Epoprostenol

Source: UK SPC (eMC) for Epoprostenol 1.5 mg powder for solution for infusion, §4.2 (https://www.medicines.org.uk/emc/product/13446/smpc). Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension; short-term dose ranging must be conducted in a hospital with adequate resuscitation equipment. DOSAGE ADJUSTMENT: increase the infusion rate by 1 to 2 nanograms/kg/min increments at intervals of at least 15 min; the need for increases from the initial long-term dose should be expected over time. Decreases should be made gradually in 2 nanograms/kg/min decrements every 15 min or longer until dose-limiting effects resolve. Abrupt withdrawal or sudden large reductions in infusion rate must be avoided because of the risk of a potentially fatal rebound effect; except in life-threatening situations, rates should be adjusted only under the direction of a physician. SEPARATE INDICATION IN THE SAME SPC — RENAL DIALYSIS (continuous infusion only, intravascularly or into the blood supplying the dialyser; a DIFFERENT indication from PAH, do not apply its ceiling to PAH): prior to dialysis 4 nanograms/kg/min intravenously for 15 mins; during dialysis 4 nanograms/kg/min into the arterial inlet of the dialyser; stop the infusion at the end of dialysis. 'The recommended dose for renal dialysis should be exceeded only with careful monitoring of patient blood pressure.' ELDERLY: there is no specific information in patients over 65 years for either indication; dose selection should be made carefully. ADMINISTRATION: only extension sets with an in-line 0.22 micron filter placed between the infusion pump and the central venous catheter must be used (a hydrophilic polyethersulfone membrane is recommended); the extension set and in-line filter must be changed at least every 48 hours. The reconstituted solution must be examined before further dilution (do not use if discoloured or containing particles) and further diluted to the final concentration within one hour of reconstitution. Because of the high pH of the final infusion solutions (pH 12.0 at 90,000 ng/ml down to pH 11.0 at 3,000 ng/ml), peripheral intravenous use should be restricted to short duration only using low concentrations, and extravasation avoided. §4.5 was not retrieved in this bundle — the interactions listed come from the US FDA label §7 plus the eMC §4.4 statement on bleeding risk; verify the full §4.5.