Is epoprostenol (prostacyclin analogue) available in the pharmacy for a patient with Pulmonary Arterial Hypertension (PAH)?

Epoprostenol Availability in Pharmacy for PAH

Yes, epoprostenol is available in pharmacies as an FDA-approved medication for pulmonary arterial hypertension (PAH), supplied as a sterile powder in single-dose vials containing either 0.5 mg or 1.5 mg that requires reconstitution before continuous intravenous infusion. 1

FDA-Approved Formulations and Supply

• Epoprostenol is available as epoprostenol for injection in 10 mL single-dose vials containing 0.5 mg (500,000 ng) or 1.5 mg (1,500,000 ng) of epoprostenol 1
• The medication must be reconstituted with 5 mL of either Sterile Water for Injection or Sodium Chloride 0.9% Injection before use 1
• Two formulations exist: the original epoprostenol with glycine and mannitol (Flolan®), and a newer thermally stable formulation with arginine and sucrose (Veletri®, Caripul®) that can be stored at room temperature 2

Approved Indications and Patient Population

• FDA approval covers treatment of PAH (WHO Group 1) to improve exercise capacity, with studies predominantly including patients with NYHA Functional Class III-IV symptoms 1
• Approved etiologies include idiopathic or heritable PAH, and PAH associated with connective tissue diseases 1
• The medication is indicated for both adult and pediatric PAH patients, with demonstrated survival benefits in multiple guidelines 3

Critical Dispensing Requirements

• Epoprostenol requires continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump 1
• The medication cannot be mixed with any other parenteral medications or solutions prior to or during administration 1
• Due to its very short half-life (2-6 minutes), the original formulation must be kept cold with ice packs during infusion, though the newer arginine-sucrose formulation has improved thermal stability 3, 2

Pharmacy Infrastructure Considerations

• Only specialized centers with 24-hour support capabilities should manage epoprostenol therapy, as emphasized by multiple guidelines 3
• Patients require extensive training in sterile medication preparation, ambulatory pump operation, and central venous catheter care before discharge 3
• The pharmacy must be prepared to provide emergency medication access, as abrupt discontinuation can be life-threatening due to rebound pulmonary hypertensive crisis 3, 1

Contraindications Affecting Dispensing

• Epoprostenol is contraindicated in congestive heart failure due to severe left ventricular systolic dysfunction 1
• It is also contraindicated in patients with pulmonary edema or hypersensitivity to the drug 1
• Rapid development of pulmonary edema after initiation suggests pulmonary veno-occlusive disease, which is an absolute contraindication 4

Mortality Benefit Supporting Availability

• Epoprostenol is the only PAH therapy proven to reduce mortality in randomized controlled trials, with zero deaths in the treatment group versus 8 deaths (20%) in the control group over 12 weeks (p=0.003) 3, 4
• Long-term survival rates are 85%, 70%, 63%, and 55% at 1,2,3, and 5 years respectively, compared to predicted survival of 59%, 46%, and 35% without treatment 3, 4