Omvoh is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.

This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of ulcerative colitis. Omvoh 100 mg solution for injection should only be used for the subcutaneous maintenance doses. Posology The recommended mirikizumab dose regimen has 2 parts. Induction dose The induction dose is 300 mg by intravenous infusion for at least 30 minutes at weeks 0, 4 and 8. (See Summary of Product Characteristics for Omvoh 300 mg concentrate for solution for infusion, section 4.2.) Maintenance dose The maintenance dose is 200 mg (i.e. two pre-filled syringes or two pre-filled pens) by subcutaneous injection every 4 weeks after completion of induction dosing. Patients should be evaluated after the 12-week induction dosing and if there is adequate therapeutic response, transition to maintenance dosing. For patients who do not achieve adequate therapeutic benefit at week 12 of induction dosing, mirikizumab 300 mg by intravenous infusion may be continued at weeks 12, 16 and 20 (extended induction therapy). If therapeutic benefit is achieved with the additional intravenous therapy, patients may initiate mirikizumab subcutaneous maintenance dosing (200 mg) every 4 weeks, starting at week 24. Mirikizumab should be discontinued in patients who do not show evidence of therapeutic benefit to extended induction therapy by week 24. Patients with loss of therapeutic response during maintenance treatment may receive 300 mg mirikizumab by intravenous infusion every 4 weeks, for a total of 3 doses (re- induction). If clinical benefit is achieved from this additional intravenous therapy, patients may resume mirikizumab subcutaneous dosing every 4 weeks. The efficacy and safety of repeated re-induction therapy have not been evaluated. Missed dose In case of a missed dose, instruct patients to inject as soon as possible. Thereafter, resume dosing every 4 weeks. Special populations Elderly No dose adjustment is required (see section 5.2). There is limited information in subjects aged = 75 years. Renal or hepatic impairment Omvoh has not been studied in these patient populations. These conditions are generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered necessary (see section 5.2). Paediatric population The safety and efficacy of Omvoh in children and adolescents aged 2 to less than 18 years have not yet been established. No data are available. There is no relevant use of Omvoh in children below 2 years for the indication of ulcerative colitis. Method of administration For subcutaneous injection only. Sites for injection include the abdomen, thigh, and back of the upper arm. After training in subcutaneous injection technique, a patient may self-inject with mirikizumab. Patients should be instructed to inject in a different location every time. For example, if the first injection was in the abdomen, the second injection—to complete a full dose—could be in another area of the abdomen.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clinically important active infections (active tuberculosis).

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. Hypersensitivity reactions In clinical studies, hypersensitivity reactions have been reported. Most were mild or moderate, severe reactions were uncommon (see section 4.8). If a serious hypersensitivity reaction, including anaphylaxis, occurs, mirikizumab must be discontinued immediately and appropriate therapy must be initiated. Infections Mirikizumab may increase the risk of severe infection (see section 4.8). Treatment with mirikizumab should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated (see section 4.3). The risks and benefits of treatment should be considered prior to initiating use of mirikizumab in patients with a chronic infection or a history of recurrent infection. Patients should be instructed to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops, discontinuation of mirikizumab should be considered until the infection resolves. Pre-treatment evaluation for tuberculosis Prior to initiating treatment, patients should be evaluated for tuberculosis (TB) infection. Patients receiving mirikizumab should be 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. Hepatic enzyme elevations Cases of drug-induced liver injury (including one case meeting Hy’s Law criteria) occurred in patients receiving mirikizumab in clinical trials. Liver enzymes and bilirubin should be evaluated at baseline and monthly during induction (including extended induction period, if applicable). Thereafter, liver enzymes and bilirubin should be monitored (every 1 - 4 months) according to standard practice for patient management and as clinically indicated. If increases in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) are observed and drug-induced liver injury is suspected, mirikizumab must be discontinued until this diagnosis is excluded. Immunisations Prior to initiating therapy with mirikizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. Avoid use of live vaccines in patients treated with mirikizumab. No data are available on the response to live or non-live vaccines. Excipients with known effect Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 200 mg dose, that is to say essentially “sodium-free”. Polysorbate This medicinal product contains 0.3 mg/mL of polysorbate 80 in each pen or syringe which is equivalent to 0.6 mg for the maintenance dose. Polysorbates may cause allergic reactions.

No

Women of childbearing potential Women of childbearing potential should use an effective method of contraception during treatment and for at least 10 weeks after treatment. Pregnancy There is a limited amount of data from the use of mirikizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Omvoh during pregnancy. Breast-feeding It is unknown whether mirikizumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast- fed infant cannot be excluded during this short period. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Omvoh therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Fertility The effect of mirikizumab on human fertility has not been evaluated (see section 5.3).

Omvoh has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile The most frequently reported adverse reactions are upper respiratory tract infections (9.8 %, most frequently nasopharyngitis), headache (3.2 %), rash (1.3 %) and injection site reactions (10.8 %, maintenance period). Tabulated list of adverse reactions Adverse reactions from clinical studies (Table 1) are listed by MedDRA system organ class. The frequency category for each reaction is based on 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). Table 1: Adverse reactions MedDRA System organ class Frequency Adverse reaction Common Upper respiratory tract infectionsa Infections and infestations Uncommon Herpes zoster Immune system disorders Uncommon Infusion-related hypersensitivity reactions Musculoskeletal and Connective Tissue Disorders Common Arthralgia Nervous system disorders Common Headache Skin and subcutaneous tissue disorders Common Rashb Very common Injection site reactionsc General disorders and administration site conditions Uncommon Infusion site reactionsd Uncommon Alanine aminotransferase increased Investigations Uncommon Aspartate aminotransferase increased a Includes: acute sinusitis, COVID-19, nasopharyngitis, oropharyngeal discomfort, oropharyngeal pain, pharyngitis, rhinitis, sinusitis, tonsillitis, upper respiratory tract infection, and viral upper respiratory tract infection. b Includes: rash, rash macular, rash maculo-papular, and rash papular and rash pruritic. c Reported during mirikizumab maintenance therapy where mirikizumab treatment is administered as subcutaneous injection. d Reported during mirikizumab induction therapy where mirikizumab treatment is administered as intravenous infusion. Description of selected adverse reactions Infusion-related hypersensitivity reactions (induction therapy) Infusion-related hypersensitivity reactions were reported in 0.4 % of mirikizumab-treated patients. All infusion-related hypersensitivity reactions were reported as non-serious. Injection site reactions (maintenance therapy) Injection site reactions were reported in 10.8 % of mirikizumab-treated patients. The most frequent reactions were injection site pain, injection site reaction and injection site erythema. These symptoms were reported as non-serious, mild and transient in nature. The results described above were obtained with the original formulation of Omvoh. In a double blind, 2-arm, randomised, single-dose, parallel design study in 60 healthy subjects comparing 200 mg mirikizumab (2 injections of 100 mg in a pre-filled syringe) of the original formulation with the revised formulation statistically significantly lower VAS pain scores were obtained with the revised (12.6) vs. the original formulation (26.1) 1 minute after injection. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) increased In the first 12 weeks, ALT increased was reported in 0.6 % mirikizumab-treated patients. AST increased was reported by 0.4 % mirikizumab-treated patients. All adverse reactions were reported as mild to moderate in severity and non-serious. Over all mirikizumab treatment periods in the ulcerative colitis and Crohn’s disease clinical development program (including the placebo-controlled and open label induction and maintenance periods), there have been elevations of ALT to = 3 x upper limit of normal (ULN) (2.3 %), = 5 x ULN (0.7 %) and = 10 x ULN (0.2 %) and AST to = 3 x ULN (2.2 %), = 5 x ULN (0.8 %) and = 10 x ULN (0.1 %) in patients receiving mirikizumab (see section 4.4). These elevations have been noted with and without concomitant elevations in total bilirubin. Immunogenicity In the ulcerative colitis studies, up to 23 % of mirikizumab-treated patients with 12 months of treatment developed anti-drug antibodies, most of which were of low titer and tested positive for neutralising activity. Higher antibody titers in approximately 2 % of subjects treated with mirikizumab were associated with lower serum mirikizumab concentrations and reduced clinical response. In the Crohn’s disease study, 12.7% of mirikizumab-treated patients with 12 months of treatment developed anti-drug antibodies, most of which were of low titer and tested positive for neutralising activity. There was no identified clinically significant effect of anti-drug antibodies on pharmacokinetics or effectiveness of mirikizumab. No association was found between anti-mirikizumab antibodies and hypersensitivity or injection-related events in either the ulcerative colitis or the Crohn’s disease studies. 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 Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Mirikizumab doses up to 2 400 mg intravenously and up to 500 mg subcutaneously have been administered in clinical trials without dose-limiting toxicity. In the event of , the patient must be monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment must be started immediately.

Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC24 Mechanism of action Mirikizumab is a humanised IgG4 monoclonal, anti-interleukin-23 (anti-IL-23) antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its

There was no apparent accumulation in serum mirikizumab concentration over time when given subcutaneously every 4 weeks. Exposure Ulcerative colitis Mean (coefficient of variation in %) Cmax and area under the curve (AUC) after induction dosing (300 mg every 4 weeks administered by intravenous infusion) in patients with ulcerative colitis were 99.7 µg/mL (22.7 %) and 538 µg*day/mL (34.4 %), respectively. The mean (CV %) Cmax and AUC after maintenance dosing (200 mg every 4 weeks by subcutaneous injection) were 10.1 µg/mL (52.1 %) and 160 µg*day/mL (57.6 %), respectively. Crohn’s disease Mean (coefficient of variation in %) Cmax and area under the curve (AUC) after induction dosing (900 mg every 4 weeks administered by intravenous infusion) in patients with Crohn’s disease were 332 µg/mL (20.6 %) and 1820 µg*day/mL (38.1 %), respectively. The mean (CV %) Cmax and AUC after maintenance dosing (300 mg every 4 weeks by subcutaneous injection) were 13.6 µg/mL (48.1 %) and 220 µg*day/mL (55.9 %), respectively. Absorption Following subcutaneous dosing of mirikizumab for ulcerative colitis, median (range) Tmax was 5 (3.08-6.75) days post dose and geometric mean (CV%) absolute bioavailability of 44 % (34 %). Following subcutaneous dosing of mirikizumab for Crohn’s disease, median (range) Tmax was 5 (3 to 6.83) days post dose and geometric mean (CV%) absolute bioavailability was 36.3% (31%). Injection site location did not significantly influence absorption of mirikizumab. Distribution The geometric mean total volume of distribution was 4.83 L(21%) in patients with ulcerative colitis and 4.40 L (14%) in patients with Crohn’s disease. Biotransformation Mirikizumab is a humanised IgG4 monoclonal antibody and is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgGs. Elimination In the population PK analysis, geometric mean (CV %) clearance was 0.0229 L/hr (34 %) and the geometric mean half-life is approximately 9.3 days (40 %) in patients with ulcerative colitis. The geometric mean (CV%) clearance was 0.0202 L/hr (38 %) and the geometric mean (CV %) half-life is also approximately 9.3 days (26 %) in patients with Crohn’s disease. Clearance is independent of dose. Dose proportionality Mirikizumab exhibited linear pharmacokinetics with dose-proportional increase in exposure over a dose range of 5 to 2 400 mg given as an intravenous infusion or over a dose range of 120 to 400 mg given as a subcutaneous injection in patients with ulcerative colitis or Crohn’s disease or in healthy volunteers. Special populations Population pharmacokinetic analysis showed that age, sex, weight, or race/ethnicity did not have a clinically meaningful effect on the pharmacokinetics of mirikizumab (see also section 4.8, “immunogenicity”). Among the 1 362 subjects with ulcerative colitis exposed to mirikizumab in Phase 2 and Phase 3 studies, 99 (7.3 %) patients were 65 years or older and 11 (0.8 %) patients were 75 years or older. Renal or hepatic impairment Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic impairment on the pharmacokinetics of mirikizumab have not been conducted. In patients with ulcerative colitis, population pharmacokinetic analysis showed that creatinine clearance (range of 36.2 to 291 mL/min) or total bilirubin (range of 1.5 to 29 µmol/L) did not affect mirikizumab pharmacokinetics. In patients with Crohn’s disease, population pharmacokinetic analysis showed that creatinine clearance (range of 26.5 to 269 mL/min) or total bilirubin (range of 1.5 to 36 µmol/L) did not affect mirikizumab pharmacokinetics.

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction and development. Carcinogenesis / mutagenesis Non-clinical studies have not been conducted to evaluate the carcinogenic or mutagenic potential of mirikizumab. Impairment of fertility No reproductive organ weight or histopathology effects were observed in sexually mature cynomolgus monkeys that received mirikizumab once weekly for 26 weeks, at a dose of 100 mg/kg (at least 20 times the human maintenance dose).

Histidine Histidine monohydrochloride Sodium chloride Mannitol (E 421) Polysorbate 80 (E 433) Water for injections

Not applicable.

2 years. After dilution Chemical and physical in-use stability has been demonstrated for diluted infusion solution prepared with sodium chloride 9 mg/mL (0.9 %) solution for 96 hours at 2 °C to 8 °C of which not more than 10 hours are permitted at non- refrigerated temperatures not to exceed 25 ºC, starting from the time of vial puncture. Chemical and physical in-use stability has been demonstrated for diluted infusion solution prepared with 5 % glucose for 48 hours at 2 °C to 8 °C of which not more than 5 hours are permitted at non-refrigerated temperatures not to exceed 25 °C, starting from the time of vial puncture. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions. Keep the diluted solution away from direct heat or light. Do not freeze the diluted solution.

Store in a refrigerator (2 ºC – 8 ºC). Do not freeze. Store in the original package in order to protect from light. Omvoh may be stored unrefrigerated for up to 2 weeks at a temperature not above 30 ºC. If these conditions are exceeded, Omvoh must be discarded.

Omvoh 100 mg solution for injection in pre-filled syringe 1 mL solution in a type I clear glass syringe. The syringe is encased in a disposable, single-dose syringe with bromobutyl rubber plunger. Pack sizes: • packs of 2 pre-filled syringes • multipacks containing 6 (3 packs of 2) pre-filled syringes. Not all pack sizes may be marketed.

For single use only. Omvoh should not be used if particles appear or if the solution is cloudy and/or distinctly brown. Do not use Omvoh that has been frozen. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Feb. 16, 2026

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