Conditions of Use

General Conditions of use

Access to and use of this website are subject to the following conditions. Please do not use this website unless you agree with these conditions. This website has been developed by the Bayer AG, Pharmaceuticals, Business Unit General Medicine (hereinafter referred to as BAYER) and is administrated by the same. We reserve the right to discontinue or to make partial or complete modifications to this website or to the General Conditions of Use, to our General Terms and Conditions, and to our Conditions of Sale and Delivery. Please note that we may make such changes at our own discretion and without prior announcement. We must therefore ask you, next time you visit this website, to view the conditions again and to note any changes or amendments that may have been made.

Surrender of use and benefit

All details, documents and illustrations published on this website are the sole property of BAYER. Any permission to use the same is granted on the proviso that the relevant copyright note is displayed on all copies, that such details are only used for personal purposes, that they are not exploited commercially, that the details are not modified in any way and that all illustrations gained from the website are only used in conjunction with the accompanying text.

Trademarks and Copyright

All trademarks on this website are the property of the Bayer Group, unless otherwise noted or in any other way perceivable as third party rights. Any unauthorized use of these trademarks or other materials is expressly prohibited and constitutes a violation of copyright, trademark law or other industrial property rights.

Limited Liability

BAYER has compiled the detailed information provided on this website from internal and external sources to the best of its knowledge and belief, using professional diligence. We endeavor to expand and update this range of information on an ongoing basis. The information on this website is purely for the purpose of presenting BAYER and its products and services. However, no representation is made or warranty given, either expressly or tacitly, for the completeness or correctness of the information on this website. Please be aware that this information although accurate on the day it was published may no longer be up to date. We therefore recommend that you check any information you obtain from this website prior to using it in whatever form. Advice given on this website does not exempt you from conducting your own checks on our latest advice - particularly our safety datasheets and technical specifications - and on our products, with a view to their suitability for the intended processes and purposes. Should you require any advice or instructions concerning our products or services, please contact us directly. Users of this website declare that they agree to access the website and its content at their own risk. Neither BAYER nor third parties involved in the writing, production or transmission of this website can be held liable for damage or injury resulting from access or the impossibility of access or from the use or impossibility of use of this website or from the fact that you have relied on information given on this website.

Websites of third-party vendors/links

This website contains links/references to third-party websites. By providing such links, BAYER does not give its approval to their contents. Neither does BAYER accept any responsibility for the availability or the contents of such websites or any liability for damage or injury resulting from the use of such contents, of whatever form. BAYER offers no guarantee that pages linked to provide information of consistent quality. Links to other websites are provided to website users merely for the sake of convenience. Users access such websites at their own risk. The choice of links should in no way restrict users to the linked pages.

Details supplied by yourself

The user of this website is fully responsible for the content and correctness of details he or she sends to BAYER as well as for the non-violation of any third-party rights that may be involved in such details. The user gives his or her consent for BAYER to store such details and to use the same for the purpose of statistical analysis or for any other specified business purpose, unless the information involves personal details, going beyond master data or usage data as defined in sections 14 and 15 of the German Tele Media Act (Telemediengesetz). In particular, BAYER is entitled to use the contents of such messages, including ideas, inventions, blueprints, techniques and expertise contained therein, for any purpose, such as the development, production and/or marketing of products or services and to reproduce such information and make it available to third parties without any limitations.

International users

This website is checked, operated and updated by BAYER at Berlin, Germany. It is intended for international use in places outside the US and Great Britain. BAYER gives no guarantee that the details presented on this website are also correct worldwide. Should you call up this website download contents, please note that it is your own responsibility to ensure that you act in compliance with local legislation applicable in that place.

Products mentioned on this website may come in different packaging, in different package sizes, or with different lettering or markings, depending on the country.

Applicable law

Any legal claims or lawsuits in conjunction with this website or its use are subject to the interpretation of the laws of the Federal Republic of Germany, except for the provisions of international private law and the Hague Convention relating to a Uniform Law on the International Sale of Goods of July 1, 1964 and in the UN Sales Convention of April 11, 1980.

Forward-Looking Statements

This website may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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