Go Beyond ALPROLIX Essentials

Here's the place to be if you want to dive deeper into ALPROLIX

THIS SCIENCE BEHIND
Fc FUSION

THIS SCIENCE BEHIND
Fc FUSION

ALPROLIX uses a natural pathway to extend factor in your bloodstream.

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INTERESTED IN GOING
BEYOND YOUR
7- OR 10-DAY SCHEDULE

INTERESTED IN GOING
BEYOND YOUR
7- OR 10-DAY SCHEDULE

Learn how people on ALPROLIX 7- or 10-day dosing schedules can work with their doctors to potentially extend to 14 days based on their response.*

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THE LARGEST CLINICAL
STUDY IN HEMOPHILIA B

THE LARGEST CLINICAL
STUDY IN HEMOPHILIA B

See the details and design of our study that involved 153 patients.

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GET THE 411 ON
ALPROLIX SAFETY

GET THE 411 ON
ALPROLIX SAFETY

Find additional ALPROLIX safety info here.

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WE ARE COMMITTED
TO MANUFACTURING
EXCELLENCE

WE ARE COMMITTED
TO MANUFACTURING
EXCELLENCE

We adhere to strict standards throughout the ALPROLIX manufacturing process.

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YOU'VE GOT VIAL
SIZE OPTIONS

YOU'VE GOT VIAL
SIZE OPTIONS

ALPROLIX offers the most vial sizes of any hemophilia B factor.

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*The recommended starting prophylaxis regimens are either 50 IU/kg once weekly, or 100 IU/kg once every 10 days. Dosing regimen can be adjusted based on individual response.

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"I feel fortunate to be in a position where I can tell people about the positive changes prophy made in my life."

Casey, on ALPROLIX

This is a personal account of an ALPROLIX Peer. Please talk to your healthcare provider about whether ALPROLIX may be right for you. Individual results may vary.

VIEW PATIENT STORIES

TALK TO YOUR DOCTOR

Whether you're looking to make the switch to ALPROLIX or already on it, it's important to talk to your doctor about your treatment and bring up any questions or concerns you might have.

THE SCIENCE BEHIND Fc FUSION

A natural pathway to extend factor in your bloodstream

While some proteins can be broken down very quickly, research shows Fc Fusion allows ALPROLIX to use your body's natural pathway to recycle and recirculate in the bloodstream longer.

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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. All rights reserved.

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:

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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.

2

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

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

Jen

2 sons with severe hemophilia B are on ALPROLIX and took part in the clinical trial.

Watch her story

Jen

2 sons with severe hemophilia B are on ALPROLIX and took part in the clinical trial.

Watch her 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. All rights reserved.

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 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.

1ST study of 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

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2ND study of 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. All rights reserved.

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.

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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. All rights reserved.

We are committed to
manufacturing excellence

We are committed to manufacturing excellence

ALPROLIX undergoes testing in all stages of the manufacturing process

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 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.

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. All rights reserved.

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.

Arrows Vials

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. All rights reserved.

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

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©2017 Bioverativ. All rights reserved.

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Questions?

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

Monday-Friday, 8am-8pm, EST