SPEVIGO Concentrate for solution for infusion Ref.[50688] Active ingredients: Spesolimab

Treatment should be initiated and supervised by physicians experienced in the management of patients with inflammatory skin diseases.

Treatment can be initiated with the pre-filled syringe as a subcutaneous injection to prevent GPP flares (see Spevigo 150 mg solution for injection in pre-filled syringe Summary of Product Characteristics) or with an intravenous dose of spesolimab to treat a GPP flare.

Posology

The recommended dose for GPP flare treatment in adults and adolescents from 12 years of age and weighing at least 40 kg is a single dose of 900 mg (two 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.

Spevigo has not been studied in patients weighing less than 40 kg. Based on pharmacokinetic modelling and simulation, the recommended dose for adolescents from 12 years of age weighing ≥30 and <40 kg is a single dose of 450 mg (one vial of 450 mg) administered as an intravenous infusion (see section 5.2). If flare symptoms persist, an additional 450 mg dose (one vial of 450 mg) 3 may be administered 1 week after the initial dose.

Clinical data for treatment of subsequent flares is very limited (see section 4.4).

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).

Special populations

Elderly

No dose adjustment is required.

Renal or hepatic impairment

Spesolimab has not been formally 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 children less than 12 years of age has not been established. No data are available.

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).

For instructions on dilution of the medicinal product before administration, see section 6.6.

The highest dose of spesolimab administered in clinical trials was 1 200 mg intravenously or subcutaneously. Adverse reactions observed in subjects receiving single or repeated doses up to 1 200 mg were consistent with the known safety profile of spesolimab.

In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and symptomatic treatment be instituted as appropriate.

Unopened vial:

3 years.

After opening:

From a microbiological point of view, once opened, the medicinal product should be diluted and infused immediately.

After preparation of infusion:

Chemical and physical in-use stability of the diluted solution has been demonstrated for 24 hours at 2°C to 30°C.

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°C to 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.

Store in a refrigerator (2°C–8°C).

Do not freeze.

Store in the original package in order to protect from light.

Prior to use, the unopened vial may be kept at temperatures up to 30°C for up to 24 hours, if stored in the original package in order to protect from light.

For storage conditions after opening and dilution of the medicinal product, see section 6.3.

7.5 mL concentrate in a colourless 10 mL glass vial (type I glass), with a coated rubber stopper and aluminium crimp cap with blue plastic button.

Pack size of 2 vials.

This medicinal product is compatible with 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).

Handling instructions:

• The vial should be visually inspected before use. If the solution is cloudy, discoloured, or contains large or coloured particulates, the vial should be discarded.
• Spevigo is for single use only.
• Aseptic technique must be used to prepare the solution for infusion:
  • For the recommended dose of 900 mg, draw and discard 15 mL from a 100 mL container of sodium chloride 9 mg/mL (0.9%) solution for injection and replace slowly with 15 mL spesolimab sterile concentrate (two vials of 450 mg/7.5 mL).
  • For the recommended dose of 450 mg, draw and discard 7.5 mL from a 100 mL container of sodium chloride 9 mg/mL (0.9%) solution for injection and replace slowly with 7.5 mL spesolimab sterile concentrate (one vial of 450 mg/7.5 mL).
  • Mix gently before use. The diluted spesolimab 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 diluted spesolimab infusion solution, if the compatibility information above is considered. The line must be flushed with sodium chloride 9 mg/mL (0.9%) solution for injection prior to and at the end of infusion. No other infusion should be administered in parallel via the same intravenous access.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.