OMVOH Concentrate for solution for infusion Ref.[50981] Active ingredients: Mirikizumab

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.

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 (i.e. two 100 mg pre-filled syringes or two 100 mg 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.

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.

Maintenance dose: The maintenance dose is 300 mg (i.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.

The 200 mg pre-filled syringe and 200 mg pre-filled pen are only for the treatment of Crohn’s disease.

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

Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit by week 24.

Special populations

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 or Crohn’s disease.

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.
  • For ulcerative colitis the infusion should be administered for at least 30 minutes.
  • For Crohn’s disease the infusion should be administered for at least 90 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 (ulcerative colitis) or 90 minutes (Crohn’s disease) infusion time.

Mirikizumab doses up to 2 400 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.

2 years.

After dilution

Chemical and physical in-use stability has been demonstrated for diluted infusion solution prepared with sodium chloride 9 mg/mL (0.9%) solution for 96 hours at 2°C to 8°C of which not more than 10 hours are permitted at non-refrigerated temperatures not to exceed 25ºC, starting from the time of vial puncture.

Chemical and physical in-use stability has been demonstrated for diluted infusion solution prepared with 5% glucose for 48 hours at 2°C to 8°C of which not more than 5 hours are permitted at non-refrigerated temperatures not to exceed 25°C, starting from the time of vial puncture.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Keep the diluted solution away from direct heat or light.

Do not freeze the diluted solution.

Unopened vial:

Store in a refrigerator (2ºC–8ºC).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

For storage conditions after dilution of the medicinal product, see section 6.3.

15 mL concentrate in a type I clear glass vial with a chlorobutyl rubber stopper, an aluminium seal and polypropylene flip top.

Pack sizes of 1 vial and 3 vials.

Not all pack sizes may be marketed.

Do not use Omvoh that has been frozen.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Dilution prior to intravenous infusion:

1. Each vial is for single use only.

2. Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution.

3. Inspect the content of the vial. The concentrate should be clear, colourless to slightly yellow and free of visible particles. Otherwise, it should be discarded.

4. Prepare the infusion bag for treatment of either ulcerative colitis or Crohn’s disease as specified below. Note that there are unique instructions and volumes specified for each indication.

Ulcerative colitis: one 15 mL vial (300 mg)

Withdraw 15 mL of the mirikizumab vial (300 mg) using an appropriately sized needle (18 to 21 gauge is recommended) and transfer to the infusion bag. If administered for the treatment of ulcerative colitis, the concentrate should be diluted only in infusion bags (bag size ranging from 50-250 mL) containing either sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose solution for injection. The final concentration after dilution is approximately 1.1 mg/mL to approximately 4.6 mg/mL.

Crohn’s disease: three 15 mL vials; total volume = 45 mL (900 mg)

First, withdraw and discard 45 mL of diluent from the infusion bag. Next, withdraw 15 mL from each of the three mirikizumab vials (900 mg) and transfer to the infusion bag, using an appropriately sized syringe and needle (18 to 21 gauge is recommended). If administered for the treatment of Crohn’s disease, the concentrate should be diluted only in infusion bags (bag size ranging from 100-250 mL) containing either sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose solution for injection. The final concentration after dilution is approximately 3.6 mg/mL to approximately 9 mg/mL.

5. Gently invert the infusion bag to mix. Do not shake the prepared bag.