nto account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
The effect of Ilumetri on human fertility has not been eva luated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
4.7 Effects on ability to drive and use machines
Ilumetri has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Summary of the safety profile
The most common adverse reactions are upper respiratory tract infections, headache, gastroenteritis, nausea, diarrhoea, injection site pain and back pain.
Tabulated list of adverse reactions
Three placebo-controlled studies (Phase 2b and two Phase 3) were integrated to eva luate the safety of Ilumetri in comparison to placebo. A total of 1,768 patients were eva luated (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
MedDRA System Organ Class
Preferred term
Frequency category
Infections and infestations
Upper respiratory tract infectionsa
Very common
Nervous system disorders
Headache
Common
Gastrointestinal disorders
Gastroenteritis
Common
Nausea
Common
Diarrhoea
Common
General disorders and administration site conditions
Injection site pain
Common
Back pain
Common
aIncluding nasopharyngitis.
Description of selected adverse reaction
Immunogenicity
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 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. Healthcare professionals are asked to report any suspected adverse reactions (see below).
United Kingdom
Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie.
4.9 Overdose
Doses up to 10 mg/kg intravenously have been safely administered in clinical trials.
In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and that appropriate symptomatic treatment be instituted immediately.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC17
Mechanism of action
Tildrakizumab is a humanized IgG1/k monoclonal antibody that specifically binds to the p19 protein subunit of the interleukin-23 (IL-23) cytokine without binding to IL-12 and inhibits its interaction with the IL-23 receptor.
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