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:
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
- 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