Flolan: Uses, Side Effects and Dosage

What is FLOLAN used for?

FLOLAN is used in adults to treat a lung condition called pulmonary arterial hypertension (PAH). This happens when there is high blood pressure in the main blood vessels in the lungs.

How does FLOLAN work?

FLOLAN widens the blood vessels to lower the blood pressure in the lungs.

What are the ingredients in FLOLAN?

Medicinal ingredient: epoprostenol sodium

Non-medicinal ingredients: glycine, mannitol, sodium chloride, and sodium hydroxide

FLOLAN comes in the following dosage forms:

Powder; 0.5 mg/vial and 1.5 mg/vial of epoprostenol (as epoprostenol sodium).

The pH 12 STERILE DILUENT for FLOLAN is also included. It is a plastic vial containing 50 mL of liquid for reconstitution of FLOLAN. The diluent contains glycine, sodium chloride, sodium hydroxide and water for injection.

Do not use FLOLAN if:

• you are allergic to epoprostenol, or to any other ingredient in FLOLAN (see “What are the ingredients in FLOLAN?” above).
• you are allergic to any medication similar to FLOLAN.
• you have heart failure.
• you developed fluid in the lungs (pulmonary edema) when you started your FLOLAN treatment.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take FLOLAN. Talk about any health conditions or problems you may have, including if you:

• have any problems with bleeding.
• have a condition called veno-occlusive disease.

• are pregnant, or think you could be, or if you are planning to become pregnant. Your healthcare professional will consider the benefit to you and the risk to your baby of taking FLOLAN while you’re pregnant.

• are breast-feeding. It is not known whether the ingredients of FLOLAN can pass into breast milk.

Other warnings you should know about:

• Pulmonary arterial hypertension and your treatment may have an effect on your ability to drive or use machinery. Don’t drive or use machines unless you’re feeling well.

• Stopping FLOLAN treatment must be done gradually. If the treatment is stopped too quickly, you may get serious side effects, including dizziness, feeling weak and breathing difficulties.
• If you have problems with the infusion pump or injection line that stops, or prevents treatment with FLOLAN, go to your hospital emergency department immediately.
• Infection of the blood (sepsis/septicemia) is a serious common side effect in people taking FLOLAN. Symptoms of sepsis include chills, with or without shaking, and fever. If you get any of these symptoms, go to your hospital emergency department immediately.
• Avoid situations that can lower blood pressure, including saunas, sunbathing or hot baths.
• A buildup of fluid in the abdomen (ascites) is a serious side effect in people taking FLOLAN. Symptoms include swelling around the stomach, abdominal pain, a feeling of fullness and/or a flat or pushed out navel. If you get any of these symptoms, talk to a healthcare professional right away.
• Your healthcare professional will arrange regular blood tests to check your blood count and how well your blood clots.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with FLOLAN:

• medicines used to prevent blood clots.
• medicines used to dissolve blood clots.
• medicines used for heart failure.
• medicines used for high blood pressure.
• medicines used for angina (chest pain).
• other medicines used to treat pulmonary arterial hypertension.
• medicines to treat inflammation or pain (also called ‘NSAIDs’).
• digoxin (a medicine used to treat heart disease).
• diuretics (water pill), used to lower fluid levels.

How to take FLOLAN:

• To take FLOLAN, you will be fitted with a permanent tube called a “central venous catheter”. Once the catheter is in place, you can be treated using an infusion pump. The pump delivers your medication through the catheter, directly to your heart.
• FLOLAN is given by slow continuous infusion (drip) into a vein.
• Your first treatment will be given to you by a healthcare professional so they can monitor you and find the best dose for you.
• If your healthcare professional decides that you can take FLOLAN at home, you will need to have a ‘significant other’ who is willing to learn about FLOLAN with you and be available in case you need help.

• Your healthcare professional will teach you and your ‘significant other’:

  • How to prepare and take FLOLAN. You can only take FLOLAN at home if your healthcare professional has shown you exactly how to use FLOLAN.
  • How to care for the catheter and how to keep the skin around the catheter exit site clean and free from infection.

How to use and care for the specific pump you are using and the accessories that you will

• use for administering the medicine (including changing the pump battery, cassette and tubing).
• Treatment will be needed for a long period of time, possibly years. You must be able to accept and care for a catheter and infusion pump in order to be treated with FLOLAN.

Take FLOLAN exactly as your healthcare professional has told you to. If you have any questions about your treatment or how to take/use FLOLAN, talk to your healthcare professional.

Steps for Reconstituting and Preparing FLOLAN

• Before use, FLOLAN powder must be dissolved (reconstituted) in the pH 12 STERILE DILUENT for FLOLAN provided. Only mix FLOLAN with the pH 12 STERILE DILUENT for FLOLAN liquid provided.
• Do not use FLOLAN if the solution shows haziness, particulate matter, discolouration, or leakage.
• The pH 12 STERILE DILUENT for FLOLAN does not contain preservative. If you have any of the dose left over, it must be thrown away.
• FLOLAN must not be used with any preparation or administration materials containing polyethylene terephthalate (PET) or polyethylene terephthalate glycol (PETG).

Your healthcare professional will tell you how much FLOLAN and pH 12 STERILE DILUENT for FLOLAN you will need to use when making up your daily supply. The following instructions explain how to reconstitute FLOLAN. They should supplement the instructions given to you by your healthcare professional.

1. 1.

   Clean your worksite and gather your supplies. Wash your hands thoroughly and then open all the packages. Remove the vial caps from the vial containing pH 12 STERILE DILUENT for FLOLAN and clean the tops of the vials with alcohol swabs.

2. 2. Attach a needle to the syringe. Break the seal on the syringe by gently pulling the plunger out slightly and then pushing it back. Draw air into the syringe; the amount of air that you draw into the syringe should be equal to the amount of pH 12 STERILE DILUENT for FLOLAN you’ve been instructed to withdraw from the vial. Insert the needle through the rubber seal of the pH 12 STERILE DILUENT for FLOLAN vial and press the plunger down to inject the air into the vial. Once all the air has been injected, pull the plunger gently back up to withdraw the prescribed amount of pH 12 STERILE DILUENT for FLOLAN. Without withdrawing the needle, invert the vial and syringe and tap the syringe gently so that any air bubbles trapped in the syringe rise towards the top. If necessary, depress the plunger gently to force the air bubbles out and then withdraw sufficient additional pH 12 STERILE DILUENT for FLOLAN to restore the required volume in the syringe. Once the required volume has been drawn into the syringe, withdraw the needle.
3. 3. Insert the needle through the rubber seal of the FLOLAN vial and inject the pH 12 STERILE DILUENT for FLOLAN gently onto the side of the vial. Always direct the flow of pH 12 STERILE DILUENT for FLOLAN towards the side of the vial and inject it gently so that the FLOLAN doesn’t foam. Allow the pressure to equalize and withdraw the needle from the vial. Now, mix the FLOLAN by gently swirling the vial. Turn the vial upside down to catch any undissolved powder near the top. Never shake the vials. If you need to mix more than one vial of FLOLAN, simply repeat this process.
4. 4. Wipe the tops of the vials with an alcohol swab again. Taking the syringe, gently pull the plunger back, and fill the syringe with the amount of air that is equal to the amount of FLOLAN to be withdrawn (your healthcare professional has told you how much FLOLAN to take). Insert the needle through the seal of the FLOLAN vial and inject the air. Then pull the plunger gently back to withdraw the reconstituted FLOLAN into the syringe. Remove any air that may be trapped in the syringe as described in step 2 above. Withdraw and place the cap back on the needle.
5. 5. You are now ready to inject the FLOLAN into your cassette. Remove the end cap from the cassette tubing; then carefully remove the needle from the syringe, discard in an appropriate manner and attach the syringe to the cassette tubing. While holding the cassette in one hand, you can use the tabletop as a third hand while you push down on the syringe to inject the solution into the cassette. Once the syringe is empty, clamp the cassette tubing near the syringe, disconnect the syringe and cap the tubing with the red cap.
6. 6.

   Wipe the top of the pH 12 STERILE DILUENT for FLOLAN vial with an alcohol wipe and let dry. Withdraw the contents of the pH 12 STERILE DILUENT for FLOLAN vials and inject them into the cassette. Using a 60 cc syringe, attach a new needle to the syringe, break the seal on the

   1. syringe by pulling the plunger out and pushing it back in. Fill the syringe with the amount of air that is equal to the amount of pH 12 STERILE DILUENT for FLOLAN needed. Insert the needle through the rubber seal, inject some of the air into the vial and allow the fluid to flow into the syringe. With the larger syringe, it may be easier to hold it in the vertical position. Push more air in as needed until you have withdrawn all of the contents of the vial. Remove any air that may be in the syringe as described in step 2 above. Once the vial is emptied, allow the pressure to equalize before you pull the needle out. If you don’t, you may lose fluid from the syringe or the vial and you will need to start the whole process over again. Withdraw and place the cap back on the needle.
7. 7. Now you are ready to inject the first syringe full of pH 12 STERILE DILUENT for FLOLAN into the cassette. To do this, uncap the cassette tubing. Carefully remove the needle from the syringe, discard in an appropriate manner and attach the syringe to the cassette tubing. Unclamp the cassette tubing and then carefully inject the solution into the cassette. When the syringe is empty, clamp the cassette tubing near the syringe, disconnect the syringe and cap the cassette tubing. You will repeat this same process to transfer the contents of the required pH 12 STERILE DILUENT for FLOLAN vial as specified by your healthcare professional into the cassette.
8. 8. After you have completed the transfer of all the required pH 12 STERILE DILUENT for FLOLAN, leave the syringe attached to the cassette tubing while you mix the solution. Gently invert the cassette at least 10 times, thoroughly mixing the FLOLAN. Now you need to remove all the air from the cassette.
9. 9.

   In order to remove the air inside the cassette, first you have to collect the air bubbles. Simply rotate the cassette around until all of the small bubbles join to form one big air pocket. Then tilt the cassette carefully so that the air pocket is in the corner where the tubing connects to the bag. To remove the air from the cassette, unclamp the tubing and pull back the plunger of the syringe until you see fluid fill the tubing. Then clamp the tubing near the connector, disconnect it and cap it with the red cap. To avoid any confusion, label the cassette with the date and time you made up the FLOLAN.

   Put the cassette into the refrigerator until it is time to use it. Store it on the top shelf to avoid spilling any food or drink onto your cassette. Always have a back-up cassette that is ready for use.

You may prepare extra cassettes, DO NOT use cassettes that have been stored in the refrigerator for more than 8 days. The use of a ‘cold pouch’ is not required for reconstituted solutions. When stored or in use, FLOLAN solution must be protected from light.

Steps for Administering FLOLAN for Injection by a Continuous Infusion Pump

You will use a pump to receive medication by continuous delivery. The instructions for use may vary depending on the particular make and model of the pump you are using. To avoid any potential interruptions in FLOLAN delivery, you should have access to a back-up infusion pump and intravenous infusion sets.

Your healthcare professional will give detailed instructions on how to use and care for the specific pump and accessories that you will use for administering the medicine (including changing the pump battery, cassette and tubing).

Steps for Caring for the Central Venous Catheter

Change the dressing on the catheter exit site 1 to 2 times per week or more frequently if needed. You will need the following equipment: dressing set, 2 sterile containers, povidone-iodine antiseptic solution, gauze swabs, 70% alcohol, povidone-iodine antiseptic ointment, sterile cotton swabs, adhesive tape (non- allergenic), transparent dressing 10 cm x 12 cm or 6 cm x 7 cm.

Maintain sterile technique at all times. If you suspect that you have contaminated anything, discard the equipment and begin again.

1. 1. Assemble equipment.
2. 2. Stabilize catheter while removing old transparent dressing.
3. 3. Open sterile dressing kit.
4. 4. Pour alcohol into sterile container.
5. 5. Pour povidone-iodine antiseptic solution into sterile container.
6. 6. Squeeze povidone-iodine antiseptic ointment onto sterile field.
7. 7. Open transparent dressings onto sterile field.
8. 8. Remove old transparent dressing.
9. 9. Clean the catheter exit site with povidone-iodine antiseptic solution soaked 2” x 2” gauze swabs, starting at the catheter exit site. Work outward in a circular extending motion extending to an 8 cm radius.
10. 10. Repeat step 9 three times.
11. 11. Never return to the catheter exit site using the same swab.
12. 12. Repeat steps 9 and 10 using an alcohol soaked 2” x 2” gauze swab.
13. 13. Apply povidone-iodine antiseptic ointment to the catheter exit site with a sterile cotton swab.
14. 14. Apply new sterile transparent dressing.
15. 15. Tape catheter to skin using ‘stress loop’.

Usual dose:

Your healthcare professional will decide how much FLOLAN you take and how long you take it for. The amount you are given is based on your body weight, and your type of illness. Your dose may be increased or decreased depending on how well you respond to treatment.

Take FLOLAN exactly as directed. Do not change your dose or stop taking FLOLAN without talking to your healthcare professional first. FLOLAN must be stopped gradually. If you abruptly stop your treatment, you may experience serious side effects.

Overdose:

Symptoms of overdose may include headache, nausea, vomiting, diarrhea, fast heart rate, warmth or tingling, or feeling like you might pass out (feeling faint/ dizziness), unconsciousness, or collapse.

What are possible side effects from using FLOLAN?

These are not all the possible side effects you may have when taking FLOLAN. If you experience any side effects not listed here, tell your healthcare professional.

• headache
• jaw pain
• diarrhea, nausea, vomiting
• stomach discomfort or pain, dry mouth
• pain (chest, bone, muscle and/or joint)
• feeling anxious, nervous, and/or agitated
• rash
• pain and/or redness at the injection site
• sweating, redness of your face (flushing)
• feeling tired, weak
• pale skin

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store unopened vials of FLOLAN powder at 15°C to 25 °C. Protect from light.
• Store vials of pH 12 STERILE DILUENT for FLOLAN at 15°C to 25° C. Do not freeze.
• Do not use FLOLAN or pH 12 STERILE DILUENT for FLOLAN after the expiry date on the label.

Reconstituted Solutions:

A ‘cold pouch’ is not required during administration. Freshly prepared reconstituted solutions or reconstituted solutions that have been stored in the refrigerator at 2°C to 8°C for no longer than 8 days can be administered up to:

• 48 hours at up to 25°C
• 36 hours at up to 30°C
• 24 hours at up to 35°C
• 12 hours at up to 40°C

Discard any unused solution after this time.

Do not freeze reconstituted solutions. Protect from light when stored or in use.

Keep out of reach and sight of children.

If you want more information about FLOLAN:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.gsk.ca, or by calling 1-800-387-7374.

Last Revised: MAR 26, 2024

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