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Chris' severe hemophilia A was diagnosed when he was two days old, after severe bleeding following his circumcision. “My mom came to check on me and found me sitting in a pool of blood.” It was the first known case of hemophilia in his family and came as a complete surprise. Since the initial diagnosis they have all learned a lot. Chris' mother has been found to be a carrier. His grandmother had two brothers that died before the age of 5, possibly due to bleeding disorders. His sister is a carrier, since re–diagnosed with mild hemophilia, platelet disorders, and other mutations. And Chris now has two kids of his own. His son's uncle has a mild case of hemophilia. His daughter is a carrier, so he is tackling hemophilia from a whole new angle. She has attended three hemophilia camps and loves them. “It's all in the family.”
Growing up, Chris always played sports. “It was a little hard to get doctors to sign off on allowing me to play baseball or other sports, but I always stayed very active. I wrestled in high school, tried bodybuilding – always pushing my body pretty hard. So, I have had a lot of bleeds.” At 17 Chris aged out of baseball and found a new favorite sport in bowling. “My doctors were happy about the bowling, since it is considered one of the safer sports.” He even bowled professionally for several years. “Bowling can be very hard on joints – wrists, shoulders, elbows, knees, and ankles. Of course, joints can also be a problem for people with hemophilia. My left ankle is my target joint. When I throw the ball, 100% of my weight is on my left ankle. I needed a treatment that would prevent joint pain and keep me healthy. In addition to my regular infusions, I always timed extra treatments around my league competitions, so that my FVIII was highest when I was bowling. That way if I twisted or rolled an ankle, I'd be protected.” Today Chris stays active with other sports he enjoys, always applying the same proactive care and caution to safeguarding his health.
Chris does not remember a lot about his childhood treatments for hemophilia but does know that he was never very happy with his medication regime until NUWIQ®. He hated infusions, has endured lots of pain, used crutches and wheelchairs – even had to learn to write with his left hand because his right hand was immobile. He tried many infusion alternatives. Some medication transitions were instigated by insurance changes, some by frequent break–through bleeding, some by persistent joint pain. One friend of his died because of an inhibitor. All this convinced Chris to look for the best product for his needs. “As an adult, my attitude has always been that I am responsible for my treatment decisions. I do my research then go in and consult closely with my doctors to achieve the best treatment outcomes.” A friend introduced him to NUWIQ and he has been on it since it came out. “It got rid of my joint pain and gave me more mobility. It's great living pain–free. I have gotten a couple of bleeds, but most of them resolve with one infusion.”
Chris is an insurance expert. He is a certified Medical Coder and teaches Medical Billing and Coding at a career college. “When I was coming up there was not a lot of information about health insurance, so I decided I would focus on this.” He knows that managing insurance coverage can be very difficult for people with chronic conditions. “In my job, I have to know the insurers, know the terminology, and know the codes that are needed to get expenses paid. In open enrollment, I can help patients know what to look for in coverage for hemophilia in order to select the best option for their needs. It's a unique skill set.” Chris has applied this knowledge and expertise to his work as a Factor My Way Patient Educator. He gives presentations on navigating coverage and understanding the appeals process in health insurance. “In my opinion, insurance companies are getting much better today. Now they have most medications on their plans, so it is a lot easier for patients to switch medications. That's a win.”
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This material represents individual patient and/or caregiver experience living with a bleeding disorder.
This content is not intended to be a substitute for professional medical advice, diagnosis or treatment. Please consult with your local Hemophilia Treatment Center physician or other health care provider if you have any questions related to management of bleeding disorders.
Este material representa la experiencia individual de un paciente o cuidador que vive con un trastorno hemorrágico
Este contenido no tiene como objetivo reemplazar el consejo, diagnóstico o tratamiento médico profesional. Consulte con el médico de su Centro de Tratamiento para la Hemofilia local u otro proveedor de atención médica si tiene preguntas relacionadas con el manejo de los trastornos hemorrágicos.
Indications and Important Safety Information for NUWIQ® [Antihemophilic Factor (Recombinant)].
Please see NUWIQ full Prescribing Information. Instructions For Use
Indications and Usage
NUWIQ® is a recombinant antihemophilic factor [coagulation factor VIII (Factor VIII)] indicated in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. NUWIQ® is not indicated for the treatment of von Willebrand Disease.
Contraindications
NUWIQ is contraindicated in patients who have manifested life-threatening hypersensitivity reactions, including anaphylaxis, to the product or its components.
Warnings and Precautions
Hypersensitivity reactions, including anaphylaxis, are possible with NUWIQ. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, or pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.
The formation of neutralizing antibodies (inhibitors) to Factor VIII can occur following the administration of NUWIQ. Monitor all patients for the development of Factor VIII inhibitors by appropriate clinical observations and laboratory tests. If the plasma Factor VIII level fails to increase as expected, or if bleeding is not controlled after NUWIQ administration, suspect the presence of an inhibitor (neutralizing antibody).
Adverse Reactions
The most frequently occurring adverse reactions (>5%) in clinical trials were upper respiratory tract infection, headache, fever, cough, lower respiratory tract infection, rhinitis, chills, abdominal pain, arthralgia, anemia, and pharyngitis.
Please see NUWIQ full Prescribing Information. Instructions For Use
Indicaciones e Información de seguridad importante de NUWIQ® [factor antihemofílico (recombinante)].
Consulte la Información de prescripción completa de NUWIQ. Instrucciones de uso
Indicaciones y uso
NUWIQ® es un factor antihemofílico recombinante [factor VIII para la coagulación (factor VIII)] indicado en adultos y niños con hemofilia A para el tratamiento y el control a demanda de los episodios hemorrágicos, el control perioperativo de las hemorragias y profilaxis de rutina con el fin de reducir la frecuencia de los episodios hemorrágicos. NUWIQ® no está indicado para el tratamiento de la enfermedad de von Willebrand.
Contraindicaciones
NUWIQ está contraindicado en pacientes que hayan manifestado reacciones de hipersensibilidad al producto o sus componentes, como anafilaxia, que ponen en riesgo la vida.
Advertencias y precauciones
Es posible que NUWIQ cause reacciones de hipersensibilidad, como anafilaxia. Los primeros signos de reacciones de hipersensibilidad que pueden progresar y derivar en anafilaxia incluyen angioedema, opresión en el pecho, disnea, sibilancias, urticaria o prurito. Si se producen reacciones de hipersensibilidad, suspenda la administración de inmediato e inicie el tratamiento adecuado.
Se pueden formar anticuerpos neutralizantes (inhibidores) del factor VIII luego de administrar NUWIQ. Controle a todos los pacientes para detectar el desarrollo de inhibidores del factor VIII mediante observaciones clínicas y análisis de laboratorio adecuados. Si el nivel del factor VIII en plasma no aumenta según lo esperado o si la hemorragia no se controla luego de la administración de NUWIQ, se debe sospechar la presencia de un inhibidor (anticuerpo neutralizante).
Reacciones adversas
Las reacciones adversas más frecuentes (>5%) que tuvieron lugar en ensayos clínicos fueron infección del tracto respiratorio superior, dolor de cabeza, fiebre, tos, infección del tracto respiratorio inferior, rinitis, escalofríos, dolor abdominal, artralgia, anemia, y faringitis.
Consulte la Información de prescripción completa de NUWIQ. Instrucciones de uso
Indications and Important Safety Information for wilate® [von Willebrand Factor/Coagulation Factor VIII Complex (Human)].
Please see wilate full Prescribing Information.
Indications
wilate® is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated in children and adults with von Willebrand disease for on-demand treatment and control of bleeding episodes and for perioperative management of bleeding. wilate is also indicated in adolescents and adults with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes; and for on-demand treatment and control of bleeding episodes.
Contraindications
wilate® is contraindicated in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reactions, to human plasma-derived products, any ingredient in the formulation, or components of the container.
Warnings and Precautions
Hypersensitivity Reactions
Hypersensitivity reactions may occur with wilate®. Signs and symptoms include angioedema, burning and stinging at the infusion site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, and wheezing that may progress to severe anaphylaxis (including shock) with or without fever. Closely monitor patients receiving wilate® and observe for any symptoms throughout the infusion period.
Because inhibitor antibodies may occur concomitantly with anaphylactic reactions, evaluate patients experiencing an anaphylactic reaction for the presence of inhibitors
Neutralizing Antibodies
VWD
Hemophilia A
Transmissible Infectious Agents
wilate® is made from human plasma. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent. There is also the possibility that unknown infectious agents may be present in the product. The risk that wilate® will transmit viruses has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and removing certain viruses during manufacture. Despite these measures, it may still potentially transmit disease.
Record the batch number of the product every time wilate® is administered to a patient, and consider appropriate vaccination (against hepatitis A and B virus) of patients in regular/repeated receipt of wilate®. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Octapharma USA, Inc., at 1-866-766-4860.
Monitoring and Laboratory Tests
Adverse Reactions
The most common adverse reactions to treatment with wilate (≥ 1%) in patients with VWD were hypersensitivity reactions, urticaria, and dizziness. The most common adverse reactions to treatment with wilate (≥ 1%) in previously treated patients with hemophilia A was pyrexia (fever).
Please see wilate full Prescribing Information.
Indicaciones e Información de seguridad importante de wilate® [complejo de factor de von Willebrand/factor VIII de la coagulación (humanos)].
Consulte la Información de prescripción completa de wilate.
Indicaciones
wilate® es un complejo de factor de von Willebrand/factor VIII de la coagulación (humanos) indicado en niños y adultos con enfermedad de von Willebrand para el tratamiento y el control a demanda de los episodios hemorrágicos y para el control perioperativo de las hemorragias. wilate también se indica en adolescentes y adultos con hemofilia A para profilaxis de rutina con el fin de reducir la frecuencia de los episodios hemorrágicos; y para el tratamiento y el control a demanda de los episodios hemorrágicos.
Contraindicaciones
wilate® está contraindicado en pacientes con reacciones de hipersensibilidad conocidas, incluidas las reacciones anafilácticas o las reacciones sistémicas graves a productos derivados de plasma humano, cualquier ingrediente de la formulación o los componentes del envase.
Advertencias y precauciones
Reacciones de hipersensibilidad
Pueden producirse reacciones de hipersensibilidad con el uso de wilate®. Los signos y síntomas incluyen angioedema, ardor y picazón en el lugar de la infusión, escalofríos, sofoco, urticaria generalizada, dolor de cabeza, ronchas, hipotensión, letargo, náuseas, inquietud, taquicardia, opresión en el pecho, hormigueo, vómitos y sibilancias que pueden progresar y derivar en anafilaxia grave (incluido shock) con o sin fiebre. Controle de cerca a los pacientes que reciban wilate® y preste atención a cualquier síntoma durante el período de infusión.
Debido a que los anticuerpos inhibidores pueden desarrollarse de forma concomitante con las reacciones anafilácticas, evalúe a los pacientes que experimenten una reacción anafiláctica para detectar la presencia de inhibidores.
Anticuerpos neutralizantes
Enfermedad de von Willebrand
Hemofilia A
Agentes infecciosos transmisibles
wilate® está hecho a partir de plasma humano. Debido a que este producto está hecho de sangre humana, puede implicar un riesgo de transmisión de agentes infecciosos, como virus y, en teoría, el agente de la variante de la enfermedad de Creutzfeldt-Jakob (vCJD). También existe la posibilidad de que haya agentes infecciosos desconocidos en el producto. El riesgo de que wilate® transmita virus se ha reducido mediante la realización de pruebas de detección a los donantes de plasma para detectar la exposición previa a determinados virus, mediante análisis para detectar la presencia de ciertas infecciones virales actuales y mediante la desactivación y eliminación de determinados virus durante la fabricación. A pesar de estas medidas, aún existe la posibilidad de que transmita enfermedades.
Registre el número de lote del producto cada vez que wilate® se administre a un paciente y considere aplicar las vacunas adecuadas (contra los virus de la hepatitis A y B) a los pacientes que reciban wilate® de manera regular o repetida. TODAS las infecciones que un médico considere que se pueden haber transmitido a través de este producto deben ser informadas por el médico u otro proveedor de atención médica a Octapharma USA, Inc., al 1-866-766-4860.
Control y análisis de laboratorio
Reacciones adversas
Las reacciones adversas más comunes al tratamiento con wilate (≥ 1 %) en pacientes con enfermedad de von Willebrand fueron reacciones de hipersensibilidad, urticaria y mareos. La reacción adversa más común al tratamiento con wilate (≥ 1 %) en pacientes con hemofilia A previamente tratados fue pirexia (fiebre).
Consulte la Información de prescripción completa de wilate.
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