Spevigo Dosage/Direction for Use

Treatment should be initiated and supervised by physicians experienced in the management of patients with inflammatory skin diseases.
Posology: The recommended dose is a single dose of 900 mg (2 vials of 450 mg) administered as an intravenous infusion.
If flare symptoms persist, an additional 900 mg dose may be administered 1 week after the initial dose.
Clinical data for treatment of subsequent flares is very limited (see Precautions).
Clinical data for concomitant use of other GPP treatments with spesolimab is limited. Spesolimab should not be used in combination with other GPP treatments, e.g. systemic immunosuppressants, to treat a flare (see Precautions and Interactions).
Elderly: No dose adjustment is required.
Renal or hepatic impairment: Spesolimab 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 spesolimab in adolescents aged 12 to 18 years have not yet been established. No data are available.
There is no relevant use of spesolimab in children below the age of 12 years.
Method of administration: This medicinal product is for intravenous infusion only. It should not be administered as an intravenous push or bolus.
Following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, it 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. No other infusion should be administered in parallel via the same intravenous access.
In the event that the infusion is slowed or temporarily stopped, the total infusion time (including stop time) should not exceed 180 minutes (see Precautions).
For instructions on dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.