SPEVIGO CONCENTRATE FOR SOLUTION FOR INFUSION 450 MG/7.5 ML

INFUSION, SOLUTION CONCENTRATE

**4.2 Posology and method of administration** Treatment with SPEVIGO should be initiated and supervised by physicians experienced in the management of patients with inflammatory skin diseases. Posology The recommended dose of SPEVIGO is a single dose of 900 mg (2 x 450 mg/7.5 ml vials) administered as an intravenous infusion. If flare symptoms persist, an additional 900 mg dose may be administered 1 week after the initial dose. _Elderly patients_ No dose adjustment is required. There is limited information in patients aged 65 years and older. _Renal and/or hepatic impairment_ SPEVIGO has not been studied in these patient populations. These conditions are generally not expected to have any clinically relevant impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered necessary. _Paediatric population_ The safety and efficacy of SPEVIGO in children below the age of 18 years have not been established. No data are available. Method of administration SPEVIGO must be diluted before use (see section Instructions for use/handling). SPEVIGO is administered as a continuous intravenous infusion through an intravenous line containing a sterile, non-pyrogenic, low protein binding in-line filter (pore size of 0.2 micron) over 90 minutes. In the event that the infusion is slowed or temporarily stopped, the total infusion time (including stop time) should not exceed 180 minutes (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Instructions for use/handling Prior to use, the unopened vial may be kept at room temperature (up to 30°C) for up to 24 hours, if stored in the original package in order to protect from light. The vial should be visually inspected before use. SPEVIGO is a colourless to slightly brownish- yellow, clear to slightly opalescent solution. If the solution is cloudy, discoloured, or contains large or coloured particulates, the vial should be discarded. Aseptic technique must be used to prepare the solution for infusion. Draw and discard 15 ml from a 100 ml container of sterile 0.9% sodium chloride solution and replace slowly with 15 ml SPEVIGO (complete content from two vials of 450 mg/7.5 ml). Mix gently before use. The diluted SPEVIGO infusion solution should be used immediately. SPEVIGO must not be mixed with other medicinal products. A pre-existing intravenous line may be used for administration of SPEVIGO. The line must be flushed with sterile 0.9% sodium chloride solution prior to and at the end of infusion. No other infusion should be administered in parallel via the same intravenous access. SPEVIGO is for single-use only and does not contain preservatives. Chemical and physical in-use stability of the diluted solution has been demonstrated for 24 hours at 2–30°C followed by 3 hours infusion time. From a microbiological point of view the diluted solution for infusion should be used immediately. If not used immediately, in use storage conditions are the responsibility of the user and would normally not be longer than 24 hours at 2–8°C, unless dilution has taken place in controlled and validated aseptic conditions. For the time between preparation and start of administration the solution for infusion should be protected from light following local standard procedures. No incompatibilities have been observed between SPEVIGO and infusion sets composed of polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP). polybutadiene and polyurethane (PUR), and in-line filter membranes composed of polyethersulfone (PES, neutral and positively charged) and positively charged polyamide (PA).