Lifeblood Winter 2014

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P1 | www.nhfcentralohio.org WINTER 2015 OOD LIFE BL A PUBLICATION OF THE CENTRAL OHIO CHAPTER OF THE NATIONAL HEMOPHILIA FOUNDATION WE ROCKED 2014!

description

We Rocked 2014!

Transcript of Lifeblood Winter 2014

Page 1: Lifeblood Winter 2014

P1 | www.nhfcentralohio.org

WIN

TER

2015OODLIFEBL

A PUBLICATION OF THE CENTRAL OHIO CHAPTER OF THE NATIONAL HEMOPHILIA FOUNDATION

WE ROCKED

2014!

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Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, New Jersey 08536 U.S.A.

SevenSECURE® and Changing Possibilities in Hemophilia® are registered trademarks of Novo Nordisk Health Care AG.© 2013 Novo Nordisk Printed in the U.S.A. 0513-00015474-1 May 2013

When you or your child has a bleeding disorder, the costs can add up quickly. SevenSECURE® is a valuable tool that may help you with health insurance, educational grants and scholarships, health and fi tness memberships, and reimbursement assistance for medical and dental expenses. And it’s now available online, so support is always a click away.

support that may help you change the possibilities in hemophilia

Discover support with SevenSECURE®. Visit ChangingPossibilities-US.com to learn more about the program and enroll today.

CHRIS FENNICKSChris has hemophilia A with inhibitors

S:7”S:10”

T:8.375”T:10.875”

B:8.875”B:11.125”

NOSV3J1482_CPiH_Patient_Ad_FULL_r6_PP.indd 1 5/31/13 12:05 PM

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LIFEBLOOD | Winter 2014 | P3

47

1012141618

PRESIDENT’S CORNERLetter from the Chapter President

CONTENTSLIFEBLOOD

2014 - 2015 CALENDAR Save the date

WILDLIGHTS AT THE ZOO!Join the Education Forum

PAGE

HIGHLIGHTS FROM THE WALK & RUN We did it!

LIFEBLOOD WINNERSCongratulations!

YOUR OSU HTC TEAMMeet your team

EXERCISE & MENSTRUAL CRAMPSPain relief the natural way

19232728313334

STATEHOUSE DAYSSave the date

FDA APPROVES 1ST COMBINATION PILLTreating Hepatitis C

ORAL HCV COMBINATION THERAPYFDA Approved

WINTER 2014

At CVS Caremark, we’ve been helping

families like yours for more than 30 years.

Our caring patient support helps ensure

safety, convenient access and satisfaction.

www.CVSCaremarkSpecialtyRx.com

Diane Linker, Client Relations Manager [email protected]

Mary Ellen Mackey, Field Sales [email protected]

©2014 Caremark. All rights reserved. 75-30419a 022014

Trust the Experience

PLANT BASED THERAPYA major step forward

RARE FORM OF HEMOPHILIANew treatment approved

A PSYCHIATRIST’S PERSPECTIVE Dr. James Hammel

DANCER’S INSPIRATIONLocal dancer making moves

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Calendar

The Central Ohio Chapter of the National Hemophilia Foundation is dedicated to providing education, advocacy and support for people with bleeding disorders.

DECEMBER 14Education Forum followed by Wildlights at the Zoo!See pg. 18 for more details.

winter 2014

March 20Chapter Open HouseDetails coming soon

MARCH 13-15 Infusion Skills Weekend(see the nurses at Nationwide Children’s Hospital for more information)

May 17Dancing For The Cure

April 14Statehouse DaysDinner and training will be provided Monday, April 13.

See pg. 23

Please visit www.dftcohio.com for more details.

Contact Information P. 614.985.3752 | E. [email protected] | www.nhfcentralohio.org

winter 2015

The 2015 Calendar will continue to grow, so be sure to check www.nhfcentralohio.org often for updates.

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LIFEBLOOD | Winter 2014 | P7

President’s Corner

Paul hemingway

CAN YOU BELIEVE IT’S ALMOST DECEMBER?

It’s a little cliché, but with the holidays comes a time to reflect upon the year and express gratitude for our triumphs and challenges. My greatest triumph might have been welcoming a new bundle of joy to our family, Elliot. Ironically, my greatest challenge also might have been…welcoming this bundle of joy to our family. Will the crying ever stop? I’m not so sure. Let the countdown to 18 begin!

It was great seeing so many people at our Annual Dinner at the Der Dutchman the first week of November. Think about how our Chapter family has grown the past year – new faces, new experiences, new leadership, and a new outlook! I am grateful to have met so many people this year at our events, and for the kindness and fellowship you have shown to my family.

It has been a remarkable year for our Chapter. While we have more to achieve, we should pause to acknowledge all that we accomplished.

Let us consider the recent triumphs that occurred just over the last few months:

Our Hemophilia Walk raised over $45,000 beating our Chapter’s goal by more than 12%. 41 teams participated. I could not believe some of the clever ideas our community used to raise money including a pajama day at school, jeans day at work, a golf tournament, and contributions from local restaurants (I have never felt less guilty about eating an enormous burrito). Congratulations to all who participated!

The Blood Run moved to the Arena District attracting three times the participants from last year raising almost three times the funds ($30,000) for our Chapter. It was quite the Halloween event for Columbus and has a lot of potential in the years to come.

Ms. Joan Wallick was honored by Nationwide Children’s Hospital for her generous donation to help establish the Joan Fellowship in Pediatric Hemostasis-Thrombosis. There are only two fellowships in the country for bleeding disorders, and one is in our backyard. Even Val Bias, CEO of the National Hemophilia Foundation, flew in to praise Ms. Wallick for her philanthropy.

Our Chapter’s board members completed board membership training…on a beautiful autumn Saturday in October… for eight hours long indoors. Every single board member attended. I was so proud to see their dedication to our community and desire to learn how to improve their service to you. I truly look forward to going into 2015 with each member of our Board!

We are developing committees and want you to be involved. If you have ever attended one of our programs– Family Camp, Hemophilia Walk, Annual Dinner, etc.– and feel that you have new ideas and would like to help in the planning and implementation, please reach out to myself, or our Executive Director, Amanda Turner at 614.634.1818 or [email protected] for more information.

To those in our Chapter who have driven awareness for our community, served one another, or raised money for our cause this year– thank you so much!

I hope as you reflect on your year, that you will acknowledge your own accomplishments and accept that the challenges you have faced were opportunities for learning and growth. I look forward to seeing you all at our new Education Forum event on Sunday, December 14th at the Columbus Marriott Northwest (see page 18 for more info) and, if my little one cooperates, at the Columbus Zoo Wildlights afterward (insert crying here).

My best wishes to your family this holiday season,

Paul

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Half the volume

IndicationsALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) is indicated for:

• Control and prevention of bleeding in patients with hemophilia A

• Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand disease (VWD) in whom desmopressin (DDAVP®) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery

Important Safety InformationALPHANATE is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.

Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with ALPHANATE should be discontinued, and emergency treatment should be sought.

Development of activity-neutralizing antibodies has been detected in patients receiving FVIII containing products. Development of alloantibodies to VWF in Type 3 von Willebrand disease (VWD) patients has been occasionally reported in the literature.

Thromboembolic events may be associated with AHF/VWF Complex (Human) in VWD patients, especially in the setting of known risk factors.

Intravascular hemolysis may be associated with infusion of massive doses of AHF/VWF Complex (Human).

Rapid administration of a FVIII concentrate may result in vasomotor reactions.

Plasma products carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.

The most frequent adverse events reported with ALPHANATE in >5% of patients are respiratory distress, pruritus, rash, urticaria, face edema, paresthesia, pain, fever, chills, joint pain, and fatigue.

© 2014 Grifols Inc. All rights reserved. Printed in USA. July 2014 A817-0714

References: 1. ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) Prescribing Information. Grifols. 2. CSL Behring. Humate P Package Insert. August 2013; 3. Octapharma. Wilate Package Insert. January 2012; 4. Kedrion. Koate-DVI Package Insert. August 2012.

Twice the factor*

Please see brief summary of ALPHANATE full Prescribing Information on adjacent page.

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.

ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) is now available in a 2000 IU FVIII vial with a reconstitution volume of only 10 mL.

That’s TWICE the amount of factor of the largest vial available for other FVIII/VWF products,1-4 so patients may require:

• Less volume

• Less time

• Fewer syringes

Isn’t it time you tried ALPHANATE?

Learn more at alphanate.com

www.grifols.comGrifols Biologicals Inc.5555 Valley Boulevard, Los Angeles, 90032 CA - USA Tel. 888-GRIFOLS (888 474 3657)

www.grifols.com

For more information: Grifols Biologicals Inc. Tel. 888-GRIFOLS (888-474-3657)

*

Half the volume

IndicationsALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) is indicated for:

• Control and prevention of bleeding in patients with hemophilia A

• Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand disease (VWD) in whom desmopressin (DDAVP®) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery

Important Safety InformationALPHANATE is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.

Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with ALPHANATE should be discontinued, and emergency treatment should be sought.

Development of activity-neutralizing antibodies has been detected in patients receiving FVIII containing products. Development of alloantibodies to VWF in Type 3 von Willebrand disease (VWD) patients has been occasionally reported in the literature.

Thromboembolic events may be associated with AHF/VWF Complex (Human) in VWD patients, especially in the setting of known risk factors.

Intravascular hemolysis may be associated with infusion of massive doses of AHF/VWF Complex (Human).

Rapid administration of a FVIII concentrate may result in vasomotor reactions.

Plasma products carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.

The most frequent adverse events reported with ALPHANATE in >5% of patients are respiratory distress, pruritus, rash, urticaria, face edema, paresthesia, pain, fever, chills, joint pain, and fatigue.

© 2014 Grifols Inc. All rights reserved. Printed in USA. July 2014 A817-0714

References: 1. ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) Prescribing Information. Grifols. 2. CSL Behring. Humate P Package Insert. August 2013; 3. Octapharma. Wilate Package Insert. January 2012; 4. Kedrion. Koate-DVI Package Insert. August 2012.

Twice the factor*

Please see brief summary of ALPHANATE full Prescribing Information on adjacent page.

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.

ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) is now available in a 2000 IU FVIII vial with a reconstitution volume of only 10 mL.

That’s TWICE the amount of factor of the largest vial available for other FVIII/VWF products,1-4 so patients may require:

• Less volume

• Less time

• Fewer syringes

Isn’t it time you tried ALPHANATE?

Learn more at alphanate.com

www.grifols.comGrifols Biologicals Inc.5555 Valley Boulevard, Los Angeles, 90032 CA - USA Tel. 888-GRIFOLS (888 474 3657)

www.grifols.com

For more information: Grifols Biologicals Inc. Tel. 888-GRIFOLS (888-474-3657)

*

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ALPHANATE®Antihemophilic Factor/von WillebrandFactor Complex (Human)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to useAlphanate safely and effectively. See full prescribing informationfor Alphanate.

ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRANDFACTOR COMPLEX [HUMAN])

Sterile, lyophilized powder for injection.

Initial U.S. Approval: 1978

--------------------------INDICATIONS AND USAGE ------------------------

Alphanate is an Antihemophilic Factor/von Willebrand FactorComplex (Human) indicated for:

• Control and prevention of bleeding in patients with hemophilia A.

• Surgical and/or invasive procedures in adult and pediatric patientswith von Willebrand Disease in whom desmopressin (DDAVP) iseither ineffective or contraindicated. It is not indicated for patientswith severe VWD (Type 3) undergoing major surgery.

----------------------DOSAGE AND ADMINISTRATION --------------------

For Intravenous use only.

Alphanate contains the labeled amount of Factor VIII expressed inInternational Units (IU) FVIII/vial and von WillebrandFactor:Ristocetin Cofactor activity in IU VWF:RCo/vial.

Hemophilia A: Control and prevention of bleeding episodes

• Dose (units) = body weight (kg) x desired FVIII rise (IU/dL or% of normal) x 0.5 (IU/kg per IU/dL).

• Frequency of intravenous injection of the reconstituted product isdetermined by the type of bleeding episode and the recommen-dation of the treating physician.

von Willebrand Disease: Surgical and/or invasive procedure inadult and pediatric patients except Type 3 undergoing majorsurgery

• Adults: Pre-operative dose of 60 IU VWF:RCo/kg body weight;subsequent doses of 40-60 IU VWF:RCo/kg body weight at8-12 hour intervals post-operative as clinically needed.

• Pediatric: Pre-operative dose of 75 IU VWF:RCo/kg body weight;subsequent doses of 50-75 IU VWF:RCo/kg body weight at8-12 hour intervals post-operative as clinically needed.

--------------------DOSAGE FORMS AND STRENGTHS ------------------

• Alphanate is a sterile, lyophilized powder for intravenous injectionafter reconstitution, available as 250, 500, 1000, 1500 and2000 IU FVIII in single dose vials.

----------------------------CONTRAINDICATIONS ---------------------------

• Patients who have manifested life-threatening immediate hyper-sensitivity reactions, including anaphylaxis, to the product or itscomponents.

----------------------WARNINGS AND PRECAUTIONS --------------------

• Anaphylaxis and severe hypersensitivity reactions are possible.Should symptoms occur, treatment with Alphanate should bediscontinued, and emergency treatment should be sought.

• Development of activity-neutralizing antibodies has been detectedin patients receiving FVIII containing products. Development ofalloantibodies to VWF in Type 3 VWD patients has beenoccasionally reported in the literature.

• Thromboembolic events may be associated with AHF/VWFComplex (Human) in VWD patients, especially in the setting ofknown risk factors.

• Intravascular hemolysis may be associated with infusion ofmassive doses of AHF/VWF Complex (Human).

• Rapid administration of a FVIII concentrate may result invasomotor reactions.

• Plasma products carry a risk of transmitting infectious agents,such as viruses, and theoretically, the Creutzfeldt-Jakob disease(CJD) agent, despite steps designed to reduce this risk.

----------------------------ADVERSE REACTIONS---------------------------

The most frequent adverse events reported with Alphanate in > 5%of patients are respiratory distress, pruritus, rash, urticaria, faceedema, paresthesia, pain, fever, chills, joint pain and fatigue.

To report SUSPECTED ADVERSE REACTIONS, contact GrifolsBiologicals Inc. at 1-888-GRIFOLS (1-888-474-3657) or FDA at1-800-FDA-1088 or www.fda.gov/medwatch.

---------------------USE IN SPECIFIC POPULATIONS --------------------

• Pregnancy: No human or animal data. Use only if clearly needed.

• Pediatric Use: Hemophilia A - Clinical trials for safety andeffectiveness have not been conducted. VWD - Age had no effecton PK.

Grifols Biologicals Inc.5555 Valley BoulevardLos Angeles, CA 90032, U.S.A. 3041048-BSU.S. License No. 1694 Revised: 06/2014

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WE D

ID IT

!

$45,722

HIGHLIGHTS FROM THEHEMOPHILIA WALK 2014...

A Special Congratulations and Thank You

to our TOP FUNDRAISING TEAM, Wil’s Warriors with team captain

Megan Schulte, for raising $5,683and to our top individual fundraiser,

Sean Gilmer of Max’s Minions.

We R

aise

d MOR

E Tha

n Our

Goal

!

Thanks to YOUR participation in the 2014 Hemophilia Walk, Baxter Healthcare donated $5,000 in our

Chapter’s name to the National Hemophilia Foundation’s research fellowships in nursing, social

work, and physical therapy!

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LIFEBLOOD | Autumn 2014 | P11

MENS1st – Matthew Fox2nd – Joseph Gibboney3rd – Drew Devier

CONGRATS TO THE RACE WINNERS:WOMENS1st – Rachel Jordan2nd – Lenna Kirby3rd – Stephanie Kuruc

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Advocacy:Jermaine Davis Philanthropy:Sean Gilmer  Community Development:Michelle McDorman Volunteerism:The Gao Family

HTC Hero:Leslie Witkoff

HTC Hero:Charmaine Biega

Lifetime Achievement:Dr. Bryce Kerlin

Congratulations to the following 2014 LIFEBLOOD Winners! 

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LIFEBLOOD | Winter 2014 | P13

make knowledge hereditary

My life, Our Future is a nationwide campaign for progress in hemophilia. Leaders in our community have come

together to offer a free genotyping test, so that you may gain a deeper understanding of your hemophilia today,

while helping to advance the breakthrough treatments of tomorrow.

mylifeourfuture.org

My Life, Our Future:Genotyping for Progress in Hemophilia Date: Time:Location:

Join us

H E M - 1 0 0 4 3 7 0

We are excited to announce that 1,000 people have enrolled in My Life, Our Future! The number marks a significant milestone in achieving our goal of genotyping as many people in the U.S. with hemophilia A and B as possible. 

By participating, you can help our community make knowledge hereditary. Your genotype can provide meaningful information about your hemophilia today, including identifying your unique mutation. More than 61 new mutations have already been discovered through the program. Genotyping may also accelerate the scientific breakthroughs of tomorrow. Once 5,000 people have enrolled in My Life, Our Future, scientists will be able to apply to research the data and samples.

My Life, Our Future enrolls 1,000

With a quick test, you can contribute to a brighter future for generations to come. Visit MyLifeOurFuture.org for more information. My Life, Our Future is currently available at Nationwide Children’s Hospital; contact Elizabeth Varga at (614) 722-3695 or [email protected] for more information.

NHF CEO, Val Bias, will be at our Chapter’s Education Forum on Sunday, December 14 to present about My Life, Our Future. Please plan to join us for this special presentation. 

Already been genotyped? Share your experience and become a Voice for Progress!

participants

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Q. When were you diagnosed with von Willebrand disease?                                           

A. I was diagnosed during my second year at medical school. Following a routine tonsillectomy, I had to return to the operating room 3 times due to ongoing bleeding. During my third trip to the hospital, I saw a hematologist and was finally diagnosed with von Willebrand disease. 

Q. Did you work with a comprehensive care team once you were diagnosed?

A. Unfortunately, no – and one of my biggest obstacles was trying to manage my bleeding disorder on my own. Having a dedicated comprehensive care team probably would have helped me tremendously, and it likely would have helped me to realize that what I was dealing with wasn’t as abnormal as I originally thought it was. 

Q. What are some of the unique challenges you have faced as a member of the bleeding disorders community?

A. From my perspective, there is a lack of education across the board, and many health care professionals don’t know enough about bleeding disorders. It’s astounding and

A Psychiatrist’s Perspective

speaks volumes that I was at one of the best medical schools in the country but was unable to get to the right specialists to get diagnosed because of the lack of widespread knowledge about these rare diseases. As a result, some individuals with bleeding disorders don’t always receive proper medical attention or care. 

Q. We know from Novo Nordisk’s HERO study that there are a variety of psychosocial issues faced by individuals with hemophilia and those who care for them. In what areas do you see hemophilia and other bleeding disorders having the greatest effect on families? 

A. This differs for each family, with the specific psychosocial challenges being influenced by factors such as diagnosis, age, environment, and resources available. One of the common themes is increased anxiety in every psychosocial aspect of our daily lives – and in ways in which the non-bleeding disorder community doesn’t necessarily contend with. At the same time, this gives us an opportunity for increased resilience as families and as a community. 

on Advocatingfor the Bleeding

Disorders Community

of Rogue Psychiatry in Medford, Oregon, knows firsthand about the psychosocial challenges associated with living with a bleeding disorder, many of which were recently outlined in Novo Nordisk’s Hemophilia Experiences, Results, and Opportunities (HERO) study. With more than a decade of experience working as a psychiatrist and a lifetime of experience living with von Willebrand disease, Dr. Hammel offers his unique perspective about the need for increased education and advocacy both within and outside of the bleeding disorders community.

Dr. James Hammel

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LIFEBLOOD | Winter 2014 | P15

“ Hemophilia doesn’t stop me from having fun.”

—Charlie,* 7 years old, loves windy days

Walgreens Infusion Services— bleeding disorder support to help you stay healthy and active

• A personal team of bleeding disorder experts

• Help, day or night

• Complete educational support

• Broad insurance coverage

To learn more, call 866-436-4376.En español, llame al 800-456-1923.

Taking beautiful care of you.

* Hypothetical patient profile. Walgreens Infusion Services locations are ACHC accredited. HHA #20881096, HHA #20885096, HHA #299991678, HHA #299992580 ©2013 Walgreen Co. All rights reserved. 13WIS0117.25-NC

BD-Ad_3x5_Hemophilia of NC_FNL-080513.indd 1 8/6/13 3:32 PM

Q. How and why did you become involved with national hemophilia advocacy groups such as the National Hemophilia Foundation?

A. I’m at the point in my career where I want to be able to advocate for and support those within the bleeding disorders community to ensure we are all getting the care and attention we need. What I went through in medical school when I was finally diagnosed was traumatizing, and I don’t want anyone to go through a similar ordeal. Advocacy organizations, such as the National Hemophilia Foundation and Hemophilia Federation of America, are among the best resources for people looking for more information about bleeding disorders. 

 

Q. One of the goals of Novo Nordisk’s HERO initiative is to advocate for improvements in quality of life and health outcomes for people living with hemophilia. Why is it important for members of the hemophilia and broader bleeding disorders community to advocate for themselves?

A. All of us who are affected by bleeding disorders need to become more involved because, as the health care environment continues to evolve, due in part to the Affordable Care Act, it is now more important than ever that resources and funding for the bleeding disorders community are prioritized. Although treating our conditions can be expensive, bleeding disorders also are serious and can be life threatening. 

Q. What plans do you have in the future for supporting the bleeding disorders community?

A. As a psychiatrist, I think it is critical for us to address the unique mental health issues faced by our community members. I’m currently working on a session to be presented at the upcoming National Hemophilia Foundation Annual Meeting this September that will focus on the many stigmas and mental health issues faced by those living with these complex conditions and their loved ones. We have to pay as much attention to these issues as

we do our ability to get treatment, because they are equally as important. I also plan to continue serving on the Board of Directors of the National Hemophilia Foundation. 

Q. Of which of your many accomplishments are you most proud?

A. I’m most proud of my 3-year-old son Nathaniel. I’ve accomplished a lot professionally and otherwise, but having him is the best thing in the world.

“I want to be able to advocate for and support those within the bleeding disorders community to ensure we are all getting the care and attention we need.“

 For more information on the HERO study findings, please visit http://www.ChangingPossibilities-US.com/Inhibitor/HERO.aspx.

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Erin Cavener, Social WorkerOne of the newest faces at the OSU HTC is Erin Cavener. Born in Columbus, but has lived all over Ohio (Marion,

Prospect, and Dayton), Erin received her Bachelor in Social Work at Bowling Green State University and her Masters in Social Work at The Ohio State University. As the newly appointed Social Worker for OSU’s HTC, Erin is still learning about her various roles within the clinic. Because of the many transitions in the HTC, Erin is committed to creating and implementing processes and procedures to ensure she is able to provide clinic patients and outpatients within the HTC the best care. She is the go to person to assist OSU HTC patients with community resources, financial questions, medication assistance, etc. She is excited to work with the Chapter on relaunching support groups for the bleeding disorder community in 2015. Erin and her partner have two daughters, ages four and 16 months. Her girls make life very busy, but she wouldn’t change a thing! Outside of keeping busying with her family, Erin is an avid wood worker and hopes to complete some unfinished projects during her “down time.”

Leslie Witkoff, Nurse CoordinatorOriginally from Maine, Leslie chose a warmer climate for college by attending the University of South Florida

in Tampa. After migrating to the Midwest, Leslie worked as the only nurse for the OSU College of Dentistry. She had a chance encounter by noticing and applying for an open position in OSU’s HTC 15 years ago – a chance she’s glad she took! Not only has Leslie served as the Nurse Coordinator at the HTC, she has also served as the Research Specialist for Benign Hematology. For the last nine months, she has filled in for the vacant Social Worker position, as well as moved to spending more of her time from research to clinic…a woman of many hats! Through this time of transition, Leslie still worked with the Chapter to host an outreach event this summer with our Amish community in Walnut Creek. Outside of OSU, Leslie enjoys reading and working in her garden. Leslie is married (26 years!) with three grown boys, two dogs, and 10 saltwater fish.

The Ohio State University Medical Center’s Hemostasis and Thrombosis Center has seen many changes over the last year. With so many new faces to keep track of, we want to ensure that you’re familiar with your OSU HTC team.

From the left Katie Johnston, Dr. Eric Kraut, Erin Cavener, and Leslie Witkoff. Missing: Dr. Tzu-Fei Wang

YOUR OSU HTC TEAM

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LIFEBLOOD | Winter 2014 | P17

Dr. Tzu-Fei Wang, Physician and Assistant Professor of Internal Medicine Division of Hematology

Originally from Taiwan, Dr. Wang went to medical school at the University of Minnesota, and then lived in LA and St. Louis before landing in Columbus in July of 2013. She was always interested in the pathophysiology and treatment of bleeding and clotting disorders, and finds it to be a privilege to take care of these patients with complicated problems and to help him deal with this illness. Dr. Wang is looking forward to working with OSU’s HTC Social Worker, Erin Cavener, and the Chapter on relaunching support groups to further educate and bring together members of the bleeding disorder community. Outside of clinic, she enjoys listening to music, eating out with friends, and traveling when possible.

Dr. Eric Kraut, Director of Hemostasis and Thrombosis Center and the Benign Hematology Program

Originally from Englewood, NJ, Dr. Kraut went to medical school at Temple University, followed by a residency at the University of Pittsburgh and then a fellowship at The Ohio State University. He trained in classical hematology and was always interested in the workings of the clotting system. His interest began at Temple University where he did his first presentation as a medical student to Dr. Sol Sherry, who is known as the “Father” of thrombolytic therapy. Dr. Kraut keeps busy outside of clinic reading and writing poetry, playing racquetball, swimming, and watching sports. His two children, two step children, and four grandchildren also keep him busy! We are excited for Dr. Kraut to co-lead a session on December 14 with Dr. Amy Dunn about platelet deficiencies during our Education Forum.

Katie Johnston, Physical TherapistOriginally from Mount Vernon, OH, Katie attended Ohio University to study biology, and then continued her education

at The Ohio State University to receive her doctorate in Physical Therapy. Katie has been with the HTC for the past six years. In addition to her time at clinic, she also works part-time at OSU’s outpatient rehab treating patients with orthopedic injuries. She provides a unique resource for the bleeding disorder community by helping to develop ways for her patients to participate in regular and safe exercise. Katie measures joint’s range of motion, addresses any musculoskeletal injuries or concerns, and screens patients for safety issues, such as increased risk of falling. Like most of the other HTC team members, Katie was drawn to working with bleeding disorder patients because she is able to make a real difference with this unique population and has witnessed firsthand the benefits that come when her patients learn and perform a safe exercise program – cardiovascular health, joint health, decrease risk of joint bleeds and injuries, and more! An avid runner, Katie keeps busy outside of work with her husband, Nick, and their two children, Matthew (6yo), Ella (1yo), and another to arrive in April, plus two dogs.

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Frustrated with the challenges of your bleeding disorder? Want to connect with other people that can relate? Have you searched to the end of the internet and are still looking for answers? Ever wonder what your rights are as a consumer?

Tentative Agenda:1:00pm – Registration Open1:30pm – Opening General Session with NHF’s CEO, Val Bias2:15pm – How to be a Savvy Consumer with Michelle Rice and National

Youth Leadership Institute participants, Lucas Rice and Callie Clark3:15pm – Breakout Education Sessions – 3 options *4:15pm – Breakout Education Sessions – 3 options *5:15pm – Group Dinner6:00pm – End of the Education Forum and travel to Wildlights at the Columbus Zoo *Younger kids will have an option to watch a movie in a nearby room with professional babysitters during the breakout education sessions. Pre-teens and teenagers will have an optional breakout education session to attend. Breakout Education Session topics will include an insurance info roundtable, a session just about

Central Ohio Chapter of NHF’s Education Forum and

Wildlights at the Zoo!Date: Sunday, December 14, 2014Time: 1:00PM-6:00PMEducation Forum Location:

Same hotel as 2014 FAMOHIORSVP:

Please join us for this half-day event with national and local speakers to discuss what YOU and your family deal with on a day to day basis. After our day of education activities and a group dinner, each attendee will receive FREE passes to see the Wildlights at the Columbus Zoo, along with one FREE parking pass per family.

http://educationforumwildlights.eventbrite.comQuestions? Contact Amanda Turner at [email protected] or 614.634.1818.

P18 | www.nhfcentralohio.org

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LIFEBLOOD | Winter 2014 | P19

Images courtesy of Jackson Sarver (sarverdigital.com)

One sure sign that the holiday season is upon us are notices and posters about BalletMet’s The Nutcracker which opens December 12 and runs until December 27 at The Ohio Theatre. This beloved story follows the journey of Clara and her Nutcracker Prince to a fantasy world of imagination. The stage will be packed with exquisite costumes and scenery, Tchaikovsky’s notable score played by the Columbus Symphony will fill the air, and of course amazing dancers starting as young as 7 years old with tell the story.

One dancer to note is Isaac Orrante, a local 10 year old with moderate hemophilia. Isaac is the son of Sonia and Jimmy Orrante, and big brother to Imara and Aiyana. Jimmy is currently a company dancer with BalletMet and Sonia, a former company dancer, teaches dance and serves as rehearsal assistant for The Nutcracker. The Orrante’s were gracious enough to talk to us about Isaac’s experience managing a bleeding disorder while engaging in such an active and rigorous pursuit like ballet.

“One dancer to note is Isaac Orrante, a local 10 year old with moderate hemophilia.“

NHF: Isaac, when did you start dancing and why? Isaac: I started dancing when I was 7 because I wanted to be onstage with my dad.

NHF: Is this your first time in the Nutcracker? Have you performed on stage before? Isaac: This is my 4th time in the Nutcracker. I have been onstage since I was a month old actually. I was in a production of the Nutty Nutcracker.

NHF: Tell us about your role in the Nutcracker. Isaac: I’m Fritz this year, Clara’s brother. I’m basically on stage to bother her and break the Nutcracker. I get a lot of practice at home with my sisters. I’m also in the battle scene and 2nd Act as a child of Mother Ginger.

Q&A

MAKING MOVES WITH HEMOPHILIA

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P20 | www.nhfcentralohio.org

NHF: How many times a week do you rehearse and for how long? Isaac: I usually rehearse two times a week for about eight hours total. I don’t get a lot of weekends in the Fall that are free.

NHF: Are there days you don’t want to go to rehearsal? If so, what motivates you to go and work your hardest? Isaac: Yes, there are days I don’t want to go, but actually once I start rehearsing it’s pretty fun and then I want to work my hardest to get better.

NHF: What is the most difficult part about being a dancer? Isaac: The form is the hardest part about being a dancer, and then there are the steps! Plus, you have to make it look easy and good!

NHF: How do you manage your bleeding disorder and your practice schedule? Isaac: Sometimes I’ve missed rehearsal because of a bad bruise from playing at school or soccer, but I infuse right away and make sure I rest after. If I have to sit out of practice I still have to watch and take notes, lots of notes!

NHF: Has your bleeding disorder affected your dancing in any way? Isaac: Only that I have to rest and take off sometimes.

NHF: What other activities are you involved in? Isaac: I’m involved in soccer and I play a lot of sports at home, but there’s not much time for anything else – well, homework.

NHF: Do any of the kids in your company/school know that you have a bleeding disorder? How did you tell them? Isaac: No, people don’t really know. Sometimes I tell them, but they don’t understand it. It’s hard to make them understand. NHF: Sonia and Jimmy, did you encourage Isaac to take ballet? S/J: We did encourage Isaac to take ballet, but he was there all the time anyway as a toddler and pre-schooler watching from the wings, hanging out backstage.

NHF: Do his siblings dance as well? S/J: His sisters do dance. The youngest, Imara, began this year, and Aiyana started shortly after Isaac.

NHF: Are you concerned about the physical challenges that Isaac would be facing performing ballet? Sonia: I am concerned about the physical challenges Isaac will encounter as he progresses though his ballet training, because eventually his joint health can become precarious. But I know as a ballet teacher that this early ballet training is extremely right for maintaining and improving the strength of small muscle groups which support joint health. Isaac went from having a potential target joint as a moderate hemophiliac to almost no incidents annually once he started ballet training. I know that’s not an example, but I do know as a former dance professional, ballet is extremely focused on small muscle group strength and flexibility.

NHF: What preventative steps does Isaac take to prevent a bleeding episode before/during/after dancing? S/J: Isaac has not had to take any preventative measures so far to prevent bleeds while dancing.

NHF: Do you think Isaac will want to continue to pursue dancing in the near future? S/J: I do think Isaac will continue to pursue dancing because as much as he loves sports, this proves more challenging, and he always wants to “win!”

NHF: Do you think that Isaac being a ballet dancer helps to encourage other children his age with a bleeding disorder not be afraid to pursue various activities? S/J: Hopefully this interview will serve as a platform to encourage others with bleeding disorders to follow their passions.

NHF: What events do you and Isaac attend with the Central Ohio Chapter? S/J: We have consistently attended the infusion sessions, because we always need the practice, but the other events often fall when Isaac has ballet. We are really excited to partner with some other dancers to produce a benefit dance concert next May to support the Chapter called Dancing for the Cure. We hope it will bring awareness to this rare condition and help raise funds for more programs for the Chapter!

Principal Dancers from BalletMet are producing a benefit concert to support the Central Ohio Chapter of NHF called Dancing for the Cure.

When: Sunday, May 17, 2015

Where: BalletMet’s Performance Space Stay tuned for more details by visiting and “liking”www.facebook.com/wearedancingfortheCURE

SAVE THE DATE

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LIFEBLOOD | Winter 2014 | P21

Friday 12/12 7:30pmSaturday 12/13 1:00pm; 5:30pmSunday 12/14 1:00pmThursday 12/18 7:30pmFriday 12/19 7:30pmSaturday 12/20 2:00pm; 7:30pmSunday 12/21 1:00pm; 5:30pmTuesday 12/23 7:30pmFriday 12/26 2:00pm; 7:30pmSATURDAY 12/27 2:00PM The Nutty Nutcracker (a fun parody created by Edward and the dancers) You’re sure to be surprised and entertained by this hilarious parody of the classic holiday tale. A Nutty Nutcracker is a show where anything can happen, and probably will!

SATURDAY 12/27 7:30PM

PRICES: Orchestra I (zone 2) -- $49 (regularly $65)Orchestra II (zone 3) -- $39 (regularly $54)Prime Mezzanine (zone 2) -- $49 (regularly $65)Mezzanine (zone 4) -- $29 (regularly $42)

Email Rick Hole at [email protected] for

DISCOUNT TICKETSwhen you say you’re with the Hemophilia Foundation.

support Issac Nutcracker?and see the

Want to

SHOW DATES TIME

Journey with Clara and her Nutcracker Prince to the Land of the Sugar Plum Fairy – a magical world of the imagination filled with colorful characters sure to enchant you and your family.The Ohio Theatre39 E State Street, Columbus, OH 43215

Page 22: Lifeblood Winter 2014

Nationwide Children’s Hospital Homecare

Nationwide Children’s Hospital Homecare is the only hospital-based pediatric home health agency in the central Ohio area. The Infusion Pharmacy partners with the Hemophilia Treatment Center at Nationwide Children’s to provide factor for pediatric patients in the state of Ohio.

Services Provided:• Infusion Pharmacy – Factor Program• Pediatric Home Medical Equipment• Retail Medical Equipment and Supplies on site• Intermittent (short-term) Nursing

• Private Duty (long-term) Nursing• Skilled Therapy Services (OT, PT, Speech)• Hospice and Home-based Palliative Care Services

for children with life-limiting illnesses

(614) 355-1100 | (800) 466-2727NationwideChildrens.org/Homecare

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LIFEBLOOD | Winter 2014 | P23

Please plan to join the

For Statehouse dayTuesday, April 14, 2015

Columbus, OHDinner and training will be provided

Monday, April 13, 2015.

Statehouse Days

Starts February 20, 2015 and closes March 31.

For more information, please visit:www.ohiobleedingdisorderscouncil.org

Hotel rooms and travel stipends available upon request, with priority to new attendees

and those driving more than 60 miles.

Contact Randi Clites at 614.574.OBDC or [email protected] for

more information or if you are unable to register online.

Hope To See You There

REGISTRATION

This is your opportunity to advocate for the bleeding disorder community. Not only will you have the

opportunity to share your personal story with the state legislators, you will be advocating for items affecting the bleeding disorder community in the

State Budget and current legislation for quality healthcare for patients.

Questions? Reach out to the Chapter’s Advocacy Committee

Chairperson, Jodi Skinner at [email protected] to hear about her experience at Statehouse Days.

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P24 | www.nhfcentralohio.org

At CSL Behring, we are committed to providing treatments and supportive services that make a meaningful difference in the lives of people with bleeding disorders and those who care for them.

We set out on this journey with you more than a century ago, starting with the development of treatments for those with rare and serious diseases.

As we look to the future, we see the promise of new innovations and opportunities —just as we always have.

Over the years, we have never lost sight of what matters most: you and the countless others who inspire our efforts every day.

©2013 CSL Behring LLC 1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USAwww.CSLBehring-us.com COA13-08-0045 9/2013

Heritage

Community

Innovation

NHF & Kroger: Community Awards ProgramEvery time you shop at Kroger and use your Kroger Plus card we get points which Kroger will then distribute as funds to our Chapter.

This is an easy and free way to support our Chapter. T o R e g i s t e r and Start Earning Points For Our Chapter, Visit krogercommunityrewards.com

Be sure to have your Kroger Plus card handy and register your card with our

YOUR CHAPTER Number: 26965

New Registration? Go to krogercommunityrewards.com Click on ‘SIGN UP TODAY’ in the ‘New Customer?’ box. Sign up for a Kroger Rewards Account.

Check your email inbox for confirmation of your registration.

You’re now ready to log in and link your rewards card to our Chapter.

Click on ‘Edit Kroger Community Rewards information’.

Register your card with YOUR Chapter Number: 26965

Don’t have a Kroger Plus Card Yet? They’re FREE, and available at the

customer service desk at any Kroger.

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LIFEBLOOD | Winter 2014 | P27

A team of researchers from the University of Florida, Gainesville (UF-G) and University of Pennsylvania (U-Penn) is developing a novel approach to tackling inhibitors in hemophilia A that uses genetically engineered plant cells. In a recent article published in the journal Blood, the authors reported making progress with the experimental therapy in mice with hemophilia A. The lead investigator of the study was Henry Daniell, PhD, Department of Biochemistry and Department of Pathology, School of Dental Medicine at U-Penn in Philadelphia.

Using genetically engineered plants, Daniell and his colleagues are developing therapeutic factor proteins that decrease unwanted treatment reactions such as anaphylaxis (a life-threatening allergic reaction) and inhibitor (antibody) responses by the immune system. The technique involves encapsulating a “tolerance-inducing protein” within plant cell walls so that when it is ingested it safely travels through the stomach before being released into the small intestines.

In this study, investigators synthesized tobacco plants and factor VIII-coded genetic material, which were fed to mice with hemophilia A. The therapy triggered an average of seven times fewer inhibitor responses. “This is a major step forward,” said study co-author Roland W. Herzog, PhD, College of Medicine, UF-G. In the future, the goal is to replace tobacco plants with lettuce plants for human use.

Researchers have been developing this novel therapeutic approach for several years to create potential vaccines against malaria and cholera, and genetically engineered insulin to help prevent diabetes. In previous studies led by Daniell, factor IX-bioencapsulated plant cells were successfully delivered to mice with hemophilia B. The therapy prevented both anaphylaxis and inhibitors.

Researchers Report Advances in Plant-Based Hemophilia A Therapy

The authors see a tremendous upside if this oral tolerance therapy were to become a viable option for humans. “Our technique, which uses plant-based capsules, has the potential to be a cost-effective and safe alternative,” said Daniell.

The article, “Suppression of Inhibitor Formation Against FVIII in a Murine Model of Hemophilia A by Oral Delivery of Antigens Bioencapsulated in Plant Cells,” was published in the September 4, 2014, issue of Blood.

Source: newKerala.com, September 4, 2014

“This is a major step forward,”

“Our technique, which uses plant-based capsules, has the potential to be a cost-effective and safe alternative,”

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P28 | www.nhfcentralohio.org

The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.

Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection. Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.

FDA approves first combination pill to treat hepatitis C

 

“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

“Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”

Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections and liver

cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis. Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 participants who had not previously received treatment for their infection (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured.In the first trial, comprised of treatment-naive participants, 94 percent of those who received Harvoni for eight weeks and 96 percent of those who received Harvoni for 12 weeks achieved SVR. The second trial showed 99 percent of such participants with and without cirrhosis achieved SVR after 12 weeks. And in the third trial, which examined Harvoni’s efficacy in treatment-experienced participants

continued on pg. 31

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I LIKE TO STAY ACTIVE.I HAVE NO PLANS TO CHANGE THAT.BeneFix is the most prescribed recombinant factor IX treatment FDA approved for hemophilia B.†

n Demonstrated bleed control in patients with moderate and severe hemophilia B n Established safety record n BeneFix Rapid Reconstitution (R2) Kit—designed for patients, by patients—offers a full range of dosing options

ImpoRtAnt SAFEty InFoRmAtIon FoR BEnEFIX• BeneFixiscontraindicatedinpatientswhohavemanifestedlife-threatening,immediatehypersensitivityreactions,includinganaphylaxis,totheproductoritscomponents,includinghamsterprotein.

•CallyourhealthcareproviderrightawayifyourbleedingisnotcontrolledafterusingBeneFix.

•AllergicreactionsmayoccurwithBeneFix.Callyourhealthcareproviderorgetemergencytreatmentrightawayifyouhaveanyofthefollowingsymptoms:wheezing,difficultybreathing,chesttightness,yourlipsandgumsturningblue,fastheartbeat,facialswelling,faintness,rashorhives.

•Yourbodycanmakeantibodies,called“inhibitors,”whichmayinterferewiththeeffectivenessofBeneFix.

• Ifyouhaveriskfactorsfordevelopingbloodclots,suchasavenouscatheterthroughwhichBeneFixisgivenbycontinuousinfusion,BeneFixmayincreasetheriskofabnormalbloodclots.ThesafetyandefficacyofBeneFixadministrationbycontinuousinfusionhavenotbeenestablished.

•SomecommonsideeffectsofBeneFixarenausea,injectionsitereaction,injectionsitepain,headache,dizzinessandrash.

WhAt IS BEnEFIX?BeneFix®CoagulationFactorIX(Recombinant)isaninjectablemedicinethatisusedtohelpcontrolandpreventbleedinginpeoplewithhemophiliaB.HemophiliaBisalsocalledcongenitalfactorIXdeficiencyorChristmasdisease.

BeneFixisnotusedtotreathemophiliaA.

please see brief summary of full prescribing Information on next page.

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.

*BeneFixwasapprovedFebruary11,1997.†IMSNationalPrescriptiondataOctober2013.

Download your free HemMobile™ app.HemMobile helps you keep track of your infusions and any bleeds you might have.

App Store is a service mark of Apple Inc. Android and Google Play are trademarks of Google Inc.

Join Our Hemophilia Community

Manufactured by Wyeth Pharmaceuticals Inc. Marketed by Pfizer Inc.

BUS640301-01 © 2014 Pfizer Inc. All rights reserved. Printed in USA/April 2014

Page 30: Lifeblood Winter 2014

Brief Summary

See package insert for full Prescribing Information. This product’s label may have been updated. For further product information and current package insert, please visit www.Pfizer.com or call our medical communications department toll-free at 1-800-934-5556.

Please read this Patient Information carefully before using BeneFix and each time you get a refill. There may be new information. This brief summary does not take the place of talking with your doctor about your medical problems or your treatment.

What is BeneFix?

BeneFix 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 or Christmas disease.

BeneFix is not used to treat hemophilia A.

What should I tell my doctor before using BeneFix?

Tell your doctor and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies.

Tell your doctor about all of your medical conditions, including if you:

• arepregnantorplanningtobecomepregnant.Itisnotknownif BeneFix may harm your unborn baby.

• arebreastfeeding.ItisnotknownifBeneFix passes into the milk and if it can harm your baby.

How should I infuse BeneFix?

The initial administrations of BeneFix should be administered under proper medical supervision, where proper medical care for severe allergic reactions could be provided.

See the step-by-step instructions for infusing in the complete patient labeling.

You should always follow the specific instructions given by your doctor. If you are unsure of the procedures, please call your doctor or pharmacist before using.

Call your doctor right away if bleeding is not controlled after using BeneFix.

Your doctor will prescribe the dose that you should take.

Your doctor may need to test your blood from time to time.

BeneFix should not be administered by continuous infusion.

What if I take too much BeneFix?

Call your doctor if you take too much BeneFix.

What are the possible side effects of BeneFix?

Allergic reactions may occur with BeneFix. Call your doctor or get emergency treatment right away if you have any of the following symptoms:

wheezingdifficulty breathingchest tightnessturning blue (look at lips and gums)fast heartbeatswelling of the facefaintnessrashhives

Your body can also make antibodies, called “inhibitors,” against BeneFix, which may stop BeneFix from working properly.

Some common side effects of BeneFix are nausea, injection site reaction, injection site pain, headache, dizziness and rash.

BeneFix may increase the risk of thromboembolism (abnormal blood clots) in your body if you have risk factors for developing blood clots, including an indwelling venous catheter through which BeneFix is given by continuous infusion. There have been reports of severe blood clotting events, including life-threatening blood clots in critically ill neonates, while receiving continuous-infusion BeneFix through a central venous catheter. The safety and efficacy of BeneFix administration by continuous infusion have not been established.

These are not all the possible side effects of BeneFix.

Tell your doctor about any side effect that bothers you or that does not go away.

How should I store BeneFix?

DO NOT FREEZE BeneFix. BeneFix kit can be stored at room temperature (below 86°F) or under refrigeration. Store the diluent syringe at 36° to 86°F (2° to 30°C). Throw away any unused BeneFix and diluent after the expiration date indicated on the label.

Freezing should be avoided to prevent damage to the pre-filled diluent syringe.

Different storage conditions are described below.

Product labeled for Room temperature Storage Store at 2° to 30°C (36° to 86°F). If you have the product kit labeled for room temperature storage, it can be stored at room temperature (below 30°C or 86°F) or in the refrigerator (2° to 8°C or 36° to 46°F).

Product labeled for Refrigerator Storage Continuous refrigeration [2° to 8°C (36° to 46°F)] If you have the product labeled for storage in the refrigerator (2° to 8°C or 36° to 46°F) and you have not taken the kit out of the refrigerator, then the expiration date printed on the package still applies. You can store the product at room temperature (below 30°C or 86°F) for up to 6 months or until it has reached its expiration date, whichever comes first.

If you have taken the product kit labeled for storage in the refrigerator out of the refrigerator and stored it at room temperature (below 30°C or 86°), then use the product within 6 months from the time you took the product out of the refrigerator or until it has reached its expiration date, whichever comes first. If you cannot remember when you took it out of the refrigerator, then subtract one year (12 months) from the date that is printed on the end flap of the carton package. The date you get is your new expiration date. Throw away any product that has gone over the new expiration date.

BeneFix does not contain a preservative. After reconstituting BeneFix, you can store it at room temperature for up to 3 hours. If you have not used it in 3 hours, throw it away.

Do not use BeneFix if the reconstituted solution is not clear and colorless.

What else should I know about BeneFix?

Medicines are sometimes prescribed for purposes other than those listed here. Do not use BeneFix for a condition for which it was not prescribed. Do not share BeneFix with other people, even if they have the same symptoms that you have.

If you would like more information, talk to your doctor. You can ask your doctor for information about BeneFix that was written for healthcare professionals.

This brief summary is based on BeneFix® Coagulation Factor IX (Recombinant) Prescribing Information LAB-0464-8.0, revised November 2011.

Manufactured by Wyeth Pharmaceuticals Inc. Marketed by Pfizer Inc.BUS420219-01 © 2012 Pfizer Inc. All rights reserved. July 2012

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LIFEBLOOD | Winter 2014 | P31

with and without cirrhosis, 94 percent of those who received Harvoni for 12 weeks and 99 percent of those who received Harvoni for 24 weeks achieved SVR. In all trials, ribavirin did not increase response rates in the participants.  The most common side effects reported in clinical trial participants were fatigue and headache.   Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Harvoni was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness. Harvoni and Sovaldi are marketed by Gilead, based in Foster City, California. Olysio is marketed by Janssen Pharmaceutical based in Raritan, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human

and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

On November 5, 2014, the U.S. Food and Drug Administration (FDA) approved the combination use of two new oral therapies, Simeprevir (Olysio™) and sofosbuvir (Sovaldi™), for the treatment of chronic hepatitis C viral (HCV) infection – both of these drugs received their initial approval in late 2013.

Simeprevir, manufactured by Johnson & Johnson, is a protease inhibitor that halts the progression of HCV, thus preventing it from reproducing. Sofosbuvir, manufactured by Gilead Sciences, is a daily oral nucleotide analogue inhibitor composed of a small molecule compound that blocks HCV’s ability to replicate. The FDA approval encompasses the combination use of simeprevir/sofosbuvir for both treatment-naive and treatment-experienced patients. Trial regimens included a 24-week duration for patients with cirrhosis (scarring of the liver) and 12 weeks for those without cirrhosis, both of which excluded the use of either ribavirin or interferon.

The new FDA approval is based on results of the COSMOS study, a phase II trial which included patients with HCV genotype 1. Rates of sustained virologic response (meaning they no longer had detectable virus in their blood) measured after the cessation of treatment were 93% among those treated with the combination for 12 weeks, and 97% among those treated for 24 weeks. The most common adverse reactions reported by more than 10% of treated patients during 12 weeks of combination treatment were fatigue in 25%, headache (21%), nausea (21%), insomnia (14%), pruritus (11%), rash (11%), and photosensitivity (7%). Dizziness (16%) and diarrhea (16%) were the most commonly reported among those patients treated for 24 weeks.

Source: Family Practice News, November 6, 2014

FDA Approves Oral HCV Combination Therapy Free of Ribavirin and Interferon

continued from pg. 28

Source: FDA Press Release, October 10, 2014

Page 32: Lifeblood Winter 2014

KOGUS-49334A_M2_Jrnl_ad.indd3-28-2013 4:50 PM Dan Capobianco / Vincent Jeffrey

Client CodeClient

LiveOverall TrimBleed

# of Colors

KN10000213ABayer/Kogenate

7.125” x 9.75”8.375” x 10.875”8.625” x 11.125”

4–CMYK

Job info

NoneNotes Fonts

Interstate (Regular), Helvetica Neue LT Std (75 Bold, 55 Ro-man, 45 Light)

ImagesBayer_Icon_4C.ai (72.01%)

Inks Cyan, Magenta,

Yellow, Black

Fonts & Images

Saved at

None

from dcapobianco3847 by

Printed At

Bayer and the Bayer Cross are registered trademarks of Bayer. © 2013 Bayer HealthCare Pharmaceuticals Inc. All rights reserved. 04/13 KN10000213A

We may be able to help.Bayer offers a range of programs that can help you navigate insurance questions about

your hemophilia A treatment. If you’re having issues with co-pays or gaps in coverage, we

may be able to offer assistance. Speak with one of our case specialists to find out more.

Call 1-800-288-8374 and press 1 to speak to a trained insurance specialist!

Having issues with co-pays or gaps in coverage for your hemophilia A treatment ???

S:7.125”

S:9.75”

T:8.375”

T:10.875”

B:8.625”

B:11.125”

Page 33: Lifeblood Winter 2014

FDA approves new treatment for rare form of hemophiliaThe U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVIII] deficiency). Acquired hemophilia A is a rare, but potentially life threatening, bleeding disorder caused by the development of antibodies (immune system proteins) directed against the body’s own FVIII, a protein important for blood clotting. When FVIII is inactivated by these autoantibodies, a person’s blood doesn’t clot normally, resulting in excessive bleeding that can occur spontaneously or following an event such as injury or surgery.

Unlike inherited hemophilia, acquired hemophilia A is not a genetic disorder and affects both males and females. The development of acquired hemophilia A has been related to other medical conditions or health states, such as pregnancy, cancer, or the use of certain medications. However, in about half of the cases, no underlying cause can be found. Diagnosis of this condition can be difficult and the severity of the bleeding can make treatment challenging.

“The approval of this product provides an important therapeutic option for use in the care of patients with this rare disease,” said Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research.

Obizur contains a recombinant analogue of porcine (pig) FVIII. Porcine FVIII is used because it is similar enough to human FVIII to be effective in blood clotting, but is less likely to be affected by the antibodies against human FVIII that are present in people with acquired hemophilia A.

The safety and efficacy of Obizur was evaluated in a clinical trial of 29 adults with acquired hemophilia A who received Obizur to treat a serious bleeding episode. The trial demonstrated the effectiveness of Obizur in the treatment of bleeding episodes. No safety concerns were identified in the trial.

Obizur received orphan drug designation by the FDA because the drug is intended for use in treatment of a rare disease or condition. 

Obizur is manufactured by Baxter Healthcare Corporation, Westlake Village, California. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: FDA Press Release, October 24, 2014

LIFEBLOOD | Winter 2014 | P33

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Exercise and Menstrual Cramps

Heating pad. Salt and vinegar potato chips. TV remote control. These creature comforts help many women get through that time of the month while they’re curled up on the couch. But there is a better way to ride out the bloating, cramps and nausea that often accompany periods. The answer is just a walk, bike ride or yoga class away.

As the old lining starts to break down, hormone-like substances called prostaglandins are released. Prostaglandins cause smooth muscles in the uterus to contract, restricting the flow of blood and oxygen to the endometrium, which dies. These muscular contractions, or cramps, squeeze the dead endometrial tissue, the menstrual flow, through the cervix and out through the vagina.

Cramps usually begin a day before the first day of menstruation and peak the next day. They can be felt in several areas—the abdomen, lower back, hips and thighs. Cramps range from mild to severe, with pain that feels dull, sharp, continuous or intermittent. How strong the cramps are may be linked to the amount of prostaglandins and leukotrienes, chemical messengers that cause inflammation and trigger contractions, her body produces. It may also be a

Cramps 101 Every month, the lining of the uterus, or endometrium, builds up to prepare for pregnancy. If the egg released by the ovaries is not fertilized, this thickened endometrium is shed. “At the time of the period, the arteries clamp down and there’s a sloughing of the tissues that had built up during the second half of the cycle,” says Michelle Warren, MD, professor of medicine and obstetrics & gynecology at Columbia University Department of Medicine in New York City. “Women with bleeding disorders may continue to ooze from those small arteries; therefore, their periods may be very heavy.” Prolonged, heavy periods are called menorrhagia.

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How physical activity can ease pain By Sarah Aldridge | 02.15.2014Originally Published February 2014

function of nerve stimulation. “There are innervations to the uterus that will cause cramping,” says Warren.

For women with dysmenorrhea, or painful periods, it’s important to rule out other conditions. Causes of secondary dysmenorrhea include ovarian cysts, pelvic inflammatory disease, endometriosis and uterine fibroids. (Read “A Difficult Combination,” HemAware: hemaware.org/story/difficult-combination.)

Pain relief the natural way The feel-good chemical in your brain, called an endorphin, is produced by the pituitary gland and hypothalamus when you exercise. Endorphin, or “endogenous morphine” (morphine produced in the body), is the natural version of morphine, the opiate pain reliever. “It increases the threshold at which you feel pain,” Warren says. Endorphin also improves your mood and gives you a sense of well-being. That’s why marathoners can become mileage junkies, logging in long runs and experiencing the so-called “runner’s high.”

So it makes sense that if you can do something physically to produce more endorphins, it’s bound to take your mind off your body. You don’t have to be an ultra-marathoner, though. Even a 30-minute exercise segments can provide a positive effect.

Exercise optionsGentle stretching of the lower back or abdominal muscles might spell relief. “You’re providing a different sensory input to that area, so it might help to alleviate some of the sensation of the cramping,” says Deb Voss, PT, ATC, CSCS, of the Hemophilia Center of Western Pennsylvania in Pittsburgh. “Low back PT exercises include knee-to-chest exercises and lower-trunk rotation.” Progressive muscle release—starting at your head or feet and tensing, then relaxing different muscle groups—might also help with cramps.

Certain yoga poses can help women dealing with painful cramps. A 2011 study in the Journal of Pediatric Adolescent Gynecology showed that pain intensity and duration were significantly lower in approximately 100 adolescent women with primary dysmenorrhea who performed the cat, cobra and fish poses. Plus, there’s the added benefit of mindful meditation and focused breathing. “With yoga, you have the whole mind-body connection,” Voss says.

”Helping to relieve stress and strain, and letting go of some physical tension may help.”Aerobic exercise, in which your body uses oxygen for fuel, elevates your heart rate and breathing. It helps improve blood flow throughout your body and refocuses your thoughts. “Involving yourself in an exercise program can be very helpful,” Warren says. “If exercise were a pill, I’d give it to everybody.”

But with your body feeling like one big throbbing cramp, it’s probably best to refrain from vigorous

exercise during your period, say experts. “Women may not feel they’re able to even develop the energy to do high-intensity activity,” says Voss. Instead, some women may prefer light hiking, walking or swimming, she says.

So next time you’re hit by a wave of menstrual cramps, stash the junk food and grab the leash. You and your four-legged friend will both benefit from a brisk walk.

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LIFEBLOOD

BOARD OF DIRECTORS

STAFF

Officers:Paul Hemingway

President

Jeff StewartVice President

Tracy KaufmanTreasurer

Michelle McDormanSecretary

 Board Members:

Kathy Chesser

Frank Gao

Shannon Hudson

Cynthia Ottavio

Jodi Skinner

 Amanda Turner

Executive DirectorSydney Boyd

Intern

Capital Graphic Design LIFEBLOOD Magazine Design

LOCAL HEMOPHILIA TREATMENT CENTERS

 Local Hemophilia Treatment Centers

Nationwide Children’s HospitalHemostatis and Thrombosis Center

700 Children’s DriveColumbus, Ohio 43205  (614) 722-2000

Ohio State University Medical CenterHemostatis and Thrombosis Center

M414 Starling Loving Hall320 W. 10th Avenue

Columbus, OH 43210

(614) 293-9441

200 E Campus View Blvd, Suite 200, Columbus, OH 43235 | P. 614.634.1818 | www.nhfcentralohio.org