Remodulin Generic Name & Formulations
Legal Class
Rx
General Description
Treprostinil 1mg/mL, 2.5mg/mL, 5mg/mL, 10mg/mL; soln for SC or IV continuous infusion.
Pharmacological Class
Prostacyclin analogue.
How Supplied
Multidose vials (20mL)—1
Manufacturer
Generic Availability
YES
Remodulin Indications
Indications
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.
Remodulin Dosage and Administration
Adult
>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.
Children
≤16yrs: not established.
Remodulin Contraindications
Not Applicable
Remodulin Boxed Warnings
Not Applicable
Remodulin Warnings/Precautions
Warnings/Precautions
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.
Remodulin Pharmacokinetics
See Literature
Remodulin Interactions
Interactions
May be potentiated by CYP2C8 inhibitor (eg, gemfibrozil) and antagonized by CYP2C8 inducer (eg, rifampin); may need to adjust dose.
Remodulin Adverse Reactions
Adverse Reactions
Infusion reactions/site pain, headache, diarrhea, nausea, jaw pain, vasodilatation, edema, hypotension; bleeding.
Remodulin Clinical Trials
See Literature
Remodulin Note
Not Applicable
Remodulin Patient Counseling
See Literature