THE SCIENCE BEHIND Fc FUSION

A natural pathway to extend factor in your bloodstream

1. Bind

Naturally produced Factor IX flows through the bloodstream and enters cells within your body; eventually breaking it down.

The Fc portion of ALPROLIX allows it to bind with an Fc receptor already in your body.


2. Redirect

The binding with Fc receptor redirects ALPROLIX back towards the bloodstream to protect ALPROLIX from being broken down inside the cell.


3. Recirculate

By using the natural Fc process, ALPROLIX is able to recirculate in the body longer. Eventually ALPROLIX is broken down, but without Fc Fusion, it wouldn't be able to recirculate in the bloodstream to extend the time you are protected* from bleeds.

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

Want to learn more
about ALPROLIX?

We'd like to send you helpful information on hemophilia B and ALPROLIX from time to time. If you're still considering ALPROLIX we'll send you a Bluetooth® speaker to listen to patient stories or if you're already on ALPROLIX, a cooler bag for factor.


Bluetooth® is a registered trademark of Bluetooth SIG, Inc.

Interested in Going beyond your 7- or 10-day schedule

No matter which starting dose you're currently on, you may be able to extend your prophy dosing schedule to 14 days based on your body's response. Here's the story:

STEP 1

If your healthcare team is pleased with the progress of your treatment, you can ask them if you might be able to extend your dosing schedule.

STEP 2

Your doctor may have to adjust your dosing to 100 IU/kg.

STEP 3

More than half of patients in the clinical trials who started with 10-day dosing (at 100 IU/kg) extended dosing to 14 days or longer*

*54% of people in the individualized prophy arm extended to ≥14-day dosing. The overall median dosing interval on study was 12.5 days.

The median interval during the last six months in 26 subjects who were on study for at least nine months was 13.8 days.

Learn about these patient journeys with ALPROLIX

Casey


Worked with his doctor to extend his dosing schedule.

Watch his story

Casey


Worked with his doctor to extend his dosing schedule.

Watch his story

Alex


Switched from on-demand to prophy.

Watch his story

Alex


Switched from on-demand to prophy.

Watch his story

Brian


Took control of his hemophilia treatments with a once-every-7-day dosing regimen.

Watch his story

Brian


Took control of his hemophilia treatments with a once-every-7-day dosing regimen.

Watch his story

Want to learn more
about ALPROLIX?

We'd like to send you helpful information on hemophilia B and ALPROLIX from time to time. If you're still considering ALPROLIX we'll send you a Bluetooth® speaker to listen to patient stories or if you're already on ALPROLIX, a cooler bag for factor.


Bluetooth® is a registered trademark of Bluetooth SIG, Inc.

The largest clinical study in hemophilia B

The numbers don't lie

The safety and efficacy of ALPROLIX has been studied in 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 126 patients treated for at least 52 weeks and 107 patients for at least 104 weeks, with multiple characteristics of ALPROLIX assessed, including safety, efficacy, and pharmacokinetics.

Adults and Adolescents
Age 12 - 71

Were studied on the once-weekly prophy regimen
  • Started with a once-weekly infusion at 50 IU/kg

  • Doses were adjusted to maintain desired Factor IX levels

Were studied to see the efficacy of on-demand dosing
  • Infusions were given as needed when bleeding episodes occurred

Were studied on the individualized prophy regimen
  • Given 100 IU/kg every 10 days and their intervals were adjusted to maintain desired Factor IX levels

Were studied to see the efficacy during surgery
  • Doses were adjusted according to the type of surgery

  • ALPROLIX was evaluated in 14 major surgeries and 15 minor surgeries

  • 4 people in this group did not participate in the other groups

Children
Age 1 - 11

Were studied on the once-weekly prophy regimen
  • All 30 previously treated patients started with once-weekly infusion at 50-60 IU/Kg

  • Allowed to adjust the dose up to 100 IU/Kg and interval between once and twice weekly

Want to learn more
about ALPROLIX?

We'd like to send you helpful information on hemophilia B and ALPROLIX from time to time. If you're still considering ALPROLIX we'll send you a Bluetooth® speaker to listen to patient stories or if you're already on ALPROLIX, a cooler bag for factor.


Bluetooth® is a registered trademark of Bluetooth SIG, Inc.

Get the 411
on Alprolix Safety

A bit more info from the clinical study

In the clinical studies of 153 previously treated people, adverse reactions occurred in 14 participants (9.2%).

Headache, abnormal sensation in the mouth, and pain in your side with blood in your urine, which may be a sign of a clot formation in the urinary collecting system occured in two people (1.3%).

Dizziness, bad taste in the mouth, breath odor, fatigue, infusion site pain, palpitations, low blood pressure, and/or decreased appetite occurred in one person (0.7%).

The obstructive clot in the urinary collecting system of the 2 subjects was resolved with hydration and they remained on the study.

Zero inhibitors were detected in the clinical study of 153 previously treated people.

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

Following administration of ALPROLIX, your body could make antibodies against your Factor IX called "inhibitors," which may stop ALPROLIX from working properly. Your healthcare provider should continue to monitor you with blood tests to check for inhibitors.

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.

Want to learn more
about ALPROLIX?

We'd like to send you helpful information on hemophilia B and ALPROLIX from time to time. If you're still considering ALPROLIX we'll send you a Bluetooth® speaker to listen to patient stories or if you're already on ALPROLIX, a cooler bag for factor.


Bluetooth® is a registered trademark of Bluetooth SIG, Inc.

We are committed to
manufacturing excellence

Alprolix undergoes testing in all stages of the manufacturing process

No matter which starting dose you're currently on, you may be able to extend your prophy dosing schedule to 14 days based on your body's response. Here's the story:

STAGE 1

Protein Production

Protein-producing host cells are grown in high-tech containers called bioreactors. These host cells produce protein into the cell media. That protein is then purified.

STAGE 2

Purification and viral clearance

To enhance viral safety, the process uses nanofiltration and purification steps that have been validated for viral clearance.

STAGE 3

Formulation

Finally, ALPROLIX 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.

Want to learn more
about ALPROLIX?

We'd like to send you helpful information on hemophilia B and ALPROLIX from time to time. If you're still considering ALPROLIX we'll send you a Bluetooth® speaker to listen to patient stories or if you're already on ALPROLIX, a cooler bag for factor.


Bluetooth® is a registered trademark of Bluetooth SIG, Inc.

You've got vial size options

ALPROLIX offers six different vial sizes

The most of any hemophilia B factor, which could help you achieve single-vial dosing. 1-7

Learn more about our manufacturing process >

1. IDELVION® [package insert]. Marburg, Germany: CSL Behring GmbH; 2017.

2. AlphaNine® SD [package insert]. Los Angeles, CA: Grifols Biologicals Inc; 2013.

3. BeneFIX® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc, a subsidiary of Pfizer Inc; 2015.

4. Ixinity® [package insert]. Berwyn, PA: Aptevo BioTherapeutics LLC; 2016.

5. Mononine® [package insert]. Kankakee, IL: CSL Behring LLC; 2016.

6. Profilnine® SD [package insert]. Los Angeles, CA: Grifols Biologicals Inc; 2010.

7. Rixubis® [package insert]. Westlake Village, CA: Baxalta US Inc; 2016.

Vials

Graphic not representative of actual drug product vial.

1. IDELVION® [package insert]. Marburg, Germany: CSL Behring GmbH; 2017.

2. AlphaNine® SD [package insert]. Los Angeles, CA: Grifols Biologicals Inc; 2013.

3. BeneFIX® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc, a subsidiary of Pfizer Inc; 2015.

4. Ixinity® [package insert]. Berwyn, PA: Aptevo BioTherapeutics LLC; 2016.

5. Mononine® [package insert]. Kankakee, IL: CSL Behring LLC; 2016.

6. Profilnine® SD [package insert]. Los Angeles, CA: Grifols Biologicals Inc; 2010.

7. Rixubis® [package insert]. Westlake Village, CA: Baxalta US Inc; 2016.

Want to learn more
about ALPROLIX?

We'd like to send you helpful information on hemophilia B and ALPROLIX from time to time. If you're still considering ALPROLIX we'll send you a Bluetooth® speaker to listen to patient stories or if you're already on ALPROLIX, a cooler bag for factor.


Bluetooth® is a registered trademark of Bluetooth SIG, Inc.

×

INDICATIONS: ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] 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.

important safety information and indications 

IMPORTANT SAFETY INFORMATION
Do not use ALPROLIX if you are allergic to ALPROLIX or any of the other ingredients in ALPROLIX.

Tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have any allergies and all your medical conditions, including if you are pregnant or planning to become pregnant, are breastfeeding or have been told you have inhibitors (antibodies) to Factor IX.

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 right away about any side effect that bothers you or does not go away, and if bleeding is not controlled using ALPROLIX.

Allergic reactions may occur with ALPROLIX. 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.

Your body can also make antibodies called "inhibitors" against ALPROLIX, which may stop ALPROLIX from working properly.

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.

INDICATIONS
ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] 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.

indications and important facts about alprolix 

IMPORTANT SAFETY INFORMATION
Do not use ALPROLIX if you are allergic to ALPROLIX or any of the other ingredients in ALPROLIX.

Tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have any allergies and all your medical conditions, including if you are pregnant or planning to become pregnant, are breastfeeding or have been told you have inhibitors (antibodies) to Factor IX.

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 right away about any side effects that bothers you or does not go away, and if bleeding is not controlled using ALPROLIX.

Allergic reactions may occur with ALPROLIX. 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.

Your body can also make antibodies called "inhibitors" against ALPROLIX, which may stop ALPROLIX from working properly.

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.

INDICATIONS
ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] 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.

Please see Full Prescribing Information

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

Questions?

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

Monday-Friday, 8am-8pm, EST

© 2020 Genzyme Corporation. All rights reserved. ALPROLIX is a registered trademark of Bioverativ Therapeutics Inc., a Sanofi company.

FIX-US-1274 V4 09/19

© 2020 Genzyme Corporation. All rights reserved. ALPROLIX is a registered trademark of Bioverativ Therapeutics Inc., a Sanofi company.

FIX-US-1274 V4 09/19

Questions?

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

Monday-Friday, 8am-8pm, EST