Omvoh (Mirikizumab)
IL-23 inhibitor for the treatment of ulcerative colitis
Quick Facts About Omvoh
Key Takeaways About Omvoh
- Targeted biologic therapy: Omvoh selectively blocks IL-23, a key inflammatory cytokine in ulcerative colitis, with a more targeted mechanism than older immunosuppressants
- Two-phase treatment: Induction with 3 IV infusions (300 mg at weeks 0, 4, and 8) followed by subcutaneous maintenance injections (200 mg every 4 weeks)
- Self-injectable maintenance: After the IV induction phase, patients can learn to self-administer the pre-filled pen injections at home
- Infection screening required: Tuberculosis testing and vaccination review are mandatory before starting treatment, as Omvoh affects the immune system
- Liver monitoring necessary: Blood tests to check liver function should be performed before and during treatment
What Is Omvoh and What Is It Used For?
Omvoh (mirikizumab) is a biologic medicine classified as an interleukin-23 (IL-23) inhibitor. It is a monoclonal antibody – a specially engineered protein that targets and blocks IL-23, a pro-inflammatory cytokine involved in intestinal inflammation. By blocking IL-23, Omvoh reduces inflammation and associated symptoms of ulcerative colitis.
Omvoh contains the active substance mirikizumab, a humanized immunoglobulin G4 (IgG4) monoclonal antibody. Monoclonal antibodies are proteins designed to recognize and bind to specific target proteins in the body. In the case of mirikizumab, the target is the p19 subunit of interleukin-23, a cytokine that plays a central role in driving the inflammatory cascade seen in inflammatory bowel disease.
Interleukin-23 is a critical upstream regulator of the immune response in the gut. It promotes the activation and expansion of T helper 17 (Th17) cells and other immune cells that produce inflammatory mediators. In ulcerative colitis, this immune pathway becomes dysregulated, leading to chronic inflammation of the colonic mucosa. By selectively blocking IL-23 signaling, mirikizumab interrupts this inflammatory cycle at an early stage, allowing the intestinal lining to heal.
Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory bowel disease (IBD) that affects the lining of the large intestine (colon) and rectum. It causes inflammation and ulcers in the innermost lining of the colon, leading to symptoms such as bloody diarrhea, abdominal pain, urgency to defecate, and rectal bleeding. The disease follows a relapsing and remitting course, with periods of active inflammation (flares) alternating with periods of remission.
Omvoh is indicated for adults with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant of conventional therapies (such as aminosalicylates, corticosteroids, or immunomodulators) or other biologic agents (such as anti-TNF antibodies). It represents an important treatment option for patients who have not achieved adequate disease control with existing therapies.
The approval of mirikizumab was supported by the LUCENT clinical trial programme, which demonstrated significant improvements in clinical remission, endoscopic improvement, and histologic-endoscopic mucosal improvement compared with placebo. In clinical trials, approximately 25% of patients achieved clinical remission at week 12 of induction therapy, and among responders who continued to maintenance, over 49% maintained clinical remission at one year.
Unlike anti-TNF agents (such as infliximab or adalimumab) that block tumour necrosis factor, Omvoh specifically targets IL-23 by binding its p19 subunit. This is distinct from ustekinumab, which blocks both IL-12 and IL-23 via their shared p40 subunit. By selectively targeting only IL-23, mirikizumab may offer a more refined approach to modulating the immune response while potentially preserving other immune functions.
What Should You Know Before Taking Omvoh?
Before starting Omvoh, your doctor must screen you for infections (especially tuberculosis), review your vaccination status, and assess your liver function. Do not use Omvoh if you have active infections or are allergic to mirikizumab. Live vaccines must not be given during treatment.
Contraindications
Omvoh must not be used in the following situations:
- Allergy to mirikizumab or any excipient: If you are allergic to the active substance or any of the other ingredients (histidine, histidine monohydrochloride, sodium chloride, mannitol, polysorbate 80, or water for injections), you should not use Omvoh. Consult your doctor if you think you may be allergic.
- Active infections: If you have an active infection that your doctor considers significant, including active tuberculosis, treatment with Omvoh should not be started until the infection has resolved.
Warnings and Precautions
Talk to your doctor or pharmacist before using Omvoh. Your doctor will assess your health status before initiating treatment. There are several important warnings and precautions to be aware of:
Infections: Omvoh can cause serious infections. Because it modifies the immune response, it may increase susceptibility to certain infections. If you have an active infection, treatment with Omvoh should not be started until the infection has cleared. Once you have started treatment, contact your doctor immediately if you develop any signs of infection, such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, or pain during urination.
Tuberculosis (TB): Tell your doctor if you have recently been in close contact with anyone who may have tuberculosis. Your doctor will examine you and may perform a tuberculosis test before starting Omvoh. If your doctor considers you to be at risk for active tuberculosis, you may receive treatment for TB before beginning Omvoh therapy.
Vaccinations: Your doctor will check whether you need any vaccinations before starting treatment. Certain types of vaccines (live vaccines) should not be given while you are using Omvoh, as the medication modifies immune function. Inactivated vaccines (such as influenza shots and pneumococcal vaccines) can generally be administered. It is recommended to bring all vaccinations up to date before starting treatment.
Omvoh can rarely cause serious allergic reactions. Stop using Omvoh and seek emergency medical care immediately if you experience any of the following symptoms: skin rash or hives, swelling of the face, lips, mouth, tongue or throat, difficulty breathing, feeling of tightness in the throat or chest pressure, dizziness, fainting, or low blood pressure.
Liver monitoring: Your doctor will perform blood tests before you start and during treatment with Omvoh to check that your liver is functioning normally. If blood tests show abnormal results, your doctor may interrupt treatment and conduct additional liver tests to determine the cause. Elevated liver enzymes have been reported in some patients taking mirikizumab.
Children and adolescents: Omvoh is not recommended for use in children and adolescents under 18 years of age, as it has not been studied in this population. There are currently no data on the safety or efficacy of mirikizumab in paediatric patients.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, seek advice from your doctor before using Omvoh. The effects of Omvoh on pregnant women are not fully known, and it is best to avoid using Omvoh during pregnancy as a precautionary measure.
Women of childbearing potential are advised to use effective contraception during treatment with Omvoh and for at least 10 weeks after the last dose. This recommendation is based on the pharmacokinetic properties of mirikizumab and the time required for the drug to be eliminated from the body.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using Omvoh. It is not known whether mirikizumab passes into breast milk. As monoclonal antibodies may be excreted in breast milk, a risk to the breastfed infant cannot be excluded, and a decision should be made in consultation with your healthcare provider.
Driving and Operating Machinery
Omvoh is not expected to affect your ability to drive or use machines. No studies on the effect of mirikizumab on driving ability have shown any impairment.
Omvoh contains less than 1 mmol (23 mg) sodium per dose, making it essentially sodium-free. It also contains polysorbate 80 (0.3 mg/mL per pen, equivalent to 0.6 mg in the maintenance dose). Polysorbates can cause allergic reactions in sensitive individuals. Inform your doctor if you have any known allergies to these substances.
How Does Omvoh Interact with Other Drugs?
Omvoh has a relatively favourable drug interaction profile compared to many other immunosuppressive medications. The most important interaction is with live vaccines, which should not be administered during treatment. No significant pharmacokinetic interactions with other common medications have been identified in clinical studies.
As a monoclonal antibody, mirikizumab is not metabolized by cytochrome P450 enzymes in the liver, which are responsible for the metabolism of most small-molecule drugs. This means that mirikizumab is unlikely to affect the blood levels of other medications that are processed by these enzymes, and other drugs are unlikely to alter mirikizumab levels.
However, there are important considerations regarding the use of Omvoh with other therapies:
| Interacting Agent | Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Live vaccines (e.g., MMR, varicella, BCG, oral polio, yellow fever) | Contraindicated | Risk of infection from live vaccine organisms due to immunomodulatory effects | Do not administer live vaccines during Omvoh treatment; complete all live vaccinations before starting therapy |
| Inactivated vaccines (e.g., influenza, pneumococcal, COVID-19 mRNA) | Caution | Immune response to vaccines may be reduced; however, vaccination is generally still recommended | Can be administered during treatment; optimal timing is before starting Omvoh if possible |
| Other immunosuppressants (e.g., azathioprine, methotrexate, ciclosporin) | Caution | Combination may increase overall immunosuppression and infection risk | Use with caution; discuss risk-benefit with your doctor; monitor for infections |
| Other biologic agents (e.g., anti-TNF, vedolizumab, tofacitinib) | Not recommended | No clinical data on combination; theoretical risk of additive immunosuppression | Avoid concurrent use with other biologics or JAK inhibitors for IBD |
| Corticosteroids (e.g., prednisolone, budesonide) | Acceptable | Often used concomitantly during induction; gradual tapering recommended | Can be used together; your doctor will aim to taper corticosteroids once Omvoh takes effect |
| Aminosalicylates (e.g., mesalazine, sulfasalazine) | No interaction | No known pharmacokinetic or pharmacodynamic interactions | Can be continued alongside Omvoh as prescribed |
Always tell your doctor, pharmacist, or nurse about all medicines you are using, have recently used, or might use. This includes prescription medicines, over-the-counter products, vitamins, and herbal supplements. Your doctor can assess whether any adjustments are needed when starting or stopping Omvoh alongside other medications.
What Is the Correct Dosage of Omvoh?
Omvoh treatment for ulcerative colitis involves two phases: an induction phase with 300 mg intravenous infusions at weeks 0, 4, and 8, followed by a maintenance phase with 200 mg subcutaneous injections (given as two 100 mg pre-filled pen injections) every 4 weeks.
Always use Omvoh exactly as your doctor or nurse has instructed. Omvoh is intended for long-term treatment. Your doctor will determine how much Omvoh you need and for how long. Regular follow-up appointments will be arranged to check that the treatment is working as intended.
Induction Phase (Hospital/Clinic Setting)
Intravenous Infusion – Weeks 0, 4, and 8
The first dose of Omvoh is 300 mg, administered by your doctor as an intravenous (IV) infusion (drip into a vein in your arm) over at least 30 minutes. You will receive a second 300 mg dose at week 4 and a third at week 8. All induction infusions are given in a healthcare setting under medical supervision.
Extended induction: If you have not responded adequately after the initial 3 infusions, your doctor may decide to continue with additional IV infusions at weeks 12, 16, and 20 before transitioning to maintenance therapy.
Maintenance Phase (Home Self-Injection)
Subcutaneous Injection – Every 4 Weeks
Four weeks after your last IV infusion, you will switch to maintenance therapy with 200 mg of Omvoh given as a subcutaneous injection every 4 weeks. The 200 mg maintenance dose is administered as 2 separate injections of 100 mg each, using 2 pre-filled pens. You should inject one pen and then immediately proceed with the second pen at a different injection site within the same body area.
After proper training from your doctor or nurse, you (or a caregiver) can self-administer the subcutaneous injections at home. Do not attempt to inject yourself until you have been shown how to do so properly.
| Treatment Phase | Dose | Route | Schedule |
|---|---|---|---|
| Induction (standard) | 300 mg | Intravenous infusion (≥30 min) | Weeks 0, 4, and 8 |
| Extended induction (if needed) | 300 mg | Intravenous infusion (≥30 min) | Weeks 12, 16, and 20 |
| Maintenance | 200 mg (2 × 100 mg pens) | Subcutaneous injection | Every 4 weeks |
Children and Adolescents
Omvoh has not been studied in children and adolescents under 18 years of age. There are no established paediatric dosing recommendations. The safety and efficacy of mirikizumab in this population have not been determined, and the medication is currently not recommended for paediatric use.
Elderly Patients
No dose adjustment is required for elderly patients. Clinical trials included patients over 65 years of age, and no overall differences in safety or efficacy were observed compared with younger adults. However, as elderly patients may have a higher baseline risk of infections, careful monitoring is advisable.
Missed Dose
If you forget to inject a dose of Omvoh, administer it as soon as possible. Then resume your regular dosing schedule of one injection every 4 weeks. Do not inject a double dose to make up for a forgotten one. Using a calendar or diary to note your injection dates can help you stay on schedule.
Overdose
If you have received more Omvoh than prescribed or received a dose earlier than scheduled, inform your doctor. In clinical trials, doses up to 600 mg IV and 400 mg SC have been administered without dose-limiting toxicity. However, increased doses may increase the risk of side effects, and your doctor will monitor you appropriately.
If you stop using Omvoh without medical guidance, your ulcerative colitis symptoms may return. Even if you feel well, the underlying inflammation may recur if treatment is discontinued prematurely. Always discuss any changes to your treatment plan with your gastroenterologist.
Self-Injection with the Pre-Filled Pen
The Omvoh pre-filled pen is designed for subcutaneous self-injection during the maintenance phase. Before your first self-injection, your doctor or nurse will demonstrate the proper technique. Key points to remember:
- Remove pens from the refrigerator and allow them to reach room temperature for 30 minutes before injecting. Do not warm them in a microwave, rinse in hot water, or place in direct sunlight.
- Choose your injection site: The abdomen (at least 5 cm from the navel), the front of the thighs (at least 5 cm above the knee and below the groin), or the back of the upper arm (if assisted by another person).
- Clean the injection site with an alcohol swab and let it air dry.
- Remove the grey base cap, place the clear base plate flat against the skin, unlock the lock ring, and press the blue injection button. Hold for up to 10 seconds until you hear a second click.
- Two injections are required for the full dose. Inject the first pen, then immediately use the second pen at a different spot in the same area.
- Rotate injection sites to minimize injection site reactions. Do not inject into skin that is tender, bruised, red, or hardened.
- Dispose of used pens in a sharps container immediately after use. Never reuse pens or share them with others.
What Are the Side Effects of Omvoh?
Like all medicines, Omvoh can cause side effects, although not everyone will experience them. The most common side effect is injection site reactions. Other common side effects include upper respiratory infections, joint pain, headache, and skin rash. Serious side effects such as severe allergic reactions are uncommon.
The side effects of Omvoh have been characterised through extensive clinical trials involving thousands of patients with ulcerative colitis. Most side effects are mild to moderate in severity and tend to decrease over time as the body adjusts to the treatment. Below is a breakdown of side effects by frequency category:
Very Common
- Injection site reactions (redness, pain, swelling, itching, or bruising at the injection site)
Common
- Upper respiratory tract infections (infections of the nose and throat, including common cold symptoms)
- Arthralgia (joint pain)
- Headache
- Skin rash
Uncommon
- Herpes zoster (shingles) – reactivation of the varicella-zoster virus
- Infusion-related allergic reactions (itching, hives, flushing)
- Elevated liver enzymes (identified through blood tests)
Rare
- Severe allergic reactions (anaphylaxis, angioedema)
- Serious infections requiring hospitalization
Injection site reactions are the most frequently reported side effect and typically occur during the first few months of subcutaneous maintenance therapy. These reactions are generally mild and tend to resolve on their own within a few days. Rotating injection sites and allowing the pen to reach room temperature before injecting can help reduce their frequency.
Upper respiratory tract infections, such as nasopharyngitis (common cold) and pharyngitis (sore throat), occur at rates similar to those seen with other biologic therapies for ulcerative colitis. Most upper respiratory infections are mild and do not require treatment interruption.
Herpes zoster (shingles) has been reported uncommonly. Patients who have previously had chickenpox carry the varicella-zoster virus in a latent form, and immunomodulatory therapy may trigger reactivation. If you develop a painful, blistering rash (typically on one side of the body), contact your doctor promptly for evaluation and antiviral treatment.
Elevated liver enzymes have been observed in some patients during clinical trials. In most cases, these elevations were mild and reversible without treatment discontinuation. However, regular liver function monitoring is recommended, and significant elevations may require dose interruption or further investigation.
If you experience any side effects, including any not listed here, talk to your doctor, pharmacist, or nurse. You can also report side effects directly to your national pharmacovigilance authority (e.g., the FDA MedWatch programme in the US, the Yellow Card Scheme in the UK, or the EMA in the EU). Reporting helps ongoing safety monitoring of medicines.
How Should You Store Omvoh?
Omvoh pre-filled pens should be stored in a refrigerator at 2–8°C. Do not freeze. They can be kept at room temperature (up to 30°C) for up to 2 weeks. Store in the original packaging to protect from light. Do not shake the pens.
Proper storage of Omvoh is essential to maintain the effectiveness and safety of the medication. As a biologic medicine containing a protein (monoclonal antibody), mirikizumab is sensitive to temperature, light, and physical agitation.
Refrigerated Storage
Store the Omvoh pre-filled pens in a refrigerator between 2°C and 8°C (36°F to 46°F). Keep the pens in their original carton to protect from light. Do not freeze the pre-filled pens. If a pen has been accidentally frozen, do not use it – discard it and use a new one. Do not warm the pens in a microwave, rinse them in hot water, or leave them in direct sunlight.
Room Temperature Storage
If needed, Omvoh can be stored outside the refrigerator for up to 2 weeks at a temperature not exceeding 30°C (86°F). Once removed from the refrigerator and stored at room temperature, do not return the pens to the refrigerator. If the pen has been stored at room temperature for more than 2 weeks or exposed to temperatures above 30°C, it must be discarded.
Before Use
Before injecting, remove the pens from the refrigerator and allow them to reach room temperature for approximately 30 minutes. Do not use the medicine if the pre-filled pen is damaged or if the liquid appears cloudy, distinctly brown, or contains particles. The solution should be clear and may range from colourless to slightly yellow. Do not shake the pen. Air bubbles in the pen are normal and will not harm you or affect your dose.
General Precautions
- Keep out of sight and reach of children.
- Do not use after the expiry date printed on the label and carton after "EXP". The expiry date refers to the last day of that month.
- Each pre-filled pen is for single use only. Do not reuse pens.
- Dispose of used pens in a sharps disposal container. Do not throw them in household waste. Ask your doctor, nurse, or pharmacist about proper disposal methods available in your area.
What Does Omvoh Contain?
Each Omvoh pre-filled pen contains 100 mg of mirikizumab in 1 mL of solution. The inactive ingredients include histidine, histidine monohydrochloride, sodium chloride, mannitol, polysorbate 80, and water for injections.
Active Ingredient
The active substance is mirikizumab, a humanized IgG4 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Each pre-filled pen contains 100 mg of mirikizumab in 1 mL of solution, giving a concentration of 100 mg/mL.
Inactive Ingredients (Excipients)
| Excipient | Function | Notes |
|---|---|---|
| Histidine | Buffer (pH stabiliser) | Maintains optimal pH for protein stability |
| Histidine monohydrochloride | Buffer | Works with histidine to maintain pH |
| Sodium chloride | Tonicity agent | Less than 1 mmol (23 mg) sodium per dose |
| Mannitol (E421) | Stabiliser / bulking agent | Sugar alcohol used to stabilise the protein |
| Polysorbate 80 (E433) | Surfactant | 0.3 mg/mL per pen; may cause allergic reactions in sensitive individuals |
| Water for injections | Solvent | Pharmaceutical-grade water |
Packaging
Omvoh is a solution in a clear glass syringe enclosed in a single-use injection pen. The solution may range from colourless to slightly yellow in appearance. It is available in packs of 2 pre-filled pens containing 100 mg each (sufficient for one maintenance dose), multipacks of 2 × 2 pre-filled pens, and multipacks of 3 × 2 pre-filled pens. Not all pack sizes may be marketed in your country.
The marketing authorisation holder is Eli Lilly Nederland B.V., and the manufacturer is Lilly France S.A.S. Omvoh received its initial European marketing authorisation in 2023 and has subsequently been approved in multiple countries worldwide, including the United States.
Frequently Asked Questions About Omvoh
Omvoh (mirikizumab) is used to treat moderately to severely active ulcerative colitis in adults. It is typically prescribed when other treatments such as aminosalicylates, corticosteroids, immunomodulators, or other biologic therapies have not provided adequate disease control or could not be tolerated. It works by blocking interleukin-23 (IL-23), reducing intestinal inflammation and helping the colonic lining to heal.
In clinical trials, some patients began to experience symptom improvement within the first few weeks of induction therapy. However, the full benefit of Omvoh is typically assessed at week 12 after three intravenous infusions. Response times vary between individuals – some patients may respond within 4 weeks, while others may need the extended induction (up to week 24) before seeing significant improvement. It is important to complete the prescribed induction course before concluding whether the treatment is effective.
Yes, during the maintenance phase, Omvoh is designed for self-administration using pre-filled pens. Your doctor or nurse will train you on the proper injection technique before you start self-injecting at home. A caregiver can also administer the injections after receiving training. The induction phase (IV infusions) must always be administered in a healthcare setting. It is important to follow the step-by-step instructions provided with the pens and to use proper injection site rotation.
Live vaccines (such as MMR, varicella, BCG, and oral polio) should not be given during treatment with Omvoh, as the medication modifies immune function and could increase the risk of infection from live vaccine organisms. Inactivated vaccines (such as annual influenza shots, pneumococcal vaccines, and COVID-19 mRNA vaccines) can generally be given during treatment, although the immune response may be slightly reduced. Your doctor should review your vaccination status and ensure all necessary vaccines are up to date before starting Omvoh.
Air bubbles in the pre-filled pen are normal and will not harm you or affect your dose. There is no need to try to remove them. Do not shake the pen to try to eliminate bubbles, as shaking can damage the protein structure of the medication. Simply proceed with the injection as directed in the instructions for use.
The safety of Omvoh during pregnancy has not been fully established. Animal studies have not shown direct harmful effects on pregnancy outcomes, but there are limited data from human pregnancies. As a precautionary measure, it is recommended to avoid Omvoh during pregnancy. Women of childbearing potential should use effective contraception during treatment and for at least 10 weeks after the last dose. If you become pregnant while taking Omvoh, contact your doctor immediately to discuss the best course of action.
References
- European Medicines Agency (EMA). Omvoh (mirikizumab) – Summary of Product Characteristics. EMA/CHMP. Last updated January 2026. Available at: ema.europa.eu/en/medicines/human/EPAR/omvoh
- D'Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2023;388(26):2444-2455. doi:10.1056/NEJMoa2207940
- Sandborn WJ, D'Haens GR, Reinisch W, et al. Mirikizumab for the treatment of ulcerative colitis (LUCENT-1): a phase 3, multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2022;399(10330):2031-2046. doi:10.1016/S0140-6736(22)00883-6
- US Food and Drug Administration (FDA). Omvoh (mirikizumab-mrkz) prescribing information. Revised 2023.
- Feagan BG, Danese S, Loftus EV Jr, et al. Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial. Lancet. 2021;397(10292):2372-2384.
- Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol. 2019;114(3):384-413. doi:10.14309/ajg.0000000000000152
- Harbord M, Eliakim R, Bettenworth D, et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis. 2017;11(7):769-784. doi:10.1093/ecco-jcc/jjx009
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023.
About the Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed physicians with specialist qualifications in gastroenterology, clinical pharmacology, and internal medicine. Our editorial process follows the GRADE evidence framework and adheres to international clinical guidelines from the EMA, FDA, ACG, and ECCO.
All pharmaceutical content undergoes rigorous review by board-certified physicians. Information is cross-referenced with official prescribing information (SmPC/PI), peer-reviewed clinical trial data, and international treatment guidelines.
iMedic receives no pharmaceutical company funding or advertising revenue. All content is editorially independent. We have no financial relationships with drug manufacturers, ensuring unbiased medical information.
Evidence level: This article is based on Level 1A evidence from phase 3 randomised controlled trials (LUCENT-1 and LUCENT-2), systematic reviews, and official regulatory documents from the EMA and FDA. Last fact-checked: .