Classes
DEA Class; Rx
Common Brand Names; Flolan, Veletri
- PAH, Prostacyclin Analogs
Description
Pharmaceutical form of prostacyclin; vasodilator and an inhibitor of platelet aggregation; improves symptoms and prolongs survival in pulmonary hypertension.
Indications
Indicated for the treatment of pulmonary hypertension to improve exercise ability in persons with WHO Group 1 pulmonary hypertension.
Contraindications
Hypersensitivity to epoprostenol
Chronic use in patients with CHF due to left ventricular systolic dysfunction
Development of pulmonary edema during initial dose titration
Adverse Effects
- Flushing (58%)
- Jaw pain (54%)
- Headache (49%)
- Myalgia (44%)
- Diarrhea (37%)
- Nausea (32%)
- Vomiting (32%)
- Flu-like symptoms (25%)
- Eczema (25%)
- Rash (25%)
- Urticaria (25%)
- Hypotension (16%)
- Anxiety (11%)
- Nervousness (11%)
- Musculoskeletal pain (2%)
- Hyperesthesia (1%)
- Tachycardia (1%)
Warnings
Initiate therapy in a setting with adequate personnel and equipment for physiologic monitoring and emergency care; dose initiation has been performed during right heart catheterization and without cardiac catheterization; during dose initiation, asymptomatic increases in pulmonary artery pressure coincident with increases in cardiac output reported rarely; in such cases, consider dose reduction, but such an increase does not imply that chronic treatment is contraindicated
Abrupt withdrawal (including interruptions in drug delivery) or sudden large reductions in dosage may result in symptoms associated with rebound pulmonary hypertension, including dyspnea, dizziness, and asthenia; in clinical trials, death attributable to interruption of therapy reported; avoid abrupt withdrawal
Use caution in patients with risk factors of bleeding
Serious blood stream infectiosn may develop from chronic infusions requiring an indwelling central venous catherer
Asymptomatic increase in pulmonary artery pressure
Some patients may develop pulmonary edema during dosing adjustments
Pregnancy and Lactation
Limited published data from case series and case reports have not established an association with therapy and major birth defects, miscarriage or adverse maternal or fetal outcomes when treatment is used during pregnancy
There are no data on presence of epoprostenol in either human or animal milk, effects on breastfed infant, or on milk production
Maximum Dosage
Absolute maximum dosage limits have not been established; maximum doses should be based on individual clinical response.
Absolute maximum dosage limits have not been established; maximum doses should be based on individual clinical response.
Safety and efficacy have not been not been established; maximum doses should be based on individual clinical response.
Safety and efficacy have not been established; maximum doses should be based on individual clinical response.
How supplied
Epoprostenol sodium
injectable, powder for reconstitution
- 0.5mg/vial
- 1.5mg/vial