Omvoh

This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of ulcerative colitis or Crohn’ disease. Omvoh 300 mg concentrate for solution for infusion should only be used for the induction dose.

3 Posology Ulcerative colitis 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. Maintenance dose The maintenance dose is 200 mg by subcutaneous injection every 4 weeks after completion of induction dosing.

It can be administered either as two pre-filled syringes or pre-filled pens of 100 mg each, or as one pre-filled syringe or pre-filled pen of 200 mg. 2 of the Summary of Product Characteristics for Omvoh 100 mg and Omvoh 200 mg solution for injection in pre-filled syringe and Omvoh 100 mg and Omvoh 200 mg solution for injection in pre-filled pen.

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. Crohn’s disease The recommended mirikizumab dose regimen has 2 parts. Induction dose The induction dose is 900 mg (3 vials of 300 mg each) by intravenous infusion for at least 90 minutes at weeks 0, 4 and 8.

e. one pre-filled syringe or pre-filled pen of 100 mg and one pre-filled syringe or pre-filled pen of 200 mg) by subcutaneous injection every 4 weeks after completion of induction dosing. The injections may be administered in any order.

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).

7 Table 1: Adverse reactions MedDRA System organ class Frequency Adverse reaction Infections and infestations Common Upper respiratory tract infectionsa 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 General disorders and administration site conditions Very common Injection site reactionsc Uncommon Infusion site reactionsd Investigations Uncommon Alanine aminotransferase increased 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.

4 % of mirikizumab-treated patients. All infusion-related hypersensitivity reactions were reported as non-serious. 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. 6) vs. 1) 1 minute after injection. 6 % mirikizumab-treated patients. 4 % mirikizumab-treated patients.

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.

8). If a serious hypersensitivity reaction, including anaphylaxis, occurs, mirikizumab must be discontinued immediately and appropriate therapy must be initiated. 8). 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 5 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.

1. Clinically important active infections (active tuberculosis).