Omvoh

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 )
• 2.1 Recommended 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 )] .
• 2.2 Recommended 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 )] .
• 2.3 Recommended 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 )] .
• 2.4 Preparation 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 the prepared infusion bag and prime the line.
• Infuse the diluted solution intravenously over a period of at least 30 minutes for the 300 mg dose; at least 90 minutes for the 900 mg dose.
• If stored refrigerated, allow the diluted solution in the infusion bag to warm to room temperature prior to the start of the intravenous infusion.
• At the end of the infusion, flush the line with 0.9% Sodium Chloride Injection or 5% Dextrose Injection.
• Administer the flush at the same infusion rate as used for OMVOH administration.
• The time required to flush OMVOH solution from the infusion line is in addition to the minimum 30-minute infusion time.
• Storage of Diluted Solution Start the infusion immediately after preparation.
• If not used immediately, store the diluted infusion solution in the refrigerator at 2°C to 8°C (36°F to 46°F).
• Use the diluted infusion solution within 48 total hours, of which not more than 5 hours are permitted at non-refrigerated temperatures not to exceed 25°C (77°F), starting from the time of vial puncture.
• Keep drug product away from direct heat or light.
• Do not freeze the diluted solution in the prepared infusion bag.
• 2.5 Preparation and Administration Instructions for Subcutaneous Injection OMVOH is intended for use under the guidance and supervision of a healthcare professional.
• Patients may self-inject OMVOH after training in subcutaneous injection technique.
• Provide proper training to patients and/or caregivers on the subcutaneous injection technique of OMVOH according to the “Instructions for Use”, included with the packaged product.
• Before injection, remove OMVOH prefilled pens or OMVOH prefilled syringes from the refrigerator, and leave at room temperature for 45 minutes.
• Do not shake the prefilled pens or prefilled syringes.
• 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, discolored, or there are visible particles.
• Sites for injection include the abdomen, thigh, and back of the upper arm.
• Instruct patients to inject in a different location (such as upper arms, thighs or any quadrant of abdomen) than the previous injection.
• Administration of OMVOH in the back of upper arm may only be performed by another person.
• Do not inject into areas where the skin is tender, bruised, erythematous, or indurated.
• OMVOH does not contain preservatives; therefore, discard any unused product.
• Do not reuse.
• If a dose is missed, administer the dose as soon as possible.
• Thereafter, resume dosing every 4 weeks.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

Use in children

The safety and effectiveness of OMVOH have not been established in pediatric patients.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 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 )] .

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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.
• 6.1 Clinical 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 (4%) 2 (1%) Headache 16 (4%) 2 (1%) Herpes viral infection f 9 (2%) 1 (1%) Infections In UC-1 through Week 12, infections were reported by 145 (15%) subjects treated with OMVOH 300 mg and 45 (14%) subjects treated with placebo.
• Serious infections were reported by less than 1% in both groups.
• Serious infections in the OMVOH group included intestinal sepsis, listeria sepsis, and pneumonia.
• In the maintenance study (UC-2) through Week 40 (a total of 52 weeks of treatment), infections were reported by 93 (24%) subjects treated with OMVOH 200 mg and 44 (23%) subjects treated with placebo.
• A case of COVID-19 pneumonia was reported as a serious infection in the OMVOH group.
• Hepatic Enzyme Elevations In UC-1 through Week 12, alanine aminotransferase (ALT) ≥5X ULN was reported by 1 (0.1%) subject treated with OMVOH 300 mg and 1 (0.3%) subject treated with placebo.
• Aspartate aminotransferase (AST) ≥5X ULN was reported by 2 (0.2%) subjects treated with OMVOH 300 mg and no subject treated with placebo.
• These elevations have been noted with and without concomitant elevations in total bilirubin.
• In UC-2 through Week 40 (a total of 52 weeks of treatment), 3 (0.8%) subjects treated with OMVOH 200 mg reported ALT ≥5X ULN and 3 (0.8%) subjects reported AST ≥5X ULN; with or without concomitant elevations in total bilirubin.
• No subjects treated with placebo experienced similar elevations [see Warnings and Precautions ( 5.4 )] .
• Crohn's Disease OMVOH was studied up to 52 weeks in subjects with moderately to severely active Crohn's disease in a randomized, double-blind, placebo-controlled study (CD-1).
• The safety population consisted of 630 subjects who received OMVOH 900 mg administered as an intravenous infusion during induction at Weeks 0, 4, and 8 followed by OMVOH 300 mg administered as a subcutaneous injection every 4 weeks and 211 subjects who received placebo [see Clinical Trials ( 14.2 )] .
• Eighty-five of the 211 placebo subjects in the safety population who did not achieve clinical response by patient-reported outcome at Week 12 were switched to blinded induction and maintenance treatment with OMVOH.
• Observed data from these 85 subjects are included in the placebo cohort up to Week 12 and in the OMVOH cohort after Week 12.
• In CD-1, OMVOH and placebo-treated subjects had different lengths of exposure, therefore, exposure adjusted incidence rates (EAIRs) are also displayed in Table 4 to compare adverse reactions.
• Common Adverse Reactions Table 4 summarizes the frequencies and EAIRs per 100 person-years (PY) for adverse reactions reported in at least 5% of subjects treated with OMVOH and at a higher frequency than placebo during CD-1.
• Table 4:
• Adverse Reactions a in Subjects with Crohn's Disease through Week 52 In a Placebo-Controlled Study (CD-1) Abbreviations:
• EAIR, exposure-adjusted incidence rate;
• PY, person-years a Reported in at least 5% of subjects and at a higher frequency than placebo b Following OMVOH 900 mg as an intravenous infusion at Week 0, Week 4, and Week 8, subjects received OMVOH 300 mg as a subcutaneous injection at Week 12 and every 4 weeks thereafter for up to an additional 40 weeks.
• In addition, eighty-five placebo subjects who did not achieve clinical response by patient-reported outcome at Week 12 were switched to blinded induction and maintenance treatment with OMVOH.
• The observed data after Week 12 from these eighty-five subjects were included in the OMVOH cohort. c EAIRs are per 100 PY.
• The EAIR per 100 PY can be interpreted as an estimated number of first occurrences of the adverse reaction of interest if 100 subjects were treated for one year. d Upper respiratory tract infections includes related terms (e.g., COVID-19, nasopharyngitis, pharyngitis, rhinitis, sinusitis, and upper respiratory tract infection). e Injection site reactions includes related terms (e.g., erythema, hematoma, induration, pain, pruritus, and reaction at the injection site). f Headache includes related terms (i.e., headache and migraine). g Elevated liver tests include related terms (e.g., ALT increased, AST increased, alkaline phosphatase increased, bilirubin increased, and GGT increased) Adverse Reactions OMVOH b N=715, PY=655 n (%) [EAIR c ] Placebo N=211, PY=120 n (%) [EAIR c ] Upper respiratory tract infections d 199 (28) [37] 47 (22) [47] Injection site reactions e 69 (10) [11] 8 (4) [7] Headache f 45 (6) [7] 9 (4) [8] Arthralgia 44 (6) [7] 11 (5) [10] Elevated liver tests g 36 (5) [6] 8 (4) [7] Hepatic Enzyme Elevations Of the subjects with reported adverse reactions of elevated liver tests ( see Table 4 ), 3 subjects treated with OMVOH reported ALT ≥5X ULN and 2 subjects reported AST ≥5X ULN.
• Neither subject had a concomitant elevation in total bilirubin.
• No subjects treated with placebo experienced similar elevations.
• Less Common Adverse Reactions (<5%) In CD-1 through Week 52, urticaria was reported by 13 (2%, 2 per 100 PY) subjects treated with OMVOH and no subjects treated with placebo.
• Infections In CD-1 through Week 52, infections were reported by 282 (39%, 58 per 100 PY) subjects treated with OMVOH and 73 (35%, 81 per 100 PY) subjects treated with placebo.
• Serious infections in the OMVOH group included abscess (including abdominal abscess, anal abscess, gluteal abscess, and perineal abscess), cellulitis, pneumonia, and sepsis.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• 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

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 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.

Quoted from the official label, section “How Supplied”.

How to store it

• 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.

Quoted from the official label, section “Storage and Handling”.

What is in it

• 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.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Mirikizumab-Mrkz