Every now and then, I’ll be posting news items from the news wires, to keep our readers updated with new offerings related to their treatment. Today I’m posting about a new reconstitution system for Bayer HealthCare’s Kogenate®FS antihemophilic factor (recombinant). (Please note this is not a paid advertisement but just an educational service to our readers. The new “Vial Adapter” offers Kogenate® FS users an additional choice in reconstitution systems.Vial Adapter is a needleless reconstitution system that contains a sterile chamber with a built-in 15-micrometer filter and a prefilled diluent syringe.
From Bayer’s press release: “Innovating in order to provide two reconstitution systems, Vial Adapter and BIO-SET®, is a great example of our commitment to delivering options that meet the needs of the entire hemophilia A community,” said Pamela Cyrus, MD, Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.
Both Kogenate® FS with BIO-SET® and Kogenate® FS with Vial Adapter are available in Grab and Go packaging, which includes:
· A prefilled diluent syringe
· The Terumo® SURFLO® Winged Infusion Set
· Alcohol swabs, a cotton pad and a latex-free bandage
· Exclusive anti-counterfeiting and tamper-evident features
· Alcohol swabs, a cotton pad and a latex-free bandage
· Exclusive anti-counterfeiting and tamper-evident features
Kogenate® FS, antihemophilic factor (recombinant) is indicated for:
· Control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A
· Peri-operative management in adults and children with hemophilia A
· Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage
Kogenate® FS is not indicated for the treatment of von Willebrand disease.
Kogenate® FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
Great Book I Just Read Something Wicked This Way Comes by Ray Bradbury
Many of us read Ray Bradbury books, like Fahrenheit 451, in high school. He is so worth reading again. In time for Halloween comes this 1962 October horror/mystery story that reads lyrically, like poetry, like artwork. Two 14-year-old best friends, Jim Nightshade and William Halloway, who live in Green Town, in the midwest, are intrigued by the dark and mysterious carnival that roars into town at 3 am one morning, long after all carnivals have packed up for the season. Headed by a fully illustrated, tattooed Mr. Dark, the carnival has a deep secret to protect, and becomes a threat to the townspeople. Mr. Dark bears a tattoo for each person in town he manages to lure into the carnival–to the carousel that twists time, or the house of mirrors that strands souls… and never lets them go. Only one person can save the townspeople… The writing is absolutely superb, colorful, vivid and memorable. The three page description of the carnival train pulling into the outskirts of town alone will stay with you. Great fall/Halloween reading for young and old… which is, by the way, one of the themes of the book! Five/five stars.
Sweltering heat, 100% humidity, long rides, sweat dripping
down our necks, back, arms, stepping gingerly through mud, grass, dirt… this
job ain’t glamorous or for the needy. Well, yes, it is for the needy; needy as
in being a child in poverty, motherless, earning a dollar a day, not having
enough to eat. These are the children with hemophilia we visited today outside
of Santo Domingo, in the Dominican Republic. It’s a day when you put your own
needs aside and realize just how shockingly removed we are from how most of the
world lives.
I first attended CampYo Sí Puedo (Yes I Can!) in Lomas Linda, just outside of Santo Domingo, the
capital, for the past four days. I was going to blog about this amazing camp
tonight, but today readjusted our reality to the real reason we exist: to get
sponsorships for deserving children in desperate situations.
Luis Miguel and mother Dulce
My day started with a shocking jolt at 8 am, after returning
from an hour-long run near the beach in the growing heat. From Tanzania, Dr.
James emailed me that Cuthbert, the little boy to whom I gave Tanzania’s first
home infusion, died of a GI bleed that could have been treated with factor
concentrate. We have been helping Tanzania for the past 6-7 years, and Cuthbert
was one of the first children with hemophilia I met there. His loss is
devastating.
But we headed out to visit the living; the children whose
needs still must be met. Visiting the children in their homes, we see how much
they lack, in the simple things we expect: clean water, sanitation,
transportation, nutritious food, books, imagination, education. Add to that
hemophilia and their lives are a daily struggle to survive, like Cuthbert’s.
Today we visited five families in about six hours. I’ll only mention two for
now.
At 10 am we rumbled along a crumbling, stony road in
Haydee’s SUV, built like a tank thankfully, to a cluster of wood shacks. The
farthest one housed the Ciriaco family. Huge plants fringed the walkways and
doors so that we had to duck sometimes. The house is made of wood slats, with
plenty of gaps in them to let sun shine in like laser beams in the morning, and
mosquitoes in at night. There are no screens, but the family does have
electricity as evidenced from the jury-rigged wires criss-crossing the shacks.
The family enjoys watching videos from camp on my iPhone
The family greeted us warmly; Luis Miguel, the son with hemophilia, sheepishly
tagged along, though he had just seen us at camp for four days! Why shy now?
His sister Nicole was not shy at all. Pretty in her beaded hair, she readily
hugged and snuggled. We all walked down to the river’s edge, where Luis
Miguel’s mother explained that the river rose in April of 2012 (11,000 impoverished
people had to relocate!) and completely flooded their meager home. They lost
most everything they had. I was told that the government came, helped for about
four days, and left. There’s no compensation, no one to sue, and certainly no
insurance. You are simply in the hands of fate.
Because the family was registered with Haydee’s
organization, the Fundación Apoyo al Hemofílico (FAHEM), they received food, clothing and support.
We snapped some pictures, interviewed the family a little then had to move on to the next three families.
At the end of the day, we drove to Wilson’s house. We drove far away from the city, on decent roads, until we started seeing less businesses and homes, and more shacks, colorful laundry strung to dry, overgrown plants and lots of chickens. Rural Dominican Republic. After asking numerous people for some sketchy directions, we eventually came to the right barrios and saw Wilson waiting by the side of the road. He hopped in, exclaimed, “Hello Laureen!” (in English no less!) and then showed us how to
navigate the dirt roads to his home.
It’s as pretty as a home can get in rural poverty. Lime green, little front porch. Inside, one giant room, divided with a cloth hung from a line, to serve as a wall. Wilson is 10, and wants someday to be a lawyer. He’s factor VIII deficient, but looks in good shape. Indeed at camp, he stole our hearts with his charm and smile. His mother Evalisa was present, and little by little, children and curious neighbors peered at us from their porches. Wilson has a sponsor already, new, and I can’t wait to share photos with him. As we chatted, little children ran about, holding hands, posing for a quick picture, which I then showed them in playback to their great amusement. Giggling, curious and trusting, I’m sure they haven’t seen our likes before!
Wilson and Laurie
I distributed some donated gifts: jewelry for the mom and grandmother, toys for the kids, and an envelope with some money for the mother. Wilson is a born businessman; he ran up to Vincente, a father of a child with hemophilia who has volunteered with FAHEM for years and who is a lawyer, and presented him with a beta fish…. in a whiskey bottle, sans whiskey. Vincente paid him a few pesos, and off we went with our fish in a bottle. I suggested we call him “Wilson,” and asked if the fish had hemophilia too.
Haydée, Vincente, and I stopped at a mall, and as we climbed out of the SUV. We strolled through the mall with our whiskey bottle, the fish sloshing about inside, causing a few security guards to turn their heads. We had a delicious lunch of chicken, discussing all the kids we saw today, with Wilson the Fish in the center of the table. Will the kids have a future? If we can get them sponsored, and continue to
get factor into the country. Well, we accomplished our goal to visit five families today, which was exhausting, but we didn’t exactly walk in their shoes for a day. It was only for a few hours, and it left us tired and contemplative.
We parted—Vincente with Wilson the Fish and I with tons of photos, visual images burned in our memory, and much work ahead of us. If you want to sponsor one of our five kids visited today (and we can show you great photos!) please visit www.SaveOneLife.netCoconut juice…
Richard Atwood, our colleague from North Carolina who researches all things in print and media hemophilia, has uncovered a great literary question: did William Butler Yeats, the Irish poet, have hemophilia?
He looks to Oliver St. John Gogarty, who published in 1963 William Butler Yeats:
A Memoir (Dublin, Republic of Ireland: The Dolmen Press. 27 pages). Richard provides a summary and comment:
Oliver St. John Gogarty, an Irish poet and physician, intended to write memoirs for nine of his famous friends. Regrettably only three were written before his death in 1957. Luckily he finished the memoir about William Butler Yeats (1865-1939), an Irish poet and dramatist. Gogarty mentions some of the accomplishments by Yeats, such as receiving the Nobel Prize and serving as a foundation Senator in the Irish Free State. He also states that Yeats disdained science while delving into the occult, mysticism, astrology, magic, seances, ghosts, and the spirit world. Gogarty praises Yeats for his poetry, especially his “intensity” of phrase by using the pouncing or surprising word. (p. 24). According to Gogarty, Yeats has the physical attributes of being 73 inches in height, being tone deaf, and having poor eyesight. Also that after undergoing the rejuvenating operations, Yeats claims to have been greatly benefited. In addition, Gogarty relates another physical condition when he and Helen Wills, a tennis champion, visit Yeats in a rented country home: “To our disappointment the maid announced that Mr. Yeats could not leave his room on account of a nosebleed. I knew that he was inclined to haemophilia. I ran up the stairs to his bedroom only to find that he had cut himself with a razor at the edge of his nostril as he was preparing to look his best.” (p. 17).
The brief memoir includes a photograph of the medallion, or plaque, of Yeats cast by T. Spicer-Simpson and a photocopy of a short poem hand-written by Sir William Watson that seems to refer to Yeats. The personal observation by a close friend, who also happens to be a physician, that Yeats is “inclined to haemophilia” is still not a medical diagnosis, though this raises serious suspicions by being from a primary source. Gogarty provides no dates for his observations, but the medical events he mentions probably occurred in 1934. The memoir may not add much to the understanding of Yeats and his poetry, but it provides an interesting personal perspective. No information is provided on the author.
Here’s a press release about a new reconstitution device from Novo Nordisk. It’s very cool that the idea originated with the Novo Nordisk’s Consumer Council, which I used to facilitate (and miss! great times):
Novo Nordisk is pleased to announce the introduction of a new reconstitution device for NovoSeven® RT (Coagulation Factor VIIa [Recombinant]). Beginning on May 1, 2013, NovoSeven® RT with MixPro™ will replace the current NovoSeven® RT and will be available to congenital hemophilia A or B patients with inhibitors, acquired hemophilia, and congenital factor VII deficiency.
Although the product will remain the same, NovoSeven® RT with MixPro™ will now include a syringe prefilled with diluent and a vial adaptor to reduce the number of steps needed to prepare NovoSeven® RT for infusion. This is expected to assist NovoSeven® RT patients and their caregivers. Previously, the NovoSeven® RT package included two vials, one containing the active drug substance as a lyophilized powder and the other containing diluent, requiring two additional steps for reconstitution.
This enhancement was developed in response to suggestions from the Novo Nordisk Consumer Council, which comprises bleeding disorder community members. NovoSeven® RT with MixPro™ received approval from the U.S. Food and Drug Administration in October 2012.
It is important to note that although the MixPro™ prefilled diluent syringe uses a standard luer-lock connector, not every needle-free IV system is compatible with glass prefilled syringes like MixPro™. If you are a health care professional with questions, please contact Novo Nordisk Medical Information at 1-877-NOVO777 for assistance and compatibility information. All others should contact a health care professional with questions.
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Something Wicked This Way Comes by Ray Bradbury
