Dosing and uses of Epoprostenol (Flolan, Veletri)
Adult dosage forms and strengths
injectable, powder for reconstitution
- 0.5mg/vial
- 1.5mg/vial
Pulmonary Hypertension
Initial: 2 ng/kg/min IV infusion pump over 24-48 hours; may initiate at lower dose if intolerant to starting dose
Titrate by 1-2 ng/kg/min q15min or longer, until desired effect or dose-limiting pharmacologic effects occur
Pediatric dosage forms and strengths
injectable, powder for reconstitution
- 0.5 mg
- 1.5 mg
Pulmonary Hypertension (Off-label)
Initial 2 ng/kg/min IV infusion pump over 24-48 hours initially; may initiate at lower dose if intolerant to starting dose
Titrate by 1-2 ng/kg/min IV q15min or longer, until desired effect or dose-limiting pharmacologic effects occur
Epoprostenol (Flolan, Veletri) adverse (side) effects
>10%
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%)
1-10%
Musculoskeletal pain (2%)
Hyperesthesia (1%)
Tachycardia (1%)
Frequency not defined
Hemorrhage
Thrombocytopenia
Warnings
Contraindications
Hypersensitivity to epoprostenoL
Chronic use in patients with CHF due to left ventricular systolic dysfunction
Development of pulmonary edema during initial dose titration
Cautions
Patients receiving epoprostenol should receive anticoagulant treatment (unless contraindicated) to decrease the risk of pulmonary thromboembolism or systemic embolism
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
Once initiated, duration of IV epoprostenol may be needed for years
Some patients may develop pulmonary edema during dosing adjustments
Rebound pulmonary hypertension may occur with abrupt interruptions or sudden reductions
Pregnancy and lactation
Pregnancy category: B
Lactation: Excretion in milk unknown; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Epoprostenol (Flolan, Veletri)
Mechanism of action
Potent peripheral vasodilator of all vascular beds; also prevents platelet aggregation
Pharmacokinetics
Half-life: 3-6 min
Metabolism: rapidly hydrolyzed in blood to metabolites
Metabolite: 6-keto-prostaglandin F1-alpha (inactive), dihydro-prostaglandin F1-alpha metabolites (unknown activity)
Excretion: Urine (84%); feces (4%)
Administration
IV Preparation
Flolan
- 3000 ng/mL: 0.5 mg vial/5 mL mfr supplied sterile diluent; withdraw 3 mL; and add sufficient diluent to make 100 mL
- 5000 ng/mL: 0.5 mg vial/5 mL mfr supplied sterile diluent; withdraw entire vial; and add sufficient diluent to make 100 mL
- 10,000 ng/mL: two 0.5 mg vials each in 5 mL mfr supplied sterile diluent; withdraw entire vial; and add sufficient diluent to make 100 mL
- 15,000 ng/mL: 1.5 mg vial/5 mL mfr supplied sterile diluent; withdraw entire vial; and add sufficient diluent to make 100 mL
Veletri
- Reconstituted in vial with only 5 mL of either sterile water for injection or 0.9% NaCl
- Further dilute reconstituted product with same diluent used for reconstitution
- Solutions of 15,000 ng/mL or above may be used for up to 25 hr at room temperature
- Lower concentrations may be used with pump reservoir changed q12hr at room temperature
IV Administration
Continuous IV infusion via central venous catheter using ambulatory infusion pump
Do not mix with any other parenteral medications or solutions prior or during administration
During treatment initiation, may be administered peripherally
Storage
Flolan
- Unopened vials are stable until date indicated on package when stored at room temperature (25 degrees C [77 degrees F]) in carton and protected from light
- Reconstituted vial: May be refrigerated (2-8 degrees C [36-46 degrees F]) for up to 48 hr
- Room temperature administration: When administered at room temperature, reconstituted solutions may be used for no longer than 8 hr
- Use with cold packs: May be administered for up to 24 hr with cold packs (change cold packs q12hr during infusion)
- Do not freeze
- Do not expose to direct sunlight
Veletri
- Unopened vials are stable until date indicated on package when stored at room temperature (25 degrees C [77 degrees F]) in carton and protected from light
- Reconstituted vial: May be refrigerated (2-8 degrees C [36-46 degrees F]) for as long as 5 days or held at up to 25 degrees C (77 degrees F) for up to 48 hr prior to use
- Final solutions of 15,000 ng/mL or above are stable at room temperature (25 degrees C) for up to 24 hr
- Less concentrated final solutions should be used for only 12 hr
- Cold packs are not needed during administration
- Do not freeze
- Do not expose to direct sunlight
