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ISSUE ONE
ADVANCES
Eliminating Worries About Blood-borne Diseases in Factor Therapy
(continued from page 1)
The Council believes this is the only sure way to eliminate the risk of pathogen
transmission in factor therapy.
Prior to this guideline being published, Baxter introduced ADVATE rAHF-PFM to the
hemophilia community. ADVATE rAHF-PFM is indicated in hemophilia A (classical
hemophilia) for the prevention and control of bleeding episodes. ADVATE rAHF-PFM is
the only recombinant Factor VIII therapy that uses no animal or human plasma proteins
in the Factor VIII processing, thereby eliminating the risk of infections caused by
pathogens that could be carried in these proteins. The preparation of ADVATE rAHF-PFM
eliminates the risk of disease transmission that may be associated with the use of humanor animal-derived plasma protein additives.
ADVATE rAHF-PFM reaffirms Baxter’s commitment to address the concerns of the
hemophilia community. If you have questions about your Factor VIII therapy, you
should talk to your doctor.
Plasma/Albumin-Free Processing
ADVATE rAHF-PFM undergoes a rigorous, multi-step
purification process that
includes a final step in
which electrical charges are
used to separate the Factor
VIII from other impurities,
leaving highly purified
Factor VIII.
Important Safety Information
ADVATE rAHF-PFM should be administered cautiously in patients with previous
hypersensitivity to constituents of Factor VIII preparation or known sensitivity to
mouse or hamster proteins.The most common related Adverse Event observed during the
ADVATE rAHF-PFM clinical studies include: strange taste in mouth, headache, dizziness
and flushing.
The formation of inhibitors has been observed with all Factor VIII products, including
ADVATE rAHF-PFM. Contact your doctor if you are not able to prevent or control
bleeding episodes with your regular doses of prescribed Factor VIII therapy.
See enclosed full prescribing information.
Terms You Should Know
Albumin (al•BYU•men) Albumin is a protein found in plasma.
There’s more information online. The following is a
list of website links and articles that may interest you:
Providing information to help empower your hemophilia therapy management.
Explore the new Galaxy. Completely redesigned
and updated with improved navigation, hemophiliagalaxy.com is updated every month with new features and helpful information.
Welcome to the premier issue of
ADVANCES!
Providing you with timely updates on
hemophilia-related information, Baxter
therapies and services.
E-mail Alerts
Get a summary of the latest scientific
and lifestyle news on hemophilia. The
“What’s New Online” e-mail bulletin
keeps you informed. Sign up at the
hemophiliagalaxy.com website.
4
Our goal is to help empower you with the
knowledge and insight to expand your horizons. It’s all part of The Baxter Factor and
what it means to you.
Learn about the latest advances
in Factor VIII therapy. On the
advate.com website, you’ll
learn how ADVATE rAHF-PFM
is made, and find questions to
ask your doctor.
Interactive
Learning
Program on
Joint Health
advate.com/content/index.html
We respect your privacy. The information you provide will only
be used for the purposes for which you have provided it. Please
note that when you contact Baxter directly, you will be providing personally identifiable information to Baxter. When you
submit personally identifiable information, you consent to its
disclosure and use for these purposes. We suggest that you do
not send clinical or medical information via email. We may
share your information with our partners who facilitate the
delivery of this information. If you ever decide that you do not
wish to receive information from us regarding our programs
and services, contact us at: Baxter Customer Service, One
Baxter Parkway, Deerfield, IL 60015 or at 1-800-423-2090. If
you have any questions, comments, concerns or complaints
about our information practices, call 1-800-422-9837 (U.S.) or
847-948-4770 (outside of the U.S.), fax your inquiry to 847948-3642, or send us mail at Center for One Baxter, One
Baxter Parkway, Deerfield, IL 60015.
Learn how a person with hemophilia can keep
joints healthy to lead a full and active life. A
complimentary, interactive learning program on
joint health is now available.
In this issue...
Blood-borne Diseases . . . . . . . . . . .Page 1
One Story . . . . . . . . . . . . . . . . . . .Page 1
Plasma (PLAZ•muh) The fluid portion of the blood in which solids (white cells,
red cells and platelets) are suspended and nutrients dissolved.
School Tips . . . . . . . . . . . . . . . . . .Page 2
Transmissible spongiform encephalopathies (TSEs) (tranz•MISS•uh•bul
SPONJ•i•form en•CEF•uh•lop•uh•theeze) Fatal brain disorders believed to be
caused by prions. Such disorders are characterized by tiny holes that give the
brain a "spongy" appearance.
References
1. Ewenstein B, Collins P, Shapiro A, et al. Global evaluation of ADVATE rAHF-PFM, an advanced category
antihemophilic factor prepared using a plasma/albumin-free method [abstract]. Blood. 2003;102(11):172.
2. National Hemophilia Foundation. MASAC recommendations concerning the treatment of hemophilia and other
bleeding disorders. MASAC Document #151, November 2003.
Baxter and ADVATE are registered trademarks of Baxter International Inc. Hemophilia Galaxy and ADVANCES
are service marks of Baxter International Inc. Copyright ©2004 Baxter Healthcare Corporation. 040791
All rights reserved. 11/04. Printed in the U.S.A.
Ask the Doctor . . . . . . . . . . . . . . . .Page 2
Joint Health . . . . . . . . . . . . . . . . . .Page 3
ADVANCES
Camp Superfly
SM
ADVANCES is a publication of Baxter BioScience with
the sole intent to be used as a resource for informational and educational purposes only.
The world is growing smaller. Through the wonders of science and technology, we make
friends, conduct business, and break bread with people on the other side of the globe. To
our betterment, we share and celebrate other cultures. To our detriment, we also share
disease-causing germs that spread through food, air and most notably, our blood supply.
Scientists call these germs pathogens.*
Pathogens have an inherent ability to mutate and survive. Since the 1970s, at least 30 new
emerging pathogens or reemerging pathogens were discovered, many entering the United
States. According to the World Health Organization’s (WHO) Division for Emerging and
Other Communicable Diseases, many jumped between species, for example, from animals
to humans.
Advances in medical science have improved safety of factor concentrates through development of recombinant technology and effective methods of inactivation and removal of
pathogens from plasma* protein additives used in preparation of recombinant factors.
However, the risk of transmission of known pathogens through plasma protein additives
cannot be completely eliminated.
The risk of contracting emerging blood-borne diseases from Factor VIII therapies that incorporate plasma or plasma proteins, such as albumin*, is not known. In November 2003, the
National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) issued
guidelines that stated:
“All efforts should be made to remove human albumin from recombinant Factor VIII
products. Moreover, increased efforts should be made to eliminate human and bovine
proteins from the manufacturing process of recombinant Factor VIII products.”
1
*See Page 4: “Terms You Should Know”
(See Page 4 for Important Safety Information.)
See Page 3 for details.
Pathogen (PATH•oh•jen) Virus, fungus, bacteria, or prions that can make you sick.
Prion (PREE•ahn) An infectious protein particle thought to cause diseases of the
central nervous system, such as transmissible spongiform encephalopathies (TSEs).
Eliminating Worries about the Transmission of
Blood-borne Diseases in Factor Therapy
. . . . . . . . . . . . . .Page 3
One
Bill Jamison of Harrisburg,
Pennsylvania recounted his
What’s New Online . . . . . . . . . . . .Page 4
experience of living with
Terms You Should Know . . . . . . . . .Page 4
hemophilia A for 49 years.
This is his story. . .
For more information on hemophilia-related information,
Baxter therapies, and services, please call The Center
for One Baxter at toll free 1-800-422-9837 (8:00 a.m. –
5:00 p.m., Central Time, Monday – Friday).
(continued on page 4)
I was diagnosed when I was 10 months old. It was
1954 and back then, they really didn’t differentiate
between hemophilia A and B. All they knew was that
it was a bleeding disorder called hemophilia.
Doctors told my parents I had about five to eight
years to live, because there was no effective treatment.
Basically, the only treatment was whole blood, fresh
frozen plasma infusion. In the early 1960s, cryoprecipitates came around and that was the next step, the
next better step.
I remember spending a considerable amount of time
in the hospital to control the internal bleeding in
my knees, hips, ankles, elbows and kidney. When
Factor VIII therapy became commercially available,
it really turned the treatment of hemophilia around
180 degrees and certainly turned my life around
completely.
(continued on page 3)
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041761
1
ISSUE ONE
School
Bill’s Story (continued from page 1)
TIPS
School can be both exciting and stressful. And when
your child has hemophilia, bridging communication
between your school, home and hemophilia treatment center (HTC) becomes even more important.
Here are three simple steps to ease this transition:
1. Recruit Your School Team.
Contact your child’s school to get the names of
the nurse, teacher, and other key players. Along
with you, your child (if appropriate), and a representative from your child’s HTC, these people will
be your key team members.
2. Schedule a Meeting.
It’s best to get an individualized educational plan
(IEP) in place before your child goes back to
school (or within the first month). Sometimes
schools even prefer to meet in the spring for the
following school year. Depending on your child’s
school, a principal, counselor, or social worker
can help to arrange and facilitate this meeting.
The purpose of the meeting is to ensure that
your child’s physical, emotional and learning
needs are being met.
3. Write the “Playbook.”
You’ll want to achieve several goals:
• Educate school personnel about hemophilia
and bleeds.
ADVANCES recently posed questions from the hemophilia community
to Steven Pipe, M.D., assistant professor of pediatrics and pediatric
medical director of the Hemophilia and Coagulation Disorders Program
at the University of Michigan. We are pleased to feature Dr. Pipe’s
answers to questions we feel are important to the hemophilia community.
I have been seeing and hearing information in the news about
mad cow disease and CJD. I have hemophilia A. Should I be
concerned about getting CJD?
— Person with Hemophilia A
One
But I never became HIV-positive. My family and I went to
the National Institutes of Health to find out why.
I became part of a study that identified eight other individuals
globally who had AIDS-resistant genes. It turned out I had
two genetic mutations. One caused my hemophilia, and the
other protected me from HIV.
I believe that the safer, the cleaner, the purer the product is,
the less chance of viral contamination. That’s a good thing.
That’s why when recombinant products came out in the early ‘90s, I switched over.
Variant CJD is a new transmissible spongiform encephalopathy (TSE)* that was recognized in 1996 and has been linked with exposure to cattle with BSE. Only one case has
been linked with receiving a blood transfusion from an affected individual. The real risk to
those relying on plasma-derived products is unknown, but thus far, no case has been
reported. Patients now have the option to consider a recombinant Factor VIII therapy rather
than a plasma-derived therapy. With new manufacturing of recombinant products, hemophilia A patients have the option to use a Factor VIII therapy without exposure to any
human or animal-derived material. As always, you should discuss any concerns with your
personal physician.
If I was giving other patients or parents advice, I would say, “Be your own best advocate.
Dig for information anywhere you can find it. Don’t be afraid to ask questions.” And I would
strongly suggest that anyone who has a child with hemophilia—especially a newly diagnosed
child with hemophilia—should get involved with the hemophilia community through their
local chapters and make an effort to meet other people in the community.
Coming Soon: Camp Superfly !
• Provide a letter from your child’s doctor covering
treatment guidelines.
If you would like to submit a general question to be considered in a future
issue of ADVANCES, please go to www.baxterfactor.com/askthedoctor.
The information provided in ADVANCES is intended for your general knowledge only and is not intended nor recommended as a substitute for professional medical advice. Always seek the advice of your physician or other qualified healthcare
professional regarding any medical condition or treatment. Nothing contained in this newsletter is intended to be used for
medical diagnosis or treatment.
Complimentary Educational
Program on Joint Health
Joint bleeds are one of the most frequently
occurring complications of hemophilia and can
result in joint damage and decreased quality of
life. However, living a full, active and productive
life, while keeping your joints healthy, is possible
even if you have hemophilia. Comprehensive
information about joint health can help.
A complimentary educational program,
Joint Health: A Guide for People With
Hemophilia and Their Families, is now
available on either CD-ROM or VHS tape.
I switched over again when ADVATE rAHF-PFM came around. This is the next generation of
product. ADVATE rAHF-PFM is also convenient, because it’s available in a smaller volume.
SM
*See Page 4: “Terms You Should Know”
• Advocate for your child to have the least restrictive environment possible while participating in
sports and activities that will keep him safe and
healthy—both physically and emotionally.
1
I had been exposed to HIV multiple times. The doctors had no idea why I wasn’t HIV-positive.
But I was told to plan on becoming (HIV) positive and dying by 1990. It was a trying time. I
had a wife, two small kids and I owned a business. A lot was on the line here.
Mad cow disease, also known as bovine spongiform encephalopathy (BSE), has been recognized for many years. Creutzfeld-Jakob disease (CJD) is a rare human equivalent that previously had been thought to exist in three forms: a genetic form that runs in families; a random form, which occurs rarely; and an accidental transmission form due to direct contact
with the prion* that causes the disease, for example, from surgical equipment or exposure
to certain human tissues.
• Find out how prescriptions for infusing (or selfinfusing) factor are handled.
• Give the school nurse key contact information
to keep on file.
I have severe hemophilia A—less than 1% Factor VIII activity. And when your factor level is
that low, you bleed. You don’t have to be a genius to figure out if you bring your levels above
1%, you’re not going to have as many bleeds. In the 1980s, when HIV came about, it
destroyed a lot of lives. Everyone associated hemophilia with HIV. If you had hemophilia, you
had AIDS. That was just the association.
To order your free copy, please visit
www.hemophiliagalaxy.com and take
the Joint Health Quiz!
First of its kind, Camp SuperflySM is a nationwide program that unites the entire bleeding/clotting disorder community. Through an ongoing series of mental and physical
activities, participants can help their organization score points and win the Grand
Prize - grant dollars to help create the super camp of their wildest dreams!
Camp SuperflySM is an idea inspired by the hemophilia community, with generous support provided by Baxter. Look for details from these organizations on how you can
join in the fun, and help your community compete in this exciting program.
For further information, The National Hemophilia
Foundation has the following educational brochures
to assist you:
The Child with a Bleeding Disorder:
First Aid For School Personnel
NHF The Student with Hemophilia: Resource
for the educator.
PI
Learn how joints work, the benefits of
exercise, and advice for sticking with a
treatment plan.
Hemophilia, Sports, and Exercise
[email protected]
800-42-HANDI
2
This interactive learning experience blends
illustrations and insightful information
on maintaining joint health.
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