Tildrakizumab: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 22, 2026🚩 Report this page

Tildrakizumab

Interleukin Inhibitors

Sold as Ilumetri · ILUMYA

GB MHRACA Health CanadaEU EMA

Drug class: Interleukin Inhibitors
Availability: See label
Routes: Subcutaneous
Markets covered: 3
Products on record: 8

L04ACInterleukin Inhibitors

Overview

Tildrakizumab is an active pharmaceutical ingredient in the Interleukin Inhibitors group (L04AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	5	May 22, 2026
CA Canada	Health Canada	2	January 23, 2026
EU European Union	EMA	1	May 7, 2026

GBUnited Kingdom· MHRA

5 products

Uses

GBOfficial regulatory label· revised April 17, 2026[1]

Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

How to take

GB

CACanada· Health Canada

2 products

Uses

CAOfficial regulatory label· revised August 7, 2025[2]

Ilumya® (tildrakizumab injection) is indicated for the treatment of adult patients with moderate- to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
4 Geriatrics).

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised May 7, 2026[3]

Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. 3

How to take

EU

Drug interactions

Known interactions involving Tildrakizumab. Select one for details. This list is informational and not a complete interaction checker.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB169730050 · revised April 17, 2026
[2]Health Canada (DPD) · 02516098 · revised August 7, 2025
[3]European Medicines Agency · EMEA/H/C/004514 · revised May 7, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised April 17, 2026[1]

3%). Tabulated list of adverse reactions Adverse reactions from clinical studies (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).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 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 Gastroenteritis Common Diarrhoea Common Gastrointestinal disorders Nausea Common Back pain CommonGeneral disorders and administration site conditions Injection site pain Common aIncluding nasopharyngitis.
Long-term Safety The safety profile of tildrakizumab observed during the long-term extensions periods of reSURFACE 1 and reSURFACE 2 was consistent with that of the double-blind periods. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised April 17, 2026[1]

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. 8). 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. 3). 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.
3). 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.
5). 5 mg/mL. Polysorbates may cause allergic reactions.

This is not medical advice. Consult a qualified healthcare professional.

1 Dosing Considerations • Ilumya (tildrakizumab injection) should be initiated and supervised by healthcare professionals experienced in the diagnosis and treatment of plaque psoriasis and familiar with the Ilumya efficacy and safety profile.
Patients may self-inject Ilumya if a healthcare professional determines that it is appropriate. 2 Recommended Dose and Dosage Adjustment The recommended dose of Ilumya is 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
Pediatrics (<18 years of age) Health Canada has not authorized an indication for pediatric use. Geriatrics (≥65 years of age) Safety and efficacy data in patients aged 65 years and older are limited. No dose adjustment is required. Duration of treatment Continuation of Ilumya should be reconsidered if a patient has not responded within 28 weeks of treatment onset.
4 Administration Ilumya is administered by subcutaneous injection. Ilumya can be injected by a healthcare professional or, after proper training in subcutaneous injection technique, patients may self- inject Ilumya if a healthcare professional determines that it is appropriate.
However, the physician should ensure appropriate follow-up of patients. Full instructions for use are provided in the package leaflet. Ilumya® (tildrakizumab injection) Product Monograph Page 5 of 36 Injections should not be administered into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis.
Ilumya does not contain any preservatives. Therefore, discard any unused product remaining in the pre-filled syringes or pre-filled pens (see 11 STORAGE, STABILITY AND DISPOSAL). The full amount of Ilumya 100 mg pre-filled syringe or pre-filled pen should be injected for each dose according to the directions provided in the respective “Instructions for Use” document.
5 Missed Dose Patients who miss a dose of Ilumya should be advised to inject this missed dose as soon as they become aware of it, and then follow with their next scheduled dose.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised August 7, 2025[2]

2%). 0%). 6%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful for identifying and for approximating rates of adverse drug reactions in real-world use. The safety profile of Ilumya in patients with moderate to severe plaque psoriasis is based on pooled data from two phase 3 trials (reSURFACE 1 and reSURFACE 2).
A total of 1255 plaque psoriasis subjects were exposed to Ilumya 100 mg or 200 mg in these 2 trials (see 14 CLINICAL TRIALS). Of these, 642 subjects were exposed for at least 52 weeks, 587 for at least 78 weeks, 469 for at least 104 weeks, and 271 for at least 256 weeks to Ilumya 100 mg.
Table 2 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the Ilumya 100 mg group than the placebo group during the 12-week, placebo- controlled period of the pooled clinical trials, reSURFACE 1 and reSURFACE 2.
1. 9% in subjects Ilumya® (tildrakizumab injection) Product Monograph Page 9 of 36 treated with Ilumya 100 mg. 3% of subjects treated with placebo. 443 subjects per patient-year of exposure. 009 subjects treated with Ilumya 100 mg per patient-year of exposure.
7% of subjects treated with Ilumya 100 mg. 009 subjects treated with Ilumya 100 mg per patient-years of exposure) occurred in subjects treated in plaque psoriasis clinical trials with Ilumya 100 mg for up to 64 weeks (see 7 WARNINGS AND PRECAUTIONS, Immune, Hypersensitivity).
In the open-label, uncontrolled, extension period of the two Phase 3 clinical trials, no cases of drug-related anaphylaxis were reported. Two cases of drug-related hypersensitivity reactions (urticaria), were reported in subjects treated with 100 mg.
Immunogenicity As with all therapeutic proteins there is the potential for immunogenicity with Ilumya. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Comparison of incidence of antibodies between products by different tests may be misleading.
3% (51/615) of subjects developed antibodies to tildrakizumab. Of the subjects who developed anti-drug antibodies, 37% (19/51, or 3% of all subjects receiving Ilumya 100 mg) had neutralizing antibodies. Presence of neutralizing antibodies was associated with lower tildrakizumab concentrations and reduced efficacy.
Adverse Reactions through Weeks 52 and 64 and the extension period Through Week 52 (Phase 2b and reSURFACE 2) and Week 64 (reSURFACE 1), the types and the frequency of the adverse reactions in the Ilumya-treated patients were similar to that observed during the first 12 weeks of treatment.
6% […]

CAOfficial regulatory label· Warnings and precautions· revised August 7, 2025[2]

Infections Ilumya is an immunomodulatory agent which has the potential to increase the risk of infection. In clinical trials, there was no increased risk of infection in subjects treated with Ilumya relative to placebo; however, patients with active infections or a history of recurrent infections were not included in clinical trials.
Ilumya should not be given to patients with any clinically important Route of Administration Dosage Form / Strength/Composition Non-Medicinal Ingredients Subcutaneous (SC) injection Sterile solution in a single- dose pre-filled syringe or pre-filled pen (100 mg / 1 mL) L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, water for injection Ilumya® (tildrakizumab injection) Product Monograph Page 6 of 36 active infection until the infection resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent infection, the risks and benefits should be considered prior to prescribing Ilumya. Patients should be instructed to seek medical advice if signs or symptoms of a clinically important infection occur.
2 Clinical Trial Adverse Reactions). Pre-treatment Evaluation for Tuberculosis Ilumya must not be given to patients with active tuberculosis (TB). Evaluate patients for TB infection according to the Canadian TB Standards prior to initiating treatment with Ilumya.
Initiate treatment of latent TB prior to initiating treatment with Ilumya. Consider anti-TB therapy prior to initiation of Ilumya in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Patients receiving Ilumya should be monitored closely for signs and symptoms of active TB during and after treatment. Immune Hypersensitivity Non-serious cases of urticaria occurred in Ilumya treated subjects in clinical trials. If a serious hypersensitivity reaction occurs, administration of Ilumya should be discontinued immediately and appropriate therapy initiated.
As with all therapeutic proteins including Ilumya, there is a potential for anaphylaxis. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue the administration of Ilumya and initiate appropriate medical treatment.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised May 7, 2026[3]

3%). Tabulated list of adverse reactions Adverse reactions from clinical studies (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).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 6 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 Diarrhoea Common Nausea Common General disorders and administration site conditions Back pain Common Injection site pain Common aIncluding nasopharyngitis.
Long-term Safety The safety profile of tildrakizumab observed during the long-term extensions periods of reSURFACE 1 and reSURFACE 2 was consistent with that of the double-blind periods. 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 via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised May 7, 2026[3]

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. 8). 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. 3). 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.
3). 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.
5). 5 mg/mL. Polysorbates may cause allergic reactions.

This is not medical advice. Consult a qualified healthcare professional.