Omvoh · 4.5 Interaction with other medicinal products and other forms of interaction · 2

HOS-099193 · has-adverse-reaction-information · PDF-Seite 6

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). 6 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 Common Arthralgia Tissue Disorders Nervous system disorders Common Headache Skin and subcutaneous tissue Common Rashb disorders General disorders and Very common Injection site reactionsc administration site conditions 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. 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 h

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HOS-099199 · has-adverse-reaction-information · PDF-Seite 27

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). 27 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 Common Arthralgia Tissue Disorders Nervous system disorders Common Headache Skin and subcutaneous tissue Common Rashb disorders General disorders and Very common Injection site reactionsc administration site conditions 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. 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

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HOS-099195 · has-contraindication-information · PDF-Seite 25

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

HOS-099189 · has-contraindication-information · PDF-Seite 4

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

HOS-099194 · has-indication-information · PDF-Seite 23

Ulcerative colitis 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. 23 Crohn’s disease Omvoh is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.

HOS-099188 · has-indication-information · PDF-Seite 2

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

HOS-099197 · has-interaction-information · PDF-Seite 27

No interaction studies have been performed. In clinical studies, concomitant use of corticosteroids or oral immunomodulators did not influence the safety of mirikizumab. Population pharmacokinetic data analyses indicated that the clearance of mirikizumab was not impacted by concomitant administration of 5-ASAs (5-aminosalicylic acid), corticosteroids or oral immunomodulators (azathioprine, 6-mercaptopurine, thioguanine, and methotrexate).

HOS-099191 · has-interaction-information · PDF-Seite 6

No interaction studies have been performed. In clinical studies, concomitant use of corticosteroids or oral immunomodulators did not influence the safety of mirikizumab. Population pharmacokinetic data analyses indicated that the clearance of mirikizumab was not impacted by concomitant administration of 5-ASAs (5-aminosalicylic acid), corticosteroids or oral immunomodulators (azathioprine, 6-mercaptopurine, thioguanine, and methotrexate).

HOS-099198 · has-pregnancy-information · PDF-Seite 27

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).

HOS-099192 · has-pregnancy-information · PDF-Seite 6

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).

HOS-099196 · has-warning-information · PDF-Seite 25

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 25 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 accordi

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HOS-099190 · has-warning-information · PDF-Seite 4

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 4 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 accordi

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