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Tony's son Andrew had problems from birth. Although his doctors ran many tests, his illness remained a mystery. When he was about one and a half, a teacher in his daycare was afraid that Andrew's bruises were the result of child abuse and informed the family that they were going to be reported to the authorities. “It was terrifying. We were so afraid that social services were going to come and take our kids. But eventually we got it worked out, and finally we also got a diagnosis for Andrew.” At almost three years old, Andrew was diagnosed with Type 2A von Willebrand Disease. “We had no family history of bleeding disorders, so it was a shock.” Andrew was a very active child and always wanted to keep up with his brother. “Andrew wanted to get out and play like other kids. But he started to develop problems with his knees. Sometimes we needed multiple infusions to stop a bleed. And this would go on about two times every month, sometimes more.” Tony and Deb would end up having to take him to the ER for treatment, which was both stressful and time–consuming. “We were very concerned about Andrew's safety. We tried to keep him in a bubble at first. But you can be too cautious. You have to keep on living and you have to let your kid be a kid. So, we became very skilled at dealing with emergencies.” Tony and Deb were determined to find a good solution for their son – one that would give him the freedom to pursue his interests while safeguarding his health. And they were successful. As a Factor My Way Patient Educator for Octapharma, Tony is eager to share his family's experience and pass along what they have learned.
When Andrew was diagnosed with VWD, he was started on an antihemophilic factor/von Willebrand factor complex “as needed,” an on–demand treatment regimen that would continue until he was about 11. Unfortunately, it was unreliable bleed control at best. “Because of the bleeds Andrew wasn't able to be a typical active boy. It was as if his life was on hold.” Then, at age 12 Andrew began to complain of knee pain. “We searched for answers, and our Hematologist decided to do an MRI to see if he could figure out the bleeds. He discovered that Andrew had a torn meniscus in his knee, an injury that would require surgery.” With Andrew's VWD, it was essential to find a way to control any bleeding associated with the knee surgery. “Our doctor asked if we would be willing to try wilate® as part of a clinical trial. We did our homework researching wilate and learned that it was developed specifically for VWD, unlike some other treatments that were originally developed for hemophilia. After much discussion as a family, we decided to participate in the trial. We are so glad we did.”
As it turned out, treatment with wilate changed Andrew's life, and the Basa's family life, for the better in several ways. It freed them from constant worry and repeated trips to the ER. With wilate, all of his treatments are done at home with very successful bleed management. With wilate Andrew was able to become the “normal” kid he always wanted to be. “He turned into a totally different kid. He could play sports with his brother. And he wasn't timid like before. Because he felt protected and just generally felt better, he became confident and unafraid.” At about age thirteen, Andrew began to self–infuse. “We were so proud of him, we cried. He was achieving the independence that he craved and that we always wanted for him.” At seventeen he took on the responsibility of managing his own care – ordering supplies and maintaining his regimen independently. Today, at nineteen, Andrew thrives on his independence — driving, biking, hanging out with friends, working as a counsellor to kids with bleeding disorders, and entering trade school to become an HVAC technician. Finding the right medication made all the difference to Andrew and his family. “VWD is such a struggle. It takes an emotional toll on the entire family. Wilate has dramatically improved things for all of us. We are 100% behind wilate because we have seen what it can do.”
“Hearing that your kid has a diagnosis of VWD can be frightening and overwhelming – believe me, I know.” That's why Tony became a Factor My Way Patient Educator. He is eager to share his experience, answer questions, and help find solutions for bleeding disorder patients, caregivers, and their families. “My best advice is to take one day at a time – and to live your life. Don't be afraid to ask questions and speak up for yourself. Don't be afraid to ask for help.” Today, Tony could not be prouder of the entire Basa family and the self–reliant, active young man that Andrew has become.
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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.
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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
Thromboembolic Events
In VWD, continued treatment using a FVIII-containing VWF product may cause an excessive rise in FVIII activity, which may increase the risk of thromboembolic events. Monitor plasma levels of VWF:RCo and FVIII activities in patients receiving wilate to avoid sustained excessive VWF and FVIII activity levels.
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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© 2023 Octapharma USA, Inc.
All Rights Reserved
Todos los derechos reservados
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