Flolan - EPOPROSTENOL (Systemic) - Marketed Lyophilized Drug Products

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.