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Main » 2021 » July » 22 » Takeda Data at ISTH 2021 Highlight the Benefits of Prophylaxis for Patients with Rare Bleeding Disorders
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Takeda Data at ISTH 2021 Highlight the Benefits of Prophylaxis for Patients with Rare Bleeding Disorders


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.

Important Notice
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

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1 ISTH 2021. Abstract [LPB0128]. Phase 3 Trial Results: Prophylaxis With Recombinant Von Willebrand Factor in Patients With Severe von Willebrand Disease.
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.
5 German Clinical Trials Register. DRKS-ID: DRKS00000556. Available at: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00000556. Last accessed: June 2021.
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.
7 ISTH 2021. Abstract [PB0554]. The Impact of PK-guided Prophylaxis on Clinical Outcomes and Resource Utilization in Hemophilia A Patients: Real-world Evidence From the CHESS II Study.
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.
11 National Hemophilia Foundation. Von Willebrand Disease. Available at:https://www.hemophilia.org/bleeding-disorders-a-z/types/von-willebrand-disease. Last accessed June 2021.
12 Connell NT, et al. ASH ISTH NHF WFH 2021 Guidelines on the Management of von Willebrand Disease. Blood Adv (2021) 5 (1): 301–325.
13 World Federation of Hemophilia. Introduction to Hemophilia: What is Hemophilia? Available at: https://bit.ly/356zUDQ. Last accessed June 2021.
14 20 Anniversary Report on the Annual Global Survey 2018. World Federation of Hemophilia. Available at: https://bit.ly/3hGDUzU. Last accessed June 2021.
15 World Federation of Hemophilia. Introduction to Hemophilia: Treatment. Available at: https://bit.ly/3b7Pfry. Last accessed June 2021.
16 NHS. Haemophilia: Treatment. Available at: https://bit.ly/3oqhAwY. Last accessed June 2021.
17 Takeda Website. Rare Diseases. Available at: https://bit.ly/3n9gvIN. Last accessed June 2021.
18 Takeda Website. U.S. Product List. Available at: https://bit.ly/35a6HYF. Last accessed June 2021.

Copyright 2021 Takeda Pharmaceutical Company Limited. All rights reserved. Takeda and the Takeda logo are registered trademarks of Takeda Pharmaceutical Company limited.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210720005119/en/

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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