These highlights do not include all the information needed to use TREPROSTINIL INJECTION safely and effectively. See full prescribing information for TREPROSTINIL INJECTION. TREPROSTINIL Injection, for subcutaneous or intravenous use Initial U.S. Approval: May 2002
Treprostinil Injection is a prostacyclin vasodilator indicated for:
Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1)
Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2)
PAH WHO Group 1 in patients with NYHA Class II-IV symptoms:
Initial dose for patients new to prostacyclin infusion therapy: 1.25 ng/kg/min; increase based on clinical response (increments of 1.25 ng/kg/min per week for the first 4 weeks of treatment, later 2.5 ng/kg/min per week). Avoid abrupt cessation. (2.2, 2.4)
Mild to moderate hepatic insufficiency: Decrease initial dose to 0.625 ng/kg/min. Severe hepatic insufficiency: No studies performed. (2.5)
Transition from Epoprostenol:
Increase the Treprostinil Injection dose gradually as the epoprostenol dose is decreased, based on constant observation of response. (2.7)
Administration:
Continuous subcutaneous infusion is the preferred mode. Use intravenous infusion if subcutaneous infusion is not tolerated. (2.1, 2.6)
Treprostinil Injection is supplied in 20 mL vials containing 20 mg, 50 mg, 100 mg, or 200 mg of treprostinil (1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL). (3)
Chronic intravenous infusions delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of blood stream infections (BSIs) and sepsis, which may be fatal. (5.1)
Do not abruptly lower the dose or withdraw dosing. (5.2)
Treprostinil may cause symptomatic hypotension. (5.4)
Treprostinil inhibits platelet aggregation and increases the risk of bleeding. (5.5)
Most common adverse reactions (incidence >3%) reported in clinical studies with treprostinil: subcutaneous infusion site pain and reaction, headache, diarrhea, nausea, jaw pain, vasodilatation, edema, and hypotension. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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