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What is PAH
(WHO Group 1)?

Pulmonary arterial hypertension

Pulmonary arterial hypertension (PAH) (WHO Group 1) is a type of high blood pressure in the arteries (blood vessels) of your lungs.

Adempas is approved to treat adults with PAH (WHO Group 1). The Adempas clinical studies included mostly patients with WHO functional class II-III symptoms. It is not known if Adempas is safe and effective in children.

WHO=World Health Organization

NORMAL BLOOD VESSELS VS PAH BLOOD VESSELS

PAH is the name of the condition that causes high blood pressure in the blood vessels of your lungs.

PAH is caused when the openings in these blood vessels shrink or become blocked due to the walls of the arteries tightening or becoming stiff and narrow from an overgrowth of cells.

How does this condition affect you?

Smaller openings or blockages in blood vessels make it more difficult for blood to get to the lungs. Because of this increased pressure, the heart has to pump harder and harder.

Over time, increased pressure in blood vessels can cause the right side of the heart to get bigger and weaker. When the right side of the heart is weakened, it has a harder time pumping enough blood and oxygen to the left side of the heart and the rest of the body.

Normal blood vessel

What does PAH feel like?

 

During the beginning stages of PAH, you might not feel like anything is wrong because not everybody experiences all of the symptoms shown below. However, as with many diseases, you might begin to experience a depressed mood, low self-esteem, frustration, anxiety, or worry as part of your condition.

SOME PAH SYMPTOMS YOU MIGHT EXPERIENCE*

Shortness of breath with exercise

Shortness of breath with exercise

Fainting or feeling tired or dizzy

Fainting or feeling tired or dizzy

Swelling in the ankles, arms, or stomach area

Swelling in the ankles, arms, or stomach area

Chest pain

Chest pain

*Adempas will not help with all of these symptoms.

Diagnosis and treatment of PAH

How is PAH diagnosed?

Some of the tests used to diagnose PAH are echocardiography (images produced by sound waves bounced off the heart and lungs) and right-heart catheterization (a tube inserted in the pulmonary artery that measures blood pressure).

Can PAH be treated?

The increased pressure in the pulmonary arteries strains the right side of the heart and it begins to fail. There is no cure for PAH, but several medications are available to help slow the progression of changes in the pulmonary arteries and help reduce symptoms. However, even with medication, about half of patients are still in WHO functional class III.

To treat your PAH (WHO Group 1), your doctor may give you Adempas. Adempas is a prescription medicine used to treat adults with PAH (WHO Group 1). The Adempas clinical studies included mostly patients with WHO functional class II-III symptoms.

Can PAH become more serious?

As PAH progresses, symptoms get worse. The WHO developed a scale for doctors to rate the severity of PAH symptoms. Your doctor will determine which WHO functional class you belong to. A lower class number (I or II) means that you have less severe symptoms. Identifying your WHO functional class is one of the ways your doctor determines an appropriate course of treatment for you.

WHO functional classes of PAH

Class I

Patients have no limitation of usual physical activity.

Class II

Patients have mild limitation of usual physical activity.
Patients are comfortable at rest.

Class III

Patients have severe limitation of usual physical activity.
Patients are comfortable at rest.

Class IV

Patients are unable to carry out any physical activity without symptoms.

Questions about PAH? Learn more in the FAQ section
 

Questions about PAH?

Learn more in the FAQ section here.

 
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 .

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Site Last Modified: 10/2021

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