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FLOLAN® is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Trials establishing effectiveness included predominantly (97%) patients with New York Heart Association (NYHA) Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (49%) or PAH associated with connective tissue diseases (51%).
DOSAGE AND ADMINISTRATION
Each vial is for single use only; discard any unused diluent or unused reconstituted solution.
Select a concentration for the solution of FLOLAN that is compatible with the infusion pump being used with respect to minimum and maximum flow rates, reservoir capacity, and the infusion pump criteria listed below.
Using aseptic technique, reconstitute FLOLAN only with STERILE DILUENT for FLOLAN or pH 12 STERILE DILUENT for FLOLAN. Table 1 gives directions for preparing several different concentrations of FLOLAN. See Table 2 for storage and administration time limits for the reconstituted FLOLAN.
Table 1: Reconstitution and Dilution Instructions for
FLOLAN Using STERILE DILUENT for FLOLAN or pH 12 STERILE DILUENT for FLOLAN.
|To make 100 mL of solution with final concentration of:||Directions:|
|3,000 ng/mL||Dissolve contents of one 0.5-mg vial with 5 mL of sterile diluent. Withdraw 3 mL and add to sufficient sterile diluent to make a total of 100 mL.|
|5,000 ng/mL||Dissolve contents of one 0.5-mg vial with 5 mL of sterile diluent. Withdraw entire vial contents and add sufficient sterile diluent to make a total of 100 mL.|
|10,000 ng/mL||Dissolve contents of two 0.5-mg vials each with 5 mL of sterile diluent. Withdraw entire vial contents and add sufficient sterile diluent to make a total of 100 mL.|
|15,000 ng/mLa||Dissolve contents of one 1.5-mg vial with 5 mL of sterile diluent. Withdraw entire vial contents and add sufficient sterile diluent to make a total of 100 mL.|
|aHigher concentrations may be prepared for patients who receive FLOLAN long-term.|
Table 2: Storage and
Administration Limits for Reconstituted FLOLAN
|When Using STERILE DILUENT for FLOLAN||When Using pH 12 STERILE DILUENT for FLOLAN|
|Stability||When used at room temperature, (15°C to 25°C; 59°F to 77°F) reconstituted solutions:
||Freshly prepared reconstituted solutions or reconstituted solutions that have been stored at 2°C to 8°C (36°F to 46°F) for no longer than 8 days can be administered up to:
|Reconstituted solutions can be
used immediately. Refrigerate at 2°C to 8°C (36°F to 46°F) if not used
Protect from light.
Do not freeze reconstituted solutions.
Initiate intravenous infusions of FLOLAN at 2 ng/kg/min. Alter the infusion by 1-to 2ng/kg/min increments at intervals sufficient to allow assessment of clinical response. These intervals should be at least 15 minutes.
During dose initiation, asymptomatic increases in pulmonary artery pressure coincident with increases in cardiac output may occur. In such cases, consider dose reduction, but such an increase does not imply that chronic treatment is contraindicated.
Base changes in the chronic infusion rate on persistence, recurrence, or worsening of the patient's symptoms of pulmonary hypertension and the occurrence of adverse vasodilatory reactions. In general, expect progressive increases in dose.
If dose-related adverse reactions occur, make dose decreases gradually in 2-ng/kg/min decrements every 15 minutes or longer until the dose-limiting effects resolve [see ADVERSE REACTIONS]. Avoid abrupt withdrawal of FLOLAN or sudden large reductions in infusion rates [see WARNINGS AND PRECAUTIONS].
Following establishment of a new chronic infusion rate, measure standing and supine blood pressure for several hours.
Initiate FLOLAN in a setting with adequate personnel and equipment for physiologic monitoring and emergency care.
Inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit. If either particulate matter or discoloration is noted, do not use.
Administer continuous chronic infusion of FLOLAN through a central venous catheter. Temporary peripheral intravenous infusion may be used until central access is established. Do not administer bolus injections of FLOLAN.
The ambulatory infusion pump used to administer FLOLAN should: (1) be small and lightweight, (2) be able to adjust infusion rates in 2-ng/kg/min increments, (3) have occlusion, end-of-infusion, and low-battery alarms, (4) be accurate to ±6% of the programmed rate, and (5) be positive-pressure-driven (continuous or pulsatile) with intervals between pulses not exceeding 3 minutes at infusion rates used to deliver FLOLAN. The reservoir should be made of polyvinyl chloride, polypropylene, or glass. Use a 60-inch microbore non-di-(2ethylhexyl)phthalate (DEHP) extension set with proximal antisyphon valve, low priming volume (0.9 mL), and in-line 0.22-micron filter.
To avoid interruptions in drug delivery, the patient should have access to a backup infusion pump and intravenous infusion sets.
Do not administer or dilute reconstituted solutions of FLOLAN with other parenteral solutions or medications. Consider a multi-lumen catheter if other intravenous therapies are routinely administered.
Select a concentration for the solution of FLOLAN that is compatible with the infusion pump being used with respect to minimum and maximum flow rates, reservoir capacity, and the infusion pump criteria listed above. When administered chronically, prepare FLOLAN in a drug delivery reservoir appropriate for the infusion pump with a total reservoir volume of at least 100 mL, using 2 vials of STERILE DILUENT for FLOLAN or 2 vials of pH 12 STERILE DILUENT for FLOLAN.
Generally, 3,000 ng/mL and 10,000 ng/mL are satisfactory concentrations to deliver between 2 to 16 ng/kg/min in adults. Higher infusion rates, and therefore, more concentrated solutions may be necessary with long-term administration of FLOLAN.
Infusion rates may be calculated using the following formula:
|Infusion Rate (mL/h) =||[Dose (ng/kg/min) x Weight (kg) x 60 min/h]|
|Final Concentration (ng/mL)|
Example calculations for infusion rates are as follows:
Example 1: for a 60-kg person at the recommended initial dose of 2 ng/kg/min using a 3,000-ng/mL concentration, the infusion rate would be as follows:
|Infusion Rate (mL/h)||[2 (ng/kg/min) x 60 (kg) x 60 (min/h)]||= 2.4 (mL/h)|
Example 2: for a 70-kg person at a dose of 16 ng/kg/min using a 15,000-ng/mL concentration, the infusion rate would be as follows:
|Infusion Rate (mL/h) =||[16 (ng/kg/min) x 70 (kg) x 60 (min/h)]||= 4.48 (mL/h)|
Dosage Forms And Strengths
For injection: 0.5 mg or 1.5 mg of epoprostenol, freeze-dried powder in a single-dose vial for reconstitution with the supplied diluent.
FLOLAN for injection is supplied as a sterile freeze-dried powder in 17-mL flint glass vials with gray butyl rubber closures.
STERILE DILUENT for FLOLAN is supplied in flint glass vials containing 50-mL diluent with fluororesin-faced butyl rubber closures with aluminum overseal and yellow plastic flip-off cap.
pH 12 STERILE DILUENT for FLOLAN is supplied in plastic vials containing 50-mL diluent with fluororesin-faced butyl rubber closures with aluminum overseal and lavender plastic flip-off cap.
|FLOLAN for injection||0.5-mg (500,000 ng) per vial, carton of 1||NDC 0173-0517-00|
|1.5-mg (1,500,000 ng) per vial, carton of 1||NDC 0173-0519-00|
|STERILE DILUENT for FLOLAN||50 mL per vial, carton of 2||NDC 0173-0518-01|
|pH 12 STERILE DILUENT for FLOLAN||50 mL per vial, carton of 2||NDC 0173-0857-02|
Storage And Handling
Proper storage and handling are essential to maintain the potency of FLOLAN for injection.
Unopened vials of FLOLAN powder are stable until the date indicated on the package when stored at room temperature, 15°C to 25°C (59°F to 77°F) and protected from light in the carton.
Unopened vials of STERILE DILUENT for FLOLAN and pH 12 STERILE DILUENT for FLOLAN are stable until the date indicated on the package when stored at room temperature, 15°C to 25°C (59°F to 77°F). DO NOT FREEZE.
Glaxo Smith Kline, Research Triangle Park, NC 27709. Revised: 04/2015
Last reviewed on RxList: 5/6/2015
This monograph has been modified to include the generic and brand name in many instances.
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