Epoprostenol is a prostaglandin (a hormone-like substance that occurs naturally in the body). Prostaglandins help to control functions in the body such as blood pressure and muscle contractions.

Epoprostenol is used to treat pulmonary arterial hypertension (PAH) and improve your ability to exercise.

Epoprostenol may also be used for purposes not listed in this medication guide.

You should not use epoprostenol if you have fluid in your lungs, or heart failure caused by a decrease in your heart's ability to pump blood back into the body.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. You may need to use epoprostenol for many years.

You may receive your first dose in a hospital or clinic setting to quickly treat any serious side effects. Your blood pressure and heart rate may also need to be monitored whenever your dose is changed.

Epoprostenol is injected with an infusion pump, usually through a permanent central intravenous (IV) catheter placed into a large vein such as in your chest. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine, which may be different for different brands of epoprostenol. Do not use epoprostenol if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

You should not stop using epoprostenol suddenly, even if you feel fine. Stopping suddenly may make your condition worse.

Call your doctor if your symptoms do not improve, or if they get worse.

To make sure there is no interruption in your treatment, you may need to have a back-up infusion pump, replacement batteries, and extra IV infusion sets. Get your prescription refilled before you run out of medicine completely.

Store epoprostenol powder in its original package at room temperature, away from moisture, heat, and light.

After mixing your medicine, you will need to use it within a certain number of hours or days. This will depend on the concentration of the mixture, the diluent used, and whether you store the mixture at room temperature or in a refrigerator. Carefully follow the mixing and storage instructions provided with your medicine. Ask your pharmacist if you have questions.

Protect the mixed medicine from light at all times, whether it is in storage or in use.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Pulmonary Hypertension:

Initial dose: 2 ng/kg/min via continuous IV infusion and titrate up in increments of 2 ng/kg/min every 15 minutes or longer until a tolerance limit is established or further increases in infusion rate not clinically warranted

Comments:
-If the initial infusion rate is not tolerated, a lower dose may be used.
-If dose-limiting pharmacologic effects occur, decrease infusion rate until this drug is tolerated.

Use: For the treatment of PAH (WHO Group 1) to improve exercise capacity; studies establishing efficacy included predominately patients with New York Heart Association (NYHA) Class III to IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated connective tissue disorders

You should not use epoprostenol if you are allergic to it, or if you have:

• fluid in your lungs (pulmonary edema); or

• congestive heart failure caused by a decrease in your heart's ability to pump blood back into the body.

Tell your doctor if you have ever had breathing problems while using epoprostenol.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Because epoprostenol is given around the clock, you should not miss a dose if you use the medicine properly. Call your doctor right away if your epoprostenol therapy is interrupted for any reason.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Your healthcare provider will tell you how to store your medication. Store your medication only as directed. Make sure you understand how to store your medication properly.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid using any infusion pump that has not been approved for use by your doctor.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Epoprostenol may cause serious side effects. Call your doctor at once if you have:

• shortness of breath with dizziness or weakness;

• a light-headed feeling, like you might pass out;

• easy bruising, unusual bleeding; or

• symptoms of pulmonary edema--anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.

Common side effects of epoprostenol may include:

• flushing (warmth, redness, or tingly feeling);

• dizziness;

• nausea, vomiting, diarrhea, stomach pain;

• trouble breathing;

• headache, jaw pain;

• fast or slow heartbeats;

• joint or muscle pain;

• flu-like symptoms; or

• feeling anxious or nervous.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• a diuretic or "water pill";

• blood pressure medications; or

• a blood thinner--warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect epoprostenol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.