Posology : מינונים

4.2   Posology and method of administration

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 300 mg concentrate for solution for infusion should only be used for the induction dose.

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.


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.

For the posology of the subcutaneous dosing regimen, see section 4.2 of the Summary of Product Characteristics for Omvoh 100 mg solution for injection in pre-filled syringe and Omvoh 100 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.

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

Omvoh 300 mg concentrate for solution for infusion is for intravenous use only. Each vial is for single use only.

For instructions on dilution of the medicinal product before administration, see section 6.6.

Administration of the diluted solution
• The intravenous administration set (infusion line) should be connected to the prepared intravenous bag and the line should be primed. The infusion should be administered for at least 30 minutes.
• At the end of the infusion, to ensure a full dose is administered, the infusion line should be flushed with sodium chloride 9 mg/mL (0.9 %) solution or 5 % glucose solution for injection.
The flush should be administered at the same rate as used for Omvoh administration. The time required to flush Omvoh solution from the infusion line is in addition to the minimum 30 minutes infusion time.