Ilumya 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: Tildrakizumab has the potential to increase the risk of infection (see Adverse Reactions).
Caution should be exercised when considering the use of tildrakizumab in patients with a chronic infection or a history of recurrent or recent serious infection.
Patients should be instructed to seek medical advice if signs or symptoms suggestive of a clinically relevant chronic or acute infection occur. If a patient develops a serious infection, the patient should be closely monitored and tildrakizumab should not be administered until the infection resolves (see Contraindications).
Pre-treatment evaluation for tuberculosis: Prior to initiating treatment, patients should be evaluated for tuberculosis (TB) infection. Patients receiving tildrakizumab should be closely monitored for signs and symptoms of active TB during and after treatment. Anti-TB therapy should be considered prior to initiating treatment in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Hypersensitivity: If a serious hypersensitivity reaction occurs, administration of tildrakizumab should be discontinued immediately and appropriate therapy initiated (see Contraindications).
Vaccinations: Prior to initiating treatment with tildrakizumab, consider completion of all appropriate immunisations according to current immunisation guidelines. If a patient has received live viral or bacterial vaccination it is recommended to wait at least 4 weeks prior to starting treatment with tildrakizumab. Patients treated with tildrakizumab should not receive live vaccines during treatment and for at least 17 weeks after treatment (see Interactions).
Excipients: This medicine contains 0.5 mg of polysorbate 80 (E 433) in each pre-filled syringe of 100 mg. Polysorbates may cause allergic reactions.
Effects on ability to drive and use machines: Tildrakizumab has no or negligible influence on the ability to drive and use machines.