Factor your way: empowering you to achieve your goals

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This is a paid public announcement from Takeda and does not constitute an endorsement of products or services. When you click on the links in this blog entry, you will be directed to the bleedingdisorders.com website. LA Kelley Communications always advises you to be a savvy consumer when contacting any company; do not reveal identifying information against your will.

Submitted by Takeda

What is hemophilia?

Hemophilia is a rare genetic bleeding disorder that prevents blood from clotting normally.1

At the time of a bleed, proteins in your blood called clotting factors form a clot and stop the bleeding.2,3 However, if you have hemophilia, your blood lacks clotting factors (such as factors VIII and IX), and as a result, you may bleed for a longer time after an injury than you would otherwise.4,5

Replacing what’s missing

The current standard of care for hemophilia is factor replacement therapy.6 Factor therapy is a proven treatment with decades of real-world use and an established safety record.7,8

Factor therapy replaces the missing blood-clotting proteins that are naturally found in your blood.9 It is administered via an intravenous injection (directly into your bloodstream), making these proteins available immediately for use.

Factor therapy can be used in different situations such as on-demand (to treat an ongoing bleed), prophylaxis (to prevent bleeds before they occur), and before or after surgery.6,10

Other treatments for hemophilia

The first non-factor therapy option more recently became available.11 To reduce bleeding, it mimics part of the function of missing clotting proteins by bridging other factors. It is administered subcutaneously and is intended for prophylactic use.

Individualizing your treatment with factor

With factor treatment, your healthcare provider (HCP) can individualize your regimen to align with your unique needs and help you achieve treatment goals.

When determining an appropriate treatment plan, your HCP looks at how factor is processed in your body; this is called pharmacokinetics (PK).13 Many factors such as body weight, age, joint status, activity levels, and bleeding frequency are used to better understand how much and how often you require factor.12

A treatment tailored to your lifestyle and activities may help make it easier for you to stick to your prophylaxis. This may help preserve your joint health by significantly reducing bleeding.12

CASE STUDY

Individualizing factor therapy can make a world of difference

Josh
Age 15 years

Josh is an active teen who enjoys playing sports. He is currently taking factor every other day (25 IU/kg) but has recently been experiencing more bleeds, particularly in his ankles. At his HCP visit, Josh mentions that he has increased his tennis practice from once weekly to 3 nights/week.

Due to an increase in Josh’s activity level, and a considerable growth spurt, he may not always be receiving optimal coverage from his current dosing regimen. His HCP recommended adjusting Josh’s dose of factor VIII and changing his infusion schedule.

After taking a few blood samples, they were able to determine what Josh’s factor levels would be at various time points following an infusion. They agreed to an individualized dosing schedule that was appropriate for Josh’s current activity level. Josh’s new dose is 35 IU/kg three times a week.

Since switching to the new dosing schedule, Josh’s bleeding has been reduced even with his increased activity.

 

 

 

 

 

 

 

 

 

Visit bleedingdisorders.com for more information about hemophilia and individualized factor therapy.

Supporting literature:

  1. Livnat T, Barg AA, Levy-Mendelovich S, Kenet G. Rare bleeding disorders—old diseases in the era of novel options for therapy. Blood Cells Mol Dis. 2017;67:63-68.
  2. Smith SA, Travers RJ, Morrissey JH. How it all starts: initiation of the clotting cascade. Crit Rev Biochem Mol Biol. 2015;50(4):326-336.
  3. Berg JM, Tymoczko JL, Stryer L. Many enzymes are activated by specific proteolytic cleavage. Biochemistry. 5th ed. New York, NY: WH Freeman; 2002. https://www.ncbi.nlm.nih.gov/books/NBK22589/. Accessed April 18, 2019.
  4. Hemophilia. National Heart, Lung, and Blood Institute (NHLBI). https://www.nhlbi.nih.gov/health-topics/hemophilia. Accessed April 17, 2019.
  5. Hemophilia. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/hemophilia/symptoms-causes/syc-20373327. Accessed April 17, 2019.
  6. Rodriguez-Merchan EC. What’s new in orthopedic surgery for people with hemophilia. Arch Bone Jt Surg. 2018;6(3):157-160.
  7. Pipe SW. New therapies for hemophilia. Hematology Am Soc Hematol Educ Program. 2016;(1):650-656.
  8. Franchini M. Current management of hemophilia B: recommendations, complications and emerging issues. Expert Rev Hematol. 2014;7(5):573-581.
  9. Rolstad EB. Perceptions of men with moderate to severe hemophilia regarding the management of their chronic disorder and utilization of community-based support. Am J Mens Health. 2015;9(6):486-495.
  10. Peyvandi F, Garagiola I, Young G. The past and future of haemophilia: diagnosis, treatments, and its complications. Lancet. 2016;388(10040):187-197.
  11. National Hemophilia Foundation. MASAC document #255. Available at: www.hemophilia.org. Accessed May 2, 2019.
  12. Valentino LA. Considerations in individualizing prophylaxis in patients with haemophilia A. Haemophilia. 2014;20(5):607-615.
  13. Pharmacokinetics. The Free Dictionary by Farlex. http://medicaldictionary.thefreedictionary.com/pharmacokinetics. Accessed April 17, 2019.
Commitment to our community is always a priority for Takeda Hematology (previously part of Shire and Baxalta). As a leader in hemophilia research, Takeda continues to innovate on your behalf, developing programs and services that support your efforts each step of the way. Takeda is focused on providing advanced hematology treatments for today and innovating for the future.

Copyright © 2019 Takeda Pharmaceutical Company Limited. All rights reserved. All trademarks are the property of their respective owners.

S48266 05/19

Patient Newsletter Article 20190226 0.6

Explore the possibilities of individualization

When I was raising a child with hemophilia over 20 years ago, all factor dosing was based on our child’s weight and severity of an injury. No one ever talked about PK. What is PK, you ask? Read below and find out! It’s essential to know if you want to individualize the dosing schedule for you or your loved one with hemophilia!

This is a paid public announcement from Shire and does not constitute an endorsement of products or services.  When you click on the links in this blog entry, you will be directed to the Shire website.  LA Kelley Communications always advises you to be a savvy consumer when contacting any company; do not reveal identifying information against your will.

We know that regardless of any similarities, no two individuals with hemophilia are the same. For example, you and another person with hemophilia who are the same age and weight may require different amounts of factor, depending on how your body uses factor.1

One of the key elements in individualizing factor treatment is understanding and utilizing pharmacokinetics (PK). This is the study of how your body uses the medicine you take,2 which in turn helps predict the factor coverage that is available within your body. PK helps predict how the treatment is working with your body. Remember, no two individuals are the same, so factor is used or removed from the blood at different rates depending on your individual PK profile.3

Your PK profile is developed during PK analysis, where your healthcare provider (HCP) draws your blood at very specific times to determine your factor levels.4,5 PK analysis helps your HCP identify and understand4,6,7:

  • Highest level of factor in your body after infusion (peak)
  • Lowest factor level after time has passed (trough)
  • Amount of time it takes for half of the infused factor to be removed from the bloodstream, known as the half-life

This PK information can help your HCP determine an optimal treatment plan for you by adjusting your infusion dose and frequency (how often factor is infused), based on how your body uses factor.1 Your HCP will also take a close look at your lifestyle and other activities, as these can have an impact on your bleeding risk. As you can see, there are many different characteristics to consider when determining the right treatment plan for you.

Individualizing prophylaxis (routine infusion of factor to prevent bleeds) may help improve the likelihood of zero bleeds while also helping to preserve joint health.8 Your joint health is very important; every joint bleed matters. It is recommended to start prophylaxis early, especially in childhood or adolescence, to help preserve your joints.9

We at Shire understand that individualized factor treatment is key. It is necessary to tailor your factor treatment to meet your unique needs. When it comes to treating hemophilia, there is no one-size-fits-all approach.1

Talk to your healthcare provider about factor treatment— an option that lets you individualize your prophylaxis regimen to meet your unique needs. Visit www.bleedingdisorders.com to learn more about factor treatment.

References

  1. Valentino LA. Considerations in individualizing prophylaxis in patients with haemophilia A. Haemophilia. 2014;20:607-615.
  2. Le J. Overview of pharmacokinetics. Merck Manual. https://www.merckmanuals.com/professional/clinical-pharmacology/pharmacokinetics/overview-of-pharmacokinetics. Accessed July 17, 2018.
  3. Collins PW, Björkman S, Fischer K, et al. Factor VIII requirement to maintain a target plasma level in the prophylactic treatment of severe hemophilia A: influences of variance in pharmacokinetics and treatment regimens. J Thromb Haemost. 2010;8(2):269-275.
  4. Poon MC, Jackson S, Brown M, McClure W. Clotting factor therapy. All About Hemophilia: A Guide for Families. Montreal, Quebec, Canada: Canadian Hemophilia Society; 2010:1-33.
  5. Lee M, Morfini M, Schulman S, Ingerslev J; and Factor VIII/Factor IX Scientific and Standardization Committee on the International Society on Thrombosis and Haemostasis. The design and analysis of pharmacokinetic studies of coagulation factors. International Society on Thrombosis and Haemostasis. https://c.ymcdn.com/sites/www.isth.org/resource/group/d4a6f49a-f4ec-450f-9e0f-7be9f0c2ab2e/official_communications/fviiipharmaco.pdf. Published March 21, 2001. Accessed June 1, 2018.
  6. University of Virginia Health System. Obtaining trough blood levels. https://med.virginia.edu/neurology/wp-content/uploads/sites/235/2015/11/obtaining-trough-blood-levels.pdf. Accessed July 27, 2018.
  7. Medical Dictionary. Definition of Cmax. Farlex Inc: Huntingdon Valley, PA; 2018. http://medical-dictionary.thefreedictionary.com/Cmax. Accessed July 30, 2018.
  8. Poon M, Lee A. Individualized prophylaxis for optimizing hemophilia care: can we apply this to both developed and developing nations? Thromb J. 2016;14(suppl 1):65-71.
  9. Bertamino M, Riccardi F, Banov L, et al. Hemophilia care in the pediatric age. J Clin Med. 2017;6(54):1-13.

 

©2018 Shire US Inc., Lexington, MA 02421.
All rights reserved. 1‐800‐828‐2088.
SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates. S41614 08/18

Shire: a hematology company with innovation in their blood

This is a paid public announcement from Shire and does not constitute an endorsement of products or services.  When you click on the links in this blog entry, you will be directed to the Shire website.  LA Kelley Communications always advises you to be a savvy consumer when contacting any company; do not reveal identifying information against your will.

 

 

 

If you had hemophilia in the 1940s, your life would have been very different from the one a person with hemophilia lives today. Then, there were no factor replacement therapies, bypassing agents, or prophylaxis regimens. For a person living with hemophilia, there was joint pain, bleeds treated with whole-blood infusions, and life spans that often didn’t reach adulthood.1-3 Clearly, a new approach to hemophilia treatment was needed. Fortunately, that’s when Baxter’s hemophilia division stepped in, which is now part of Shire, as of 2016.4

A revolution begins

It began with an aggressive and passionate effort to provide people with hemophilia a bleed-free life more than 70 years ago.5 Then in 1966, one of our scientists, a hemophilia patient himself, had a significant breakthrough. Dr. Murray Thelin helped create one of the first factor VIII replacement therapies and ushered in the modern age of hemophilia treatment.3,6

Although the first factor VIII replacement therapies were a life-changing improvement for tens of thousands of people with hemophilia, the innovation didn’t stop there.

In the years that followed, we advanced the treatment of hemophilia A, hemophilia B, hemophilia A or B with inhibitors, von Willebrand disease, and acquired hemophilia A with significant developments. Many of these were firsts: the first recombinant factor VIII treatment, the first needleless transfer device, the first recombinant factor VIII treatment free of blood-based additives, the first recombinant treatment for people with von Willebrand disease, and the first recombinant porcine factor VIII for acquired hemophilia.6-9

The breakthroughs continue

Thanks to the many contributions that have been made in the past, and which Shire continues to make, to the treatment of bleeding disorders, Shire’s vision for patients with a bleeding disorder is closer to realization than ever before.

Today, the focus is on using individualized prophylactic dosing for preventing bleeds.10 With a recent Shire development, the first FDA-cleared PK dosing software for use in hemophilia, people with hemophilia can conveniently estimate their PK profile and the factor levels in their body at any given time. This may allow patients to tailor their prophylaxis to their activities while ensuring adequate factor coverage.11-13

And the innovation continues. Research and development is going strong with 20 ongoing clinical trials in bleeding disorders, including one in gene therapy, as well as advancements in other novel therapies. Shire has engaged hundreds of the world’s leading scientists, researchers, and patient support specialists to help them.5

Most fundamentally, Shire is collaborating with the bleeding disorders community, including patient associations that have enabled the diagnosis of more than 30,000 hemophilia patients around the world.5 Shire has listened to, learned from, and championed their needs. This bleeding disorders community is our community. It’s why Shire is always pushing ahead, proactively shaping the future of bleeding disorders and continually elevating care for patients.

  1. Philipp C. The aging patient with hemophilia: complications, comorbidities, and management issues. Hematology Am Soc Hematol Educ Program. 2010;2010:191-196. 
  2. History of bleeding disorders. National Hemophilia Foundation. https://www.hemophilia.org/Bleeding-Disorders/History-of-Bleeding-Disorders. Accessed August 30, 2018.
  3. Dateline Federation: Honoring Our Past, Building Our Future. 41st ed. Washington, DC: Hemophilia Federation of America; 2014. http://www.hemophiliafed.org/dateline/HFA_Dateline_2014_Q2_Summer/HFA_Dateline_2014_Q2_Summer.pdf. Accessed August 30, 2018.
  4. Shire to combine with Baxalta, creating the global leader in rare diseases [news release]. January 11, 2016. https://www.shire.com/-/media/shire/shireglobal/shirecom/pdffiles/newsroom/2016/shire-to-combine-with-baxalta-pr-1-11-16-final.pdf?la=en&hash=A7A87F964B4026EDB959A608A5D57357795DCC44. Accessed September 14, 2018.
  5. Shire’s 70+ year commitment to the hemophilia community [news release]. June 6, 2018. https://www.shire.com/newsroom/2018/january/7sossj. Accessed August 30, 2018.
  6. Kingdon HS, Lundblad RL. An adventure in biotechnology: the development of haemophilia A therapeutics – from whole-blood transfusion to recombinant DNA to gene therapy. Biotechnol Appl Biochem. 2002;35:141-148.
  7. Grillberger L, Kreil TR, Nasr S, Reiter M. Emerging trends in plasma-free manufacturing of recombinant protein therapeutics expressed in mammalian cells. Biotechnol J. 2009;4:186-201.
  8. Janbain M, Leissinger C, Kruse-Jarres R. Acquired hemophilia A: emerging treatment options. J Blood Med. 2015;6:143-150.
  9. Shire, Inc. The first and only recombinant treatment for adults affected by von Willebrand disease, launches in the US. [press release]. https://www.shire.com/newsroom/2016/august/nbtjyp. Accessed September 28, 2018.
  10. Berntorp E, Spotts G, Patrone L, Ewenstein BM. Advancing personalized care in hemophilia A: ten years’ experience with an advanced category antihemophilic factor prepared using a plasma/albumin-free method. Biologics. 104:8;115-127.
  11. Collins PW. Personalized prophylaxis. Haemophilia. 2012;18(suppl 4):131-135.
  12. Hazendonk HCAM, van Moort I, Mathôt RAA, et al. Setting the stage for individualized therapy in hemophilia: what role can pharmacokinetics play? Blood Rev. 2018;32(4):265-271.
  13. US Food & Drug Administration. Substantially Equivalent 510(k) Device Information: BK170028. https://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/UCM592876.pdf. Accessed September 28, 2018.

S41615 10/18

Factor replacement–treatment you can rely on

I travel to many countries where factor is not available to patients with hemophilia and it’s heartbreaking to see the damage bleeding can do. We are fortunate in this country to have factor replacement therapy. Read below for a quick summary of its benefits, and why it’s so important for patients.

This is a paid public announcement from Shire and does not constitute an endorsement of products or services.  When you click on the links in this blog entry, you will be directed to the Shire website.  LA Kelley Communications always advises you to be a savvy consumer when contacting any company; do not reveal identifying information against your will.

When it comes to living with your hemophilia, having confidence in your treatment is important. For more than 50 years, factor replacement has been the standard of care in the treatment of hemophilia A and B with proven efficacy in preventing bleeds through prophylaxis and low risk of thrombotic events.1-4  

Factor-based therapy replaces what’s missing in the coagulation cascade for people with hemophilia, thus working within the body’s natural hemostatic process.3,5

Factor replacement represents a comprehensive approach to treating hemophilia. It can be used in multiple scenarios to meet different treatment needs that vary from person to person such as prophylaxis (routine infusion of factor to prevent bleeds), on-demand use (infusion of factor to control bleeding episodes), and during or after surgery.3,6

A one-size-fits-all treatment approach does not meet the unique needs of each individual.7 Your healthcare provider can individualize your regimen by adjusting your infusion dose and frequency (how often factor is infused) based on:

  • How your body uses factor
  • Your activity level
  • Your lifestyle needs

Individualizing your prophylactic treatment can help reduce bleed rates in some patients with hemophilia A.8

Reducing bleeds is necessary to preserve your joints. Even a single bleed matters, and there is evidence that the number of joint bleeds a patient experiences can lead to the development of joint disease.9 Remember, if bleeds are not treated immediately, this can result in permanent joint damage.2

Decades of clinical studies and real-world use have shown that early prophylaxis with factor-based treatment can reduce the risk of joint bleeds and preserve joint health in some patients with hemophilia A.2,10-15

To effectively manage your hemophilia, be sure to ask your healthcare provider about an established treatment that offers options for individualization. With decades of documented success in managing, controlling, and reducing bleeds in more than 170 clinical studies, factor treatment remains a trusted and well-studied treatment option in patients with hemophilia.1, 15, 16

Commitment to the hemophilia community is always a priority to Shire. As a leader in hemophilia research, Shire continues to innovate on your behalf, developing programs and services that support your efforts each step of the way. Shire is focused on providing advanced hematology treatments for today and innovating for the future. 17

Talk to your healthcare provider to learn more about how factor works and all the ways it can help patients like you with hemophilia. Visit www.bleedingdisorders.com to discover if factor treatment is right for you.

References

  1. Center for Biologics Evaluation and Research. User fee billable biologic products and potencies approved under Section 351 of the PHS Act. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm122936.htm. Accessed July 17, 2018.
  2. Price VE, Hawes SA, Chan AKC. A practical approach to hemophilia care in children. Paediatri Child Health. 2007;12(5):381-383.
  3. Peyvandi F, Garagiola I, Young G. The past and future of haemophilia: diagnosis, treatments, and its complications. Lancet. 2016;388:187-197.
  4. Coppola A, Franchini M, Makris M, Santagostino E, Di Minno G, Mannucci PM. Thrombotic adverse events to coagulation factor concentrates for treatment of patients with haemophilia and von Willebrand disease: a systematic review of prospective studies. 2012;18:e173-e187.
  5. Berg JM, Tymoczko JL, Stryer L. Many enzymes are activated by specific proteolytic cleavage. In: Biochemistry. 5th ed. New York, NY: WH Freeman; 2002. https://www.ncbi.nlm.nih.gov/books/NBK22589/?rendertype. Accessed July 24, 2018.
  6. World Federation of Hemophilia. Guidelines for the management of hemophilia. 2nd ed. Montreal, Quebec: World Federation of Hemophilia; 2012:1-80.
  7. Valentino LA. Considerations in individualizing prophylaxis in patients with haemophilia A. Haemophilia. 2014;20:607-615.
  8. Yamasaki N, Fujii T, Fujii T. Individualized prophylaxis can contribute to decreasing annualized bleeding rate (ABR) in adult persons with hemophilia A. 2018;24(suppl 5):1-194.
  9. Collins PW, Blanchette VS, Fischer K, et al. Break-through bleeding in relation to predicted factor VIII levels in patients receiving prophylactic treatment for severe hemophilia A. J Thromb Haemost. 2009;7:413-420.
  10. Bertamino M, Riccardi F, Banov L, et al. Hemophilia care in the pediatric age. J Clin Med. 2017;6(54):1-13.
  11. Manco-Johnson MJ, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007;357(6):535-544.
  12. Manco-Johnson MJ, Soucie JM, Gill JC for the Joint Outcomes Committee of the Universal Data Collection, US Hemophilia Treatment Center Network. Prophylaxis usage, bleeding rates,and joint outcomes of hemophilia, 1999 to 2010: a surveillance project. 2017;129(17):2368-2374.
  13. Khawaji M, Astermark J, Von Mackensen S, Akesson K, Berntorp E. Bone density and heath-reated quality of life in adut patients with severe hemophilia. Haemophilia. 2011;17:304-311.
  14. Rodriguez-Merchan EC. Aspects of current management: orthopaedic surgery in haemophilia. 2012;18:8-16.
  15. Franchini M, Mannucci PM. The history of hemophilia. Semin Thromb Hemost. 2014;40:571-
  16. NIH Clinical Trials Registry. Ongoing and complete clinical trials using factor in patients with hemophilia. https://clinicaltrials.gov/ct2/results/details?term=Factor+VIII&recr=Closed&fund=2. Accessed July 17, 2018.
  17. Shire website. https://www.shire.com/who-we-are/areas-of-focus/hematology

©2018 Shire US Inc., Lexington, MA 02421.
All rights reserved. 1 ‐ 800 ‐ 828 ‐ 2088.
SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates. S41613 08/18

Shire’s pursuit of a zero-bleed future

The following is sponsored by Shire. Change is good, unless it affects your treatment. Here, we bring you interesting facts about Shire’s products…and reputation as an industry leader. While companies can undergo name changes in our community’s long history, the products remain the same, as does Shire’s commitment to patients.

Laurie

This is a paid public announcement from Shire and does not constitute an endorsement of products or services. When you click on the links in this blog entry, you will be directed to the ADVATE ® [Antihemophilic Factor (Recombinant)] website. LA Kelley Communications always advises you to be a savvy consumer when contacting any company; do not reveal identifying information against your will.

For over 7 decades, the rare bleeding disorders teams that are now part of Shire have worked toward transforming ideas into products that have the potential to change the lives of patients by reducing bleeds.1,2

ADVATE ® [Antihemophilic Factor (Recombinant)] was one of those ideas, and in 2003, it was introduces as the first recombinant factor VIII free of blood-based additives. ADVATE is not used to treat von Willebrand disease; do not use ADVATE if you are allergic to mice or hamsters or to any ingredients in ADVATE.3-5

In 2011, ADVATE was approved for routine prophylaxis in adults and children with hemophilia A.3 Did you know that in a clinical study ADVATE reduced bleeds by 98% when patients switched from on-demand to prophylaxis?3,6

What is Prophylaxis in Hemophilia A?

Prophylaxis refers to regular infusion of clotting factor concentrates to help prevent bleeds from occurring.7 In the case of hemophilia A, one option is taking ADVATE prophylaxis to try and help prevent a bleed from occurring.3

In a clinical study:

  • There was a 98% reduction in bleeds (median annual bleed rate [ABR] from 44 to 1^1 ) when patients switched from on-demand to prophylaxis3,6
  • Patients experiences a 97% reduction in joint bleeds (from 38.7 to 1 median joint ABR) after switching from on-demand to prophylaxis3
    • 42% of patients experiences zero bleeds during 1 year of prophylaxis with ADVATE (22 out of 53 patients in the per-protocol* group)3

The clinical study mentioned above was a multicenter, open-label, prospective, randomized, 2-arm, controlled postmarketing clinical study of the relative efficacy of ADVATE use in 2 prophylactic treatment regimens compared to that of on-demand treatment; 53 previously treated patients (PTPs) with severe to moderately severe hemophilia A (FVIII level <2 IU/dL) were analyzed in the per-protocol group. Subjects were initially treated for 6 months of on-demand therapy and then randomized to 12 months of either a standard prophylaxis regimen (20-40 IU/kg every 48 hours) or a pharmacokinetic-driven prophylaxis regimen (20-80 IU/kg every 72 hours). ABRs for the two prophylaxis regimens were comparable.3,6

You should also know important safety information about ADVATE, such as symptoms of an allergic reaction to ADVATE, that your body may form inhibitors to factor VIII that may stop ADVATE from working properly, and the most common side effects.3 See additional safety information below this video and talk to your doctor to see if ADVATE may be right for you.

Want to learn more about how we do it? We went to one of our manufacturing facilities to show you just how much detail goes into each little vial.

Watch it here.

ADVATE [Antihemophilic Factor (Recombinant)] Important Information

What is ADVATE?

  • ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia).
  • ADVATE is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A. Your healthcare provider (HCP) may give you ADVATE when you have surgery.
  • ADVATE can reduce the number of bleeding episodes in adults and children (0-16 years) when used regularly (prophylaxis).

ADVATE is not used to treat von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

Who should not use ADVATE?
Do not use ADVATE if you:

  • Are allergic to mice or hamsters.
  • Are allergic to any ingredients in ADVATE.

Tell your HCP if you are pregnant or breastfeeding because ADVATE may not be right for you.

What should I tell my HCP before using ADVATE?
Tell your HCP if you:

  • Have or have had any medical problems.
  • Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
  • Have any allergies, including allergies to mice or hamsters.
  • Are breastfeeding. It is not known if ADVATE passes into your milk and if it can harm your baby.
  • Are or become pregnant. It is not known if ADVATE may harm your unborn baby.
  • Have been told that you have inhibitors to factor VIII (because ADVATE may not work for you).

What important information do I need to know about ADVATE?

  • You can have an allergic reaction to ADVATE. Call your HCP right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.
  • Do not attempt to infuse yourself with ADVATE unless you have been taught by your HCP or hemophilia center.

What else should I know about ADVATE and Hemophilia A?

  • Your body may form inhibitors to factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADVATE from working properly. Talk with your HCP to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

What are possible side effects of ADVATE?

  • Side effects that have been reported with ADVATE include: cough, headache, joint swelling/aching, sore throat, fever, itching, unusual taste, dizziness, hematoma, abdominal pain, hot flashes, swelling of legs, diarrhea, chills, runny nose/congestion, nausea/vomiting, sweating, and rash. Tell your HCP about any side effects that bother you or do not go away or if your bleeding does not stop after taking ADVATE.

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.

For additional safety information, click here for Prescribing Information and discuss with your HCP.

*Per-Protocol: subjects who had >90% of the predicted number of infusions and no major   protocol deviations.6

†44 bleeds (IQR, 20.8), 1 bleed (IQR, 4.1); IQR=Interquartile range, the range of values of the variable in a statistical distribution that lies between the upper and lower quartiles.8

References:

  1. Our Story. Our History. https://www.baxter.com/our-story/our-history. Accessed June 25, 2018.
  2. About Shire. Our story. https://www.shire.com/who-we-are/our-story. Accessed May 1, 2018.
  3. ADVATE Prescribing Information.
  4. Négrier C, Shapiro A, Berntorp E, et al. Surgical evaluation of a recombinant factor VIII prepared using a plasma/albumin-free method: efficacy and safety of Advate in previously treated patients. Thromb Haemost. 2008;100(2):217-223.
  5. Grillberger L, Kreil TR, Nasr S, Reiter M. Emerging trends in plasma-free manufacturing of recombinant protein therapeutics expressed in mammalian cells. Biotechnol J. 2009;4(2):186-201.
  6. Valentino LA, Mamonov V, Hellmann A, et al. A randomized comparison of two prophylaxis regimens and a paired comparison of on-demand and prophylaxis treatments in hemophilia A management. J Thromb Haemost. 2012;10:359-367.
  7. What is Prophylaxis? https://www.wfh.org/en/abd/prophylaxis/what-is-prophylaxis. Accessed June 4, 2018.
  8. Interquartile Range definition. MedlinePlus.
    https://www.merriam-webster.com/dictionary/interquartile%20range. Accessed May 10, 2018.

© 2018 Shire US Inc., Lexington, MA 02421. All rights reserved. 1-800-828-2088.
SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
ADVATE is a trademark or registered trademark of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc.
S39238 07/18