Hiking for Hemophilia

Yesterday was a beautiful, sunny, crisp fall day in New England, and perfect for a hike. Hiking is even better when you can hike to help!

The Hemophilia Alliance of Maine (HAM) hosted its fourth annual Hike4HAM, at Camden Hills State Park, where we would hike up Mt. Battie. A one-hour hike up offered spectacular views of Penobscot Bay, a way to earn a great lunch, and enjoy the company of our “family,” the hemophilia community.

This was really special for me. For years I’ve been promising the dedicated staff at HAM I’d try to make their walk, or hike, or annual meeting. Something always came up that interfered with that plan. But Saturday, September 15… all clear to go! Doug and I drove the three hours to Camden Hills, enjoying the New England scenery and quaint towns. Maine is an absolutely beautiful state, “The Way Life Should Be,” as its slogan says.

I didn’t think I knew any of the families. One of the reasons HAM was founded is that it’s so difficult for Maine families to come to the New England regional events. Although New England is significant in size, a combination of six states, we really do have our own cultures. Massachusetts is different than Maine, which is different than Vermont or even New Hampshire. I was looking forward to meeting new families and maybe connecting with some who might be on our mailing list.

 

The Greene Team!

Families were grouped in teams, usually with a name of a family member with a bleeding disorder, like “Team Thomas.” Industry reps were there with tables of product info and giveaways, and donuts! It was fun to connect with known friends like Sandy (Octapharma), Tommy (Novo Nordisk), Ron (CSL Behring), Lisa (Bioverativ) and Victoria (Aptevo). And to see Jill Packard, president and founder of HAM. As we started our hike in the chilly air, it progressively got warmer as we moved, and I fell in to chatting with an adorable 10-year-old named Emery.

Emery

A long time ago I seemed to have more time and focus to chat with families, and got to know so many through these past 30 years. As we hiked, I loved asking Emery all about his hemophilia: he has hemophilia A, he told me–“…that’s factor VIII.” And he self-infuses–impressive! His little brother Hamilton has hemophilia too. Watching Emery I was impressed at his stamina, and absolutely no joint damage. You would never know this child has hemophilia. He jumped off a boulder, landed hard and kept hiking!

Families hiked in teams, and through the woods came moms, dads, uncles, aunts, friends, grandparents, lots of children and even dogs!

An hour later, we were rewarded with a view of clouds… we were above the cloud and fog line, which obscured the bay but still made for a worthwhile climb. As did the fundraising: HAM raised about $20,000 on this hike, which we were proud to contribute to–I even got a medal for being one of the top donors!

After the hike we had hamburgers, corn on the cob, potato salad and lemonade. I sat with folks I didn’t think I knew, but as we shared names, they knew me and shared stories of how my book Raising a Child with Hemophilia had helped them, especially back in the days long before HAM was founded. One mom told me RCH and our newsletter PEN were the only connections she had with the hemophilia community. That was so sweet to hear! And with HAM, she is now well connected.

Congratulations to Jill and team for creating HAM, for holding the hike, and for all the participants, particularly the industry reps who give up so many weekends to participate in our local events. I hope to hike next year too!

See Complete Gallery of Photos Here

Laurie Kelley with Lisa Schmitt and family

 

He Planted Kindness: Kyle Callahan

 A tree is known by its fruit; a man by his deeds. A good deed is never lost; he who sows courtesy reaps friendship, and he who plants kindness gathers love.  —St. Basil

I’m in Nashville, waiting to board my flight home, leaving behind many hemophilia community members who came to pay tribute to a fallen giant, Kyle Callahan. Kyle, a 52-year-old with hemophilia, passed away suddenly on August 26. For a man who had survived so much in his life, and engaged in outrageous adventures and high-speed fun, it was stunning news.

Nashville baked in 90° weather when I arrived yesterday afternoon; I hurried over to Union Station, a magnificent building and scene of Kyle and Diane’s wedding 24 years earlier. It was healing to see so many people in our community that I’ve known for decades and admire: Craig Mears and wife Kelly, John Jarratt, Dianne (Martz) Griffith (Kyle’s mother), Louise Hardaway, who helped Dianne set up her original business in 1980 (and is mother-in-law of Pat “Big Dog” Torrey), and more. Our community runs deep in memories, connections and affection.

Diane and Kyle Callahan

Inside the big room where we gathered was a head table filled with memorabilia: A Harley Davidson sign, a signed football, a photo of his beloved Doberman, a collage of the many adventures he and his wife Diane shared.

Kyle was born in South Dakota, but always revealed a bit of a southern accent, after living in Nashville most of his life. I met Kyle in 1992, after first meeting Dianne, his mother, who had just started Hemophilia Health Services, a specialty pharmacy that prided itself on the “human factor.” More than just a slogan, HHS was the booth at NHF meetings that had soft colors, music, chairs and warm representatives. Dianne created a new way of providing factor to customers, with a high-touch, personable approach. My first meeting with Kyle is imbedded in my mind: a tall, good-looking 26-year-old who looked years younger, with strawberry-blond hair, freckles and a dazzling smile. About 7 years later, Dianne retired and Kyle was nominated by the board to become president. I wondered how this “young man” could possibly take on this responsibility?

He assumed responsibility and would later rocket HHS to become the largest hemophilia specialty pharmacy in America. From revenues of $30 million to over $1 billion.

I watched Kyle grow, and he became a friend, a colleague, mentor and supporter of my work. I needed an article reviewed for accuracy; Kyle agreed to do it. I needed a book reviewed—Kyle again agreed! I needed to interview a captain of industry about changing insurance—Kyle again. I wanted to set up a factor donation program to stop the waste of unwanted factor—Kyle invited me to Nashville to learn how their operations ran. That tour became the basis of how we constructed Project SHARE, so we were in compliance. And that came in handy when one morning at work I looked up, and an FDA agent named Jason was staring down at me, badge in hand, because he heard we were shipping “drugs.” We sailed through our first inspection with flying colors.

HHS collected factor that patients returned, and donated them to us. Kyle helped fund the program, which continues today, and which has given over $130 million worth of factor to developing countries.

When I wanted to start a child sponsorship program, Save One Life, Kyle again agreed to help support us. And he and Diane sponsor 17 children with hemophilia in developing countries.

Laurie Kelley with Kyle’s mother, Dianne Griffith, founder of Hemophilia Health Services

But above and beyond all this, the most important, most impressive things about Kyle were not so quantifiable. That charming man with the dazzling smile I met in 1992 never once wavered in civility, humility, and kindness. And he endured much; at one NHF meeting, I barely recognized him. I’m afraid I stared when I saw him; he was so gaunt from his illness. But still, that smile. That charm. He always was gentle. He always was available. He seemed to carry no baggage; he was present, in the moment, focused on whoever he was with. He laughed easily and smiled perpetually. He was the real deal. That’s called integrity.

Kyle and I connected on helping others less fortunate, but also on the lighter side of things. We were both adventurers, and I loved reading about his adventures and he liked knowing mine. I joke that he flew planes; I jump out of them. He drove race cars; I tried cooking. We both loved traveling to foreign places, the more exotic the better! I always tried to send him a birthday card each June, except for last year when I confessed I was climbing a volcano in the Congo; he gave me a pass!

After he retired for a time, before he started a new venture, he and Diane took a few years to travel the world. I have Christmas cards of them in Egypt, sitting on camels; holding a koala bear in Australia.

When I learned he and Diane were going to Antarctica, I was so excited for them and envious—it’s a place I have always wanted to visit. I’m a voracious reader about polar exploration. Following an NHF meeting, waiting at the airport, I shared my knowledge of polar exploration and especially the Shackleton story. Kyle assured me they were going to South Georgia island to see his grave. It’s a hunk of rock that contained an old whaling station. Would it be possible to send me a postcard from there (in case I never get there myself)?

Not long after I received a postcard of Ernest Shackleton’s gravesite from Kyle and Diane. That is kindness itself.

I  have kept that postcard on my bookcase, next to all my travel and adventure books, to remind me to go there someday. Someday…

The postcard seems to be a calling card now, to get with it, and live life like Kyle. Our days are numbered, and no one knows when we will depart. Kyle flew planes, scuba dived, drove race cars, was a pilot, drove a Harley, commanded a beautiful yacht. And through all of it, he never lost his gentle grace, his smile, his zen-like composure, his kindness, his humility. He never said a bad word about anyone. And no one, not even his competitors, ever said a bad word about him—an amazing feat in the specialty pharmacy business. Everyone who spoke yesterday said the same thing: he was perhaps the kindest person you could ever meet.

Kyle’s message to me seems to be: 1) Live each day to the fullest, 2) chase your dreams; they can come true! and 3) be kind. Always. To everyone.

Good-bye Kyle, and thank you for leaving the world a better place. More adventures await you, and we will try to catch up with you one day!

Diane Callahan has asked that donations in Kyle’s name be made to www.SaveOneLife.net, or to the Tennessee Bleeding Disorder Foundation.

 

 

 

How does your school-age child understand hemophilia?

Published in August 2018 PEN

With the start of the school year comes new teachers, nurses, and caretakers for your child. You may be explaining to many adults what hemophilia is and how they should properly respond if your child has an issue. But, how do you go about teaching your child about their hemophilia? In this excerpt from our latest issue of PEN, we delve into how children understand their bleeding disorders and what you can do to help present information  for them to digest. 

Teaching Your School-Age Child About Hemophilia 

One of the biggest challenges we have as parents of children with hemophilia is teaching our children about their disorder. We often use words like hematoma, factor, and deficiency; and concepts like prophy, coagulation, and heredity. But children understand these words and concepts very differently than adults do.

If you don’t know how your child’s mind works at various stages of his development, then teaching him about hemophilia becomes hit-or-miss. But when you know how he thinks, you can tailor information in a way that he can easily understand. So to teach your child about hemophilia, you need to know how he processes his world in general, and hemophilia concepts in particular.

 

The School-Age Child’s Thinking Tools

Between ages 7 and 11, the school-age child is in a fascinating stage of cognitive development. “Cognitive” refers to how he thinks, how he processes incoming information about his world—basically, his ability to think logically. Just as he has a skeletal structure that develops as he grows, he also has a mental structure that develops as he matures, filtering information in a way he can grasp.

Your child’s mental structure is characterized by five major thinking tools that are constantly evolving:

Causal thinking: Figuring out when something causes something else, using a step-by-step process. A preschooler doesn’t typically think step-by-step.

Internalized thinking: Moving from understanding his world mainly through his senses—where things happen outside him—to realizing that things can happen inside him.

Gradient thinking: Knowing that the world isn’t just polar opposites, like good guys and bad guys. There are now shades of gray, degrees of intensity. A good guy might do something bad. Your child can also distinguish parts from the whole.

Empathic thinking: Starting to see the world from another’s point of view.

Time: Understanding that he doesn’t exist just in the present, but that he has a past and a future.

For understanding hemophilia, the most important of these five thinking tools may be causal thinking. Your child can now try to figure out how one thing causes another. Like…What causes bleeding? A blood clot? What is genetic transmission? It’s hard to explain these concepts when your child doesn’t understand causality. These are more sophisticated thinking tools than he had as a preschooler, yet a school-age child, ages 7 to 11, is most comfortable using his new thinking tools on things and places he knows best—the tangible, visible world. So let’s see how he uses these thinking tools on various topics in hemophilia, starting with blood.

How He Understands Blood

Unlike a preschooler, your school-age child understands the concept of the whole and its parts. So you can explain blood in terms of what it’s made of. Children between ages 7 and 9 believe that blood is a red liquid, but also that it’s composed of “stuff—water, food and energy.” Children between ages 9 and 11 tend to describe blood in more abstract terms. “It’s cells. Little roundish stuff. They’re red and blue.” A child develops from concrete to more abstract thinking, so this is perfectly acceptable!

Now you can introduce the idea that blood has components: white blood cells, red blood cells, and platelets. While preschoolers focus on things outside the body, mainly what they can see, hear, and feel, a school-age child realizes there are things inside him that he can’t see. So he’s ready to learn about simple blood components, especially those related to his hemophilia.

How He Understands Hemophilia

Because he understands a whole and its parts, your child can now categorize things. A preschooler might describe hemophilia as “blood,” or “something I have,” but a school-age child can classify hemophilia as a “blood disorder,” or “when blood doesn’t stop bleeding.”

He also progresses from describing hemophilia as his own specific injury (“It’s when I get a hurt knee”) to seeing it as a condition (“It’s when someone gets hurt and bleeds a lot”). This is the empathic thinking tool: he knows he is not the only one to have hemophilia. He now says that hemophilia is when “boys with hemophilia have to go to the hospital sometimes.” Compare this to the preschooler reply, “When I have to go to the hospital.”

Your child also has matured from an external to a more internal focus. A preschooler might say, “Hemophilia is bruises,” but a school-age child will say, “My blood doesn’t work right.” What is it that doesn’t work right? Well, he understands the concept of a whole and its parts, and he’s ready to know that blood is composed of parts. So he can deduce that hemophilia means “something’s missing” in his blood. Some children say that they have “lost” something, or that their blood is “too thin.” These answers reflect the “something’s missing” idea. For example, “It’s when you’re missing some factors that help to make it so if you slam your knee against something it doesn’t swell up as much. You’ll have to replace the factor.”

Misconceptions and medical inaccuracies abound as your school-age child struggles to understand hemophilia. “It’s a blood disease. You lose part of your blood and you need to get more blood.” At this stage, what’s important is not so much that his answers are right or wrong, but how he arrives at his interesting conclusions.

So teach your child that hemophilia is a “blood disorder.” Teach him that blood is made up of parts, and that he is “missing” a part. There’s no need to get too specific at first, for example by mentioning factor and proteins; just stick to general concepts and ideas. To help him visualize, use a concrete example, like the falling dominoes. Remember that a school-age child is increasingly able to understand more abstract terms, but he needs the help of concrete examples.

How He Understand Genetics

Learning about heredity is a great way to exercise the “missing step” concept in a step-by-step sequence. To a preschooler, hemophilia is just something he was born with. To a school-age child, something had to happen to cause hemophilia.

What is that something? His parents are usually the missing step. Your child possesses the thinking tool of time, so he may realize that hemophilia could have started in his family many years ago, even centuries ago.

But how exactly does hemophilia get from one person to another? Most school-age children name a causal agent—the thing or event that caused hemophilia to happen. This can be a parent, blood, a chromosome, sperm, or even “vibes,” as one boy phrased it.

Understanding often differs among younger children (ages 7–9) and older children (ages 10–11). When asked how they got hemophilia, younger children may simply reply, “Mom” or “Mom and Dad.” Some children name blood. “It streams through your family, through their blood. I got it when I was two or three. My uncle gave it to me.” This child is medically incorrect, but he’s trying to sort it out logically: a family member had hemophilia, I have hemophilia, and…maybe my uncle gave it to me?

School-age children may also understand or accept some basic heredity rules, such as “mothers are carriers.” This makes sense to them, because a “carrier” is a causal agent.

From ages 9 through 11, a child’s answers and thought processes become more sophisticated. The causal agent may be chromosomes, which only a few children can discuss at this stage. Remember that school-age children are still very concrete—more comfortable with things that they see, hear, feel, and smell. Chromosomes are abstract. Some children identify an “X thing” as the causal agent, but don’t understand the idea in purely scientific terms. To them, X and Y are not parts of the cells. They’re more like “germs” that other family members “catch.” One boy explained, “Mom’s a carrier. She has two little things inside her, little Xs. They’re like little eggs. She has a good X and a bad little X in her. My brother got the good carrier and I got the bad carrier.”

Ask your child, “Where did your hemophilia come from?” and let him figure it out on his own; don’t judge his answer at first or try to answer for him. You can work on the details later, supplying more accurate information once you’ve listened to his explanation and understood his thinking.

 

To read more on this topic download our August 2018 PEN today at

https://www.kelleycom.com/product-category/newsletters/pen/

Thank you, Barry!

On Friday I went for a 32-mile bike ride, on my usual route that winds through back roads of the north shore of Massachusetts, out to Plum Island to the ocean. It’s a ride I did with Barry Haarde twice, and I thought of how he pushed me into cycling longer than my usual 12 miles, and faster than my usual 13 mph. I actually clocked myself at 15.7 mph. Not bad for age 60.

Last Sunday, August 12, we gathered on a different beach, Odiorne Point in New Hampshire, to remember Barry and his amazing contributions to our community and in particular to the nonprofit I founded, Save One Life. About 50 people from all over the country: California, Connecticut, Denver, Texas, Washington DC and Barry’s family from Florida, trooped in with bicycles to recreate the last 10 miles of his first cross-country journey.

Martha Hopewell, executive director of Save One Life, gave a deeply stirring speech that highlighted Barry’s achievements and impact:

“It was just seven years ago, on this very same day, we celebrated Barry’s first ride across the US at Laurie’s house. We toasted his 3,667 miles and had no clue, at that time, that he would ride 16,728 more or, for that matter, raise over $250,000 for Save One Life!

“Barry’s accomplishment comes after much physical hardship. Barry contracted HIV in the 1980s from contaminated blood products used to treat his severe hemophilia. He also contracted hepatitis C, which required four years of grueling interferon treatments, during which he almost lost his life.” Barry didn’t publicly reveal his HIV status until 2008. “Once Barry made that courageous choice, however, he has been an increasingly vocal advocate for the hemophilia and HIV communities ever since.”

Martha Hopewell, Director of Save One Life

“When Barry undertook his first tour in 2012, he rode for 50 days through ten states and Canada. In addition to raising funds to help needy children, you all know that each day he rode in memory of family and friends lost to AIDS. When Barry finally dipped his wheel in the Atlantic after his first comment was, “Let’s do it again next year!” “And so he did, with the team at Save One Life, his employers at Hewlett Packard and many supporters encouraging him as he overcame physical and psychological barriers to make history. Barry’s goal was to ride through every state. He didn’t quite make it, but his Wheels for the World rides got him to 37 of them…not bad at all!” “We celebrate Barry today. We will forever cherish his enthusiasm for riding and his passion for his blood brothers and sisters around the world. He is here with us at this very special memorial. God bless Barry, and all those in whose hearts you will always live.”

We lost Barry in February. Not everyone knows this, but he took his own life. Despite his beloved status in our community, his fame, with years still ahead of him, he could not outride the darkness that dogged him. Teddy Roosevelt, one of our most accomplished of presidents, and an athlete in his own right, suffered from depression, and wrote, “Black care rarely sits behind a rider whose pace is fast enough.” Barry once told me, “Endurance athletes like me aren’t always heading towards a goal; we’re often running away from something.”

As I rode back from Plum Island on Friday, I could vividly see in my mind Barry ahead of me, his lanky figure balanced on his carbon-framed steed, his left hand shooting our and pointing downward each time we neared a pothole or a crack in the asphalt. His way of warning me of danger ahead. I thought, maybe his legacy is not so much how much money he raised, but of the need to be aware of our community’s potholes and cracks—the mental health issues, particularly depression, that lurk insidiously in our community. I hope addressing these becomes Barry’s true legacy.

Read the press release about the even August 12. Link here https://www.prweb.com/releases/cyclist_barry_haarde_honored_for_his_legacy/prweb15699984.htm

Thanks to our co-host, New England Hemophilia Association, to board members Ujjwal Bhattarai and family, Myrish Antonio and husband Jojo, Chris Bombardier and wife Jessica for attending, to our staff at Save One Life (Martha, Jodi Kristy), to all of Barry’s dear friends who attended, and to Shire and Aptevo Therapeutics, The Alliance Pharmacy and George King Bio-Medical for making this event possible. 

Martha also added thanks to the corporations that sponsored Barry’s rides over the years. The biggest sponsor was Baxter/Baxalta, which contributed almost 40% of Barry’s total with $100,000.  The Alliance Pharmacy distinguished itself as being the only company to support all six of Barry’s rides for a total of $30k.  Biogen/Bioverativ, Bayer Healthcare, George King Bio-Medical, Amerisource Bergen, Matrix Health Group, Aptevo Therapeutics, American Homecare Federation, Emergent Biosolutions and Optum Rx also contributed to this success.

 

Wheels for the World was championed by the Lone Star Chapter of Barry’s home state of Texas, Hemophilia of Indiana, NEHA and Sangre de Oro. The Colburn Keenan Foundation also gave in 2014.

 Most special to Barry were the nearly 250 individuals who gave to his effort. Priscilla Oren was the first donor of every ride! She is joined by Kevin Anderson and Lisa Schober who devotedly donated to all six rides.

 

 

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.

Shire’s pursuit of a zero-bleed future

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.
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