Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Almirall, S.A., Ronda General Mitre, 151, 08022, Barcelona, Spain
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Clinically important active infection, e.g. active tuberculosis (see section 4.4).
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Ilumetri has the potential to increase the risk of infection (see section 4.8). Caution should be exercised when considering the use of Ilumetri 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 Ilumetri should not be administered until the infection resolves.
Prior to initiating treatment with Ilumetri, patients should be evaluated for tuberculosis (TB) infection. Patients receiving Ilumetri should be closely monitored for signs and symptoms of active TB during and after treatment. Anti-TB therapy should be considered prior to initiating Ilumetri in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
If a serious hypersensivity reaction occurs, administration of Ilumetri should be discontinued immediately and appropriate therapy initiated.
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 Ilumetri should not receive live vaccines during treatment and for at least 17 weeks after treatment (see section 4.5).
No data are available on the response to live or inactivated vaccines. Live vaccines should not be given concurrently with Ilumetri (see section 4.4).
Concomitant medicines affecting Ilumetri pharmacokinetics are not expected since it is cleared from the body by general protein catabolism processes with no contribution of cytochrome P450 (CYP450) enzymes, and it is not eliminated by renal or hepatic pathways. Furthermore, Ilumetri does not impact the pharmacokinetics of concomitant medicines metabolized by CYP450 enzymes either through direct or indirect mechanisms (see section 5.2).
The safety and efficacy of Ilumetri in combination with other immunosupressive agents, including biologics, or phototherapy has not been evaluated.
Women of childbearing potential should use an effective method of contraception during treatment and for at least 17 weeks after treatment.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tildrakizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Ilumetri during pregnancy.
It is unknown whether tildrakizumab is excreted in human milk. Available toxicological data in cynomolgus monkey have shown negligible levels of Ilumetri in milk on postnatal day 28 (see section 5.3). In humans, during the first few days after birth antibodies may be transferred to the newborns through milk. In this short period, a risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ilumetri therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
The effect of Ilumetri on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Ilumetri has no or negligible influence on the ability to drive and use machines.
The most common adverse reactions are upper respiratory tract infections, headache, gastroenteritis, nausea, diarrhoea, injection site pain and back pain.
Three placebo-controlled studies (Phase 2b and two Phase 3) were integrated to evaluate the safety of Ilumetri in comparison to placebo. A total of 1,768 patients were evaluated (705 patients on 100 mg, 708 patients on 200 mg and 355 patients on placebo). These 355 patients on placebo were subsequently crossed over to tildrakizumab.
Adverse reactions (Table 1) are listed by MedDRA system organ class (SOC) and frequency, 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); and not known (cannot be estimated from available data).
Table 1. List of adverse reactions:
Very common: Upper respiratory tract infectionsa
Common: Headache
Common: Gastroenteritis, Nausea, Diarrhoea
Common: Injection site pain, Back pain
a Including nasopharyngitis.
In pooled Phase 2b and Phase 3 analyses 7.3% of Ilumetri-treated patients developed antibodies to Ilumetri. No apparent association between the development of antibodies to Ilumetri to lower efficacy and the development of treatment emergent adverse events was observed.
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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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