"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
(epoprostenol sodium) for injection
Read this Patient Information before you start taking FLOLAN and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is FLOLAN?
FLOLAN is a prescription medicine used to treat people with certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of the lungs. FLOLAN can improve your ability to be physically active.
It is not known if FLOLAN is safe and effective in children.
Who should not use FLOLAN?
Do not use FLOLAN if you:
- have certain types of heart failure. Talk to your healthcare provider before using FLOLAN if you have heart failure.
- are allergic to FLOLAN or any of the ingredients in FLOLAN. See the end of this leaflet for a complete list of ingredients in FLOLAN.
What should I tell my healthcare provider before using FLOLAN?
Before you use FLOLAN, tell your healthcare provider if you:
- are allergic to any medicine.
- are pregnant or plan to become pregnant. It is not known if FLOLAN will harm your unborn baby. You and your healthcare provider should decide if you will use FLOLAN.
- are breastfeeding or plan to breastfeed. It is not known if FLOLAN passes into your breast milk. You and your healthcare provider should decide if you will take FLOLAN or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:
- a “water pill” (diuretic)
- a medicine for high blood pressure (hypertension)
- a blood thinner medicine (antiplatelet or anticoagulant medicine)
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist when you get a new medicine.
How should I use FLOLAN?
- FLOLAN should only be given by infusion through a catheter placed in a vein (intravenous infusion) using an infusion pump.
- Your first treatment will be given to you by your healthcare provider or nurse. This is so your healthcare provider can monitor you and find the best dose for you.
- If your healthcare provider decides that you or your caregiver can give infusions of FLOLAN at home, you or your caregiver will receive training on the right way to mix and infuse FLOLAN. Do not try to infuse FLOLAN until you have been shown the right way to infuse FLOLAN by your healthcare provider.
- 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.
- Use FLOLAN exactly as your healthcare provider tells you to.
- Do not change your dose or stop your infusion without talking to your healthcare provider. Stopping FLOLAN suddenly can cause serious side effects.
- You should have a backup infusion pump and extra supplies needed for your infusion of FLOLAN.
- Follow your healthcare provider's instructions for taking blood thinner medicines, if prescribed for you.
- Before you use FLOLAN, you must mix (reconstitute) FLOLAN
powder with a diluent. There are 2 different types of diluents:
- STERILE DILUENT for FLOLAN (comes in a glass bottle)
- pH 12 STERILE DILUENT for FLOLAN (comes in a plastic
Do not mix FLOLAN with any other diluent. You must use STERILE DILUENT for FLOLAN or pH 12 STERILE DILUENT for FLOLAN.
See “How should I store and use FLOLAN?” for more information about how to use and store FLOLAN the right way.
- A mixed solution of FLOLAN is clear and colorless. Do not use FLOLAN if the mixed solution looks discolored or cloudy, or if the solution has flakes or particles in it.
Using more than the prescribed dose of FLOLAN can lead to death. If you use more than the prescribed dose of FLOLAN, call your healthcare provider or go to the nearest emergency room right away.
What are the possible side effects of FLOLAN?
FLOLAN can cause serious side effects, including:
- Fluid in your lungs (pulmonary edema). If you develop pulmonary edema after starting FLOLAN, your healthcare provider will stop your treatment and you should not receive FLOLAN again.
- Worsening symptoms of pulmonary arterial hypertension (PAH) with a sudden decrease in the dose of FLOLAN. Do not change your dose of FLOLAN or stop your infusion without talking to your healthcare provider. If you suddenly stop or decrease your dose of FLOLAN you may develop worsening symptoms of your PAH, including shortness of breath, dizziness, weakness, or loss of strength.
- Widening of your blood vessels (vasodilation). Vasodilation reactions can happen after you start FLOLAN. These reactions are common and may cause low blood pressure (hypotension), flushing, nausea, vomiting, dizziness, and headache. Your healthcare provider should check your blood pressure regularly during treatment with FLOLAN, especially when you start FLOLAN and after your dose is changed.
- Increased risk for bleeding. FLOLAN affects how well your blood clots, so your risk for bleeding is increased. This is especially true if you have other risk factors for bleeding. Tell your healthcare provider if you develop any unusual bruising or bleeding.
The most common side effects of FLOLAN include:
- jaw pain
- muscle or bone pain
- nausea or vomiting
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of FLOLAN. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.
How should I store and use FLOLAN?
- Store FLOLAN powder at room temperature between 59°F to 77°F (15°C to 25°C).
- Protect FLOLAN powder from light. Keep unopened vial of FLOLAN in the carton until you are ready to mix.
- Store the STERILE DILUENT for FLOLAN and the pH 12 STERILE DILUENT for FLOLAN at room temperature, 59°F to 77°F (15°C to 25°C). Do not freeze.
- Vials of STERILE DILUENT for FLOLAN, and pH 12 STERILE DILUENT for FLOLAN are for one-time use only. Throw away any unused diluent.
- Throw away any vials of FLOLAN powder, STERILE DILUENT for FLOLAN, and pH 12 STERILE DILUENT for FLOLAN that are out of date or that you no longer need.
How to store mixed solutions of FLOLAN:
- Once FLOLAN and the diluent are mixed together, you may use right away or store in the refrigerator. Refrigerate at 36°F to 46°F (2°C to 8°C).
- Protect the mixed solution of FLOLAN from light until you are ready to use it.
- Do not freeze mixed solutions. Throw away any mixed
solution that has been frozen.
If you are using STERILE DILUENT for FLOLAN (comes in a glass bottle) for mixing:
- If the mixed solution will be used at room
- Use the mixed solution over a period of no longer than 8 hours after mixing if not stored in the refrigerator.
- If the mixed solution has been stored in the refrigerator, infuse it over a period of no longer than 8 hours after removing it from the refrigerator.
- You may store the mixed solution for up to 40 hours in the refrigerator.
- Throw away any mixed solution if it has been refrigerated for more than 40 hours.
- If the mixed solution will be used with a cold pouch:
- You may store the mixed solution in the refrigerator for up to 24 hours.
- Take the mixed solution out of the refrigerator and use
it with the cold pouch over a period of no longer than 24 hours. Change the
cold pouch every 12 hours.
The mixed solution may be kept either in the refrigerator or in the cold pouch, or a combination of the two, for no more than 48 hours. After 48 hours, throw away any mixed solution.
- If the mixed solution will be used at room temperature:
If you are using pH 12 STERILE DILUENT for FLOLAN (comes in a plastic bottle) for mixing:
- Freshly prepared mixed solutions may be stored in the refrigerator for up to 8 days.
- Mixed solutions (freshly prepared or taken out of the refrigerator) are stable for up to 3 days at 77°F (25°C), up to 2 days at 86°F (30°C), up to 1 day at 95°F (35°C) or up to 12 hours at 104°F (40°C).
- FLOLAN mixed with pH 12 STERILE DILUENT for FLOLAN does not require use with a cold pouch.
- Throw away any mixed solution if it has been refrigerated for more than 8 days.
Keep FLOLAN and all medicines out of the reach of children.
General information about the safe and effective use of FLOLAN
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use FLOLAN for a condition for which it was not prescribed. Do not give FLOLAN to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about FLOLAN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about FLOLAN that is written for health professionals.
For more information, go to www.FLOLAN.com or call 1-888-825-5249.
What are the ingredients in FLOLAN?
Active ingredient: epoprostenol sodium.
Inactive ingredients: glycine, mannitol, sodium chloride. Sodium hydroxide may have been added.
The STERILE DILUENT for FLOLAN and the pH 12 STERILE DILUENT for FLOLAN contain: glycine, sodium chloride, sodium hydroxide, and Water for Injection.
Last reviewed on RxList: 5/6/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Flolan Information
Flolan - User Reviews
Flolan User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.