SPEVIGO

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 or with an intravenous dose of spesolimab to treat a GPP flare (see Spevigo 450 mg concentrate for solution for infusion Summary of Product Characteristics).

Posology The recommended dose for GPP flare prevention in adults and adolescents from 12 years of age and weighing at least 40 kg is a subcutaneous loading dose of 600 mg (either four 150 mg injections or two 300 mg injections), followed by 300 mg (either two 150 mg injections or one 300 mg injection) administered subcutaneously every 4 weeks.

Spevigo has not been studied in patients weighing less than 40 kg. 2). Clinical data on concomitant use of other GPP treatments with spesolimab is limited. 5). GPP flare treatment during subcutaneous GPP prevention treatment If a patient experiences a GPP flare while receiving subcutaneous Spevigo, the GPP flare may be treated with intravenous Spevigo (see Spevigo 450 mg concentrate for solution for infusion Summary of Product Characteristics).

Initiating or reinitiating subcutaneous GPP prevention treatment after intravenous GPP flare treatment Four weeks after treatment with intravenous Spevigo, subcutaneous Spevigo can be initiated or reinitiated. A subcutaneous loading dose is not required.

Missed dose If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time. 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.

Method of administration The injection should be administered subcutaneously in the upper thighs or abdomen. The pre-filled syringe should not be injected into areas where the skin is tender, bruised, erythematous, indurated, or scarred.

If multiple injections are required one right after the other, a different injection site should be chosen for each injection, at least 2 cm away from the other injection site. Adults and adolescents from 12 years of age and weighing at least 40 kg The 600 mg subcutaneous loading dose (see section Posology) should be administered by a healthcare professional.

For subsequent subcutaneous 300 mg doses, if the healthcare professional determines that it is appropriate, patients may self-inject or caregivers may administer the pre-filled syringe after proper training in subcutaneous injection technique.

For a complete 300 mg dose, either two 150 mg pre-filled syringes are required to be injected, one right after the other or one 300 mg pre-filled syringe is required to be injected. Detailed instructions for use are provided in the respective package leaflet.

Adolescents from 12 years of age weighing ≥ 30 and <40 kg Spevigo should be administered by a healthcare professional. For the 300 mg subcutaneous loading dose (see section Posology) either two 150 mg pre-filled syringes are required to be injected, one right after the other or one 300 mg pre-filled syringe is required to be injected.

For a subsequent 150 mg dose, one 150 mg pre-filled syringe is required to be injected.

2%) (see Description of selected adverse reactions). Tabulated list of adverse reactions Table 1 provides a list of the adverse reactions reported in clinical trials as well as in the post-marketing setting. The adverse reactions are listed by MedDRA System Organ Class (SOC) and frequency category using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (frequency cannot be estimated from the available data).

6% of patients treated with placebo. 9%) in the spesolimab group and no patient in the placebo group. 3% of patients treated with placebo. 2%) in the Spevigo group and no patient in the placebo group. Infections observed in clinical trials with spesolimab were generally mild to moderate with no distinct pattern regarding pathogen or type of infection.

Hypersensitivity Hypersensitivity comprises immediate systemic hypersensitivity reactions, including anaphylactic reaction. Immediate systemic hypersensitivity reactions have been reported in open-label extension trials and the post-marketing setting.

Injection site reactions Injection site reactions include erythema, swelling, pain, induration, warmth, exfoliation, papule, pruritus, rash, and urticaria at the injection site. Injection site reactions were typically mild to moderate in severity.

Paediatric population The available data for adolescents are limited. 1). Overall, the safety profile in adolescents treated with spesolimab (n=6) was consistent with the safety profile in adults and no new safety concerns have been identified.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). In patients with a chronic infection or a history of recurrent infection, the potential risks and expected clinical benefits of treatment should be considered prior to prescribing spesolimab.

Treatment with spesolimab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients should be instructed to seek medical advice if signs or symptoms of clinically important infection occur during or after treatment with spesolimab.

If a patient is on treatment with Spevigo subcutaneous injection for GPP flare prevention, and develops a clinically important active infection, treatment with Spevigo should be stopped. Re-initiation can be considered once the infection resolves or is adequately treated.

Pre-treatment evaluation for tuberculosis Prior to initiating treatment with spesolimab, patients should be evaluated for tuberculosis (TB) infection. 3). Anti-TB therapy should be considered prior to initiating spesolimab treatment in patients with latent TB, a history of TB or possible previous exposure to people with active tuberculosis in whom an adequate course of treatment cannot be confirmed.

During and after spesolimab treatment, patients should be monitored for signs and symptoms of active TB. Hypersensitivity reactions Hypersensitivity reactions may occur with monoclonal antibodies such as spesolimab. Hypersensitivity may include immediate reactions such as anaphylaxis and delayed reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS).

8). 3). Use in patients with an immediate, life-threatening GPP flare For the treatment of GPP flares, see Spevigo 450 mg concentrate for solution for infusion Summary of Product Characteristics. There is no experience from the use of spesolimab in patients with an immediate, life-threatening flare of GPP or a flare requiring intensive care treatment.

Concomitant use with other GPP treatments or immunosuppressants The safety and efficacy of spesolimab in combination with immunosuppressants, including biologics, have not been evaluated systematically. 1). Spesolimab is not recommended for use in combination with other GPP treatments.

To prevent the risk of GPP flares, tapering of previous treatments should be considered at initiation of spesolimab GPP prevention therapy. g. in case of worsening or after a flare) at the discretion of the treating physician. Immunisations It is unknown whether spesolimab affects the efficacy of vaccines.

5). The interval between live vaccinations and initiation of spesolimab therapy should be at least 4 weeks. Live vaccines should not be administered during and for at least 16 weeks after treatment with spesolimab. Prior to initiating spesolimab for GPP flare prevention, completion of all appropriate immunisations should be considered according to current immunisation guidelines.

Peripheral neuropathy The potential for peripheral neuropathy with spesolimab is unknown. Cases of peripheral neuropathy have been reported in clinical trials with spesolimab. Physicians should be vigilant for symptoms potentially indicative of new-onset peripheral neuropathy.

8 mg of polysorbate 20 in each 2 ml pre-filled syringe. Polysorbates may cause allergic reactions. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.

4). g. 4).