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When Kerri was five or six months old, her mother noticed bruising on her chest – just about at the height of the tray on her highchair. Thinking that this was odd, and feeling concerned, she took Kerri to the pediatrician. After further testing, Kerri was diagnosed a few months later with Type 3 von Willebrand Disease, the most severe, and the rarest form of the bleeding disorder. Although Kerri's family was unaware of any genetic history with the disease, it turned out that her parents are both carriers, as are her sisters, although everyone but Kerri is asymptomatic. “I was very fortunate to be diagnosed so early. That is not everyone's experience.” Many times, women are not diagnosed with von Willebrand Disease until they reach the age of puberty, or even until childbirth. “I became a nurse because of my own medical history and because I wanted to provide the same compassionate care I received growing up from my nurses to other people. I am very interested in women's health, especially around pregnancy and childbearing. I love taking care of the mom and baby.”
The diagnosis of von Willebrand disease was surprising for Kerri's parents and caused them considerable stress. “My parents were worried all the time. They were definitely helicopter parents and very protective of me. I wore a helmet and kneepads, and sometimes elbow pads, growing up. I never went to day care. It was definitely difficult for them. As I've grown up, I've become my own caregiver. But to this day, my mom still worries about me.” As a child, and into adulthood, Kerri was treated by several hematologists. Despite their area of specialization, most of them had only seen one or two patients with Type 3 VWD and consequently were learning how to best treat the illness alongside Kerri and her family. “I've had good experiences with all my doctors, but I have definitely had to work harder to communicate what was going on with me and to advocate for the care I needed.” When Kerri began menstruating in the 9th grade she had tremendous difficulties with bleeding. It took six months and use of a lot of factor to get it under control. She tried several different birth control pills to control her flow. “My body would just get used to the pill I was on, and eventually the bleeding would become problematic again. It might have been helpful if my hematologist had referred me to a gynecologist once I got my period, but it just didn't happen.”
Until discovering Octapharma and wilate, Kerri had never met any other people with Type 3 VWD. “I went to the VWD Connect Conference supported by Octapharma, which is designed specifically for Type 3 patients. It really opened my eyes and inspired me to get more involved with the Type 3 community. For the first time I met people with experiences similar to mine and learned so much from them about how they were being treated and what they were doing to manage the disease. That's where I learned more about wilate, which I had been interested in a few years earlier. I was intrigued by its 1:1 ratio of VWF and FVIII as well as its lower dosing requirements.” Throughout her childhood, Kerri had mostly been prescribed Humate–P, and sometimes Alphanate®. Her bleeding was treated as needed (on–demand) for joint bleeds, nosebleeds, and sports injuries. With adolescence and adulthood, Kerri experienced heavy and prolonged menstrual bleeding, very common in women with VWD, and was treated more frequently and with higher doses to manage her symptoms. “I was looking for something different – something that would better manage my bleeding and joint pain, but not require huge doses.” The first doctor from whom Kerri requested wilate declined to change her prescription. On her second attempt with a new hematologist she finally got her way. “Doctors can be reluctant to move you off a medication that they think is working, especially if the drug you want to try is a relatively new one.” Kerri has been on wilate since 2019, self–infusing at home or work. “I treat myself when I need it and can manage any bleeds very effectively. I am very active – I like to run, hike and swim in the ocean, and joint and muscle pain make that harder. My knees, in particular, can get stiff and achy. On wilate my whole body feels different. I am able to do the things I enjoy with much less pain and I definitely feel better after strenuous workouts. Wilate works really well for me.” Kerri infuses on demand whenever she feels she needs it. And she stays very active in the bleeding disorders community, both in online forums as well as in–person events. “There's nothing like meeting fellow VWD patients in person. That's why I became a Factor My Way Patient Educator. It gives me a whole new way to connect and share information. I love it.”
“Lots of people with bleeding disorders are reluctant to self–infuse. I learned to self–infuse in high school, but I was uncomfortable doing it on my own. Sticks can be intimidating.” Now that she is a nurse, Kerri finds self–infusion much easier, and is comfortable and proficient doing it completely on her own. Prior to self–infusion, when she had a bleed she had to go to a clinical setting or have a nurse come to her home for infusions. “It took up a lot of time. Self–infusing is much more convenient and makes it easier to stay compliant. Plus, it makes traveling so much easier. I talk to patients about why they are uncomfortable and try to help get them over their fears. You get a great sense of independence if you can do infusions yourself. It gives you control and peace of mind. That's transformative.”
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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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Este sitio web utiliza cookies y almacena información en su computadora. Algunas de ellas son fundamentales para mejorar nuestro sitio web y su experiencia de usuario. Al utilizar este sitio web, acepta el uso de estas cookies. Consulte nuestra Declaración de privacidad de datos para obtener más detalles. Declaración de privacidad de datos para obtener más detalles.
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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© 2022 Octapharma USA, Inc.
All Rights Reserved
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