TALK ABOUT YOUR ALPROLIX THERAPY

“I’M CONCERNED ALPROLIX ISN’T WORKING”

“I’VE HAD A LIFESTYLE CHANGE LIKE STARTING A NEW SPORT OR ACTIVITY OR GAINED SOME WEIGHT”

“I WOULD LIKE TO BE ABLE TO EXTEND MY DOSING SCHEDULE ON ALPROLIX”†

“I’M HAVING A “DIFFERENT EXPERIENCE” NOW THAT I STARTED ON ALPROLIX”

IT’S NOT UNCOMMON TO EXPERIENCE A PERIOD OF ADJUSTMENT WHEN TRANSITIONING TO A DIFFERENT HEMOPHILIA THERAPY. YOU MAY HAVE HAD A BREAKTHROUGH BLEED. OR YOU MAY WONDER IF IT’S POSSIBLE TO EXTEND YOUR DOSING SCHEDULE. WHATEVER YOUR REASON, IT’S IMPORTANT TO WORK OUT ANY ISSUES WITH YOUR DOCTOR. THAT’S WHY WE’VE PROVIDED A FEW OF THE MORE COMMON SITUATIONS THAT COULD COME UP AS THOUGHT STARTERS TO GET THE CONVERSATION GOING.

If you’ve experienced a bleed since you started on ALPROLIX,

talk to your doctor. There are many reasons bleeds can happen.

One of these reasons may be a sign that you may need an

adjustment to your dosing schedule to maintain proper protection.

In the clinical trial patients experienced a median of 1 or fewer

spontaneous bleed per year.

Keep a log of any breakthrough bleeds you experience and show it to

your doctor at your next appointment.

The recommended 7-day starting dose is 50 IU/kg while the

recommended 10-day or longer extended dose is 100 IU/kg

depending on how your body responds. In children under 12 years of

age the recommended starting regimen is 60 IU/kg once weekly.

ALPROLIX has been shown effective in treating breakthrough bleeds.

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

†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.

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.

Always talk to your doctor about changes in your life or what you’re

planning to change.

Your ALPROLIX dosing regimen should fit your individual needs so your

doctor may adjust your dosing schedule to make sure you’re protected

from bleeds*

Your factor regimen is based on your body’s weight and metabolism.

So your doctor may need to adjust your ALPROLIX dosage or schedule

depending on lifestyle changes.

Important Safety Information

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

Please see Indications and Important Safety Information on page 2 and see Full Prescribing Information

Extending your dosing schedule may be possible: More than half of

the people who started on an every 10-day dosing regimen at

100 IU/kg extended to 14 days or longer between infusions in

the clinical trial.† You will need to work with your doctor to extend.

Before meeting with your doctor write down your current ALPROLIX

schedule, track your infusions and take note of any bleeds so you can

bring those to your visit.

At your visit, talk about how you and your doctor feel it’s going on

ALPROLIX. Discuss what an ideal extended dosing schedule would

be for you, extending will typically include a dose adjustment

to 100 IU/kg.

It is not uncommon to feel different when changing your dosing

regimen. It’s important that you don’t make any dosing changes on

your own during this transition period. Always work with your doctor.

Be sure to tell your doctor about it.

It may take time to adjust to a different dosing regimen. It’s important

to follow your doctor’s instructions during this period.

Regular check-ins will help your doctor assure an effective

transition to ALPROLIX.

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INDICATIONS AND IMPORTANT SAFETY INFORMATIONIMPORTANT FACTS ABOUT ALPROLIX® [COAGULATION FACTOR IX (RECOMBINANT), FC FUSION PROTEIN]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.

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 IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ALPROLIX? 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.

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 their 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.

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 USAU.S. License #2078

Please see Full Prescribing Information. This file is an electronic PDF from ALPROLIX.com.

©2017 Bioverativ. All rights reserved. FIX-US-1315 11/17

THE LARGEST CLINICAL STUDY IN HEMOPHILIA B

1ST STUDY OF ADULTS AND ADOLESCENTS, AGE 12 – 71

2ND STUDY OF CHILDREN, AGE 1 – 11

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PEOPLE

63PEOPLE

29

PEOPLE

12

PEOPLE

30

WERE STUDIED ON THE ONCE-WEEKLY PROPHY REGIMEN

WERE STUDIED ON THE ONCE-WEEKLY PROPHY REGIMEN

WERE STUDIED TO SEE THE EFFICACY OF ON-DEMAND DOSING

WERE STUDIED ON THE INDIVIDUALIZED PROPHY REGIMEN

WERE STUDIED TO SEE THE EFFICACYDURING SURGERY

> Started with a once-weekly infusion at 50 IU/kg

> Doses were adjusted to maintain desired Factor IX levels

> All 30 previously treated patients startedwith once-weekly infusion at 50-60 IU Kg

> Allowed to adjust the dose up to 100 IU/Kgand interval between once and twice weekly

> Infusions were given as neededwhen bleeding episodes occurred

> Given 100 IU/kg every 10 days andtheir intervals were adjusted to maintain desired Factor IX levels

> Doses were adjusted according to the type of surgery

> ALPROLIX was evaluated in 14 major surgeriesand 15 minor surgeries

> 4 people in this group did not participate inthe other groups

PEOPLE

27

NOTES

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