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FLOLAN- epoprostenol sodium injection, powder, lyophilized, for solutionDILUENT- water solution


  1. Patient Information
  2. Advise Patients:
  3. What Is Flolan?
  4. Before You Use Flolan, You Must Mix (reconstitute) Flolan Powder With A Diluent. There Are 2 Different Types Of Diluents:
  5. Flolan Can Cause Serious Side Effects, Including:
  6. The Most Common Side Effects Of Flolan Include:
  7. How Should I Store And Use Flolan?
  8. How To Store Mixed Solutions Of Flolan:
  9. If You Are Using Sterile Diluent For Flolan (comes In A Glass Bottle) For Mixing:
  10. If The Mixed Solution Will Be Used At Room Temperature:
  11. If The Mixed Solution Will Be Used With A Cold Pouch:
  12. If You Are Using Ph 12 Sterile Diluent For Flolan (comes In A Plastic Bottle) For Mixing:
  13. Active Ingredient:
  14. Inactive Ingredients:
  15. Usual Dose:
  16. Revised: 12/2018document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Advise Patients: 

FLOLAN must be reconstituted only with STERILE DILUENT for FLOLAN or pH 12 STERILE DILUENT for FLOLAN.
Reconstituted solution prepared with STERILE DILUENT for FLOLAN must be used with a cold pouch if not administered within 8 hours.
Reconstituted solutions prepared with pH 12 STERILE DILUENT for FLOLAN do NOT require use with a cold pouch.
FLOLAN is infused continuously through a permanent indwelling central venous catheter via a small, portable infusion pump. Thus, therapy with FLOLAN requires commitment by the patient to drug reconstitution, drug administration, and care of the permanent central venous catheter. Patients must adhere to sterile technique in preparing the drug and in the care of the catheter, and even brief interruptions in the delivery of FLOLAN may result in rapid symptomatic deterioration. A patient s decision to receive FLOLAN should be based upon the understanding that there is a high likelihood that therapy with FLOLAN will be needed for prolonged periods, possibly years. Consider the patient's ability to accept and care for a permanent intravenous catheter and infusion pump.
FLOLAN prepared with pH 12 STERILE DILUENT for FLOLAN must not be used with any preparation or administration materials containing PET or PETG. Only use materials provided by a healthcare provider or pharmacist.
To adjust infusion rates of FLOLAN only under the direction of a physician.
To avoid interruptions in drug delivery, the patient should have access to a backup infusion pump and intravenous infusion sets.
To contact their healthcare providers if any unusual bruising or bleeding develops.

Trademark is owned by or licensed to the GSK group of companies.

GlaxoSmithKline

Research Triangle Park, NC 27709

2018 GSK group of companies or its licensor.

FLL:8PI

PATIENT INFORMATION

FLOLAN (flow-lan)

(epoprostenol sodium)

for injection, for intravenous use

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.

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.

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 bottle)
Do not mix FLOLAN with any other diluent. You must use STERILE DILUENT for FLOLAN or pH 12 STERILE DILUENT for FLOLAN.
FLOLAN prepared with pH 12 STERILE DILUENT for FLOLAN must not be used with any preparation or administration materials containing polyethylene terephthalate (PET) or polyethylene terephthalate glycol (PETG). Only use materials provided by a healthcare provider or pharmacist.
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.

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: 

dizziness
jaw pain
headache
muscle or bone pain
nausea or vomiting

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 1-800-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: 

1.

If The Mixed Solution Will Be Used At Room Temperature: 

Use the mixed solution over a period ofno longer than 8 hoursafter mixingif not stored in the refrigerator.
If the mixed solution has been stored in the refrigerator, infuse it over a period ofno longer than 8 hours after removing it from the refrigerator.
You may store the mixed solution for up to40 hoursin the refrigerator.
Throw away any mixed solution if it has been refrigerated for more than 40 hours.
2.

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 You Are Using Ph 12 Sterile Diluent For Flolan (comes In A Plastic Bottle) For Mixing: 

3.
Freshly prepared mixed solutions may be stored in the refrigerator for up to8 days.
4.
Mixed solutions (freshly prepared or taken out of the refrigerator) are stable for up to3 daysat 77 F (25 C), up to2 daysat 86 F (30 C), up to1 dayat 95 F (35 C) or up to12 hoursat 104 F (40 C).
5.
FLOLAN mixed with pH 12 STERILE DILUENT for FLOLAN does not require use with a cold pouch.
6.
Throw away any mixed solution if it has been refrigerated for more than8 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 that you have. It may harm them.

This leaflet summarizes the most important information about FLOLAN. You can ask your healthcare provider or pharmacist for information about FLOLAN that is written for health professionals.

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.

GlaxoSmithKline

Research Triangle Park, NC 27709

Trademark is owned by or licensed to the GSK group of companies.

2018 GSK group of companies or its licensor.

FLL:5PIL

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 12/2018

PRINCIPAL DISPLAY PANEL

NDC 0173-0517-00

FLOLAN

(epoprostenol sodium)

for Injection

0.5 mg/vial (500,000 ng/vial)

Must be reconstituted. For intravenous infusion after dilution.

Note: Use only STERILE DILUENT for FLOLAN or pH 12 STERILE DILUENT for FLOLAN for reconstitution and dilution.

Rxonly

Single-Use Vial

Each vial contains epoprostenol sodium equivalent to 0.5 mg (500,000 ng) epoprostenol, 3.76 mg glycine, 2.93 mg sodium chloride, and 50 mg mannitol. Sodium hydroxide may have been added to adjust pH.

Usual Dose: 

See prescribing information.

Store at 15oand 25oC (59oto 77oF).

Do not accept if plastic overseal is missing or not securely fitted.

GlaxoSmithKline

RTP, NC 27709

Rev. 4/16

10000000140667

Flolan 1.5 mg label

PRINCIPAL DISPLAY PANEL

NDC 0173-0518-00

STERILE DILUENT for FLOLAN

Contains drug diluent for use only with FLOLAN(epoprostenol sodium) for Injection.

Each vial contains 94 mg Glycine, 73.3 mg sodium chloride, sodium hydroxide (added to adjust Ph), AND Water for Injection, USP.

For reconstitution information see package insert for FLOLAN(epoprostenol sodium) for Injection.

Store at 15 to 25 C (59 to 77 F).

DO NOT FREEZE.

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in England

10000000023966 Rev. 1/06
Flolan Diluent label

PRINCIPAL DISPLAY PANEL

NDC 0173-0857-02

pH 12 Sterile Diluent for FLOLAN

Use only with FLOLAN(epoprostenol sodium) for Injection

Single-Use Vial.

Discard Unused Portion

50 Ml

Rx only

For reconstitution information see package insert for FLOLAN(epoprostenol sodium) for Injection.

Store at 15 to 25 C (59 to 77 F).

DO NOT FREEZE.

Do not accept if plastic overseal is missing or not securely fitted.

GlaxoSmithKline, RTP, NC 27709

Made in England

10000000133560 Rev. 3/15
Flolan Diluent pH12 label
FLOLAN
epoprostenol sodium injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0173-0517
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPOPROSTENOL SODIUM(UNII: 4K04IQ1OF4) (EPOPROSTENOL - UNII:DCR9Z582X0)EPOPROSTENOL0.5 mg
Inactive Ingredients
Ingredient NameStrength
GLYCINE(UNII: TE7660XO1C)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
MANNITOL(UNII: 3OWL53L36A)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0173-0517-001 in 1 CARTON; Type 0: Not a Combination Product12/08/1995
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02044412/08/1995
FLOLAN
epoprostenol sodium injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0173-0519
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPOPROSTENOL SODIUM(UNII: 4K04IQ1OF4) (EPOPROSTENOL - UNII:DCR9Z582X0)EPOPROSTENOL1.5 mg
Inactive Ingredients
Ingredient NameStrength
GLYCINE(UNII: TE7660XO1C)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
MANNITOL(UNII: 3OWL53L36A)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0173-0519-001 in 1 CARTON; Type 0: Not a Combination Product12/08/1995
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02044412/08/1995
DILUENT
water solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0173-0518
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER(UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)WATER1 mL in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCINE(UNII: TE7660XO1C)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0173-0518-012 in 1 TRAY05/06/2003
150 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02044405/06/2003
DILUENT
water solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0173-0857
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER(UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)WATER1 mL in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCINE(UNII: TE7660XO1C)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0173-0857-022 in 1 TRAY04/01/2016
150 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02044404/01/2016
Labeler -GlaxoSmithKline LLC (167380711)

Revised: 12/2018document Id: 

fdc8a203-458f-4662-bd81-09783a8a936dSet id: 8e4b636e-ee9c-4111-779d-28c8369d283bVersion: 16Effective Time: 20181212GlaxoSmithKline LLC



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