Brand Name

Omvoh

Generic Name
Mirikizumab-Mrkz
View Brand Information
FDA approval date: October 26, 2023
Classification: Interleukin-23 Antagonist
Form: Injection, Kit

What is Omvoh (Mirikizumab-Mrkz)?

OMVOH TM is an interleukin-23 antagonist indicated for the treatment of moderately to severely active ulcerative colitis in adults OMVOH is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

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Related Clinical Trials

MIrikizumab in UC - a Real-woRld prOspective multicenteR Registry
MIrikizumab in UC - a Real-woRld prOspective multicenteR Registry
Enrollment Status: Recruiting
Publish Date: July 09, 2025

Summary: The goal of this observational study is to learn about how effective mirikizumab (Omvoh) is when treating patients with ulcerative colitis (UC) Does mirikizumab (Omvoh) lead to a reduction in symptoms at intervals throughout one year? Participants being prescribed mirikizumab (Omvoh) as part of their regular medical care for UC will answer online survey questions about their bowel habits for 1 yea...

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Mirikizumab (Omvoh) - an IL-23 antagonist for Crohn's disease.
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Brand Information

Omvoh (mirikizumab-mrkz)
1INDICATIONS AND USAGE
OMVOH is indicated for the treatment of:
  • moderately to severely active ulcerative colitis in adults.
  • moderately to severely active Crohn's disease in adults.
2DOSAGE FORMS AND STRENGTHS
OMVOH is a clear to opalescent, colorless to slightly yellow to slightly brown solution available as:
  • Intravenous Infusion:
  • Subcutaneous Use:
3CONTRAINDICATIONS
OMVOH is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients
4ADVERSE REACTIONS
The following topics are also discussed in detail in the Warnings and Precautions section:
  • Hypersensitivity Reactions
  • Infections
  • Tuberculosis
  • Hepatotoxicity
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
5DESCRIPTION
Mirikizumab-mrkz is a humanized immunoglobulin G4 (IgG4) variant monoclonal antibody that is directed against the p19 subunit of IL-23 and does not bind IL-12. Mirikizumab-mrkz is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and it is composed of two identical light chain polypeptides and two identical heavy chain polypeptides with an overall molecular weight of approximately 147 kDa.
6HOW SUPPLIED/STORAGE AND HANDLING
OMVOH (mirikizumab-mrkz) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow to slightly brown solution for intravenous infusion or subcutaneous injection.
OMVOH is supplied in indication specific packaging as:
Note to Pharmacist: The entire carton of 2 prefilled pen or 2 prefilled syringes are to be dispensed as a unit.
Each 100 mg/mL single-dose prefilled pen or prefilled syringe consists of a 1 mL glass syringe with a fixed 27-gauge ½ inch needle.
Each 200 mg/2 mL single-dose prefilled pen or 200 mg/2 mL (100 mg/mL) prefilled syringe consists of a 2 mL glass syringe with a fixed 27-gauge 8 mm needle.
7PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
8MG PREFILLED PEN INSTRUCTIONS FOR USE
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Eli Lilly and Company
Indianapolis, IN 46285, USA
US License Number 1891
OMVOH™ is a trademark of Eli Lilly and Company.
Copyright © 2023, 2025, Eli Lilly and Company. All rights reserved.
Revised: October 2025
The OMVOH prefilled Pen meets the current dose accuracy and functional requirements of ISO 11608-1 and 11608-5.
OMV-0005-IFU-PEN-20251023
9MG PREFILLED SYRINGE INSTRUCTIONS FOR USE
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
OMVOH
Copyright © 2024, 2025, Eli Lilly and Company. All rights reserved.
Revised: October 2025
OMV-0003-IFU-PFS-20251023
10MG + 200 MG PREFILLED PEN INSTRUCTIONS FOR USE
INSTRUCTIONS FOR USE
OMVOHTM(ahm-voh)
(mirikizumab-mrkz)
injection, for subcutaneous use
Prefilled Pens
One 200 mg/2 mL Prefilled Pen and one 100 mg/mL Prefilled Pen for a full dose of 300 mg
Figure
Figure
This Instructions for Use contains information on how to inject OMVOH.
Before you use the OMVOH prefilled Pens, read and carefully follow all the step-by-step instructions.
Important information you need to know before injecting OMVOH
  • Your healthcare provider should show you how to prepare and inject OMVOH using the prefilled Pens.
  • Keep this Instructions for Use and read it as needed.
  • Each OMVOH prefilled Pen is for
  • The OMVOH prefilled Pen contains glass parts. Handle it carefully. If you drop it on a hard surface,
  • Your healthcare provider can help you decide where on your body to inject your dose. Read the
  • If you have vision or hearing problems,
  • See
INSTRUCTIONS FOR USE
Before you use the OMVOH prefilled Pens, read and carefully follow all the step-by-step instructions.
2 Prefilled Pens = full 300 mg dose
After your first injection,
With your second prefilled Pen
You must inject 2 prefilled Pens to complete your full 300 mg dose.
Parts of the OMVOH Prefilled Pens
Inject both prefilled Pens in any order for a full 300 mg dose.
The 200 mg/2 mL prefilled Pen is larger than the 100 mg/mL prefilled Pen.
Preparing to inject OMVOH
Gather supplies
Inspect the prefilled Pens and the medicine
Remove both prefilled Pens from the carton.
Make sure you have the right medicine.
The medicine inside should be clear. It may be colorless to slightly yellow to slightly brown.
Wait 45 minutes
Do not warm up the prefilled Pens with a microwave, hot water, or direct sunlight.
With the gray base cap on, allow the prefilled Pens to warm up to room temperature for 45 minutes before injecting.
Choose and clean your injection sites
Your healthcare provider can help you choose the injection sites that are best for you.
Injecting OMVOH
1. Uncap the first prefilled Pen (the prefilled Pens may be used in any order)
2. Place and unlock
3. Press and hold for 15 seconds
4. Inject the second prefilled Pen
Choose a new injection site at least 2 inches away and clean it.
With your second prefilled Pen,
You must inject 2 prefilled Pens to complete your full 300 mg dose.
Throwing away (disposing of) OMVOH Prefilled Pens
Throw away both used prefilled Pens
Storing OMVOH Prefilled Pens
Refrigeration
  • In the original carton, store your prefilled pens in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date.
  • Do not freeze. Do not use OMVOH if it has been frozen.
Room Temperature
  • If needed, your prefilled Pens may be stored at room temperature for up to 2 weeks in the original carton.
  • When OMVOH has been stored at room temperature, do not return it to the refrigerator.
  • Throw away (dispose of) OMVOH if not used within 2 weeks at room temperature.
  • Protect your prefilled Pens from light until use.
Do not use the prefilled Pens and throw away (see Throwing away (disposing of) OMVOH Prefilled Pens) if they have been:
Keep OMVOH and all medicines out of the reach of children.
Commonly asked questions
Additional Information:
If you have more questions about how to use the OMVOH prefilled Pens:
Used OMVOH Prefilled Pen disposal
Put the used OMVOH prefilled Pens in an FDA-cleared sharps disposal container right away after use.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
There may be state or local laws about how you should throw away needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
Do not recycle your used sharps disposal container.
Read the Medication Guide for OMVOH inside this box to learn more about your medicine.
Manufactured by:
OMVOH
Copyright © 2025, Eli Lilly and Company. All rights reserved.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. Approved: January 2025
The OMVOH prefilled Pen meets the current dose accuracy and functional requirements of ISO 11608-1 and 11608-5.
OMV-0001-300MG-PEN-IFU-20250115
11MG + 200 MG PREFILLED SYRINGE INSTRUCTIONS FOR USE
INSTRUCTIONS FOR USE
OMVOHTM(ahm-voh)
(mirikizumab-mrkz)
injection, for subcutaneous use
Prefilled Syringes
One 200 mg/2 mL (100 mg/mL) Prefilled Syringe and One 100 mg/mL Prefilled Syringe for a Full Dose of 300 mg.
Figure
Figure
This Instructions for Use contains information on how to inject OMVOH.
Before you use the OMVOH prefilled Syringes, read and carefully follow all the step-by-step instructions.
Important information you need to know before injecting OMVOH
  • Your healthcare provider should show you how to prepare and inject OMVOH using the prefilled Syringes.
  • Keep this Instructions for Use and read it as needed.
  • Each OMVOH prefilled Syringe is for
  • Your healthcare provider can help you decide where on your body to inject your dose. Read the
  • If you have vision problems,
  • See
INSTRUCTIONS FOR USE
Before you use the OMVOH prefilled Syringes, read and carefully follow all the step-by-step instructions.
2 Prefilled Syringes = full 300 mg dose
After your first injection,
With your second prefilled Syringe
You must inject 2 prefilled Syringes to complete your full 300 mg dose.
Parts of the OMVOH prefilled Syringes
Inject both prefilled Syringes in any order for a full 300 mg dose.
The 200 mg/2 mL (100 mg/mL) prefilled Syringe is larger than the 100 mg/mL prefilled Syringe.
Preparing to inject OMVOH
Gather supplies
Inspect the prefilled Syringes and the medicine
Remove both prefilled Syringes from the carton.
Make sure you have the right medicine.
The medicine inside should be clear. It may be colorless to slightly yellow to slightly brown.
Wait 45 minutes
Do not warm up the prefilled Syringes with a microwave, hot water, or direct sunlight.
With the needle cap on, allow the prefilled Syringes to warm up to room temperature for 45 minutes before injecting.
Choose and clean your injection sites
Your healthcare provider can help you choose the injection sites that are best for you.
Injecting OMVOH
1. Uncap the first prefilled Syringe (the prefilled Syringes may be used in any order)
2. Pinch the injection site and insert the needle
3. Inject the medicine
4. Inject the second prefilled Syringe
Choose a new injection site at least 2 inches away and clean it.
With your second prefilled Syringe,
You must inject 2 prefilled Syringes to complete your full 300 mg dose.
Throwing away (disposing of) OMVOH Prefilled Syringes
Throw away both used prefilled Syringes
Storing OMVOH Prefilled Syringes
Refrigeration
  • In the original carton, store your prefilled Syringes in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date.
  • Do not freeze. Do not use OMVOH if it has been frozen.
Room Temperature
  • If needed, your prefilled Syringes may be stored at room temperature for up to 2 weeks in the original carton.
  • When OMVOH has been stored at room temperature, do not return it to the refrigerator.
  • Throw away (dispose of) OMVOH if not used within 2 weeks at room temperature.
  • Protect your prefilled Syringes from light until use.
Do not use the prefilled Syringes and throw away (see Throwing away (disposing of) OMVOH Prefilled Syringes) if they have been:
Keep OMVOH and all medicines out of the reach of children.
Commonly asked questions
Additional Information:
If you have more questions about how to use the OMVOH prefilled Syringes:
Used OMVOH Prefilled Syringe disposal
Put the used OMVOH prefilled Syringes in an FDA-cleared sharps disposal container right away after use.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
There may be state or local laws about how you should throw away needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
Do not recycle your used sharps disposal container.
Read the Medication Guide for OMVOH inside this box to learn more about your medicine.
Manufactured by:
OMVOH
Copyright © 2025, Eli Lilly and Company. All rights reserved.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Approved: January 2025
OMV-0001-300MG-PFS-IFU-20250115
12MG PREFILLED PEN INSTRUCTIONS FOR USE
Throwing away (disposing of) OMVOH prefilled Pen
Manufactured by:
OMVOH™ is a trademark of Eli Lilly and Company.
Copyright © 2025, Eli Lilly and Company. All rights reserved.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Approved: October 2025
The OMVOH prefilled Pen meets the current dose accuracy and functional requirements of ISO 11608-1 and 11608-5.
OMV-0001-200MG-PEN-IFU-20251023
13MG PREFILLED SYRINGE INSTRUCTIONS FOR USE
Manufactured by:
OMVOH is a trademark of Eli Lilly and Company.
Copyright © 2025, Eli Lilly and Company. All rights reserved.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Approved: October 2025
OMV-0001-200MG-PFS-IFU-20251023