Epoprostenol (e-poe-PROST-en-ol)

Treats pulmonary arterial hypertension (PAH).

Brand Name(s):

Flolan, Veletri

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. A nurse or other trained health professional will teach you or a caregiver how to give this medicine. This medicine is given as an infusion through a catheter that is placed into a vein. Do not use more medicine than your doctor tells you to. Do not stop your treatment unless your doctor tells you to.
• Your doctor or nurse will teach you how to prepare the medicine and how to use the pump for the infusion. This medicine must be given continuously by a portable pump. Make sure you understand all instructions. Ask your doctor or home healthcare provider if you have any questions.
• Ask your doctor who to call if you have any problems with the infusion pump. You may be given a second pump in case the first pump stops working. Make sure you have access to this pump as a backup at all times.
• Your health caregiver should show you how to mix your medicine. Mix the powder only with the liquid that your caregiver told you to use. Do not mix epoprostenol with other medicines.
  • Flolan®: Mix with pH 12 sterile diluent for Flolan®.
  • Veletri®: Mix with sterile water for injection, USP, or sodium chloride 0.9% injection, USP.
• Do not use the medicine bag or bottle if it is discolored or has particles in it.
• Use only the supplies provided in the medication kit to inject Flolan®. The mixed medicine must be injected using the provided infusion tubing, because it has a filter that will remove any solid pieces or specks in the liquid.
• You will need to continue using this medicine for a long period of time, possibly for many years. Talk with your doctor if you have any concerns about this.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Different brands of this medicine have different storage instructions. Follow the instructions that came with your specific medicine.
  • Flolan®: After you mix the powder and the liquid, store this mixture at room temperature up to 3 days at 25°C, 2 days at 30°C, or up to 12 hours at 40°C. Do not freeze. Protect from light. Throw away any mixture that has been refrigerated for more than 8 days.
  • Veletri®: After you mix the powder with the liquid, store this mixture in the refrigerator for up to 8 days. Do not freeze. If you use the mixture right away, it does not need to be cold.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how epoprostenol works. Tell your doctor if you are using any of the following:
  • Digoxin
  • Blood pressure medicine
  • Blood thinner (including warfarin)
  • Diuretic (water pill)
  .

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart disease, heart failure, lung disease, or bleeding problems.
• This medicine may cause the following problems:
  • Pulmonary edema (fluid in the lungs)
  • Low blood pressure
  • Increased risk of bleeding
• You must keep the area around the catheter clean to prevent infection. Tell your doctor or health caregiver right away if you think you have an infection.
• Do not stop using this medicine suddenly or change your dose unless your doctor tells you to. Stopping the medicine may worsen the symptoms of your condition. Check with your doctor before stopping it completely.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, cough, pale skin
• Extreme warmth or redness in the face, neck, arms, or upper chest
• Fast, slow, or uneven heartbeat
• Fever, chills, cough, sore throat, body aches
• Lightheadedness, dizziness, or fainting
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Severe redness, pain, rash, swelling, or a hard lump where the needle is placed
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, vomiting, loss of appetite
• Feeling nervous or anxious
• Headache
• Jaw or muscle pain
• Skin rash, itching, or sores

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088