digoxin immune fab digifab logo DIGIFab

Privacy Policy

This Site is owned by BTG (“Site”). This Privacy Policy is designed to tell you about our practices regarding collection, use, and disclosure of information that you may provide via this Site or that we may acquire from your use of the Site. We ask you to read this Privacy Policy carefully. There are terms and conditions associated with your usage and viewing of this Site. View these terms and conditions here.

In the event that you submit any material for inclusion on this Site (including without limitation, personal information, know-how, comments, ideas, questions, techniques, abstracts or similar), you agree (i) that such material will not be deemed to be confidential (ii) that such material will not be deemed to be proprietary and (iii) to grant to BTG an irrevocable, worldwide, perpetual, royalty-free, non-exclusive license to use, disclose, copy, modify, adapt, publicly display and translate all or any of such material for any purpose whatsoever without restriction. We reserve the right, in our absolute discretion, to remove or delete, without notice, any material you submit for inclusion on this Site. We also have the right to disclose your identity to any third party who is claiming that any material posted or uploaded by you to our Site constitutes a violation of their intellectual property rights, or of their right to privacy.

Information collected by BTG

Website Use:

You can visit our Site and view most of the content anonymously; however, like many websites, we may collect the following personal information from you both by asking specific questions on the Site and by permitting you to communicate directly with BTG: (i) your name;
(ii) email address; (iii) phone number; and (iv) any other information volunteered by you. We may hold your personal information in physical and electronic form and will hold, use and otherwise process the data in accordance with applicable data protection legislation.

In addition, as you navigate through the Site, certain information can be passively collected using various technologies. Like most website operators, we track IP addresses, use both session and persistent cookies, and assign internet tags. We may also collect personal data from third party sources, including publicly accessible data bases, marketing partners, social media platforms and information we collect when we monitor other websites.

HCPs:

If you are a healthcare professional, we may collect additional personal information about you either through your use of the Site or in relation to other interactions that you have with BTG, including:

  • personal details, including your name, age, gender and contact details;
  • professional details such as your job title, your professional field of expertise, your professional credentials, data related to your membership of associations and boards and any other professional affiliations you may have, and data relating to scientific research, publication of your research and articles, adverse event data and data related to your use of our products and your interactions with us; and
  • details of any interactions with BTG, including information relating to your use of our products, and the services you provide to your patients
Adverse Events:

If you are prescribed and/or administered one of our products, we may be notified by you or by someone acting on your behalf either directly or via one of our websites that an adverse event may have occurred. BTG takes the steps required by applicable regulations that may include attempts to and collection of personal identifiable information and treatment information related to your experience with a BTG product. When notified of a potential adverse event, the associated information is collected and used exclusively for the purposes required by applicable law and regulations.

If you provide us with personal data relating to a third party, we will assume you are authorized to share that data with us
and that we are permitted to process that data in accordance with this privacy policy.

How BTG uses your data - Purposes for processing

We collect and process personal data about you to enable us to:

  • improve the content of our Site and the level of service we provide to you. This includes responding to your queries and sending administrative information to you, such as changes to our terms and policies
  • operate our business effectively and in accordance with our legal obligations as a healthcare company selling medicinal products and medical devices. This includes responding to reports that you make, or that someone else makes on your behalf, relating to adverse events suffered as a result of one of our products to enable us to monitor product safety, complying with applicable laws, regulation and guidance, which might include responding to the requests of regulators, government agencies or the courts
  • engage with third parties with whom we have a contractual relationship or a legitimate interest in so doing
  • allow us to make sure you receive updated information on BTG's activities and business that may be of interest to you
  • improve our operations. This might include research to analyse trends and use of our website for internal review purposes or to improve the services we provide to you

If you are an HCP, we may collect and process your personal data to manage a contractual relationship with you (or the Healthcare Organisation you work for) or if we have a legitimate business purpose in processing your data. This may include planning or effecting collaborations with you, arranging visits or meetings and better understanding your areas of expertise and interest so that we can ensure our communications to you are relevant.

Medical Contact Data Form - if you have completed a medical contact form on this Site, we will use the data provided to transfer the information to the correct BTG team who will respond as required. BTG will retain any information provided as part of a medical contact form as requested for regulatory audit purposes.

Lawful grounds for processing

Our processing of your personal data is necessary for the purposes of legitimate interests pursued by us, namely: (i) to keep our clients and suppliers informed about our business services; (ii) to evaluate, develop and improve our products and website; (iii) to respond appropriately to queries received about our business and products; (iv) to prevent fraud; (v) to protect our business interests; and (vi) to ensure complaints are investigated.

We may also process your personal data because it is necessary for a contract that you are a party to or are negotiating.

It may be necessary to process your personal data to comply with a legal obligation.

We may also use your personal data for purposes that are compatible with the purposes we have described to you including archiving purposes in the public interest, scientific research or statistical purposes, if permitted by data protection laws.

Sharing your personal information

  • We occasionally use other companies to provide limited services on our behalf, including (but not limited to) travel agents, hotels and transportation services, as well as printing, packaging and mailing company reports. We will only provide those companies with your personal data to the extent it is needed to deliver the service and they are prohibited from using that information for any other purpose(s)
  • In relation to our adverse event reporting obligations, we may need to share your personal data with appropriate regulatory authorities as described previously
  • We may also share your personal information with a potential buyer in connection with (a) the sale, assignment, or other transfer of our business, in which case we will require any such buyer to agree to treat it in accordance with applicable Data Protection Legislation; or
    (b) where required by applicable laws, court orders, or government regulations
  • We only disclose your personal data to other third parties where we consider this necessary as a matter of law; to exercise, defend or protect our legal rights; or, to protect your vital interests or those of other people
  • We may disclose your personal data to any of our affiliates worldwide that agree to treat such information in accordance with this Privacy Policy or a policy which is no less restrictive than this Privacy Policy

Data Transfer Abroad

Information about you in our possession may be transferred to other countries (for the avoidance of doubt, if your residence is within the European Economic Area (EEA), this may include countries outside the EEA). You understand and accept that these countries may have differing (and potentially less stringent) laws relating to the degree of confidentiality afforded to the information it holds and that such information can become subject to the laws and disclosure requirements of such countries.

Where cross-border data transfer requirements exist (e.g. EEA), BTG and any third parties working on our behalf will comply with applicable legal and/or regulatory requirements. We or they may also require the recipient to subscribe to international frameworks intended to enable secure data sharing. In the case of transfers by us, we may also transfer your information where:(i) the transfer is to a country deemed to provide adequate protection of your information by the European Commission; or (ii) where you have consented to the transfer.

Your rights

You have a number of rights concerning the way that we use your information. At any time, you have the right to:

  • be informed about the processing of your personal data (i.e. for what purposes, what types, to what recipients it is disclosed, storage periods, any third party sources from it was obtained, confirmation of whether we undertake automated decision-making, including profiling, and the logic, significance and envisaged consequences);
  • request access to or a copy of any personal data we hold about you;
  • request the rectification of your personal data, if you consider that it is inaccurate;
  • request the erasure of your personal data, if you consider that we do not have the right to hold it;
  • object to your personal data being processed for a particular purpose or to request that we stop using your information in certain circumstances;
  • ask us to transfer a copy of your personal data to you or to another service provider or third party where technically feasible; or
  • ask us to stop or start sending you marketing messages at any time by using the below contact details

Any request for access to or a copy of your personal data must be in writing and we will endeavor to respond within a reasonable period and in any event within one month in compliance with applicable data protection legislation.

When you are asked to provide your personal data to us, you have the option to decline. However, if you choose not to provide such data or, if you initially consent to processing but later withdraw your consent, BTG may not be able to provide the services you have requested.

Personal Information Retention

We will only keep the information we collect about you on our systems or with third parties for as long as required for the purposes set out above or as required to comply with any legal obligations to which we are subject. We will delete, destroy or anonymise data that is no longer needed for the purposes.

Automated processing

We do not carry out automated decision-making or profiling in relation to your personal data.

Children

This Site is not directed at children under 16, and we do not knowingly collect, use or disclose personally identifiable information from anyone under the age of 16. If we become aware that we have unknowingly collected personally identifiable information from a child under the age of 16, we will make reasonable efforts to delete such information from our records.

Security

We take appropriate steps to protect your personally identifiable information as you transmit your information from your computer to our Site or otherwise provide us with your information and to protect such information from loss, misuse, unauthorized access, disclosure, alteration, or destruction. You should keep in mind that no Internet transmission is ever 100% secure or error-free.

Use of Google Analytics

This Site uses Google Analytics, a web analytics service provided by Google, Inc.

Google Analytics sets a cookie in order to evaluate your use of the Site and compile reports for us on activity on the Site to help us understand how visitors engage with the Site and track visitor interactions. Google Analytics collects information anonymously and without identifying individual visitors.

Google stores the information collected by the cookie on servers in the United States. Google may also transfer this information to third parties where required to do so by law, or where such third parties process the information on Google's behalf. Google will not associate your IP address with any other data held by Google. Google Analytics uses its own cookies to store information, such as what time the visit occurred, whether the visitor has been to the Site before, and what Site referred the visitor to the web page. To disable this type of cookie, some browsers will indicate when a cookie is being sent and allow you to decline cookies on a case-by-case basis. In addition to declining cookies, you can also install the Google Analytics Opt-out Add-on in your browser, which prevents Google Analytics from collecting information about your Site visits.

Learn more about the Google Analytics Opt-out Browser Add-on and other Google Analytics privacy information:

Changes

As part of BTG's commitment to compliance with data protection legislation, and to reflect changes in BTG's operating procedures, BTG may update the terms of this policy from time to time. We therefore ask you to check it occasionally to ensure that you are aware of the most recent version which will apply each time you access this Site. If the changes we make are material, we also may post a notice regarding the changes on our website or mobile applications and related licensing agreements. Subsequent changes in this Privacy Policy will not apply to information that was collected before such change was made. This Privacy Statement was last updated on 13 July 2018.

Contact Information

BTG Plc or its affiliates Legal Notice are the controllers of your personal data as described in this Privacy Policy.

If you have any questions, concerns or comments about this Privacy Policy, wish to exercise any of your rights or if you wish to contact BTG (and its data protection officer) about the personally identifiable information held about you, please email BTG at info@btgplc.com.

If you have any concerns about our use of your information, you also have the right to make a complaint to the Information Commissioner's Office, which regulates and supervises the use of personal data in the UK, via their helpline on 0303 123 1113.

INDICATIONS AND USAGE

DIGIFab is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose, including:

  • Known suicidal or accidental consumption of fatal doses of digoxin: 10 mg or more of digoxin in healthy adults, or 4 mg (or more than 0.1 mg/kg) in healthy children, or ingestion of an amount that can cause steady state serum concentrations of ≥10 ng/mL;
  • Chronic ingestions causing steady-state serum digoxin concentrations >6 ng/mL in adults or 4 ng/mL in children;
  • Manifestations of life-threatening toxicity of digoxin overdose such as severe ventricular arrhythmias, progressive bradycardia, and second or third degree heart block not responsive to atropine, serum potassium levels exceeding 5.5 mEq/L in adults or 6 mEq/L in children with rapidly progressive signs and symptoms of digoxin toxicity.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

General

Suicidal ingestion may result from more than one drug. Consider toxic effects of other drugs or poisons in cases where signs and symptoms of digitalis toxicity are not relieved by administration of DIGIFab.

Rapid drop in serum potassium concentration may occur after treatment. Monitor frequently.

Patients with poor cardiac function may deteriorate secondary to the withdrawal of the inotropic action of digoxin by DIGIFab. Monitor frequently and provide additional inotropic support if needed. Postpone re-digitalization, if possible, until the Fab fragments have been eliminated; this may require several days or a week or longer in patients with impaired renal function.

Hypersensitivity Reactions

Anaphylaxis and hypersensitivity reactions are possible. Carefully monitor patients for signs and symptoms of an acute allergic reaction and if one occurs, stop the infusion and treat immediately with appropriate emergency medical care.

Patients with known allergies to sheep protein or those who have previously received intact ovine antibodies or Fab are particularly at risk for an anaphylactic reaction.

Do not administer DIGIFab to patients with a known history of hypersensitivity to papaya or papain unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available.

Use of DIGIFab in Renal Failure

The elimination half-life of DIGIFab in renal failure has not been clearly defined. Monitor patients with severe renal failure who receive DIGIFab for a prolonged period for possible recurrence of toxicity. Monitoring of free (unbound) digoxin concentrations after the administration may be appropriate.

Laboratory Tests

DIGIFab may interfere with digitalis immunoassay measurements. Thus, standard serum digoxin concentration measurements may be clinically misleading until the Fab fragments are eliminated from the body. This may take several days or a week or more in patients with markedly impaired renal function. If possible, obtain serum digoxin samples before DIGIFab administration to establish the level of serum digoxin at the time of diagnosis.

The total serum digoxin concentration may rise precipitously following administration of DIGIFab, but this will be almost entirely bound to the Fab fragment and not able to react with receptors in the body.

Adverse Reactions

The most common adverse reactions (>7%) related to DIGIFab administration are worsening congestive heart failure (13%), hypokalemia (13%) and worsening atrial fibrillation (7%).

Please see full Prescribing Information.