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 infusion; if not tolerated, may give by IV 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. 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.
≤16yrs: not recommended.
Should be administered by experienced clinicians in PAH diagnosis and treatment. IV route: risk of blood stream infections and sepsis; may be fatal. Avoid abrupt withdrawal or sudden large dose reduction. Hepatic or renal insufficiency; titrate gradually. Elderly. Labor & delivery. Pregnancy (Cat.B). Nursing mothers.
Increased risk of symptomatic hypotension with concomitant diuretics, antihypertensives, other vasodilators. May be potentiated by CYP2C8 inhibitor (eg, gemfibrozil). May be antagonized by CYP2C8 inducer (eg, rifampin). Increased risk of bleeding with anticoagulants.
Infusion reactions/site pain, headache, diarrhea, nausea, jaw pain, vasodilatation, dizziness, edema, pruritus, hypotension.
Multidose vials (20mL)—1