontaneous bleed rate of 0.88.
In a clinical trial, the median dosing interval for the individualized prophylaxis group was 12.5 days.§
These were two different groups that were studied in the clinical trial. They were not designed to be compared to each other.
*ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.†Severe hemophilia was defined as Factor IX activity 2% or less without any treatment.‡The 10-day dosing regimen in the Prescribing Information was adapted from the clinical study.§26 people who were in the study for at least nine months reached a median dosing interval of 13.8 days. This was during the last six months they were in the study.
What are some additional risks associated with ALPROLIX?You should be aware that there are other safety considerations with ALPROLIX.
- Adverse events
- Anaphylactic reactions. No event of anaphylaxis was reported in the clinical study. Allergic reactions may occur with ALPROLIX
- 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. No inhibitors were observed in clinical studies of ALPROLIX
- Talk to your healthcare provider about any other questions you may have before starting ALPROLIX
- ALPROLIX may increase the risk of formation of 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.
What should I know about how ALPROLIX is manufactured?ALPROLIX is a recombinant Factor IX protein.
- ALPROLIX is not derived from human blood and contains no preservatives
- The HEK (human embryonic kidney) cell line was selected for the manufacturing of ALPROLIX
- ALPROLIX undergoes testing in all stages of the manufacturing process: protein production, purification, viral clearance, and formulation
- To enhance viral safety, the purification process incorporates nanofiltration and purification steps that have been validated for viral clearance
- Strict standards of quality are maintained during the manufacturing of ALPROLIX
What vial sizes are available?ALPROLIX is supplied in single-use vials labeled 250, 500, 1000, 2000, 3000 or 4000 International Units (IU) per vial of ALPROLIX as lyophilized powder. Liquid diluent comes in a prefilled syringe.
Will changing factors increase the risk of getting an inhibitor?Zero inhibitors were detected in the largest clinical study in hemophilia B3.
- Your body could also make antibodies against your factor called "inhibitors," which may stop ALPROLIX from working properly. Because inhibitors have been reported with factor replacement therapies, people taking ALPROLIX should continue to be monitored by their healthcare provider.
- If you have developed an inhibitor with use of another Factor IX therapy, you may be at an increased risk of anaphylaxis with use of ALPROLIX.
- Formation of neutralizing antibodies (inhibitors) to Factor IX has been reported following administration of ALPROLIX, including in previously untreated patients.
What was the study design?B-LONG, a multi-center, prospective, open-label clinical trial (N=123) evaluated the safety and efficacy of ALPROLIX in 123 previously treated male patients with severe hemophilia B, ages 12-71 (Factor IX activity 2% or less). Followed for up to 77 weeks, multiple characteristics of ALPROLIX were assessed, including safety, efficacy, and pharmacokinetics:3-6
- In the once-weekly group, 63 people were given an initial dose of 50 IU/kg, which was adjusted to maintain desired Factor IX trough levels.
- In the individualized prophylaxis group, 29 people were initially given 100 IU/kg every 10 days and their intervals were adjusted to maintain desired factor IX trough levels.
- In the on-demand group, 27 people infused as needed with doses ranging between 20 to 100 IU/kg depending on the severity of the bleed.
- In the surgical group, 12 people received ALPROLIX for bleed management in 14 major surgeries. 15 minor surgeries were also evaluated. Doses were adjusted according to the type of surgery. 4 people in this group did not participate in the other groups.
What are the important questions to ask my doctor about transitioning to ALPROLIX?Here are some questions to cover with your healthcare provider:
- I've heard that the starting prophylaxis infusion schedule for ALPROLIX is every 7 or 10 days and that my doctor may adjust my regimen (dose and schedule) as needed. How would you recommend I get started and ensure I’m on the right regimen?
- I've heard that breakthrough bleeds can be treated with ALPROLIX. If I get a bleed after starting my prophy schedule, how do I treat it?
- How would we confirm that I'm covered and I am on the right dosing schedule if I changed to ALPROLIX?
- I've heard ALPROLIX has a "long half-life." What does that mean?
- What causes ALPROLIX to have a prolonged half-life?
- What are the risks and possible side effects of ALPROLIX?
- What have you heard about ALPROLIX?
- Do you think ALPROLIX is the right treatment option for me?
- Should I consider a free trial of ALPROLIX?
What are the options for covering the cost of ALPROLIX?Bioverativ offers the following financial assistance programs to qualifying individuals:
- Free Trial Plus Program: offers a 30-day supply at no cost to you. You may also be eligible to receive free ALPROLIX for up to 1 year, if needed, until your healthcare coverage begins
- Copay Program: provides savings on out-of-pocket costs
- Factor Access Program: helps with caps and gaps in insurance
- Insurance Counseling: assistance with understanding your insurance coverage and finding other options
Does ALPROLIX offer a free 30-day supply?Yes. With the Free Trial Plus Program you may be eligible to receive a 30-day supply of free ALPROLIX. You may also be eligible to receive free ALPROLIX for up to 1 year, if needed, until your healthcare coverage begins. Learn more about the Free Trial Plus Program.
Where can I get additional supplies such as needles, gauze, bandages, and tubing?If you are getting ALPROLIX through a specialty pharmacy (SPP), the SPP will usually provide these kinds of supplies. However, if you are receiving your ALPROLIX through the Free Trial Plus Program, contact a MyALPROLIX™ Coordinator at 1-855-MyALPROLIX (692-5776) to help obtain these supplies for you.
How can I contact a representative?Community Relations, or CoRe, Managers are ready to support you. You can enter your ZIP code to locate your CoRe Manager and e-mail him or her directly.