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Omvoh ® ▼ (mirikizumab)
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Omvoh® (mirikizumab): Preparation and administration of intravenous infusion
Prepare the infusion using aseptic technique. Mirikizumab should be diluted in either 0.9% sodium chloride or 5% glucose solution for injection and administered for at least 30 or 90 minutes.
Omvoh® (mirikizumab): How to prepare and administer the intravenous infusion
Diluting the Omvoh concentrate requires aseptic techniques. Preparation and administration are specific to the indication.1 This step-by-step response explains the reconstitution and administration of Omvoh infusion.
What do I need to prepare the mirikizumab infusion solution?
For patients with ulcerative colitis, you need1
- 1 Omvoh vial (300 mg)
- 1 Infusion bag with 50 – 250 ml diluent
For patients with Crohn’s disease, you need1
- 3 Omvoh vials (900 mg)
- 1 Infusion bag with 100 – 250 ml diluent
Dilute the concentrate from the vial with a sodium chloride 9 mg/ml (0.9 %) solution for injection or a 5 % glucose solution for injection. Do not dilute it with other solutions.1
The approximate diluted concentrations in the summary of product characteristics (SmPC) consider that an IV bag may contain an overfill.2
How to prepare the intraveneous infusion?
Each vial is for single use only.1
Use an aseptic technique to ensure the sterility of the prepared solution.1
Inspect the vial(s)
Prepare the IV solution
To prepare the solution:
- Take a needle with a suitable size (18 - 21 gauge recommended).1
- For Ulcerative Colitis, 300 mg is required for each dose administered during the induction phase.
Withdraw 15 mL of the mirikizumab vial (300 mg) and transfer it to the infusion bag.
The final concentration after dilution is approximately 1.1 mg/mL to approximately 4.6 mg/mL.1
- For Crohn’s disease, 900 mg dose is required for each dose administered during the induction phase.
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.
The final concentration after dilution is approximately 3.6 mg/mL to approximately 9 mg/mL.1
- Gently invert the infusion bag to mix. Do not shake it.1
The density of the Omvoh 20 mg/ml concentrate in the vial is 1.01 g/ml.2
Do not use infusion bags whose labeled nominal volume is less than the minimum volume or greater than the maximum volume stated above, as stability has not been demonstrated under those dilution conditions.2
Lilly does not have data on which volume of infusion solution to use or an analysis of infusion site reactions during infusion related to the volume of infusion used.2
During clinical trials, investigational sites were not required to consistently use the same volume for each infusion.2
How to infuse mirikuzumab
Connect the intravenous (IV) administration set (infusion line) to the prepared infusion bag and prime the line.1,3
The minimum infusion time depends on the indication:3
- Ulcerative Colitis: Infuse over at least 30 minutes.
- Crohn's disease: Infuse over at least 90 minutes.
Do not coinfuse with other electrolytes or other medications.3
Flush the infusion line at the end of the infusion to ensure a full dose. Flush it with3
- sodium chloride 9 mg/mL (0.9 %) solution for injection, or
- 5 % glucose solution for injection.
Administer the flush at the same infusion rate used for Omvoh administration. The time required to flush the infusion line is in addition to the minimum infusion time.3
References
1Omvoh 300 mg concentrate for solution for infusion [summary of product characteristics] Eli Lilly Nederland B.V., The Netherlands (UK)
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Omvoh 300 mg concentrate for solution for infusion [Package Information Leaflet] Eli Lilly Nederland B.V., The Netherlands (UK)
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Date of Last Review: 07 May 2024