Omvoh mirikizumab-mrkz 100 mg/mL Injection, Solution, 2 syringes
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Interleukin-23 Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Omvoh is a biologic medication — a lab-engineered protein that targets a very specific part of your immune system called IL-23. IL-23 is a signaling molecule that drives the gut in...
- What exactly is Omvoh and how is it different from other IBD treatments?
- No — only at the start. The first three doses are intravenous infusions given at a clinic at Weeks 0, 4, and 8. After that, starting at Week 12, you switch to subcutaneous injectio...
- Do I have to keep going to the clinic for infusions the whole time?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Mirikizumab-mrkz — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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0.1 mg / 1 mL
UNII 4QD397987E
An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
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0.9 mg / 1 mL
UNII X573657P6P
Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
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33 mg / 1 mL
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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0.3 mg / 1 mL
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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2.9 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $5,962.62 | $11,925.24 / 2 ml |
| Medicare Part B allowsASP · J2267 | $32.658 / J2267 unit | — |
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🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Omvoh 100 mg/mLthis 00002-8870-27 | Eli | 2 syringes | — | — | FDA listed | — |
| Omvoh 100 mg/mL 00002-8011-27 | Eli | 2 syringes | — | — | FDA listed | — |
| Omvoh 100 mg/mL 00002-1442-11 | Eli | 1 syringe | — | — | FDA listed | — |
| Omvoh 100 mg/mL 00002-3116-11 | Eli | 1 syringe | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Oct 26, 2035 |
Is there a biosimilar for OMVOH 200 MG DOSE - 2 SYRINGES?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
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What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00002-8870-27 You're viewing this | 2 SYRINGE in 1 CARTON (0002-8870-27) / 1 mL in 1 SYRINGE (0002-8870-01) | 2024-04-29 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS 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. OMVOH TM is an interleukin-23 antagonist indicated for the treatment of: moderately to severely active ulcerative colitis in adults ( 1 ) moderately to severely active Crohn's disease in adults ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Prior to Treatment Initiation Evaluate patients for tuberculosis (TB) infection. ( 2.1 , 5.3 ) Obtain liver enzymes and bilirubin levels. ( 2.1 , 5.4 ) Complete all age-appropriate vaccinations according to current immunization guidelines.
( 2.1 , 5.5 ) Recommended Dosage for Ulcerative Colitis Induction Dosage : Week 0, Week 4, and Week 8: Infuse 300 mg intravenously over at least 30 minutes. ( 2.2 ) Maintenance Dosage : Week 12 and every 4 weeks thereafter: Inject 200 mg subcutaneously (given as either one injection of 200 mg or as two consecutive injections of 100 mg each). ( 2.2 ) Recommended Dosage for Crohn's Disease Induction Dosage : Week 0, Week 4, and Week 8: Infuse 900 mg intravenously over at least 90 minutes.
( 2.3 ) Maintenance Dosage : Week 12 and every 4 weeks thereafter: Inject 300 mg subcutaneously (given as two consecutive injections of 100 mg and 200 mg in any order). ( 2.3 ) Preparation and Administration Instructions See the full prescribing information for preparation, administration and storage information for intravenous infusion and subcutaneous injection. ( 2.2 , 2.3 , 2.4 , 2.5 )
2.1Recommended Evaluations and Immunizations Prior to Treatment Initiation Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with OMVOH [see Warnings and Precautions ( 5.3 )] . Obtain liver enzymes and bilirubin levels prior to initiating treatment with OMVOH [see Warnings and Precautions ( 5.4 )] . Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions ( 5.5 )] .
2.2Recommended Dosage for Ulcerative Colitis Induction Dosage Week 0, Week 4, and Week 8: Infuse 300 mg intravenously over at least 30 minutes [see Dosage and Administration ( 2.4 )]. Maintenance Dosage Week 12 and every 4 weeks thereafter : Inject 200 mg subcutaneously (given as one injection of 200 mg or as two consecutive injections of 100 mg each) [see Dosage and Administration ( 2.5 ) and How Supplied/Storage and Handling ( 16 )] .
2.3Recommended Dosage for Crohn's Disease Induction Dosage Week 0, Week 4, and Week 8 : Infuse 900 mg intravenously over at least 90 minutes [see Dosage and Administration ( 2.4 )]. Maintenance Dosage Week 12 and every 4 weeks thereafter : Inject 300 mg subcutaneously (given as two consecutive injections of 100 mg and 200 mg in any order) [see Dosage and Administration ( 2.5 ) and How Supplied/Storage and Handling ( 16 )] .
2.4Preparation and Administration Instructions for Intravenous Infusion OMVOH for intravenous use is intended for administration by a healthcare provider using aseptic technique. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be a clear to opalescent, colorless to slightly yellow to slightly brown solution, and free of visible particles.
Do not use OMVOH if it is cloudy or there are visible particles. Prior to intravenous administration, determine the dose needed based on the patient's indication (see Table 1 below). For Crohn's disease, discard 45 mL of the infusion bag prior to adding vial contents.
Withdraw the required amount of solution from the vial(s) using a 18 gauge to 21 gauge needle and transfer to an infusion bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection (see Table 1 below). Do not mix with other drugs. Do not dilute or infuse through the same intravenous line with other solutions.
Table 1: Intravenous Induction Dose and Volume of Diluent Required Indication Intravenous Induction Dose Number of OMVOH 300mg/15mL vials needed Volume of 0.9% Sodium Chloride or 5% Dextrose Injection Ulcerative colitis 300 mg 1 50 mL, 100 mL, or 250 mL Crohn's disease 900 mg 3 100 mL or 250 mL Gently invert the infusion bag to mix the contents. Do not shake the prepared infusion bag. Connect the intravenous administration set (infusion line) to…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS OMVOH is a clear to opalescent, colorless to slightly yellow to slightly brown solution available as: Intravenous Infusion: Injection: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial Subcutaneous Use: Injection: 100 mg/mL solution in a single-dose prefilled pen Injection: 100 mg/mL solution in a single-dose prefilled syringe Injection: 200 mg/2 mL solution in a single-dose prefilled pen Injection: 200 mg/2 mL (100 mg/mL) solution in a single-dose prefilled syringe Intravenous Infusion ( 3 ) Injection: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial Subcutaneous Injection ( 3 ): Injection: 100 mg/mL solution in a single-dose prefilled pen Injection: 100 mg/mL solution in a single-dose prefilled syringe Injection: 200 mg/2 mL solution in a single-dose prefilled pen Injection: 200 mg/2 mL (100 mg/mL) solution in a single-dose prefilled syringe
⛔ Contraindications ▾
4 CONTRAINDICATIONS OMVOH is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients [see Warnings and Precautions ( 5.1 )] . History of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients. ( 4 , 5.1 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : Serious hypersensitivity reactions, including anaphylaxis and infusion-related reactions, have been reported. If a severe hypersensitivity reaction occurs, discontinue and initiate appropriate treatment. ( 5.1 ) Infections : OMVOH may increase the risk of infection.
Do not initiate treatment with OMVOH in patients with a clinically important active infection until the infection resolves or is adequately treated. If a serious infection develops, do not administer OMVOH until the infection resolves. ( 5.2 ) Tuberculosis : Do not administer OMVOH to patients with active TB infection.
Monitor patients receiving OMVOH for signs and symptoms of active TB during and after treatment. ( 5.3 ) Hepatotoxicity : Drug-induced liver injury has been reported. Monitor liver enzymes and bilirubin levels at baseline and for at least 24 weeks of treatment and thereafter according to routine patient management.
Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. ( 5.4 ) Immunizations : Avoid use of live vaccines. ( 5.5 )
5.1Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with OMVOH administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction [see Adverse Reactions ( 6.1 )] . If a severe hypersensitivity reaction occurs, discontinue OMVOH immediately and initiate appropriate treatment.
5.2Infections OMVOH may increase the risk of infection [see Adverse Reactions ( 6.1 )] . Do not initiate treatment with OMVOH in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing OMVOH.
Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer OMVOH until the infection resolves.
5.3Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with OMVOH. Do not administer OMVOH to patients with active TB infection. Initiate treatment of latent TB prior to administering OMVOH.
Consider anti-TB therapy prior to initiation of OMVOH in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after OMVOH treatment. In clinical trials, subjects were excluded if they had evidence of active TB, a past history of active TB, or were diagnosed with latent TB at screening.
5.4Hepatotoxicity A case of drug-induced liver injury (alanine aminotransferase [ALT] 18x the upper limit of normal (ULN), aspartate aminotransferase [AST] 10x ULN, and total bilirubin 2.4x ULN) in conjunction with pruritus was reported in a clinical trial subject following a longer than recommended induction regimen. OMVOH was discontinued. Liver test abnormalities eventually returned to baseline.
Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment. Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis.
Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.
5.5Immunizations Avoid use of live vaccines in patients treated with OMVOH. Medications that interact with the immune system may increase the risk of infection…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following topics are also discussed in detail in the Warnings and Precautions section: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Tuberculosis [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Most common adverse reactions are: Ulcerative colitis (≥2%) : Induction : upper respiratory tract infections and arthralgia. ( 6.1 ) Maintenance: upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection.
( 6.1 ) Crohn's disease (≥5%) : upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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. Ulcerative Colitis OMVOH was studied up to 12 weeks in subjects with moderately to severely active ulcerative colitis in a randomized, double-blind, placebo-controlled induction study (UC-1). In subjects who responded to induction therapy in UC-1, long term safety up to 52 weeks was evaluated in a randomized, double-blind, placebo-controlled maintenance study (UC-2) and a long-term extension study [see Clinical Studies ( 14.1 )] .
In the induction study (UC-1), 1279 subjects were enrolled of whom 958 received OMVOH 300 mg administered as an intravenous infusion at Weeks 0, 4, and 8. In the maintenance study (UC-2), 581 subjects were enrolled of whom 389 received OMVOH 200 mg administered as a subcutaneous injection every 4 weeks. Table 2 summarizes the adverse reactions reported in at least 2% of subjects and at a higher frequency than placebo during UC-1.
Table 2: Adverse Reactions a in Subjects with Ulcerative Colitis through Week 12 in a Placebo-Controlled Induction Study (UC-1) a Reported in at least 2% of subjects and at a higher frequency than placebo. b OMVOH 300 mg as an intravenous infusion at Weeks 0, 4, and 8. c Upper respiratory tract infections includes related terms (e.g., COVID-19, nasopharyngitis, pharyngitis, rhinitis, sinusitis, and upper respiratory tract infection). Adverse Reactions OMVOH 300 mg Intravenous Infusion b N=958 n (%) Placebo N=321 n (%) Upper respiratory tract infections c 72 (8%) 20 (6%) Arthralgia 20 (2%) 4 (1%) In the induction study (UC-1), infusion-related hypersensitivity reactions were reported by 4 (0.4%) subjects treated with OMVOH and 1 (0.3%) subject treated with placebo.
Table 3 summarizes the adverse reactions reported in at least 2% of subjects and at a higher frequency than placebo during the 40-week controlled period of UC-2. Table 3: Adverse Reactions a in Subjects with Ulcerative Colitis through Week 40 In a Placebo-Controlled Maintenance Study (UC-2) a Reported in at least 2% of subjects and at a higher frequency than placebo b OMVOH 200 mg as a subcutaneous injection at Week 12 and every 4 weeks thereafter for up to an additional 40 weeks. c Upper respiratory tract infections includes related terms (e.g., COVID-19, nasopharyngitis, pharyngitis, rhinitis, sinusitis, and upper respiratory tract infection). d Injection site reactions includes related terms (e.g., erythema, hypersensitivity, pain, reaction, and urticaria at the injection site). e Rash is composed of several similar terms. f Herpes viral infection includes related terms (e.g., herpes zoster, herpes simplex, and oral herpes).
Adverse Reactions OMVOH 200 mg Subcutaneous Injection b N=389 n (%) Placebo N=192 n (%) Upper respiratory tract infections c 53 (14%) 23 (12%) Injection site reactions d 34 (9%) 8 (4%) Arthralgia 26 (7%) 8 (4%) Rash e 16…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1CYP450 Substrates Increased concentrations of cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation associated with certain diseases including Crohn's disease may suppress the formation of CYP450 enzymes. Therapeutic proteins, including mirikizumab-mrkz, that decrease the concentrations of these pro-inflammatory cytokines may increase the formation of CYP450 enzymes resulting in decreased CYP450 substrate exposure. Upon initiation or discontinuation of OMVOH in patients treated with concomitant CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP450 substrate as needed.
See the prescribing information of specific CYP450 substrates.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to OMVOH during pregnancy. Pregnant women exposed to OMVOH and healthcare providers are encouraged to call Eli Lilly and Company at 1-800-Lilly-Rx (1-800-545-5979). Risk Summary Available data from case reports of mirikizumab-mrkz use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Although there are no data on mirikizumab-mrkz, monoclonal antibodies can be actively transported across the placenta, and mirikizumab-mrkz may cause immunosuppression in the in utero-exposed infant. An enhanced pre- and post-natal development study conducted in pregnant monkeys at a dose 20 times the maximum recommended human dose (MRHD) revealed no adverse developmental effects to the developing fetus, or harm to infant monkeys from birth through 6 months of age. There are risks of adverse pregnancy outcomes associated with increased disease activity in women with inflammatory bowel disease (see Clinical Considerations) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and Embryo/Fetal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester.
It is unclear whether mirikizumab-mrkz may interfere with an infant's immune response to infections. Therefore, monitoring for the development of serious infection during the first 2 months of life in infants exposed in utero is recommended. Data Animal Data An enhanced pre- and postnatal development study was conducted in cynomolgus monkeys administered mirikizumab-mrkz by intravenous injection during organogenesis to parturition at a dose of 300 mg/kg twice weekly (20 times the MRHD based on exposure comparisons).
Mirikizumab-mrkz crossed the placenta in monkeys. No maternal toxicity was noted in this study. No mirikizumab-mrkz-related effects on morphological, functional or immunological development were observed in infant monkeys from birth through 6 months of age.
However, incidences of embryo/fetal loss were higher in the treated groups compared to control (6.7% [1 of 15] in controls vs 26.7% [4 of 15] at 300 mg/kg (20 times the MRHD, based on exposure comparisons) but were within the range of historical control data. Following delivery, most adult female cynomolgus monkeys and all infants from the mirikizumab-mrkz-treated group had measurable serum concentrations up to 28 days postpartum. In the infant monkeys, mean serum concentrations were approximately 4.8 times the respective mean maternal concentrations.
8.2Lactation Risk Summary There are no data on the presence of mirikizumab-mrkz in human milk, the effects on the breastfed infant, or the effects on milk production. Endogenous maternal IgG and monoclonal antibodies are transferred in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to mirikizumab-mrkz are unknown.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for OMVOH and any potential adverse effe…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to OMVOH during pregnancy. Pregnant women exposed to OMVOH and healthcare providers are encouraged to call Eli Lilly and Company at 1-800-Lilly-Rx (1-800-545-5979). Risk Summary Available data from case reports of mirikizumab-mrkz use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Although there are no data on mirikizumab-mrkz, monoclonal antibodies can be actively transported across the placenta, and mirikizumab-mrkz may cause immunosuppression in the in utero-exposed infant. An enhanced pre- and post-natal development study conducted in pregnant monkeys at a dose 20 times the maximum recommended human dose (MRHD) revealed no adverse developmental effects to the developing fetus, or harm to infant monkeys from birth through 6 months of age. There are risks of adverse pregnancy outcomes associated with increased disease activity in women with inflammatory bowel disease (see Clinical Considerations) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and Embryo/Fetal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester.
It is unclear whether mirikizumab-mrkz may interfere with an infant's immune response to infections. Therefore, monitoring for the development of serious infection during the first 2 months of life in infants exposed in utero is recommended. Data Animal Data An enhanced pre- and postnatal development study was conducted in cynomolgus monkeys administered mirikizumab-mrkz by intravenous injection during organogenesis to parturition at a dose of 300 mg/kg twice weekly (20 times the MRHD based on exposure comparisons).
Mirikizumab-mrkz crossed the placenta in monkeys. No maternal toxicity was noted in this study. No mirikizumab-mrkz-related effects on morphological, functional or immunological development were observed in infant monkeys from birth through 6 months of age.
However, incidences of embryo/fetal loss were higher in the treated groups compared to control (6.7% [1 of 15] in controls vs 26.7% [4 of 15] at 300 mg/kg (20 times the MRHD, based on exposure comparisons) but were within the range of historical control data. Following delivery, most adult female cynomolgus monkeys and all infants from the mirikizumab-mrkz-treated group had measurable serum concentrations up to 28 days postpartum. In the infant monkeys, mean serum concentrations were approximately 4.8 times the respective mean maternal concentrations.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of OMVOH have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 795 OMVOH-treated subjects in the two ulcerative colitis clinical studies, 64 subjects (8%) were 65 years of age and older, while 10 subjects (1%) were 75 years of age and older. Of the 715 OMVOH-treated subjects in the Crohn's disease clinical study, 22 subjects (3%) were 65 years of age and older, while 6 subjects (1%) were 75 years of age and older). These clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger adult subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger subjects. No clinically meaningful differences in the pharmacokinetics of mirikizumab-mrkz were observed in subjects 65 years of age and older compared to younger adult subjects [see Clinical Pharmacology ( 12.3 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Mirikizumab-mrkz is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is involved in mucosal inflammation and affects the differentiation, expansion, and survival of T cell subsets, and innate immune cell subsets, which represent sources of pro-inflammatory cytokines. Research in animal models has shown that pharmacologic inhibition of IL-23p19 can ameliorate intestinal inflammation.
Mirikizumab-mrkz inhibits the release of pro-inflammatory cytokines and chemokines.
12.2Pharmacodynamics In both study UC-1 (induction) and study UC-2 (maintenance), a positive relationship was observed between Mirikizumab-mrkz average concentration and rates of clinical remission and clinical response [see Clinical Studies ( 14.1 )] . Mirikizumab exposure response relationships have not been fully characterized in subjects with Crohn's disease.
12.3Pharmacokinetics Mirikizumab-mrkz exhibited linear pharmacokinetics with dose-proportional increase in exposure over a dose range of 60 to 2400 mg given as an intravenous injection or over a dose range of 200 to 400 mg given as a subcutaneous injection, in healthy volunteers. There was no apparent accumulation of mirikizumab-mrkz concentrations in serum over time when administered as a subcutaneous injection every 4 weeks to subjects with ulcerative colitis or Crohn's disease. The estimated exposure parameters of mirikizumab-mrkz at steady state are summarized in Tables 5 for ulcerative colitis and 6 for Crohn's disease.
Table 5: Mirikizumab-mrkz Estimated Systemic Exposure at Steady State in Subjects with Ulcerative Colitis a OMVOH 300 mg as an intravenous infusion over at least 30 minutes at Weeks 0, 4, and 8. b OMVOH 200 mg as 2 subcutaneous injections (100 mg/mL each) at Week 12 and every 4 weeks thereafter for up to an additional 40 weeks. c AUC tau, ss = area under the concentration-versus-time curve over one dosing interval at steady state; C max, ss = maximum concentration at steady state; C trough, ss = concentration at the end of the dosing interval at steady state; CV = geometric coefficient of variation.
OMVOH 300 mg Intravenous Infusion a Geometric mean (CV%) OMVOH 200 mg Subcutaneous Injection b Geometric mean (CV%) C max, ss (μg/mL) c 99.7 (22.7%) 10.1 (52.1%) AUC tau, ss (μg*day/mL) c 538 (34.4%) 160 (57.6%) C trough, ss (μg/mL) c 2.75 (101%) 1.70 (83.3%) Table 6: Mirikizumab-mrkz Estimated Systemic Exposure at Steady State in Subjects with Crohn's Disease a OMVOH 900 mg as an intravenous infusion over at least 90 minutes at Weeks 0, 4, and 8. b OMVOH 300 mg as 2 subcutaneous injections (100 mg/mL and 200 mg/2 mL) at Week 12 and every 4 weeks thereafter up to Week 52. c AUC tau, ss = area under the concentration-versus-time curve over one dosing interval at steady state; C max, ss = maximum concentration at steady state; C trough, ss = concentration at the end of the dosing interval at steady state; CV = geometric coefficient of variation.
OMVOH 900 mg Intravenous Infusion a Geometric mean (CV%) OMVOH 300 mg Subcutaneous Injection b Geometric mean (CV%) C max, ss (μg/mL) c 332 (21%) 13.6 (48%) AUC tau, ss (μg*day/mL) c 1820 (38%) 220 (56%) C trough, ss (μg/mL) c 10.4 (108%) 2.52 (88%) Absorption Following subcutaneous dosing of OMVOH for ulcerative colitis median (range) T max was 5 (3.08 to 6.75) days post dose and geometric mean (CV%) absolute bioavailability was 44% (34%). Following subcutaneous dosing of OMVOH for Crohn's disease, median (range) T max was 5 (3 to 6.83) days post dose and geometric mean (CV%) absolute bioavailability was 36.3% (31%).
Injection site location (abdomen, upper arm, or thigh) did not significantly influence bioavailability of mirikizumab-mrkz following subcutaneous injection. Distribution In subjects with ulcerative colitis, the geometric mean (CV%) total volume of distribution was
4.83 L (21%…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Mirikizumab-mrkz is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is involved in mucosal inflammation and affects the differentiation, expansion, and survival of T cell subsets, and innate immune cell subsets, which represent sources of pro-inflammatory cytokines. Research in animal models has shown that pharmacologic inhibition of IL-23p19 can ameliorate intestinal inflammation.
Mirikizumab-mrkz inhibits the release of pro-inflammatory cytokines and chemokines.
📦 How Supplied / Storage and Handling ▾
16 HOW 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: Table 10: Packaging Information for OMVOH Presentation Indication Package Size NDC Code Single-dose Vial 300 mg/15 mL (20 mg/mL) Ulcerative colitis and Crohn's disease Carton of 1 0002-7575-01 Single-dose Prefilled Pen 100 mg/mL + 100 mg/mL Ulcerative colitis Carton of 2 0002-8011-27 200 mg/2 mL Ulcerative colitis Carton of 1 0002-3116-11 200 mg/2 mL + 100 mg/mL Crohn's disease Carton of 2 (1 of each) 0002-7717-11 Single-dose Prefilled Syringe 100 mg/mL + 100 mg/mL Ulcerative colitis Carton of 2 0002-8870-27 200 mg/2 mL (100 mg/mL) Ulcerative colitis Carton of 1 0002-1442-11 200 mg/2 mL (100 mg/mL) + 100 mg/mL Crohn's disease Carton of 2 (1 of each) 0002-7722-11 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. Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F).
Do not freeze. Do not use OMVOH if it has been frozen. Do not shake.
Keep OMVOH in the original carton to protect from light until the time of use. OMVOH is sterile and preservative-free. Discard any unused portion.
If needed, the prefilled pen or prefilled syringe may be stored at room temperature up to 30°C (86°F) for up to 2 weeks in the original carton to protect from light. Once OMVOH has been stored at room temperature, do not return to the refrigerator. If these conditions are exceeded, OMVOH must be discarded.
The vial, prefilled pen, and prefilled syringe are not made with dry natural rubber latex.
📦 Storage and Handling ▾
Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use OMVOH if it has been frozen.
Do not shake. Keep OMVOH in the original carton to protect from light until the time of use. OMVOH is sterile and preservative-free.
Discard any unused portion. If needed, the prefilled pen or prefilled syringe may be stored at room temperature up to 30°C (86°F) for up to 2 weeks in the original carton to protect from light. Once OMVOH has been stored at room temperature, do not return to the refrigerator.
If these conditions are exceeded, OMVOH must be discarded. The vial, prefilled pen, and prefilled syringe are not made with dry natural rubber latex.
📋 Description ▾
11 DESCRIPTION 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. OMVOH for intravenous infusion for ulcerative colitis and Crohn's disease OMVOH (mirikizumab-mrkz) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow to slightly brown solution in a single-dose vial for intravenous infusion after dilution.
OMVOH injection 300 mg /15 mL vial is available in 2 formulations: Each mL contains 20 mg of mirikizumab-mrkz, anhydrous citric acid (0.4 mg), polysorbate 80 (0.5 mg), sodium chloride (8.8 mg), sodium citrate (2.1 mg), and Water for Injection. The OMVOH solution has a pH range of 5.0 to 6.0. Each mL contains 20 mg of mirikizumab-mrkz, anhydrous citric acid (0.1 mg), histidine (0.1 mg), L-histidine hydrochloride monohydrate (0.9 mg), mannitol (33 mg), polysorbate 80 (0.5 mg), sodium chloride (2.9 mg), sodium citrate (0.2 mg), and Water for Injection.
The OMVOH solution has a pH range of 5.0 to 5.8. OMVOH (mirikizumab-mrkz) injection 100 mg/mL prefilled pen or prefilled syringe for subcutaneous use for ulcerative colitis and Crohn's disease OMVOH (mirikizumab-mrkz) injection is a sterile, preservative free, clear to opalescent, colorless to slightly yellow to slightly brown solution for subcutaneous use available as 100 mg of mirikizumab-mrkz in a 1 mL single-dose prefilled pen or single-dose prefilled syringe. The prefilled pen and prefilled syringe contain a 1 mL glass syringe with a fixed 27-gauge ½ inch needle.
The OMVOH 100 mg prefilled pen and prefilled syringe are manufactured to deliver 100 mg of mirikizumab-mrkz. Each mL is composed of 100 mg mirikizumab-mrkz, histidine (0.1 mg), L-histidine hydrochloride monohydrate (0.9 mg), mannitol (33 mg), polysorbate 80 (0.3 mg), sodium chloride (2.9 mg), and Water for Injection. The OMVOH solution has a pH range of 5.0 to 5.8.
OMVOH (mirikizumab-mrkz) injection 200 mg/2 mL prefilled pen or 200 mg/2 mL (100 mg/mL) prefilled syringe for subcutaneous use for ulcerative colitis and Crohn's disease OMVOH (mirikizumab-mrkz) injection is a sterile, preservative free, clear to opalescent, colorless to slightly yellow to slightly brown solution for subcutaneous use. The 2 mL prefilled pen and prefilled syringe each contain a 2 mL glass syringe with a fixed 27-gauge 8 mm needle. The OMVOH 200 mg prefilled pen and prefilled syringe are manufactured to deliver 200 mg of mirikizumab-mrkz.
Each mL is composed of 100 mg mirikizumab-mrkz, histidine (0.1 mg), L-histidine hydrochloride monohydrate (0.9 mg), mannitol (33 mg), polysorbate 80 (0.3 mg), sodium chloride (2.9 mg), and Water for Injection. The OMVOH solution has a pH range of 5.0 to 5.8.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Hypersensitivity Reactions Advise patients to discontinue OMVOH and seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] . Infections Advise patients that OMVOH may lower the ability of their immune system to fight infections and to contact their healthcare provider immediately if they develop any symptoms of infection [see Warnings and Precautions ( 5.2 )] .
Tuberculosis Advise patients to contact their healthcare provider if they experience symptoms suggestive of TB (e.g., unexplained fever, cough, or difficulty breathing) [see Warnings and Precautions ( 5.3 )] . Hepatotoxicity Inform patients that OMVOH may cause liver injury. Advise patients to seek immediate medical attention if they experience symptoms suggestive of liver dysfunction (e.g., unexplained rash, nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine) [see Warnings and Precautions ( 5.4 )] .
Immunizations Advise patients that vaccination with live vaccines is not recommended during OMVOH treatment and immediately prior to or after OMVOH treatment. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Instruct patients to inform their healthcare provider that they are taking OMVOH prior to receiving a vaccination [see Warnings and Precautions ( 5.5 )] .
Pregnancy Advise patients who are exposed to OMVOH during pregnancy to contact Eli Lilly and Company [see Use in Specific Populations ( 8.1 )] . Administration Instruct patients in preparation and administration of OMVOH, including choosing anatomical sites for subcutaneous administration, and proper subcutaneous injection technique. Instruct patients in the technique of prefilled pen or prefilled syringe disposal [see Instructions for Use] .
Instruct ulcerative colitis patients or caregivers to administer either: Two 100 mg prefilled pens or two 100 mg prefilled syringes to achieve the full 200 mg dose of OMVOH. One 200 mg prefilled pen or one 200 mg prefilled syringe to achieve the full 200 mg dose of OMVOH. Instruct Crohn's disease patients or caregivers to administer a 100 mg prefilled pen or prefilled syringe and a 200 mg prefilled pen or prefilled syringe in any order to achieve the full 300 mg dose of OMVOH.
Eli Lilly and Company, Indianapolis, IN 46285, USA US License No. 1891 Copyright © 2023, 2025, Eli Lilly and Company. All rights reserved.
Pat.: www.lilly.com/patents OMV-0009-USPI-20251104
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 10/2025 Medication Guide OMVOH TM (ahm-VOH) (mirikizumab-mrkz) injection, for intravenous or subcutaneous use What is the most important information I should know about OMVOH?
OMVOH can cause serious side effects, including: Serious allergic reactions. OMVOH may cause serious allergic reactions that may need to be treated in a hospital and may be life-threatening. Stop using OMVOH and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: fainting, dizziness, feeling lightheaded (low blood pressure) swelling of your face, eyelids, lips, mouth, tongue, throat, or trouble swallowing trouble breathing, throat tightening or wheezing chest tightness fast heartbeat or pounding in your chest (tachycardia) severe itching, hives, or redness all over your body sweating Infections.
OMVOH may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should not start treatment with OMVOH until your infection is gone. Before starting your treatment with OMVOH, your healthcare provider should test you for tuberculosis (TB).
If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with OMVOH. Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with OMVOH and after treatment. Before starting OMVOH, tell your healthcare provider if you think you have an infection or have symptoms of an infection such as: fever, sweating, or chills muscle aches and pain cough or shortness of breath blood in your mucus (phlegm) flu-like symptoms headache warm, red, or painful skin or sores on your body diarrhea or stomach pain weight loss nausea or vomiting pain during urination After starting OMVOH, tell your healthcare provider right away if you have any symptoms of an infection.
Liver problems. OMVOH may cause liver problems. Your healthcare provider will do blood tests to check your liver enzyme and bilirubin levels before treatment, for at least 24 weeks during treatment, and possibly after treatment with OMVOH.
Your healthcare provider may hold or stop your treatment if needed. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including: unexplained rash nausea vomiting stomach-area (abdominal) pain feeling tired loss of appetite yellowing of the skin or the whites of your eyes dark urine What is OMVOH? OMVOH is a prescription medicine used to treat: adults with moderately to severely active ulcerative colitis adults with moderately to severely active Crohn's disease It is not known if OMVOH is safe and effective in children.
Do not use OMVOH if you: are allergic to mirikizumab-mrkz or any of the ingredients in OMVOH. See the end of this Medication Guide for a complete list of ingredients in OMVOH. Before you use OMVOH, tell your healthcare provider about all your medical conditions, including if you: have any of the conditions or symptoms listed in the section “ What is the most important information I should know about OMVOH? ” have recently received or are scheduled to receive any vaccinations.
Medicines that affect your immune system may increase your risk of getting an infection after receiving live vaccines. You should be brought up to date with all age required vaccines before starting treatment with OMVOH. You should avoid receiving ‘live’ vaccines right before, during, or right after treatment with OMVOH.
Tell your healthcare provider that you are taking OMVOH before receiving a vaccine. are pregnant, or plan to become pregnant. It is not known if OMVOH will harm your unborn baby. There will be a pregnancy registry to collect information about women who are exposed to OMVOH during pregnancy.
If you become pregnant while taking OMVOH, you are encouraged to repo…