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How Adempas® works          

Adempas® – an sGC stimulator

A wide range of patients with PH can achieve everyday activities due to Adempas® and its direct stimulation of sGC independently of nitric oxide.1, 2 Adempas® is a distinct class of oral treatment. Adempas® demonstrates rapid, sustained and significant improvements in patients with inoperable, persistent or recurrent CTEPH, as well as PAH.3-6

Two large, international Phase III trials, CHEST-1 and PATENT-1, demonstrated the efficacy and tolerability of Adempas® in treating patients with inoperable, persistent or recurrent CTEPH or PAH, respectively.3,4 Patients with CTEPH or PAH, achieved rapid and sustained improvements across a broad range of clinically-important endpoints, enabling patients to achieve more everyday activities:1,3-6

  • Exercise capacity (as measured by improvement in six minute walk distance compared with placebo; the primary endpoint of both CHEST-1 and PATENT-1)

  • Overall disease severity (as measured by improvement in WHO functional class)

  • Cardiac output

  • Heart and lung function (as measured by NT-pro BNP, PVR and PAP)

  • Reduced breathlessness (as measured by improvements in Borg dyspnea score)

  • Time to clinical worsening (in PATENT-1)

The two-year extension studies, CHEST-2 and PATENT-2, showed that the benefits of Adempas® were sustained long-term.5,6 In patients with CTEPH or PAH, exercise capacity (as measured by 6MWD) and overall disease severity (as measured by WHO functional class) was either improved or sustained at two years.5,6 Additionally, Adempas® was well-tolerated by patients over the long-term with no new safety signals.5,6

Moreover, for patients with CTEPH or PAH, a total of 82% and 79%, respectively, of patients remained free from long-term clinical worsening and 93% remained alive after two years of treatment with Adempas®.5,6

Adempas® addresses areas of high unmet medical need

With Adempas®, patients with inoperable CTEPH, or persistent or recurrent CTEPH after surgical treatment, have a pharmacologic treatment that can improve their everyday possibilities.3,6 A wide range of patients with PAH, including treatment-naïve and pre-treated patients, can achieve rapid and sustained improvement across a broad range of endpoints using Adempas®.4,5 Adempas® is the first oral treatment to show significant and sustained efficacy as monotherapy or as part of a combination regimen with ERAs or prostanoids in patients with PAH.4, 7-11

Addressing different forms of PH underscores Bayer’s commitment to understanding this severe and life-threatening condition and help to improve the lives of people with PH.

 

Pulmonary hypertension

PH is a severe, progressive and life-threatening condition in which the pressure in the pulmonary arteries is significantly increased due to various mechanisms.12 It is defined as an elevated mean pulmonary arterial pressure of ≥ 25mmHg at rest.13

There are 5 main types of PH, all associated with a reduction in exercise capacity, increased arterial pressure and premature death.9,10

In PH, pulmonary vascular injury causes endothelial dysfunction and vascular remodeling through proliferation and hypertrophy of endothelial smooth muscle cells. This endothelial dysfunction causes vasoconstriction, inflammation and thrombosis which, in turn, results in the progressive increase in pulmonary vascular disease.14,15

 

In healthy individuals, nitric oxide plays a key role in blood vessel regulation

Endogenous nitric oxide, produced by the endothelial cells of blood vessels, is one of the factors that helps regulate vascular tone, proliferation and inflammation.16,17

Nitric oxide binds to, and stimulates, sGC, a key enzyme that enhances the synthesis of a signaling molecule, cGMP. cGMP, in turn, has the following physiologic effects:17

  • induces vasorelaxation

  • inhibits smooth muscle proliferation, leukocyte recruitment and platelet aggregation

Together, these form the NO-sGC-cGMP pathway.16

Adempas<sup>®</sup> nitric oxide key role in blood vessel regulation - cGMP

 

Endothelial dysfunction associated with PH results in nitric oxide deficiency

Low levels of endogenous nitric oxide results in under-stimulation of sGC, which in turn causes decreased cGMP generation.14,17 Without cGMP, arterial walls tighten and thicken, and fibrosis, platelet aggregation, cell proliferation and inflammation occur.17

Patients with CTEPH or PAH are often nitric oxide deficient and this is associated with a poor prognosis.18,19

 

Adempas® directly stimulates sGC independently of nitric oxide and can restore the NO-sGC-cGMP pathway

Adempas® binds to and directly stimulates sGC independently of nitric oxide.1,2 Adempas® also facilitates the binding of any remaining endogenous nitric oxide to sGC in patients with inoperable, persistent or recurrent CTEPH or PAH.2

This may explain why Adempas® has such broad efficacy in terms of more than one type of PH and multiple clinical endpoints.

Adempas<sup>®</sup> restores NO-sGC-cGMP pathway and decreases endothelial dysfunction

 

Watch the video to see how Adempas® works

Starting Adempas®

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References

 
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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