Active Ingredient: Riociguat
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.
Adempas is indicated for the treatment of PAH in paediatric patients aged less than 18 years of age and body weight ≥50 kg with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 1 milligrams riociguat, 3 times daily, over the duration of 2 weeks. Afterwards, oral, between 1 milligrams riociguat and 2.5 milligrams riociguat, 3 times daily.
The recommended starting dose is 1 mg 3 times daily for 2 weeks. Doses should be taken 3 times daily approximately 6 to 8 hours apart.
Dose should be increased by 0.5 mg 3 times daily every two weeks to a maximum of 2.5 mg 3 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 3 times a day. 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 3 times daily.
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) for adults patients.
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.
In case treatment has to be interrupted for 3 days or more, treatment should be restarted with 1 mg 3 times daily for 2 weeks and continued with the dose titration regimen as described above.
Sildenafil must be discontinued in adults at least 24 hours prior to administration of riociguat.
Tadalafil must be discontinued at least 48 hours in adults prior to administration of riociguat.
Riociguat must be discontinued in adults at least 24 hours prior to administration of a PDE5 inhibitor.
It is recommended to monitor for signs and symptoms of hypotension after any transition.
For patients prone to hypotension, as a precautionary measure, switches between fed and fasted riociguat intake are not recommended because of increased peak plasma levels of riociguat in the fasting compared to the fed state.
For:
In case that patient weight is ≥ 50 kg, oral, 1 milligrams riociguat, 3 times daily, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 50 kg, oral, between 1 milligrams riociguat and 2.5 milligrams riociguat, 3 times daily. The maximum allowed total dose is 7.5 milligrams riociguat daily.
The recommended starting dose is 1 mg 3 times daily for 2 weeks. Doses should be taken 3 times daily approximately 6 to 8 hours apart.
Titration of riociguat dose is to be performed based on the patient’s systolic blood pressure and general tolerability at the discretion of the treating physician/healthcare provider. If systolic blood pressure is ≥90 mmHg for the 6 to <12 years age group or ≥95 mmHg for the 12 to <18 years age group and the patient has no signs or symptoms of hypotension, the dosage should be increased by 0.5 mg every 2 weeks to a maximum dose of 2.5 mg 3 times daily.
If systolic blood pressure falls below these specified levels the dosage 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 the specified levels, or the patient shows signs and symptoms of hypotension the current dose should be decreased by 0.5 mg 3 times daily.
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) for paediatric patients with body weight of at least 50 kg.
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.
In case treatment has to be interrupted for 3 days or more, treatment should be restarted with 1 mg 3 times daily for 2 weeks and continued with the dose titration regimen as described above.
Sildenafil must be discontinued in children at least 24 hours prior to administration of riociguat.
Tadalafil must be discontinued at least 72 hours in children prior to administration of riociguat.
Riociguat must be discontinued in children at least 24 hours prior to administration of a PDE5 inhibitor.
It is recommended to monitor for signs and symptoms of hypotension after any transition.
For patients prone to hypotension, as a precautionary measure, switches between fed and fasted riociguat intake are not recommended because of increased peak plasma levels of riociguat in the fasting compared to the fed state.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.