OMVOH

This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of Crohn’s disease. Omvoh 100 mg solution for injection and Omvoh 200 mg solution for injection should only be used for the subcutaneous maintenance doses.

Posology The recommended mirikizumab dose regimen has 2 parts. v. 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. Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit by week 24. Missed dose In case of a missed dose, instruct patients to inject as soon as possible.

Thereafter, resume dosing every 4 weeks. 2). There is limited information in subjects aged ≥ 75 years. Renal or hepatic impairment Omvoh has not been studied in these patient populations. 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 Crohn’s disease. 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.

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 aIncludes: 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.

All adverse reactions were reported as mild to moderate in severity and non-serious. 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. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 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 300 mg dose, that is to say essentially “sodium-free”.

9 mg for the maintenance dose to treat Crohn’s disease. Polysorbates may cause allergic reactions.

1. Clinically important active infections (active tuberculosis).