This page (together with the Privacy and Cookie Policy) tells you about the terms on which you may use the website, whether as a guest or a registered user (“Terms of Use”). Please read these Terms of Use carefully before you start to use the website. By using our website, you indicate that you accept these Terms of Use and that you agree to comply by them. If you do not agree with these Terms of Use, you do not have permission to access the contents of the Site and you should cease using the website immediately.
This website (“website”) is owned and operated by Chugai Pharma UK Limited (“Chugai”, “Our” or “We”). We are a private limited company registered in England and Wales under company number 2814621 and have a registered office at Mulliner House, Flanders Road, London, W4 1NN, United Kingdom.
Chugai Pharma UK Limited will not be responsible for any damages resulting from the use of this website or the information presented on this website. For further details, please read the following “Terms of use.”
Access to Chugai’s website is permitted on a temporary basis, and we reserve the right to withdraw or amend the service we provide on our website without notice (see below). We will not be liable if for any reason our website is unavailable at any time or for any period. From time to time, we may restrict access to some parts of our website, or our entire website, to users who have registered with us.
If you choose, or you are provided with, a user identification code, password or any other piece of information as part of our security procedures, you must treat such information as confidential, and you must not share it with any other person. We have the right to disable any user identification code or password, whether chosen by you or allocated by us, at any time, if in our opinion you have failed to comply with any of the provisions of these Terms of Use. You agree to notify us immediately upon becoming aware of any unauthorised disclosure or use of your user identification code and/or password.
You are responsible for making all arrangements necessary for you to have access to Chugai’s website. You are also responsible for ensuring that all persons who access the website through your internet connection are aware of these Terms of Use, and that they comply with them.
Provided you observe, at all times, these Terms of Use, we grant you a revocable (at any time), non-exclusive, personal, non-commercial, worldwide, non-transferable, royalty free licence to use Chugai training materials from this website. This Licence may not be transferred, novated, assigned and/or sub-licensed to any third party. All rights not expressly granted in the training materials Licence are fully reserved by us, our Affiliates*. Nothing in the training material Licence grants you any right or licence to use any of our trademarks.
You may not copy, reproduce, republish, post, broadcast, transmit, make available to the public, sell or otherwise reuse or commercialise the Chugai training materials in any way. You may not edit, alter, adapt or add to the Chugai training materials in any way, nor combine the Chugai training materials with any other material. You may not download or use the files for the purpose of promoting, advertising, endorsing or implying any connection between you (or any third party) and us, our agents or employees, or any contributors to the Chugai training materials. You may not use the Chugai the training materials in any way that could bring our name or that of any Chugai Affiliate into disrepute or otherwise cause any loss or damage to us or any Chugai Affiliate.
* “Affiliates” means any corporation or other business entity controlling, controlled by or under common control with Chugai Pharma UK Limited from time to time and, for the purposes of this definition, “control” shall mean direct or indirect ownership of (i) fifty per cent (50%) or more of the voting securities or voting interest in such corporation or other entity; or (ii) fifty per cent (50%) or more of the interest in the profit or income in the case of a business entity other than a corporation; or (iii) in the case of a partnership, any other comparable interest in the general partner.
The intention of this website is to promote a broader understanding of Chugai and the therapy areas in which it operates. In no way is this website intended to solicit an investment in the company on the part of the users. Furthermore, this website is not intended to solicit investment in any other securities.
Parties wishing to make a link to this website must first obtaining our prior written consent at [email protected]. Following such consent any such link must be presented in a way that is fair and legal and does not damage Chugai’s reputation or take advantage of it. You must not establish a link in such a way as to suggest any form of association, approval or endorsement on our part where none exists. You must not establish a link from any website that is not owned by you.
Parties are asked to take measures, such as including remarks, so that users can easily recognise that the established link is to the Chugai website. Chugai is in no way responsible for the contents of any sites establishing links with Chugai’s website. Chugai reserves the right to withdraw linking permission without notice.
We may provide hyperlinks from this website to websites of other organisations including websites of associated companies. Their inclusion must not be taken to imply any endorsement or validation by us of the content of the linked website. Chugai do not accept responsibility or liability for any losses or penalties that may be incurred or for the accuracy of hyperlinks to third party websites or the content of such third-party websites. Please note, that these terms and conditions apply only to this website and Chugai will not be liable for the contents of linked websites or any transactions carried out with organisations operating those websites.
The intellectual property rights in this website, and in the material published on it including without limitation, in all documents, files, text, images, audio files, Podcasts, video files, tutorials, graphics, are owned by Chugai Pharma UK Limited, its Affiliates (as defined above) or our external partners except for any third party owned content which has been identified as such. These works are protected by copyright laws and treaties around the world. All such rights are reserved.
You are authorised to make a single copy and to print extracts or documents from this website (except for any third party owned content which has been identified as such) for your non-commercial use provided any such copy or print retains all copyright or other proprietary notices and any disclaimer contained within them. All Chugai names, logos and trademarks may not be used or reproduced without our prior written consent. Chugai’s status as the authors of material on our website must always be acknowledged.
You may not use any diagrams, illustrations, photographs, video or audio sequences or any graphics separately from any accompanying text. No links to this website may be included in any other website without Chugai’s prior written permission.
We cannot guarantee that you have any right to use third party owned content which is available on this website, and you must obtain permission from the third party owner before using or downloading such content. Content which is copyright protected may not be changed nor may any author attribution notice or copyright notice appearing on such content be altered without first obtaining the appropriate consents.
All product names referred to on this website are trademarks of Chugai Pharma UK Limited or its Affiliates, except for those marks which are indicated as owned by other companies and all rights are reserved.
This website may contain third party owned content (e.g. images, articles, data feeds or abstracts) and may also include hypertext links to third party owned websites. Chugai will provide such third-party content and links as a courtesy to you. Links are provided for your information only. We have no control over any third party owned websites or content referred to, accessed by or available on this website and, therefore, we do not endorse, sponsor, recommend or otherwise accept any responsibility for such third-party websites or content or for the availability of such websites. In particular, we do not accept any liability arising out of any allegation that any third party owned content (whether published on this, or any other, website) infringes the intellectual property rights of any person or any liability arising out of any information or opinion contained on such third-party website or content.
You must not misuse our website by knowingly introducing viruses, trojans, worms, logic bombs or other material which is malicious or technologically harmful. You must not attempt to gain unauthorised access to our website, the server on which our website is stored or any server, computer or database connected to our website. You must not attack our website via a denial-of-service attack or a distributed denial-of service attack.
By breaching this provision, you would commit a criminal offence under the Computer Misuse Act 1990. We will report any such breach to the relevant law enforcement authorities and we will cooperate with those authorities by disclosing your identity to them. In the event of such a breach, your right to use our website will cease immediately.
We will not be liable for any loss or damage caused by a distributed denial-of-service attack, viruses or other technologically harmful material that may infect your computer equipment, computer programs, data or other proprietary material due to your use of our website or to your downloading of any material posted on it, or on any website linked to it.
Chugai has taken reasonable care in compiling this website, we are not responsible for any action taken by any person or organisation, wherever they are based, as a result, direct or otherwise, of information contained in or accessed through this website whether such information is provided by us or by a third party. Nothing on this website should be construed as the giving of advice or the making of any recommendation and this website should not be relied upon as the basis for any decision or action. As a result of ongoing medical advances and developments, the information on this website may not always be completely up to date and, for this reason, such information is provided on an “AS IS” and “AS AVAILABLE” basis.
Chugai cannot guarantee the accuracy and completeness of all information contained on the website. In other words, Chugai does not guarantee that the information is without error, is useful or will match the needs of each customer. Chugai also does not guarantee that there will be no errors with the website, or that the server providing this website is free of computer viruses or other potentially harmful items. Chugai is not responsible for any trouble, loss or damage resulting from the use of this website or from the information contained on this website.
Commentary and other materials posted on the website are not intended to amount to medical advice on which reliance should be placed. We therefore disclaim all liability and responsibility arising from any reliance placed on such materials by any visitor to our website, or by anyone who may be informed of any of its contents.
C-GB-00000602 January 2023
AKYNZEO®
(netupitant/palonosetron hydrochloride)
Prescribing Information for Akynzeo
For full information please refer to the Summary of Product Characteristics before prescribing.
Presentations: 300 mg netupitant and palonosetron hydrochloride equivalent to 0.5 mg of palonosetron.
Indications: In adults, for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Dosage and Administration:
Adults: One 300 mg/0.5 mg capsule administered approximately one hour prior to the start of each chemotherapy cycle. The hard capsule should be swallowed as a whole. The recommended oral dexamethasone dose should be reduced by approximately 50% when co-administered with Akynzeo capsules. Elderly: No dosage adjustment is necessary in the elderly. Caution should be exercised when using this product in patients over 75 years, due to the long half-life of the active substances and the limited experience in this population. Paediatric population: The safety and efficacy in children have not been established. Renal impairment: Dosage adjustment is not considered necessary in patients with mild to severe renal impairment. No data is available for patients with end stage renal disease requiring haemodialysis and therefore use in these patients should be avoided. Hepatic impairment: No dosage adjustment is necessary for patients with mild or moderate hepatic impairment. Limited data is available in severe hepatic impairment and therefore, should be used with caution in these patients.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy.
Precautions and Warnings for Use: Palonosetron in Akynzeo may increase large bowel transit time and patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration. There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone or in combination with other serotonergic medical products. Appropriate observation of patients for serotonin syndrome-like symptoms is advised. Caution should be exercised with the concomitant use of Akynzeo capsules and drugs that increase the QT interval or in patients who are likely to develop prolongation of the QT interval. Hypokalaemia and hypomagnesaemia should be corrected prior to administration. This medicinal product should be used with caution in patients receiving concomitant orally administered active substances that are metabolised primarily
through CYP3A4 and with a narrow therapeutic range. Patients should be monitored for increased toxicity of chemotherapeutic agents that are substrates for CYP3A4. Netupitant in Akynzeo may also affect the efficacy of chemotherapeutic agents that need activation by CYP3A4 metabolism. Contains sorbitol and sucrose. Patients with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. May also contain lecithin derived from soya. Patients with known hypersensitivity to peanut or soya, should be monitored closely for signs of an allergic reaction. Since Akynzeo capsules may cause dizziness, somnolence and fatigue, patients should be cautioned against driving and operating machinery if such symptoms occur.
Common Side Effects: Headache, constipation, fatigue.
Prescribers should consult the Summary of Product Characteristics in relation to other adverse reactions.
Legal Category: POM.
Package Quantities and Prices:
GB (PLGB 12333/0018): 1 x 300 mg/0.5 mg hard capsule £69
Northern Ireland (EU/1/15/1001/001): 1 x 300 mg/0.5 mg hard capsule £69
Ireland (EU/1/15/1001/001): 1 x 300 mg/0.5 mg hard capsule
Marketing Authorisation Holder: Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, Republic of Ireland.
UK & Ireland Distributor: Chugai Pharma UK Limited, Mulliner House, Flanders Road, Turnham Green, London W41NN.
Date of Preparation: October 2022.
C-GB-00000544
Additional Information is available in the SmPC or on request from Chugai Pharma UK Ltd., Mulliner House, Flanders Road, Turnham Green, London W4 1NN. Tel: +44 (0) 01748 827 276 Email: [email protected]
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C-GB-00000702 January 2023
Given the emetogenic potential of FOLFOX chemotherapy:
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C-GB-00000702 January 2023
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C-GB-00000702 January 2023
Please visit www.chugai.eu for more information about Chugai Pharma UK Ltd.
C-GB-00000651 January 2023
UK: Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Chugai Pharma UK Ltd at [email protected] or Tel: +44 (0) 208 987 5600