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).

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. 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 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.

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 or contact our company data protection officer at the following address:

Group Data Protection Officer
Bayer AG
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.

MORE IMPORTANT SAFETY INFORMATION

Important Safety Information and Indications

Adempas can cause serious birth defects if taken during pregnancy.

Females must not be pregnant when they start taking Adempas (riociguat) tablets or become pregnant during treatment with Adempas.
Females who are able to get pregnant must have a negative pregnancy test before beginning treatment with Adempas, each month during treatment, and 1 month after you stop treatment with Adempas. Talk to your doctor about your menstrual cycle. Your doctor will decide when to do the test.
- Females who are able to get pregnant are females who:
  - Have entered puberty, even if they have not started their period, have a uterus, and have not gone through menopause (have not had a period for at least 12 months for natural reasons, or have had their ovaries removed).
- Females who are not able to get pregnant are females who:
  - Have not yet entered puberty, do not have a uterus, or have gone through menopause.

Females who are able to get pregnant must use two acceptable forms of birth control, during Adempas treatment and for one month after stopping Adempas.

If you have had a tubal sterilization, have a progesterone implant, or have an IUD (intrauterine device), these methods can be used alone and no other form of birth control is needed.
Talk with your doctor or gynecologist (a doctor who specializes in female reproduction) to find out how to prevent pregnancy during treatment with Adempas.
- Do not have unprotected sex. Talk to your doctor or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your doctor may tell you to use emergency birth control.
- Tell your doctor right away if you miss a menstrual period or think you may be pregnant for any reason.

If you are the parent or caregiver of a female child who started taking Adempas before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. Tell your doctor right away if you notice that she is developing breast buds or any pubic hair. Your doctor should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period.

Females can only receive Adempas through a restricted program called the Adempas Risk Evaluation and Mitigation Strategies (REMS) program. If you are a female who can become pregnant, you must talk to your doctor, understand the benefits and risks of Adempas, and agree to all of the instructions in the Adempas REMS program. Males can receive Adempas without taking part in the Adempas REMS program.

Do not take Adempas if:

you are pregnant, plan to become pregnant, or become pregnant during treatment with Adempas. Adempas can cause serious birth defects.
you take:
- another medicine called a soluble guanylate cyclase stimulator (sGC). Ask your healthcare provider if you are not sure if you are taking an sGC medicine
- a nitrate medicine to treat high blood pressure or heart disease, such as nitroglycerin, or a medicine called a nitric oxide donor, such as amyl nitrite
- certain other medicines that contain sildenafil (Revatio or Viagra), tadalafil (Adcirca or Cialis), vardenafil (Levitra or Staxyn), dipyridamole, or theophylline. Revatio and Adcirca are also used to treat PAH
you have pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP).

Ask your doctor or pharmacist if you are not sure if you take any of the medicines listed above.

Before you take Adempas, tell your doctor if you:

smoke; have recently had serious bleeding from your lungs, or if you have had a medical procedure called bronchial arterial embolization to stop you from coughing up blood; have problems with your heart or blood circulation; have low blood pressure; have liver problems; have kidney problems or are on dialysis; have narrowing of the pulmonary veins, a condition called pulmonary veno-occlusive disease or PVOD; have any other medical conditions.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Adempas and other medicines may affect each other causing side effects. Do not start any new medicine until you check with your doctor.

What should I avoid while taking Adempas?

Do not get pregnant while taking Adempas. If you miss a menstrual period, or think you might be pregnant, call your doctor right away.
It is not known if Adempas passes into your breast milk. You should not breastfeed if you take Adempas. Talk to your doctor about the best way to feed your baby if you take Adempas.
Adempas may make you feel dizzy. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how Adempas affects you. Talk with your doctor if you are concerned about when it is safe for you to do these activities.
Smoking. Adempas may not work as well if you smoke during treatment. Tell your doctor if you stop smoking or start smoking during treatment with Adempas, because your dose of Adempas may need to be changed.

Adempas can cause serious side effects including:

Serious birth defects.
Reduced blood pressure. This may cause symptoms of low blood pressure, such as lightheadedness, chest pain, and dizziness especially in people who are dehydrated, have a severe blockage of blood flow out of the heart, or have certain other medical problems. Your doctor will check you for any of these problems.
Increased risk of bleeding, including bleeding from the respiratory tract. Tell your doctor right away if you cough up blood during treatment with Adempas.
Worsening of symptoms in people with Pulmonary Veno-Occlusive Disease (PVOD). If you have PVOD, treatment with Adempas may cause a build-up of fluid in your lungs (pulmonary edema) which may result in shortness of breath. Your doctor may tell you to stop taking Adempas and switch you to a different medicine.

The most common side effects of Adempas are:

Headache; dizziness; indigestion; swelling of your hands, legs, feet, and ankles (peripheral edema); nausea; diarrhea; and vomiting

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Adempas.

Indications

Adempas is a prescription medicine used to treat adults with:

chronic thromboembolic pulmonary hypertension (CTEPH) (WHO Group 4) treated with surgery but who continue to have high pulmonary blood pressure (persistent) or it comes back after surgery (recurrent), or that cannot be treated with surgery.
- CTEPH is a type of high blood pressure in the arteries of your lungs caused by blood clots that narrow or block blood flow. Adempas can improve your ability to exercise (measured by 6-minute walk distance) and can help to improve some of your symptoms.
pulmonary arterial hypertension (PAH) (WHO Group 1)
- PAH is a type of high blood pressure in the arteries of your lungs. Adempas can improve your ability to exercise (measured by 6-minute walk distance), improve some of your symptoms, and help slow down the worsening of your physical condition [this includes death, heart/lung transplant, a surgery to reduce pressure in your lung, hospitalization for worsening of pulmonary hypertension, start of a new PAH-specific treatment, continued decline in your ability to exercise (measured by a 6-minute walk distance) and some of your symptoms].

The Adempas clinical studies included mostly patients with WHO functional class II-III symptoms. It is unknown if Adempas is safe and effective in children.

For important risk and use information please see the full Prescribing Information , including Boxed Warning and Medication Guide .

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.

BAYER, the Bayer Cross, Adempas, and Aim are registered trademarks of Bayer.

All other trademarks are property of their respective owners. These trademark owners are not affiliated with Bayer and do not sponsor or endorse Bayer or this product.

Site Last Modified: 10/2021