Privacy Statement

This website (hereinafter the “Website”) is provided by Bayer Aktiengesellschaft. (hereinafter “us” or “we”). For further information regarding the provider of the Website, please refer to our imprint.

 

Handling of personal data

In the following we wish to provide you with information on how we handle your personal data when you use our Website. Unless otherwise indicated in the following chapters, the legal basis for the handling of your personal data results from the fact that such handling is required to make available the functionalities of the Website requested by you (Art. 6(1)(b) General Data Protection Regulation).

 

Using our Website

Accessing our Website

When you call up our Website, your browser will transfer certain information to our web server. This is done for technical reasons and required to make available to you the requested information. To facilitate your access to the Website, the following information are collected, briefly stored and used:

  • IP address
  • date and time of access
  • Time zone difference to Greenwich Mean Time (GMT)
  • Content of request (specific site)
  • Status of access/HTTP status code
  • Transferred volume of data
  • Website requesting access
  • Browser, language settings, version of browser software operating system and surface

Moreover, to protect our legitimate interests, we will store such information for a limited period of time in order to be able to initiate a tracking of personal data in the event of actual or attempted unauthorized access to our servers (Art. 6(1)(f) General Data Protection Regulation). 

 

Registration and login

In order to be able to use certain services of our Website, you need to first register an account with us, where you are able to determine your personal login credentials that you need to be able to log into your personal account. For this registration and subsequent login procedure, we collect the following information about you:

User name and password

We process this personal data in order to provide you with an access to the services of our Website. They are deleted in case you deactivate your user account.

 

Setting of cookies

What are cookies?

This Website uses so-called “cookies”. Cookies are small text files that are stored in the memory of your terminal via your browser. They store certain information (e.g. your preferred language or site settings) which your browser may (depending on the lifespan of the cookie) retransmit to us upon your next visit to our Website.

 

What cookies do we use? 

We differentiate between two categories of cookies: (1) functional cookies, without which the functionality of our Website would be reduced, and (2) optional cookies used for e.g. website analysis and marketing purposes. The following tables contain a detailed description of the optional cookies we use:

Subject to your consent

We only use optional cookies if we have obtained your prior consent (Art. 6(1)(a) General Data Protection Regulation). Upon your first access to our Website, a banner will appear, asking you to give us your consent to the setting of optional cookies. If your consent is given, we will place a cookie on your computer and the banner will not appear again as long as the cookie is active. After expiration of the cookie’s lifespan, or if you actively delete the cookie, the banner will reappear upon your next visit to our Website and again ask for your consent.

 

How to prevent the setting of cookies

Of course you may use our Website without any cookies being set. In your browser, you can at any time configure or completely deactivate the use of cookies. This may, however, lead to a restriction of the functions or have adverse effects on the user-friendliness of our Website. You may at any time object to the setting of optional cookies by using the respective objection option indicated in the table above.

 

Website Analysis with Google

On our Website we use a web analysis service of Google Inc., 1600 Amphitheatre Parkway, Mountain View, CA 94043, United States (“Google”).

Google will analyze your use of our Website on our behalf. To this purpose, we use the cookies described in more detail in the above table. The information collected by Google in connection with your use of our Website (e.g. the referring URL, our webpages visited by you, your browser type, your language settings, your operating system, your screen resolution) will be transmitted to a server of Google in the US, where it will be stored and analyzed. The respective results will then be made available to us in anonymized form. Your usage data will not be connected to your full IP address during this process. We have activated on our Website the IP anonymizing function offered by Google, which will delete the last 8 bits (type IPv4) or the last 80 bits (type IPv6) of your IP address after each data transfer to Google. Moreover, Google is certified under the EU-US Privacy Shield, which ensures that an adequate level of data protection is maintained with respect to the processing of personal data by Google in the US.

You may withdraw your consent to the use of web analysis at any time, either by downloading and installing the provided Google Browser Plugin or by administrating your consents in the above table, in which case an opt-out cookie will be placed. Both options will prevent the application of web analysis only as long as you use the browser on which you installed the plugin and do not delete the opt-out Cookie. 

 

Subscription to our newsletter

On our Website, you may subscribe to receive our newsletter. Based on your prior consent, we will collect and use the email address you indicate for providing you with the newsletter (Art. 6(1)(a) General Data Protection Regulation).

If you wish to receive a customized newsletter, you may, on a voluntary basis, provide us with the following additional information: 

Name and surname

Title

Gender

For subscription to our newsletter we use the so-called double opt-in procedure. After you have subscribed to the newsletter on our Website, we will send you a message to the indicated email address asking for your confirmation. If you do not confirm your subscription, your subscription will automatically be deleted. In order to prevent any misuse of your personal data, we will log your subscription and confirmation, filing the IP address you use when subscribing, the time of your subscription and confirmation, the messages sent by us regarding your subscription, and the wording of your subscription and confirmation.

You may at any time with future effect withdraw your consent to receive our newsletter, in which case we will also delete your personal data connected to receiving our newsletter. To declare that you wish to unsubscribe, you may use the respective link included in all newsletters, or refer to the contacts indicated below (Contact).

 

Use of the recommendation function

If you wish to recommend us to others, you can do so by using the recommendation function on our Website. You may, in your and our legitimate interest, send a message to any person if you assume that the recipient wishes to receive such information. We delete the personal data involved with this (e.g. name and email address) after the recommendation is sent.

 

Information on side effects and quality complaints

This Website is not intended or designed for communications regarding side effects, lack of therapeutic effect, medication errors, grey market products/counterfeit medicine, incorrect or off-label use, quality complaints

and/or other issues regarding the safeness or quality of Bayer products. If you wish to report side effects or make a quality complaint, please contact your health care professional (e.g. physician or pharmacist), your local health authority, or use our Website for the report of undesirable side effects.

If you nevertheless report to us undesirable side effects or other issues regarding the safeness or quality of Bayer products, we will be legally bound to deal with your communication and may have to contact you for clarification purposes. Subsequently, we may have to notify the competent health authorities of the issues reported by you. In this context, your information will be forwarded in pseudonymized form, i.e. no information by which you may be directly identified will be passed on. We may also have to forward these pseudonymized notifications to our group companies and cooperation partners, to the extent these are likewise obliged to notify their respectively competent health authorities.

 

Transfer of personal data for commissioned processing 

For the processing of your personal data we will to some extent use specialized service contractors. Such service contractors are carefully selected and regularly monitored by us. Based on respective data processor agreements, they will only process personal data upon our instruction and strictly in accordance with our directives. 

 

Processing of personal data outside the EU / the EEA

Your personal data will in part also be processed in countries outside the European Union (“EU”) or the European Economic Area (“EEA”), which may have a lower data protection level than European countries. In such cases, we will ensure that a sufficient level of protection is provided for your personal data, e.g. by concluding specific agreements with our contractual partners (copy available on request), or we will ask for your explicit consent to such processing.

 

Information regarding your rights

The following rights are in general available to you according to applicable data privacy laws:

Right of information about your personal data stored by us;

Right to request the correction, deletion or restricted processing of your personal data;

Right to object to a processing for reasons of our own legitimate interest, public interest, or profiling , unless we are able to proof that compelling, warranted reasons superseding your interests, rights and freedom exist, or that such processing is done for purposes of the assertion, exercise or defense of legal claims;

Right to data portability;

Right to file a complaint with a data protection authority;

You may at any time with future effect withdraw your consent to the processing of your personal data. For further information please refer to the chapters above describing the processing of personal data based on your consent.

If you wish to exercise your rights, please address your request to the contact indicated below. (-> Contact).

 

Contact

For any questions you may have with respect to data privacy, please write an e-mail to (bjoern.malinka AT bayer.com) or contact our company data protection officer at the following address: 

Bjoern Malinka
Bayer AG
Kaiser-Wilhelm-Allee 1
51368 Leverkusen

 

Amendment of Privacy Statement

We may update our Privacy Statement from time to time. Updates of our Privacy Statement will be published on our Website. Any amendments become effective upon publication on our Website. We therefore recommend that you regularly visit the site to keep yourself informed on possible updates.

Indication

Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

Important Safety Information

Warnings and Precautions:
  • Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression–notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia–has been reported in patients treated with Xofigo.

    Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure

 

  • Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be ≥1.5 × 109/L, the platelet count ≥100 × 109/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 109/L and the platelet count ≥50 × 109/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care

 

  • Concomitant Use With Chemotherapy: Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued

 

  • Increased Fractures and Mortality in Combination With Abiraterone Plus Prednisone/Prednisolone: Xofigo is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials. At the primary analysis of the phase 3 ERA-223 study that evaluated concurrent initiation of Xofigo in combination with abiraterone acetate plus prednisone/prednisolone in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received Xofigo in combination with abiraterone acetate plus prednisone/prednisolone compared to patients who received placebo in combination with abiraterone acetate plus prednisone/prednisolone. Safety and efficacy with the combination of Xofigo and agents other than gonadotropin-releasing hormone analogues have not been established

 

  • Embryo-Fetal Toxicity: The safety and efficacy of Xofigo have not been established in females. Xofigo can cause fetal harm when administered to a pregnant female. Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with Xofigo

 

Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations

Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients’ oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia

Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo

Secondary Malignant Neoplasms: Xofigo contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223 dichloride, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow-up for patients on the trial

Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the Xofigo group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy

Adverse Reactions: The most common adverse reactions (≥10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%)

For important risk and use information about Xofigo, please see the Full Prescribing Information.

You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. For Bayer products, you can report these directly to Bayer by clicking here.

© 2022 Bayer. All rights reserved. June 2022

Bayer, the Bayer Cross, Xofigo, and the Xofigo Access Services logo are registered trademarks of Bayer.

Site Last Modified: 06/22

THIS SITE IS FOR US AUDIENCES ONLY.