Adempas 1 mg film-coated tablets
Each film-coated tablet contains 1 mg of riociguat.
Excipients with known effect:
Each film-coated tablet contains 37.2 mg lactose (as monohydrate), see section 4.4.
For the full list of excipients, see section 6.1.
Film-coated tablet.
Pale yellow, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 1 and an “R” on the other side.
Chronic thromboembolic pulmonary hypertension (CTEPH)
Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with
• inoperable CTEPH,
• persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity (see section 5.1).
Pulmonary arterial hypertension (PAH)
Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity.
Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease (see section 5.1).
Treatment should only be initiated and monitored by a physician experienced in the treatment of CTEPH or PAH.
Posology
Dose titration
The recommended starting dose is 1 mg three times daily for 2 weeks. Tablets should be taken three times daily approximately 6 to 8 hours apart (see section 5.2).
Dose should be increased by 0.5 mg three times daily every two weeks to a maximum of 2.5 mg three times daily, if systolic blood pressure is ≥95 mmHg and the patient has no signs or symptoms of hypotension. In some PAH patients, an adequate response on the 6-minute walk distance (6MWD) may be reached at a dose of 1.5 mg three times a day (see section 5.1). If systolic blood pressure falls below 95 mmHg, the dose should be maintained provided the patient does not show any signs or symptoms of hypotension. If at any time during the up-titration phase systolic blood pressure decreases below 95 mmHg and the patient shows signs or symptoms of hypotension the current dose should be decreased by 0.5 mg three times daily.
Maintenance dose
The established individual dose should be maintained unless signs and symptoms of hypotension occur. The maximum total daily dose is 7.5 mg i.e., 2.5 mg 3 times daily. If a dose is missed, treatment should be continued with the next dose as planned.
If not tolerated, dose reduction should be considered at any time.
Food
Tablets can generally be taken with or without food. For patients prone to hypotension, as a precautionary measure, switches between fed and fasted Adempas intake are not recommended because of increased peak plasma levels of riociguat in the fasting compared to the fed state (see section 5.2).
Treatment discontinuation
In case treatment has to be interrupted for 3 days or more, restart treatment at 1 mg three times daily for 2 weeks, and continue treatment with the dose titration regimen as described above.
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