For information about data processing within the scope of Pharmacovigilance, please refer to our Pharmacovigilance Privacy Notice.
At Chugai, we understand that protecting your privacy is very important. That’s why we have taken the necessary steps to meet worldwide data privacy requirements. We treat your personal data according to the laws of England and Wales and other applicable EU laws which regulate the collection, storage, process, access and transfer of personal data, including the UK General Data Protection Regulation (“UK GDPR”), the UK Data Protection Act 2018 (“DPA2018”), and the European General Data Protection Regulation (“EU GDPR”), and in accordance with our internal personal data management processes.
This notice applies to customers and other interested parties’ personal data (“personal data”) collected and processed in the course of our business relationship. Personal data may be collected from Chugai’s online resources and communications which include digital content such as websites, e-mail, apps, systems, portals and other online tools (altogether “online resources”) that display a link to this notice. This notice also applies to personal data collected from offline resources and communications. This notice does not apply to third-party online resources to which Chugai’s website may link, where Chugai does not control the content or the privacy practices of such resources.
In this notice personal data means ‘personal data’ as defined in the UK GDPR and refers to any information relating to you that can identify you either directly (e.g., name) or indirectly (e.g., an identification number).
In collecting and processing this personal data Chugai Pharma Europe Ltd. and/or our UK affiliate Chugai Pharma UK Ltd, where the latter have the relationship with you, are the controllers of your personal data. When we say “Chugai”, “we”, “us” or “our”, we are referring to the controller.
The registered company address and contact details for each company are shared in the ‘Contact Us’ section below.
Chugai has appointed a data protection officer (DPO) who can respond to any enquiries about our use of your personal data. If you have any questions about this notice, including any requests to exercise your legal rights, please contact the DPO using the details set out below:
Please review this notice to learn more about how we collect, use, share and protect information online. It is important that the personal data we hold about you is accurate and current, please keep us informed if your personal data changes during your relationship with us.
Personal Information: We may collect this personal data in the course of our business relationship, when you use our websites, register for webinars, events, or online resources, or when you contact us or as part of the services we provide.
You can choose not to provide any personal data; however, depending on your interactions with us this may restrict our relationship with you and/or we may not be able to provide the services you have requested. Within the scope of our business relationship, you must provide personal data that is necessary for the establishment, execution and termination of a business relationship and for the fulfilment of the associated contractual obligations or which we are legally obliged to collect. Without this data, we will generally not be able to enter into, perform and terminate a contract with you. If you do not provide us with the necessary information and documents, we may not enter into or continue the business relationship requested by you.
Depending on your interaction with us, we may collect information such as:
Directly from you when you:
From 3rd Parties:
Protecting your privacy is very important to us and we are committed to processing your personal data in compliance with applicable laws.
Our legal basis for collecting and using the personal data described above will depend on the personal information concerned and the specific context in which we collect it. However, we will normally collect personal data from you only where we have your consent to do so, or where the processing is in our legitimate interests and not overridden by your data protection interests or fundamental rights and freedoms (for example network and information systems security). In some cases, we may also have a legal obligation to collect personal data from you or may otherwise need the personal data to protect your vital interests or those of another person.
If we ask you to provide personal data to comply with a legal requirement, we will make this clear at the relevant time and advise you whether the provision of your personal data is mandatory or not) as well as the possible consequences if you do not provide your personal data).
For the establishment and implementation of the business relationship as well as for pre-contractual measures, we do not use fully automated decision-making.
The following is a list of the ways that we may use your personal information in the course of our relationship, and the reason we rely on for doing so:
| What we use your personal information for (Purpose) | Our reasons (Legal Basis) |
|---|---|
| Management of Online Resources | Validate and manage your accounts in our online resources; undertake online resources administration and personalisation; to ensure that content from our online resources is presented in the most effective manner for you and for your computer; to administer our online resources and for internal operations, including troubleshooting, data analysis, testing, research, statistical and survey purposes; managing network and data security - as part of our efforts to keep our website safe and secure. |
| To make suggestions and recommendations to you of our online resources and/or about goods or services that may interest you. | Consent (Cookies) |
| Management of our Customer Relationship | The processing of data is carried out for the provision in the context of the implementation of our contracts with our contractual partners or for the implementation of pre-contractual measures that take place upon request. Further details on the data processing purposes can be found in the relevant contractual documents. |
| Where necessary, we process your data beyond the actual performance of the contract to protect legitimate interests of us or third parties. Examples: Maintenance of customer database, including combining data about you from various sources (e.g., information you provide to us and personal data which is collected during your relationship with us); Market and opinion research; Establishing contact, sending information material and invitations to events, carrying out customer segmentations and identifying optimisation potentials; Assertion of legal claims and defence in legal disputes. | Legitimate Interest |
| Processing and responding to complaints received from you | Consent |
| Managing any concerns you raise in line with our Whistleblowing Process | Legal Obligation |
| Contacting you by telephone, email or post | Consent/Legitimate Interest/Legal Obligation (Legal basis subject to the need to contact) |
| To allow you to participate in interactive features of our service, when you choose to do so; or to enable you to take part in any market research we include on or link to or from our website, or in which we invite you to take part. | Consent |
| To notify you about changes to our service | Legitimate Interest/Contract |
| To make suggestions and recommendations to you of our online resources and/or about goods or services that may interest you or them | Legitimate Interest |
| Management of our Marketing Communications | To send you personalized communications electronically (e-mail, SMS, MMS) about our services and products. Chugai’s marketing communication activities include sending you electronic direct marketing (promotional content) and utilising technical functionalities to track e-mail deliverability and engagement for targeting purposes and to improve user experience. These allow us to measure or understand your preferences and the effectiveness of advertising we serve to you and to deliver relevant advertising to you. |
| Further information regarding the processing of personal data that we undertake can be found below, however, if you have questions about, or need further information, concerning the legal basis on which we collect and use your personal information, please contact us using the contact details provided in this notice. | Consent (Opt-in) |
Further information regarding the processing of personal data that we undertake can be found below, however, if you have questions about, or need further information, concerning the legal basis on which we collect and use your personal information, please contact us using the contact details provided in this notice.
Chugai relies on your opt-in to send you marketing communications. Data relating to your interests, preferences and practices may be collected as part of your interactions with us, whether through digital channels or non-digital channels. This data will be used by Chugai to analyse and predict your professional preferences and interests, and in particular they may be used during our communications about our services and products to ensure we use appropriate communication channels and offer you information with personalized content which is of interest to you.
We may use this data in order to provide information to an individual who has agreed to receive information from us. We may also use the data in aggregate form with no personally identifiable information in order to provide analysis internally and to share with others when appropriate.
Chugai may use social networks and third-party sites to communicate personalised content based on your preferences and practices on these social networks and third-party sites. If you wish to avoid such communications, be sure to personalize your settings in these social networks and third-party sites in accordance with their privacy policies.
When we receive a regulatory complaint from a person, we create a file containing the details of the complaint, including the identity of the complainant. It may contain health related information. We will only use the personal information we collect to process the complaint.
We will keep personal data contained in complaint files in line with our retention policy. It will be retained in a secure environment and access to it will be restricted according to the “need to know” principle.
Detailed information about how we process your personal data in relation to our whistleblowing process is available here.
We process and store your personal data as long as this is necessary for the fulfilment of our contractual, legal or official obligations. If the data is no longer required it is regularly deleted, unless its – temporary – storage is necessary for the following purposes: to comply with applicable legal, tax or accounting requirements.
You have several choices regarding your personal data. You could decide not to submit any personal data at all by not entering it into any forms or data fields on our website and not using any available personalised services. If you choose to submit personal data, you have the right to see and correct your data at any time. Some of our processes may ask for your permission for certain uses of your information and you can agree to or decline those uses.
If you opt-in for particular services or communications, such as an e-newsletter or marketing, you will be able to unsubscribe at any time by following the instructions included in each communication. If you decide to unsubscribe from a service or communication, we will work to process this request promptly, although we may require additional information to do so.
Depending on the type of processing and our legal basis for it, you may have the right to:
If you wish to exercise any of these rights, contact our DPO by using the details under the How to Contact Us section of this notice.
No Fee is Usually Required
You will not have to pay a fee to access your personal data (or to exercise any of the other rights). However, we may charge a reasonable fee if your request is clearly unfounded, repetitive or excessive. Alternatively, we may refuse to comply with your request in these circumstances.
What We May Need from You
We may need to request specific information from you to help us confirm your identity and ensure your right to access your personal data (or to exercise any of your other rights). This is a security measure to ensure that personal data is not disclosed to any person who has no right to receive it. We may also contact you to ask you for further information in relation to your request to speed up our response.
Time Limit to Respond
We try to respond to all legitimate requests within one month. Occasionally it may take us longer than a month if your request is particularly complex or you have made a number of requests. In this case, we will notify you and keep you updated.
Right to Complain to the Supervisory Authority
You have the right to make a complaint at any time to the Information Commissioner’s Office (ICO), the UK supervisory authority for data protection issues (www.ico.org.uk). We would, however, appreciate the chance to deal with your concerns before you approach the ICO so please contact us in the first instance.
Chugai uses technology and security precautions, rules and other procedures to protect your personal data from unauthorised access, improper use, disclosure, loss or destruction. To ensure the confidentiality of your data, Chugai uses industry standard firewalls and password protection. It is, however, your personal responsibility to ensure that the computer you are using is adequately secured and protected against malicious software, such as trojans, computer viruses and worm programs. You are aware of the fact that without adequate security measures (e.g. secure web browser configuration, up-to-date antivirus software, personal firewall software, no usage of software from dubious sources) there is a risk that the data and passwords you use to protect access to your data, could be disclosed to unauthorised third parties.
Where we have given you (or where you have chosen) a password which enables you to access certain parts of our website, you are responsible for keeping this password confidential. We ask you not to share a password with anyone.
Within Chugai, access to your data is granted to those functions that need it to fulfil our contractual and legal obligations or to implement our legitimate interests. We may transfer your personal data to companies affiliated with us, insofar as this is permissible within the framework of the purposes and legal bases described above.
Chugai may share personal data about you with various outside companies or agents working on our behalf to help fulfil business transactions (such as providing customer services) and to help fulfil business operations such as sending marketing and/or customer communications about our products, services and offers including market research and telemarketing; maintaining our customer database and website; conducting analytics, marketing and website optimisation including search engines and online marketing and for the performance of any contract we enter into with you.
In addition, we may share personal data that we collect from you with our company’s headquarters, subsidiaries and affiliates globally or store that data with them. As part of our strategic alliance with Roche, and as members of the Roche Group, we may pass your details to a third party or another member of the Roche Group as part of a co-promotional activity, only where such party is acting on our behalf to send you information (where you have consented to receive such information) and/or as otherwise required by law.
In these cases, we ensure that the processing of personal data is carried out in accordance with applicable data protection laws.
We may also disclose personal data for these purposes:
(a) in connection with the sale, assignment or other transfer of the business of the website to which the data relates;
(b) to respond to appropriate requests of legitimate government agencies or where required by applicable laws, court orders, or government regulations; or
(c) where needed for corporate audits or to investigate or respond to a complaint or security threat.
No Third-Party Direct Marketing Use: We will not sell or otherwise transfer the personal data you provide to us to any third parties for their own direct marketing use unless we provide clear notice to you and obtain your explicit consent for your data to be shared in this manner.
Transfers: Data is only transferred to countries outside the UK (so-called third countries) insofar as
In this context, compliance with an adequate level of data protection is ensured by appropriate safeguards, e.g. adequacy decision or international data transfer agreements, and where applicable, further measures.
When you interact with our website or online resources, we may collect technical information as described below:
Aggregate Information: such as statistical or demographic data. Aggregated data may be derived from your personal data but is not considered personal data in law as this data does not directly or indirectly reveal your identity. For example, we may aggregate your usage data to calculate the percentage of users accessing a specific website feature. However, if we combine or connect aggregated data with your personal data so that it can directly or indirectly identify you, we treat the combined data as personal data which will be used in accordance with this privacy notice.
Browse Public Pages on our Websites
If you browse public pages on our website, i.e. content that you can access without being logged in to an account you may have with us, we collect and process only non-sensitive information about you. We will however process your personal information to the extent required to deliver the public content you request from us, for example to format it for your browser. We will also process your personal information to meet our legitimate interests to protect the security of our website systems, and to measure the audiences for the various types of content provided. To do this, we use:
Automatically Collect Information: We automatically receive certain types of information whenever you interact with us on our website and in some e-mails, we may send each other. Automatic technologies we use may include, for example, web server logs/IP addresses, cookies, web beacons and third-party application and content tools. These technologies may be updated from time to time to reflect new functionalities that are available.
Chugai may use these different types of cookies:
Some of our cookies are known as ‘session’ cookies and expire after you leave our website. Others are ‘persistent’ cookies that are stored on your device in between browser sessions and allow your preferences or actions to be remembered. They remain on your device for varying lengths of time, but in any event no longer than two years. Cookies can be removed manually before they expire via your browser settings.
Chugai automatically places strictly necessary cookies in its websites, but we will never place other types of cookies without your consent, and you will be prompted to accept or refuse those.
Managing Cookies: As described above, you can choose to accept or decline cookies. You can do so by selecting your preference when you are prompted, alternatively you can click on the Cookie My Profile button accessible in the footer of our website. Alternatively, if you wish to prevent cookies from tracking you anonymously as you navigate our website, you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. All browsers allow you to fine-tune cookie settings and determine which ones to accept and which to disable or delete. Your browser can also notify you when you receive new cookies. Please consult your browser’s ‘help’ section for more information on adjusting your cookie settings.
Some cookies allow you to take advantage of some of our website’s essential features, so we recommend you leave them turned on. If you block or otherwise reject cookies the website may not function correctly, and you may not be able to access restricted parts of the website that require you to log in.
For more general information about cookies and their managements visit: http://www.allaboutcookies.org
Our website may, from time to time, contain links to third-party websites, plug-ins and applications., e.g. links to and from the websites of our affiliates or to any number of websites that may offer useful information to our visitors. Clicking on those links or enabling those connections may allow third parties to collect or share data about you. If you follow a link to any of these websites, please note that these websites have their own privacy policies and that we do not accept any responsibility or liability for these policies or those linked websites. When you leave our website, we encourage you to read the privacy policy of every website you visit.
If a website has particular provisions relating to privacy that differ from those stated here, those provisions will be disclosed to you on the page on which the personal data is collected.
Our websites are directed at an adult audience. We do not collect any personally identifiable information from anyone we know to be under the age of thirteen (13) without the prior, verifiable consent of his or her legal representative. Such legal representative has the right, upon request, to view the information provided by the child and/or to require that it be deleted.
If you have a business or professional relationship with Chugai, we may use information you submit on our website to fulfil your requests and develop our business relationship with you and the entities you represent. We may also share such information with third parties acting on our behalf.
Chugai Pharma Europe Ltd and Chugai Pharma UK Ltd have appointed a data protection officer (DPO) who can respond to any enquiries about our use of your personal data. If you have any questions about this notice, including any requests to exercise your legal rights, please contact the UK DPO using the details set out below:
We keep this Privacy and Cookie Notice under regular review, and we will place any updates on this website in response to changing legal, technical, or business developments. When we make significant changes to this notice, we will take appropriate measures to inform you. When we change any processing that is based on consent, we will ask you for a new consent. We encourage you to periodically review this page for the latest information on our privacy practices.
C-GB-00001598 February 2025
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]
You are now leaving the CINVAcademy website and entering a third-party website. Please confirm if you wish to continue.
C-GB-00000702 January 2023
Given the emetogenic potential of FOLFOX chemotherapy:
You are now leaving the CINVAcademy website and entering a third-party website. Please confirm if you wish to continue.
C-GB-00000702 January 2023
You are now leaving the CINVAcademy website and entering a third-party website. Please confirm if you wish to continue.
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