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Pulmonary arterial hypertension (PAH) Clinical criteria: Treatment Phase: Initial treatment following dose titration Patient must have WHO Functional Class III PAH at treatment initiation with this drug; OR Patient must have WHO Functional Class IV PAH at treatment initiation with this drug, AND The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'), AND Patient must have completed the dose titration phase, AND The treatment must not be as monotherapy. Treatment criteria: Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. Population criteria: Patient must have had at least one PBS-subsidised PAH agent prior to this authority application. Select one appropriate strength (determined under the 'Initial treatment - dose titration' phase) and apply under this treatment phase (Initial treatment following dose titration) once only. Should future dose adjustments be required, apply under the 'Continuing treatment' restriction. A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat. For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil. PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. PAH (WHO Group 1 pulmonary hypertension) is defined as follows: (i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or (ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“Selexipag is an oral, selective, IP prostacyclin receptor agonist, and is structurally and pharmacologically distinct from prostacyclin and its analogues.”
“Elimination of selexipag is predominantly via metabolism with a mean terminal half-life of 0.8-2.5 h. The active metabolite has a half-life of 6.2-13.5h.”
“Selexipag and its active metabolite both undergo oxidative metabolism mainly by CYP2C8 and to a smaller extent CYP3A4.”
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