Spevigo Special Precautions

Traceability: In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file.
Infections: SPEVIGO may increase the risk of infections. During the 1-week placebo-controlled period in the Effisayil-1 trial, infections were reported in 17.1% of patients treated with SPEVIGO compared with 5.6% of patients treated with placebo (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 SPEVIGO. Treatment with SPEVIGO 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 SPEVIGO.
Pre-treatment evaluation for tuberculosis: Patients should be evaluated for tuberculosis (TB) infection prior to initiating treatment with SPEVIGO. SPEVIGO should not be administered to patients with active TB infection.
Anti-TB therapy should be considered prior to initiating SPEVIGO in patients with latent TB or a history of TB in whom an adequate course of treatment cannot be confirmed. After SPEVIGO 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 SPEVIGO. 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, SPEVIGO should be discontinued immediately and appropriate treatment should be initiated (see Contraindications).
If a patient develops mild or moderate infusion-related reaction, SPEVIGO should be stopped and appropriate medical therapy should be considered (e.g., systemic antihistamines 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).
Immunisations: No specific studies have been conducted in patients who have recently received live viral or live bacterial vaccines. The interval between live vaccinations and initiation of SPEVIGO therapy should be at least 4 weeks. Live vaccines should not be administered for at least 16 weeks after treatment with SPEVIGO.
Peripheral neuropathy: The potential for peripheral neuropathy with SPEVIGO 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 900 mg 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.