Spevigo Special Precautions

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.
Infections: Spesolimab may increase the risk of infections (see Adverse Reactions).
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 after treatment with spesolimab.
Pre-treatment evaluation for tuberculosis: Prior to initiating treatment with spesolimab, patients should be evaluated for tuberculosis (TB) infection. Spesolimab is contraindicated to patients with active TB infection (see Contraindications).
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. After spesolimab treatment, patients should be monitored for signs and symptoms of active TB.
Hypersensitivity and infusion-related reactions: Hypersensitivity and infusion-related 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).
If a patient develops signs of anaphylaxis or other serious hypersensitivity, spesolimab treatment should be discontinued immediately and appropriate treatment should be initiated (see Contraindications).
If a patient develops mild or moderate hypersensitivity during the infusion, treatment should be stopped and appropriate medical therapy should be considered (e.g., systemic anti-histamines and/or corticosteroids). Upon resolution of the reaction, the infusion may be restarted at a slower infusion rate with gradual increase to complete the infusion (see Dosage & Administration).
Use in patients with an immediate, life-threatening GPP flare: 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: The safety and efficacy of spesolimab in combination with immunosuppressants, including biologics, have not been evaluated systematically (see Interactions). In the GPP flare treatment clinical study, there was a washout period for most other treatments (biologics, other systemic immunomodulating treatments), while some treatments were discontinued before initiation of spesolimab treatment with no washout period required (methotrexate, cyclosporine, retinoids, topical treatments) (see Pharmacology: Pharmacodynamics under Actions).
Concomitant use of other immunosuppressants and spesolimab is not recommended. At initiation of spesolimab treatment, other GPP treatments should be stopped and other treatments (e.g. with systemic immunosuppressants) should not be used concomitantly to treat the flare.
Re-treatment: Very limited efficacy and safety data are available for re-treatment with spesolimab for a subsequent new flare. Data are available for five patients with GPP who received re-treatment at a subsequent new flare and followed up for a minimum of 8 weeks.
Immunisations: It is unknown whether spesolimab affects the efficacy of vaccines.
No data are available on the potential secondary transmission of infection by live vaccines in patients receiving spesolimab (see Interactions). The interval between live vaccinations and initiation of spesolimab therapy should be at least 4 weeks. Live vaccines should not be administered for at least 16 weeks after treatment with spesolimab.
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.
Excipients: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium free'.
Effects on ability to drive and use machines: Spevigo has no or negligible influence on the ability to drive and use machines.