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  • US Name:

    Adempas

  • Israeli Names:

    Adempas

  • Active Ingredients:

    Riociguat

  • Brand Manufacturer:

    Bayer

  • Manufacturer Location:

    Germany

  • Click here to view Product Insert

Adempas

Adempas is prescribed to treat high blood pressure in the lungs, known as pulmonary hypertension. It works to relax and widen the blood vessels in the lungs so that blood can flow more easily. It may also be prescribed to treat another type of high blood pressure in the lungs caused by blood clots, when surgery is not an option.

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Adempas (generic name: riociguat) is prescribed to treat adults who are diagnosed with pulmonary arterial hypertension (PAH). It is also prescribed for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who have either been treated surgically but who still have persistent high pulmonary blood pressure, or who are inoperable.

Adempas is a member of the drug class known as soluble guanylate cyclase (sGC) stimulators that are intended to keep blood vessels dilated. sGC is a naturally-occurring chemical that interacts with nitric oxide (NO). Adempas stimulates sGC to boost the level of interactions with NO. This has the effect of assisting blood flow through the lung’s blood vessels.

By lowering blood pressure, Adempas can improve the ability to exercise (measured by a standard 6-minute walk), reduce some of the symptoms, and help to slow down any progression in the deterioration of physical conditions.

Adempas can cause serious side effects including:

  • Serious birth defects
  • Reduced blood pressure – causing symptoms like lightheadedness, chest pain, and dizziness especially in people who are dehydrated
  • Increase the risk of bleeding, including from the respiratory tract. Consult with the  doctor immediately if you cough up blood during treatment
  • Worsening of symptoms if you have Pulmonary Veno-Occlusive Disease (PVOD). Adempas may cause pulmonary edema which may result in shortness of breath. You may be told to stop taking Adempas or to switch to a different medicine.

In any such case, consult immediately with the prescribing physician or your pharmacist.

The most common mild side effects are:

  • Headaches
  • Dizziness
  • Indigestion
  • Peripheral edema (swelling of the hands, legs, feet, and ankles)
  • Nausea
  • Diarrhea
  • Vomiting

If these side effects persist or get worse, talk to your doctor or pharmacist.

NOTE

Adempas can cause serious birth defects if taken during a pregnancy. Females must not be pregnant when they start taking Adempas, nor become pregnant during treatment without first discussing this with the prescribing physician. In cases where it is decided to prescribe Adempas when the patient is able to get pregnant, there should be two acceptable forms of birth control (or a progesterone implant, or an intrauterine device) during the treatment period, and for one month after stopping.

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.

Make sure your prescribing doctor and dispensing pharmacist have a complete list of all your current medications. Your doctor should not prescribe Adempas if you are taking another medicine containing an sGC or a different nitrate medicine to treat high blood pressure or heart disease, such as nitroglycerin, or any medicine called a nitric oxide donor, such as amyl nitrite. Drugs that contain sildenafil (Revatio or Viagra), tadalafil (Adcirca or Cialis), vardenafil (Levitra or Staxyn), dipyridamole, or theophylline cannot be taken alongside Adempas. 

Talk to your doctor or pharmacist if you think they are not aware that you take any of the medicines listed above.

Adempas may result in dizziness. Don’t drive, operate machinery, or do other activities that require mental alertness or coordination until you know how Adempas affects you. Talk with the pharmacist or your doctor if you are concerned about whether it is safe for you to do these activities.

Adempas may be affected if you smoke during treatment. If you stop smoking or start smoking during treatment, tell your doctor because your dose may need to be changed.

Adempas is prescribed to treat adults with a type of high blood pressure in the arteries of the lungs known as pulmonary arterial hypertension (PAH), or those who suffer from chronic thromboembolic pulmonary hypertension (CTEPH) who, after treatment with surgery, still have persistent or recurrent high pulmonary blood pressure, or patients with CTEPH who cannot be treated with surgery.

Why is Adempas prescribed?

Pulmonary arterial hypertension (PAH) is a condition that is caused when openings in the blood vessels in the lungs shrink or become blocked due to the walls of the arteries tightening and becoming rigid or narrowing from an overgrowth of the cells lining them. This makes it more difficult for blood to reach the lungs, requiring the heart to pump harder. 

Over time, the increased pressure could result in the muscles of the right side of the heart to get weaker and the chambers to expand, resulting in a fall in blood and oxygen to the left side of the heart. PAH is diagnosed through echocardiography (images produced by sound waves bounced off the heart and lungs) and catheterization (measurement of blood pressure directly in the heart through a tube inserted in the pulmonary artery.)

There is no cure for PAH, but Adempas helps slow the progression of weakening in the pulmonary arteries and so reduce symptoms. 

Chronic thromboembolic pulmonary hypertension (CTEPH) is a type of high blood pressure in the arteries of the lungs resulting from blood clots that narrowed the paths or blocked blood flow.

When left untreated, patients with CTEPH have a very short life expectancy, and where indicated a surgical procedure called pulmonary thromboendarterectomy (PTE) is able to significantly improve the quality of life. In cases where a patient was treated with surgery but has persistent or recurrent CTEPH, and for patients who cannot be treated with surgery, Adempas is approved as a first-line treatment.

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