epoprostenol

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Pronunciation: EE poe PROST en ol

Brand: Flolan, Veletri

What is the most important information I should know about epoprostenol?

You should not use this medication if you are allergic to epoprostenol, if you have breathing problems when you first start using epoprostenol, or if you have congestive heart failure caused by a decrease in your heart's ability to pump blood back into the body.

Before using epoprostenol, tell your doctor if you have a bleeding or blood clotting disorder, heart disease, liver or kidney disease, or high blood pressure.

Epoprostenol is injected into a vein using an infusion pump, usually through a permanent central intravenous (IV) catheter placed into a large vein (such as in your chest). You may need to use this medication for many years.

You may be shown how to use an infusion pump at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

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

Tell your doctor about all other drugs you use, especially medicines to prevent blood clots.

Do not stop using epoprostenol without first talking to your doctor, even if you feel fine or have no symptoms. Even short breaks in the flow of your medication through the IV can cause the treatment to stop working. Missing doses or stopping suddenly may make your condition worse and you may have symptoms such as dizziness, weakness, or trouble breathing.

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

What is epoprostenol?

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). It improves your ability to exercise.

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

What should I discuss with my healthcare provider before using epoprostenol?

You should not use this medication if you are allergic to epoprostenol, if you have breathing problems when you first start using epoprostenol, or if you have congestive heart failure caused by a decrease in your heart's ability to pump blood back into the body.

To make sure you can safely use epoprostenol, tell your doctor if you have any of these other conditions:

  • a bleeding or blood clotting disorder;
  • heart disease;
  • high blood pressure;
  • kidney disease; or
  • liver disease.

FDA pregnancy category B. Epoprostenol is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether epoprostenol passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use epoprostenol?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. You may need to use this medication for many years.

Epoprostenol is injected into a vein using a computerized, portable infusion pump to control the rate of medication you receive. Because epoprostenol must be used long-term, it is usually given through a permanent central intravenous (IV) catheter placed into a large vein (such as in your chest).

You may be shown how to use an infusion pump at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

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

You may be given other medications to prevent blood clots while you are receiving epoprostenol.

Epoprostenol is a powder medicine that must be mixed with a liquid (diluent) before using it. Use only the diluent provided with your medication and do not mix epoprostenol with any other medications or diluents not approved by your doctor.

If you are using the injections at home, be sure you understand how to properly mix and store the medicine. These directions are different for the Flolan and Veletri brands of this medication. Be sure you understand all mixing and storage directions for the specific brand of epoprostenol you are using.

After mixing Flolan with the diluent, store in the refrigerator and use within 48 hours. After mixing Veletri with the diluent, store in the refrigerator and use within 5 days.

The Veletri and diluent mixture may also be stored at room temperature but you must use it within 48 hours after it was mixed.

Protect the mixed medicine from light and do not freeze. Throw away any epoprostenol and diluent mixture that has become frozen, has changed colors, or has any particles in it. Call your doctor for a new prescription. The epoprostenol and diluent mixture must be protected from light at all times, whether it is in storage or in use.

Do not stop using epoprostenol without first talking to your doctor, even if you feel fine or have no symptoms. Missing doses or stopping suddenly may make your condition worse and you may have symptoms such as dizziness, weakness, or trouble breathing.

Even short breaks in the flow of your medication through the IV can cause the treatment to stop working. To make sure there is no interruption in your treatment, you may need to have a back-up infusion pump in case your first pump fails to work properly. Also keep replacement batteries and extra IV infusion sets on hand at all times. Get your prescription refilled before you run out of medicine completely.

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

Store unopened vials of epoprostenol and its diluent at cool room temperature (below 77 degrees F), away from moisture, heat, and light. Keep in the original carton.

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while using epoprostenol?

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

What are the possible side effects of epoprostenol?

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

Call your doctor at once if you have a serious side effect such as:

  • fever, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
  • chest pain, trouble breathing;
  • fast, slow, or uneven heart rate;
  • pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • blood in your urine or stools;
  • coughing up blood;
  • feeling like you might pass out; or
  • numbness or increased sensitivity anywhere in your body.

Less serious side effects may include:

  • flushing (warmth, redness, or tingly feeling);
  • nausea, vomiting, diarrhea, stomach pain;
  • headache or jaw pain;
  • joint or muscle pain;
  • dizziness, sweating; or
  • feeling anxious, nervous, or agitated.

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.

What other drugs will affect epoprostenol?

Epoprostenol can increase your risk of bleeding. This effect is increased when you also use medicines to prevent blood clots, such as:

  • heparin or warfarin (Coumadin, Jantoven);
  • alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase);
  • dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra), tinzaparin (Innohep); or
  • abciximab (ReoPro), anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), ticlopidine (Ticlid), tirofiban (Aggrastat).

Tell your doctor about all other medications you use, especially:

  • digoxin (digitalis, Lanoxin);
  • a diuretic (water pill);
  • heart or blood pressure medications;
  • aspirin or an NSAID (nonsteroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with epoprostenol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about epoprostenol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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