Active Ingredient: Selexipag
Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.
Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
400 - 3,200 ug
From 200 To 1,600 ug 2 time(s) per day every day
400 ug
Each patient should be up-titrated to the highest individually tolerated dose, which can range from 200 micrograms given twice daily to 1,600 micrograms given twice daily (individualised maintenance dose).
The recommended starting dose is 200 micrograms given twice daily, approximately 12 hours apart. The dose is increased in increments of 200 micrograms given twice daily, usually at weekly intervals. At the beginning of treatment and at each up-titration step it is recommended to take the first dose in the evening. During dose titration some adverse reactions, reflecting the mode of action of selexipag (such as headache, diarrhoea, nausea and vomiting, jaw pain, myalgia, pain in extremity, arthralgia, and flushing), may occur. They are usually transient or manageable with symptomatic treatment. However, if a patient reaches a dose that cannot be tolerated, the dose should be reduced to the previous dose level.
In patients in whom up-titration was limited by reasons other than adverse reactions reflecting the mode of action of selexipag, a second attempt to continue up-titration to the highest individually tolerated dose up to a maximum dose of 1,600 micrograms twice daily may be considered.
The highest tolerated dose reached during dose titration should be maintained. If the therapy over time is less tolerated at a given dose, symptomatic treatment and/or a dose reduction to the next lower dose should be considered.
If a dose is missed, it should be taken as soon as possible. The missed dose should not be taken if the next scheduled dose is within approximately 6 hours.
If treatment is missed for 3 days or more, selexipag should be restarted at a lower dose and then up-titrated.
There is limited experience with abrupt discontinuation of selexipag in patients with PAH. No evidence for acute rebound has been observed.
However, if the decision to withdraw selexipag is taken, it should be done gradually while an alternative therapy is introduced.
When co-administered with moderate CYP2C8 inhibitors (e.g., clopidogrel, deferasirox and teriflunomide), reduce the dosing of selexipag to once daily . If the therapy is not tolerated at a given dose, symptomatic treatment and/or a dose reduction to the next lower dose should be considered. Revert to twice daily dosing frequency of selexipag when co-administration of moderate CYP2C8 inhibitor is stopped.
It is to be taken orally in the morning and in the evening. To improve tolerability, it is recommended to take selexipag with food and, at the beginning of each up-titration phase, to take the first increased dose in the evening.
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