Hypersensitivity to the active substance, to the parent molecule octocog alfa or to any of the excipients listed in the SmPC. Known allergic reaction to mouse or hamster protein
Special warnings and precautions for use
The medicinal product contains traces of mouse and hamster proteins. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
The formation of neutralising antibodies (inhibitors) against factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.
In general, all patients treated with coagulation factor VIII should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree’.
Adverse Reactions
Very common (≥1/10)
Headache
Common (≥1/100 to <1/10)
Dizziness, Diarrhoea, Nausea, Rash
Uncommon (≥1/1000 to <1/100)
Factor VIII inhibition in previously-treated patients (PTPs), Hypersensitivity, Ocular hyperaemia, Flushing, Drug eruption, Eosinophil count increased, Infusion related reaction
For the ADYNOVATE US Prescribing Information, please refer here.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit https://www.takeda.com.
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2 ISTH 2021. Abstract [PB0917]. Pharmacokinetics/Pharmacodynamics (PK/PD) of Recombinant von Willebrand Factor (vonicog alfa) in Adult Patients with von Willebrand Disease (VWD) During Prophylactic Treatment.
3 ISTH 2021. Abstract [PB0924]. Burden of Illness in Patients with von Willebrand Disease: A Systematic Review.
4 ISTH 2021. Abstract [PB0927]. Characteristics and Treatment of Patients with von Willebrand Disease (VWD) in General Practice Settings in the United Kingdom.
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6 ISTH 2021. Abstract [PB0509]. Does Pharmacokinetic-guided Prophylaxis with Antihemophilic Factor (Recombinant) Improve Bleeding Rates over Standard Prophylaxis? Real-world Data from the AHEAD German Study.
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8 ISTH 2021. Abstract [PB0542]. Looking Beyond Fixed-Dose Rurioctocog Alfa Pegol Prophylaxis: Post hoc Analysis of PK-guided Regimens From the PROPEL Phase 3 Study.
9 ISTH 2021. Abstract [PB0837]. Design of a phase 3, randomized, controlled study of prophylactic and on-demand treatment with recombinant ADAMTS13 for patients with severe congenital thrombotic thrombocytopenic purpura.
10 ISTH 2021. Abstract [PB0483]. The Clinical Burden of Congenital and Immune-mediated Thrombotic Thrombocytopenic Purpura: A Retrospective Cohort Analysis.
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Contacts
Media Contacts:
Japanese Media
Ryoko Matsumoto
ryoko.matsumoto@takeda.com
+81 (0) 3-3278-3414
Media outside Japan
Linda Calandra
linda.calandra1@takeda.com
+1 617 301 2092
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