Frequently Asked Questions

We get these questions a lot

Here are answers to the questions we seem to get the most. Your CoRe Manager is a great person to contact if you need more information or contact Patient Services.

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.

What prophylaxis dosing options does ALPROLIX offer?

The recommended starting prophylaxis regimens are either 50 IU/kg once weekly, or 100 IU/kg once every 10 days. In children under 12 years of age start at 60 IU/kg once weekly. Dosing regimen can be adjusted based on your individual response.

What is Fc Fusion and how does it help prolong ALPROLIX’s half-life?

Fc Fusion is the science behind ALPROLIX.


To understand what Fc Fusion does, we first need to dive into a little biology.


Your bloodstream contains proteins that have specific jobs to do, like stopping bleeds. Your body constantly breaks down these proteins and rebuilds them through a natural recycling pathway. Some proteins last in your body longer than others.


ALPROLIX “rides along” this natural recycling pathway to allow factor to remain in your body longer after infusion. So, in summary, based on pre-clinical studies, it is believed that:


  1. The Fc portion of ALPROLIX temporarily binds to a specific receptor in the body. 
  2. This binding Fc receptor is thought to redirect ALPROLIX back toward the bloodstream—away from where it would otherwise be broken down.
  3. ALPROLIX is released back into the bloodstream, where it can temporarily recirculate and help with hemostasis.

How effective is ALPROLIX at treating bleeds in adults and adolescents?

In the B-LONG clinical study, ALPROLIX controlled bleeds in people using prophylaxis and treating on-demand. Out of 636 bleeds:

Percentage of Bleeds Treated
90.4% of Bleeds Treated
97.3% of Bleeds Treated
100% of Bleeds Treated
Number of Infusions
1 Infusion
2 Infusions
3 Infusions

Did prophylaxis treatment with ALPROLIX provide effective protection* from bleeds?

Yes. In a clinical study of 153 people ages 12 to 71 with severe hemophilia B:


    • Adult and adolescent patients using ALPROLIX once-weekly have been shown to have a median of 1.04 spontaneous and 2.95 bleeds per year overall 
    • Adult and adolescent patients using ALPROLIX once every 10 days have been shown to have a median of 0.88 spontaneous and 1.38 overall bleeds per year.
    • Pediatric patients using ALPROLIX once every week have been shown to have a median of 0 spontaneous and 1.97 overall bleeds per year.

The dosing regimen can be adjusted based on individual response. So you should speak with your HCP to see what dosing regimen would work best for you.


*ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.

What were the most common drug-related side effects of ALPROLIX?

The most common drug-related side effects of ALPROLIX are headache, abnormal sensation of the mouth, and pain in your side with blood in your urine, which may be a sign of clot formation in the unrinary collecting system.


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.

Is there data about inhibitor formation from the ALPROLIX clinical trial?

ALPROLIX was studied in the largest clinical trial in hemophilia B. 123 previously treated patients were evaluated, and zero inhibitors were detected. 


In the clinical trial evaluating ALPROLIX for safety and efficacy, 123 previously treated male patients with severe hemophilia B changed from their current Factor IX to ALPROLIX. There were zero inhibitors in the 153 previously treated patients using ALPROLIX in the clinical studies.


Formation of neutralizing antibodies (inhibitors) to Factor IX has been reported following administration of ALPROLIX, including in previously untreated patients. 


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.

What was the study design?

The safety and efficacy of ALPROLIX has been studied in a two completed and one ongoing extension study of 153 patients ages 1-71. Patients were previously treated males with severe to moderately severe hemophilia B. There were 123 patients treated for at least 52 weeks and 93 patients for at least 104 weeks, with multiple characteristics of ALPROLIX assessed, including safety, efficacy, and pharmacokinetics:


  • 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 between 1% to 3% above baseline, as clinically indicated to prevent bleeding.
  • 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 between 1% to 3% above baseline, as clinically indicated to prevent bleeding.
  • In the on-demand group, 27 people infused as needed depending on the severity of the bleed.
  • In the pediatric group, 30 previously treated patients were started with a once weekly infusion at 50-60 IU/kg and were allowed to adjust their doses up to 100 IU/kg and at intervals between once and twice weekly.

What are the important questions to ask my doctor about transitioning to ALPROLIX?

Every question is an important one, especially when you want to learn more about a different treatment. The Talk to Your Doctor section can help you prepare for your next discussion with your healthcare team. It also provides a downloadable guide to take into your appointment. Here are a few questions from our guide for discussions with your healthcare provider:


  1. How many infusions do I typically have every: Week? Month? Year?
  2. On average, how many bleeds do I typically have per month?
  3. How many infusions does it typically take to stop a bleed?

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 trial program?

Yes. You may be eligible to receive your first 30-day supply of ALPROLIX immediately with a valid prescription from your healthcare provider. You may also be eligible to receive free factor for up to 1 year, if your healthcare insurance does not cover ALPROLIX. Learn more about the Free Trial Plus Program by calling 1-855-MyALPROLIX (1-855-692-5776). Those patients with Medicare, Medicaid, and other government healthcare beneficiaries are not eligible for the free trial program.

Where can I get additional supplies, such as needles, gauze, bandages, and tubing?

If you are getting ALPROLIX through a Specialty Pharmacy Provider (SPP), the SPP will provide supplies like these. 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?

Bioverativ Community Relations and Education, 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.

ENTER YOUR ZIP CODE AND WE'LL FIND THE CoRe NEAREST YOU.

GET MORE ALPROLIX INFORMATION

ALPROLIX 101:
GET THE ESSENTIALS

LEARN MORE

ALPROLIX
PATIENT STORIES

WATCH THEIR STORIES

indications and important facts about alprolix 

What is the most important information i should know about ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein]? You should not use ALPROLIX if you are allergic to ALPROLIX or any of the other ingredients in ALPROLIX. Tell your healthcare provider if you have had an allergic reaction to any Factor IX product prior to using ALPROLIX.
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.

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.


THE MOST COMMON SIDE EFFECTS OF ALPROLIX 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. These are not all the possible side effects of ALPROLIX. Talk to your healthcare provider for more information and about any side effect that bothers you or does not go away.


WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE STARTING ALPROLIX?

Tell your healthcare provider about all your health conditions, including if you:

  • Have or have had any medical problems.
  • Are taking any prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal medicines.
  • 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).

AFTER STARTING ALPROLIX:

If your bleeding is not controlled and you experience a lack of clinical response to Factor IX therapy, call your healthcare provider right away.

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 ALPROLIX with other people, even if they have the same symptoms that you have.


ALPROLIX INDICATIONS

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.


HOW SHOULD I RECEIVE 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 ALPROLIX by themselves or with the help of a family member. See the booklet called "Instructions for Use" packaged in your ALPROLIX for directions on infusing ALPROLIX. If you are unsure of the procedure, please ask your healthcare provider.


IMPORTANT FACTS ABOUT ALPROLIX

Please read this information carefully before using ALPROLIX and each time you get a refill, as there may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.


QUESTIONS?

The risk information provided here is not comprehensive. To learn more, talk about ALPROLIX with your healthcare provider or pharmacist.
The FDA-approved product labeling can be found at www.alprolix.com or 1-855-MyALPROLIX (692-5776).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.


MANUFACTURED BY

Bioverativ Therapeutics Inc.
Waltham, MA 02451 USA
U.S. License #2078



Please see Full Prescribing Information

Questions?

1-855-MYALPROLIX (1-855-692-5776)

Monday-Friday, 8am-8pm, EST

BIVV logo

©2017 Bioverativ. All rights reserved.

Alprolix logo

FIX-US-1277

Questions?

1-855-MYALPROLIX (1-855-692-5776)

Monday-Friday, 8am-8pm, EST