Active Ingredient: Treprostinil
Treprostinil is indicated for the treatment of adult patients with WHO Functional Class (FC) III or IV and:
to improve exercise capacity.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
1.25 - 54 ug
From 1.25 To 54 ug once every day
1.25 ug
The recommended initial infusion rate is 1.25 ng/kg/min. If this initial dose is poorly tolerated, the infusion rate should be reduced to 0.625 ng/kg/min.
The infusion rate should be increased under medical supervision in increments of up to 1.25 ng/kg/min per week for the first four weeks of treatment and then up to 2.5 ng/kg/min per week.
The dose should be adjusted on an individual basis and under medical supervision in order to achieve a maintenance dose at which symptoms improve and which is tolerated by the patient.
During the follow-up phase of a clinical trial in CTEPH patients, the mean doses reached after 12 months were 31 ng/kg/min, after 24 months 33 ng/kg/min, and after 48 months 39 ng/kg/min. The respective maximum doses observed in the clinical trial were 52 ng/kg/min, 54 ng/kg/min and 50 ng/kg/min respectively.
Abrupt withdrawal or sudden marked reductions in the dose of treprostinil may cause a rebound of symptoms of chronic thromboembolic pulmonary hypertension. It is therefore recommended that interruption of treprostinil therapy is avoided and that the infusion is re-started as soon as possible after an abrupt accidental dose reduction or interruption. The optimal strategy for reintroducing treprostinil infusion needs to be determined on a case by case basis by medically qualified personnel. In most cases, after an interruption of up to 4 hours, restarting of treprostinil infusion can be done using the same dose rate; interruptions for up to 24 hours may require a dose reduction of up to 50% of the most recent dose with a subsequent uptitration to the clinically effective dose. Longer periods of interruption may require the dose of treprostinil to be re-titrated from even lower flow rates. In any case, the reintroduction of treprostinil should be under medical supervision.
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