Omvoh 100 mg/ml

/ Eli Lilly

Ulcerative colitis
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 (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.
Crohn’s Disease
Induction dose
The induction dose is 900 mg (3 vials of 300 mg each) by i.v. infusion for at least 90 minutes at weeks 0, 4 and 8.
Maintenance dose
The maintenance dose is 300 mg by subcutaneous injection every 4 weeks after completion of induction dosing. Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit by week 24.

Ulcerative colitis
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
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.

* Hypersensitivity to the active substance or to any of the excipients
* Clinically important active infections (active tuberculosis).

Hypersensitivity reactions
In clinical studies, hypersensitivity reactions have been reported. Most were mild or moderate, severe reactions were uncommon. 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. Treatment with mirikizumab
should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated.
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 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
Essentially “sodium-free”
This medicinal product contains 0.3 mg/mL of polysorbate 80 in each pen or syringe
See prescribing information for full details.

Very common: Injection site reactions
Common: Upper respiratory tract infections, Arthralgia, Headache, Rash.

No interaction studies have been performed

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. As a precautionary measure, it is preferable to avoid the use of this medical product during pregnancy.
Lactation: 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 therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Mirikizumab doses up to 2400 mg intravenously and up to 500 mg subcutaneously have been administered in clinical trials without dose-limiting toxicity. In the event of overdose, the patient must be monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment must be started immediately.

This medical product may be stored unrefrigerated for up to 2 weeks at a temperature not above 30 ºC. If these conditions are exceeded, must be discarded.