Dosing & Uses
Dosage Forms & Strengths
injectable, powder for reconstitution
- 0.5mg/vial
- 1.5mg/vial
Dosage Forms & Strengths
injectable, powder for reconstitution
- 0.5 mg
- 1.5 mg
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse 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
Postmarketing Reports
Blood and lymphatic: Anemia, hypersplenism, pancytopenia, splenomegaly, thrombocytopenia
Endocrine and Metabolic: Hyperthyroidism
Gastrointestinal: Hepatic failure
Respiratory, Thoracic, and Mediastinal: Pulmonary embolism
Cardiovascular: High output cardiac failure
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 & Lactation
Pregnancy
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 risks to the mother and fetus from untreated pulmonary arterial hypertension; in animal reproduction studies, pregnant rats and rabbits received epoprostenol sodium during organogenesis at exposures of 2.5 and 4.8 times the maximum recommended human dose (MRHD), respectively, and there was no effect on the fetus
Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death
Lactation
There are no data on presence of epoprostenol in either human or animal milk, effects on breastfed infant, or on milk production; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition
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
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
- Do not use preparation and administration materials containing polyethylene terephthalate (PET) or polyethylene terephthalate glycol (PETG); PET/PETG products may become damaged when used with Flolan’s mfr supplied with sterile diluent which is alkaline (pH 12)
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
Images
Patient Handout
Formulary
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