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|Flolan

EPOPROSTENOL (Systemic)

Some commonly used brand names are:

In the U.S.—

• Flolan

In Canada—

• Flolan

Other commonly used names are Prostacyclin , PGI ₂ , and PGX .

Category

• Antihypertensive (pulmonary)
• vasodilator

Description

Epoprostenol (e-poe-PROST-en-ole) belongs to a group of agents called prostaglandins. Prostaglandins occur naturally in the body and are involved in many biological functions. Epoprostenol is used to treat the symptoms of primary pulmonary hypertension, or the high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Epoprostenol works by relaxing blood vessels and increasing the supply of blood to the lungs, reducing the workload of the heart.

This medicine is available only with your doctor"s prescription, in the following dosage form(s):

• Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For epoprostenol, the following should be considered:

Allergies—Tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Epoprostenol has not been studied in pregnant women and, although epoprostenol has not been shown to cause birth defects or other problems in animals, it is not recommended for use in pregnant women unless absolutely necessary. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether epoprostenol passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Although there is no specific information comparing use of this medicine in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of epoprostenol in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. It is important that your health care professional know if you are taking any prescription or nonprescription (over-the-counter [OTC]) medicines.

Other medical problems—The presence of other medical problems may affect the use of epoprostenol. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease or
• Lung disease—Epoprostenol may make these conditions worse

Proper Use of This Medicine

Your doctor or nurse will teach you how to prepare the medicine and use the pump for administering the medicine. Epoprostenol must be administered continuously by a portable pump that is operated by a small computer. The medicine will be delivered directly to the heart through a catheter that will be inserted into a vein in the chest.

Epoprostenol should be reconstituted only with the sterile diluent that is supplied with this medicine. The reconstituted medicine should not be mixed with other solutions or medicines. Use the following procedure for reconstituting your daily supply:

• Clear an area to work in and clean the area with alcohol. Gather your supplies. Wash your hands thoroughly with soap and water and then open all packages. Remove the vial cap from the vial containing the sterile diluent, clean the tops of the vials with alcohol swabs, and let the vial tops dry before proceeding.

• To withdraw the sterile diluent
• If not already attached, attach a needle to the syringe. Gently pull the plunger out slightly and push it back to break the syringe seal. Draw air into the syringe that is about equal to the amount of sterile diluent you"ve been instructed to withdraw from the vial. Insert the needle at an angle, completely through the rubber seal of the vial. Turn the vial and syringe upside down (the syringe-vial unit is now vertical) and carefully press the plunger, injecting some or all of the air into the vial. Then aim the tip of the needle into the fluid and carefully pull the plunger slowly back to withdraw the diluent and/or allow the pressure to fill the syringe with the diluent. Continue pushing the remaining air into the vial, allowing the liquid to enter the syringe until the prescribed amount of diluent has been drawn into the syringe. Without withdrawing the needle, tap the syringe gently so that any air bubbles trapped in the syringe rise toward the top of the syringe. If air bubbles appear, depress the plunger gently to force the air bubbles out (into the vial) and then withdraw enough additional diluent to restore the needed volume in the syringe. (Holding the syringe-vial as a unit in a vertical position and keeping the needle tip in the fluid while withdrawing the diluent may help minimize the amount of air drawn into the syringe.) Once the required volume has been drawn into the syringe, let the syringe-vial pressure equalize and slowly withdraw the needle from the vial.

• To reconstitute the epoprostenol
• Insert the same needle through the rubber seal of the vial of epoprostenol and inject the sterile diluent gently onto the side of the vial. The flow of the sterile diluent should be directed toward the side of the vial and injected slowly in order to prevent the medicine from foaming. Once the pressure has equalized, withdraw the needle from the vial. Gently swirl the vial to mix the epoprostenol. Turn the vial upside down to catch any undissolved powder near the top of the vial. Never shake the vials. Repeat this process if you need to mix more than one vial of epoprostenol.

• To draw out the reconstituted epoprostenol
• Wipe the top of the reconstituted epoprostenol vial with an alcohol swab and let it dry. Change the needle on the syringe and then gently pull back the syringe plunger and fill the syringe with the amount of air that is equal to the amount of reconstituted epoprostenol you have been instructed to withdraw. Insert the needle through the seal of the vial and inject the air into the vial. Be sure to keep the needle tip below the fluid line and then pull the plunger back gently to withdraw the reconstituted epoprostenol into the syringe. Remove any air that may be trapped in the syringe as described above. Withdraw the needle and replace the needle cap on the syringe.

• To inject the reconstituted epoprostenol into the cassette
• Remove the end cap from the cassette tubing. Carefully remove the needle from the syringe (be sure to discard the needle in an appropriate manner) and attach the syringe to the cassette tubing. Hold the cassette in one hand and push the plunger to inject the reconstituted solution into the cassette (alternatively, you may find it useful to use a tabletop or other solid structure to steady the plunger while pushing down on the syringe to inject the solution). When the syringe is empty, clamp the cassette tubing near the syringe. Disconnect the syringe and replace the cassette tubing end cap.

• To inject the remaining diluent into the partially filled cassette
• Using a 60 mL syringe, attach a new needle to the syringe and follow the above procedures for breaking the syringe seal and wiping the tops of the sterile diluent vials. Fill the syringe with the amount of air that is equal to the amount of sterile diluent you will remove from the first vial. Insert the needle through the rubber seal and slowly inject some of the air into the vial, allowing the fluid to flow into the syringe. Continue to push air gently into the vial until all of the fluid in the vial has flowed into the syringe. Remove any air that may be in the syringe as described above. Allow the pressure to equalize before you pull the needle out or you may lose fluid from the syringe. (If this occurs, the whole process needs to be repeated.) Withdraw the needle and replace the needle cap on the syringe. You may find it easier to hold the larger syringe in an upside down, vertical position while withdrawing the fluid in the vial.

• To inject the sterile diluent into the cassette
• Uncap the clamped cassette tube and carefully remove the needle from the syringe (discarding the needle in an appropriate manner). Attach the syringe to the cassette tubing. Unclamp the cassette tubing and carefully inject the solution into the cassette. When the syringe is empty, clamp the cassette tube near the syringe and disconnect the syringe. Replace the cap on the cassette tube. If more diluent is needed to fill the cassette, repeat steps 6 and 7 with an additional vial of diluent; however, after completing the transfer of all of the required diluent, clamp the tubing, but leave the syringe attached to the cassette tubing while you mix the solution. Gently turn the cassette upside down at least 10 times to thoroughly mix the reconstituted epoprostenol with the additional diluent.

• To remove air from the cassette
• To remove the air from inside the cassette, slowly turn the cassette until all of the small bubbles of air join to form one air pocket. Tilt the cassette gently so that the air pocket is in the corner where the tubing connects to the cassette. Unclamp the tube and pull back the plunger of the syringe until you see fluid fill the tubing. Clamp the tube near the connector and remove the syringe and replace the cap on the tubing. Label the cassette with the current time and date. Store the cassette in the refrigerator (preferably, on the top shelf to avoid spilling any food or drink on it) until it is time to use it. Make up a new cassette each day and use the cassette you refrigerated the day before so that you will always have a back-up cassette.

• To use the pump
• The instructions for the use of the pump may vary depending on the particular make and model of the pump. Your doctor or nurse will give detailed instructions on how to use and care for the particular pump and accessories that you will use for administering your medicine. These instructions should include how to change the pump battery, cassette, and tubing. Remember to change the gel packs every 12 hours or every 8 hours if the surrounding temperature approaches 86 °F.
• Maintain sterile technique at all times. If you suspect that you have contaminated anything, throw away the accessories and begin again.

Dosing—The dose of epoprostenol will be different for different patients and will be determined by your doctor. The amount of medicine you take may have to be increased gradually by your doctor. It must never be stopped suddenly. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of epoprostenol. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the concentration of the reconstituted medicine and the rate at which the infusion pump delivers the medicine.

• For injection dosage form:
  • For primary pulmonary hypertension and pulmonary hypertension secondary to scleroderma spectrum of disease:
    • Adults—Initially, 2 nanograms per kilogram (kg) (0.9 nanogram per pound) of body weight per minute. Your doctor may increase your dose as necessary.
    • Children—Use and dose must be determined by your doctor.

Missed dose—Epoprostenol has to be administered by a continuous intravenous infusion and it must never be stopped suddenly.

Storage—To store this medicine:

• Keep out of the reach of children.
• Do not keep outdated medicine, or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

• Unopened vials
• Store unopened vials away from heat and direct light.
• Keep the medicine and the diluent from freezing.
• Do not store unopened vials in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.

• Reconstituted injection
• Store the reconstituted injection in the refrigerator, away from direct light. However, keep the medicine from freezing. Any medicine that has been frozen should be thrown away. Reconstituted solutions should be kept either in the refrigerator or in a cold pouch, or a combination of the two, for no more than 48 hours. Do not expose reconstituted solution to temperatures higher than 25 °C (77 °F).
• If the reconstituted solution has particles in it or is discolored, it should be discarded.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits. This will allow your doctor to make sure the medicine is working properly and to change the dosage if needed.

Be sure to report any signs of infection at the catheter site to your doctor. Also, if you develop a sudden fever, contact your doctor as soon as possible .

Avoid the use of saunas, hot baths, or sunbathing, or other situations that may cause blood vessels to dilate, resulting in low blood pressure and increasing the possibility of dizziness, light-headedness, or fainting.

Do not suddenly stop using this medicine. Stopping suddenly may bring on symptoms of your condition and can be dangerous. Check with your doctor before stopping completely .

Your doctor may want you to carry a medical identification card stating that you are using this medicine.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

If you stop using this medicine abruptly or your dosage is reduced suddenly, symptoms of your condition may recur. If your medicine is suddenly stopped or reduced, check with your doctor immediately , especially if any of the following side effects occur:

Difficult or labored breathing; dizziness; fainting; weakness

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 01/04/1999
Revised: 09/04/2000

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