SPEVIGO CONCENTRATE FOR SOLUTION FOR INFUSION 450 MG/7.5 ML [SIN16883P]
Active ingredients: SPEVIGO CONCENTRATE FOR SOLUTION FOR INFUSION 450 MG/7.5 ML
Last updated 24 April 2026
Product Info
SPEVIGO CONCENTRATE FOR SOLUTION FOR INFUSION 450 MG/7.5 ML
[SIN16883P]
Product information
Active Ingredient and Strength | SPESOLIMAB - 450 MG/7.5 ML |
Dosage Form | INFUSION, SOLUTION CONCENTRATE |
Manufacturer and Country | BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG - GERMANY |
Registration Number | SIN16883P |
Licence Holder | BOEHRINGER INGELHEIM SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | L04AC22 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Therapeutic indications
Spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy.
Dosing
4.2 Posology and method of administration
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 (two 450 mg/7.5 mL vials) administered as an intravenous infusion.
If flare symptoms persist, an additional 900 mg dose (two 450 mg/7.5 mL vials) may be administered 1 week after the initial dose.
Clinical data for treatment of subsequent flares is very limited (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
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 sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Elderly
No dose adjustment is required.
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 spesolimab in adolescents aged 12 to 18 years have not 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 section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
For instructions on dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Contraindications
4.3 Contraindications
Severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Clinically important active infections (e.g. active tuberculosis, see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).