Generic Name and Formulations:
Treprostinil 1mg/mL, 2.5mg/mL, 5mg/mL, 10mg/mL; soln for SC or IV continuous infusion.
United Therapeutics Corp.
Indications for REMODULIN:
Pulmonary arterial hypertension (PAH) in patients with NYHA Class II–IV symptoms, to diminish symptoms associated with exercise. PAH patients requiring transition from Flolan (epoprostenol), to reduce the rate of clinical deterioration.
>16yrs: Give preferably by SC continuous infusion; if not tolerated, may give by IV continuous infusion (dilution required). Treatment-naïve: initially 1.25ng/kg/min (or 0.625ng/kg/min, if not tolerated); may increase dose based on response by increments of 1.25ng/kg/min per week for 1st 4 weeks of treatment, then 2.5ng/kg/min per week. Infusion rate: see full labeling. Doses >40ng/kg/min: limited experience. Mild-to-moderate hepatic insufficiency: initially 0.625ng/kg/min; increase cautiously. Severe hepatic insufficiency: not studied. Transition from Flolan (epoprostenol): increase treprostinil dose gradually as the epoprostenol dose is decreased, based on response (see full labeling). Transition to implantable IV infusion pump: see full labeling.
≤16yrs: not established.
Should be administered by experienced clinicians in PAH diagnosis and treatment. IV route: risk of blood stream infections and sepsis; may be fatal. Low systemic arterial pressure: risk of symptomatic hypotension. Avoid abrupt withdrawal or sudden large dose reduction. Hepatic or renal insufficiency; titrate gradually. Elderly. Labor & delivery. Pregnancy. Nursing mothers.
May be potentiated by CYP2C8 inhibitor (eg, gemfibrozil) and antagonized by CYP2C8 inducer (eg, rifampin); may need to adjust dose.
Infusion reactions/site pain, headache, diarrhea, nausea, jaw pain, vasodilatation, edema, hypotension; bleeding.
Multidose vials (20mL)—1