Starting Adempas^®

What is Adempas^®?

Adempas^® is a distinct class of oral treatment for PH that directly stimulates sGC independently of nitric oxide.^1,2 A wide range of patients with PH can now - due to the specific mechanism of action of Adempas^® – achieve more of their everyday activities.^1-5 For adult patients with inoperable CTEPH, or persistent or recurrent CTEPH after surgical treatment, or for patients with PAH, Adempas^® is a potential pharmacologic treatment option having demonstrated rapid and sustained significant efficacy in these indications.^3,4,6,7

Why is stimulation of sGC important?

In patients with PH, sGC is under-stimulated due to endothelial dysfunction in the pulmonary arteries and the resultant decrease in endogenous nitric oxide.^5,8-10 Patients with CTEPH and PAH are often nitric oxide deficient and this is associated with a poor prognosis.^9,10

For patients with CTEPH and PAH, sGC stimulation is fundamental for treatment success; it helps to relieve many of the debilitating symptoms through the regulation of vascular tone, cell proliferation and inflammation.⁸

Adempas^® works independently of nitric oxide and directly stimulates sGC, helping a wide range of patients with PH achieve everyday activities.^1-5 Moreover, Adempas^® improves symptoms without being associated with liver toxicity and after an initial titration phase does not require long-term monitoring.¹

Who is Adempas^® for?

Adempas^® is the first and only approved pharmacologic treatment for more than one type of PH – inoperable, persistent or recurrent CTEPH and PAH.¹

Adempas^® is indicated for the treatment of adult patients with inoperable CTEPH, or persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity.¹

Adempas^®, as monotherapy or in combination with ERAs or prostanoids, is indicated for the treatment of adult patients with PAH to improve exercise capacity.¹

With Adempas^®, patients with CTEPH have a pharmacologic treatment that may redefine their everyday possibilities.¹ In addition, a wide range of patients with PAH can now achieve rapid and sustained improvement across a broad range of endpoints using Adempas^®.^1,3,4,6,7

How should Adempas^® be taken

Patients prescribed Adempas^® take it orally as a tablet three times daily (TID). Each tablet should be taken approximately 6-8 hours apart with or without food. Adempas^® is available in the following tablets¹:

Adempas<sup>®</sup> Dosing - How should Adempas<sup>®</sup> be taken

diagram of Adempas^® tablets with blister pack colors

Your patients with PH are unique. Consequently, Adempas^® is tailored at the start of treatment to find the optimum dose for them. The starting dose of Adempas^® is 1 mg TID or 0.5 mg TID, depending upon your country label. Just at the start of Adempas^® treatment, patients undergo a titration phase. For the first eight weeks only (ten weeks if the starting dose is 0.5 mg TID) patients should be assessed every two weeks for any signs or symptoms of hypotension, or any other potential treatment-related side effects.¹

Depending upon the findings of each assessment, a patient’s dose of Adempas^® can be increased by 0.5 mg TID, maintained at the current dose, or decreased by 0.5 mg TID. This means that during the titration phase patients can be receiving Adempas^® dosages of 0.5 mg, 1 mg, 1.5 mg, 2 mg or the maximum dose of 2.5 mg TID.¹

After the eight week titration phase, you will have helped your patient reach their maintenance Adempas^® dose, which is then continued indefinitely. If the patient’s need changes then you can still adjust this maintenance dose according to your clinical judgment and discussion with your patient.

Remember, there is no ‘right’ Adempas^® dose, just the dose that is right for each of your patients. For information on the dosage of Adempas^®, please check your local prescribing information.

Safety and tolerability

Adempas^® is well tolerated over both the short and long-term.^1,3,4,6,7 The safety profile of Adempas^® has been examined robustly in two large-scale international Phase III trials, in which a total of 704 patients received at least one dose of Adempas^®.^3,4,6,7 The safety profile was similar for patients with CTEPH or PAH.^3,4 Patient discontinuation with Adempas^® due to treatment-related adverse events was low (< 3%) and similar to placebo.^1,3,4

Reported treatment-related side-effects were mostly mild or moderate. The most common treatment-related adverse effects are: headache, dizziness, dyspepsia, peripheral edema, nausea, diarrhea and vomiting.¹ The long-term open label extension studies (CHEST-2 and PATENT-2) showed that Adempas^® was well-tolerated with a safety profile similar to that at the end of the CHEST-1 and PATENT-1 studies. No new long-term safety signals were observed for Adempas^® after two years of treatment.^6,7

Note that Adempas^® is contraindicated during pregnancy, in patients on PDE5 inhibitors, on nitrates or nitric oxide donors, and in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP).¹

How it works

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Videos

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References

Adempas® Expanded Company Core Data Sheet, Version 2, September 2013. Return to content
Grimminger F et al. Eur Respir J 2009; 33:785–792. Return to content
Ghofrani HA et al. New Engl J Med 2013; 369: 330-40. Return to content
Ghofrani HA et al. New Engl J Med 2013; 369: 319-29. Return to content
Ghofrani HA et al. Future Cardiol 2010; 6:155-66. Return to content
155-66. 6. Ghofrani HA et al. Lancet Respir Med. 2016; 4: 361-71. Return to content
Simonneau G, et al. Lancet Respir Med 2016; 4: 372–80. Return to content
Stasch J-P et al. Circulation 2011; 123: 2263-73. Return to content
Kielstein JT et al. Arterioscler Thromb Vasc Biol 2005; 25: 1414-18. Return to content
Skoro-sajer N et al. Am J Respir Crit Care Med 2007; 176: 1154-60. Return to content

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

Starting Adempas®

What is Adempas®?