Epoprostenol

Epoprostenol is a prescription medication used for the treatment of pulmonary hypertension.

• Epoprostenol is available under the following different brand names: Flolan, Veletri

Adult and pediatric dosage

Injectable, powder for reconstitution

• 0.5mg/vial
• 1.5mg/vial

Pulmonary Hypertension

Adult dosage

• Initial: 2 ng/kg/min IV infusion pump over 24-48 hours; may initiate at a lower dose if intolerant to starting dose  
• Titrate by 1-2 ng/kg/min every 15 mins or longer, until desired effect or dose-limiting pharmacologic effects occur.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Epoprostenol include:

• nausea,
• vomiting,
• diarrhea,
• dizziness,
• headache,
• flushing (redness, warmth, or tingly feeling),
• sweating,
• stomach pain,
• jaw pain,
• muscle or joint pain,
• injection site reactions (pain, redness, swelling),
• anxiety,
• nervousness, or
• agitation.

Serious side effects of Epoprostenol include:

• fever,
• trouble breathing,
• fainting,
• chest pain,
• irregular heart rate, or
• coughing up blood.

Rare side effects of Epoprostenol include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Epoprostenol has severe interactions with no other drugs.
• Epoprostenol has serious interactions with the following drug:
  • lofexidine
• Epoprostenol has moderate interactions with at least 86 other drugs.
• Epoprostenol has minor interactions with at least 28 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity to epoprostenol
• Chronic use in patients with CHF due to left ventricular systolic dysfunction
• Development of pulmonary edema during initial dose titration

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Epoprostenol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Epoprostenol?”

Cautions

• 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 bloodstream infections may develop from chronic infusions requiring an indwelling central venous catheter
• Asymptomatic increase in pulmonary artery pressure
• Some patients may develop pulmonary edema during dosing adjustments
• Chronic use and dose adjustment
  • During chronic use, deliver drug continuously on an ambulatory basis through a permanent indwelling central venous catheter; unless contraindicated
  • Administer anticoagulant therapy to patients receiving therapy to reduce the risk of pulmonary thromboembolism or systemic embolism through a patent foramen ovale
  • To reduce risk of infection, use aseptic technique in reconstitution and administration of therapy and routine catheter care
  • Because the drug is metabolized rapidly, even brief interruptions in delivery of drug may result in symptoms associated with rebound pulmonary hypertension including dyspnea, dizziness, and asthenia
  • Intravenous therapy will likely be needed for prolonged periods, possibly years, so consider the patient’s capacity to accept and care for a permanent intravenous catheter and infusion pump
  • Adjust dosage during chronic use at the first sign of recurrence or worsening of symptoms attributable to pulmonary hypertension or occurrence of adverse events associated with drug; following dosage adjustments, monitor standing and supine blood pressure and heart rate closely for several hours

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 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 the presence of epoprostenol in either human or animal milk, effects on the breastfed infant, or milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from the drug or underlying maternal condition