Drug Facts
Composition & Profile
Identifiers & Packaging
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.; PACKAGE LABEL – Omvoh 300 mg Vial Cartons There are two formulations for this product NDC 0002-7575-01 15 mL omvoh TM (mirikizumab-mrkz) injection 300 mg/15 mL (20 mg/mL) For Intravenous Infusion After Dilution Single-Dose Vial - Discard Unused Portion Dispense enclosed Medication Guide to each patient. Rx only omvoh.com Lilly Classic Formulation contains the following inactive ingredients:anhydrous citric acid, polysorbate 80, sodium chloride, sodium citrate, and Water for Injection. Alternate Formulation contains the following inactive ingredients: anhydrous citric acid, histidine, L-histidine hydrochloride monohydrate, mannitol, polysorbate 80, sodium chloride, sodium citrate, and Water for Injection. PACKAGE LABEL – Omvoh 300 mg Vial Carton - Classic Formulation PACKAGE LABEL – Omvoh 300 mg Vial Carton - Alternate Formulation; PACKAGE LABEL – Omvoh Prefilled Pen 200 mg Dose Carton - Ulcerative Colitis NDC 0002-8011-27 omvoh TM (mirikizumab-mrkz) injection 100 mg/mL For Subcutaneous Use Only This carton contains a total dose of 200 mg. Inject both prefilled pens one after the other for a full dose of 200 mg. Note to Pharmacist: The entire carton is to be dispensed as a unit. 2 x 1 mL single-dose prefilled pens Rx only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL – Omvoh 100 mg Prefilled Pen; PACKAGE LABEL – Omvoh Prefilled Syringe 200 mg Dose Carton - Ulcerative Colitis NDC 0002-8870-27 omvoh TM (mirikizumab-mrkz) injection 100 mg/mL For Subcutaneous Use Only Note to Pharmacist: The entire carton is to be dispensed as a unit. This carton contains a total dose of 200 mg. Inject both prefilled syringes one after the other for a full dose of 200 mg. 2 x 1 mL single-dose prefilled syringes Rx only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL – Omvoh 100 mg Prefilled Syringe; PACKAGE LABEL – Omvoh Prefilled Pen 300 mg Dose Carton - Crohns Disease NDC 0002-7717-11 omvoh TM (mirikizumab-mrkz) injection 200 mg/2 mL 100 mg/mL For Subcutaneous Use Only Note to Pharmacist: The entire carton is to be dispensed as a unit. This carton contains a total dose of 300 mg. Inject both prefilled pens one after the other for a full dose of 300 mg. 1 x 2 mL single-dose prefilled pen 1 x 1 mL single-dose prefilled pen Rx only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL – Omvoh 300 mg Prefilled Pen; PACKAGE LABEL – Omvoh Prefilled Syringe 300 mg Dose Carton - Crohns Disease NDC 0002-7722-11 omvoh TM (mirikizumab-mrkz) injection 200 mg/2 mL (100 mg/mL) 100 mg/mL For Subcutaneous Use Only Note to Pharmacist: The entire carton is to be dispensed as a unit. This carton contains a total dose of 300 mg. Inject both prefilled syringes one after the other for a full dose of 300 mg. 1 x 2 mL single-dose prefilled syringe 1 x 1 mL single-dose prefilled syringe Rx only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL – Omvoh 300 mg Prefilled Syringe; PACKAGE LABEL – Omvoh Prefilled Pen 200 mg Single Injection Dose Carton - Ulcerative Colitis NDC 0002-3116-11 omvoh TM (mirikizumab-mrkz) injection 200 mg/2 mL For Subcutaneous Use Only This carton contains a total dose of 200 mg. Only one injection is required for a full dose. 1 x 200mg/2mL single dose prefilled pen Rx only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL – Omvoh 200 mg Prefilled Syringe; PACKAGE LABEL – Omvoh Prefilled Syringe 200 mg Single Injection Dose Carton - Ulcerative Colitis NDC 0002-1442-11 omvoh TM (mirikizumab-mrkz) injection 200 mg/2 mL (100 mg/mL) For Subcutaneous Use Only This carton contains a total dose of 200 mg. Only one injection is required for a full dose. 1 x 200 mg/2 mL single-dose prefilled syringe Rx only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL – Omvoh 200 mg Prefilled Syringe
- 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.
- PACKAGE LABEL – Omvoh 300 mg Vial Cartons There are two formulations for this product NDC 0002-7575-01 15 mL omvoh TM (mirikizumab-mrkz) injection 300 mg/15 mL (20 mg/mL) For Intravenous Infusion After Dilution Single-Dose Vial - Discard Unused Portion Dispense enclosed Medication Guide to each patient. Rx only omvoh.com Lilly Classic Formulation contains the following inactive ingredients:anhydrous citric acid, polysorbate 80, sodium chloride, sodium citrate, and Water for Injection. Alternate Formulation contains the following inactive ingredients: anhydrous citric acid, histidine, L-histidine hydrochloride monohydrate, mannitol, polysorbate 80, sodium chloride, sodium citrate, and Water for Injection. PACKAGE LABEL – Omvoh 300 mg Vial Carton - Classic Formulation PACKAGE LABEL – Omvoh 300 mg Vial Carton - Alternate Formulation
- PACKAGE LABEL – Omvoh Prefilled Pen 200 mg Dose Carton - Ulcerative Colitis NDC 0002-8011-27 omvoh TM (mirikizumab-mrkz) injection 100 mg/mL For Subcutaneous Use Only This carton contains a total dose of 200 mg. Inject both prefilled pens one after the other for a full dose of 200 mg. Note to Pharmacist: The entire carton is to be dispensed as a unit. 2 x 1 mL single-dose prefilled pens Rx only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL – Omvoh 100 mg Prefilled Pen
- PACKAGE LABEL – Omvoh Prefilled Syringe 200 mg Dose Carton - Ulcerative Colitis NDC 0002-8870-27 omvoh TM (mirikizumab-mrkz) injection 100 mg/mL For Subcutaneous Use Only Note to Pharmacist: The entire carton is to be dispensed as a unit. This carton contains a total dose of 200 mg. Inject both prefilled syringes one after the other for a full dose of 200 mg. 2 x 1 mL single-dose prefilled syringes Rx only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL – Omvoh 100 mg Prefilled Syringe
- PACKAGE LABEL – Omvoh Prefilled Pen 300 mg Dose Carton - Crohns Disease NDC 0002-7717-11 omvoh TM (mirikizumab-mrkz) injection 200 mg/2 mL 100 mg/mL For Subcutaneous Use Only Note to Pharmacist: The entire carton is to be dispensed as a unit. This carton contains a total dose of 300 mg. Inject both prefilled pens one after the other for a full dose of 300 mg. 1 x 2 mL single-dose prefilled pen 1 x 1 mL single-dose prefilled pen Rx only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL – Omvoh 300 mg Prefilled Pen
- PACKAGE LABEL – Omvoh Prefilled Syringe 300 mg Dose Carton - Crohns Disease NDC 0002-7722-11 omvoh TM (mirikizumab-mrkz) injection 200 mg/2 mL (100 mg/mL) 100 mg/mL For Subcutaneous Use Only Note to Pharmacist: The entire carton is to be dispensed as a unit. This carton contains a total dose of 300 mg. Inject both prefilled syringes one after the other for a full dose of 300 mg. 1 x 2 mL single-dose prefilled syringe 1 x 1 mL single-dose prefilled syringe Rx only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL – Omvoh 300 mg Prefilled Syringe
- PACKAGE LABEL – Omvoh Prefilled Pen 200 mg Single Injection Dose Carton - Ulcerative Colitis NDC 0002-3116-11 omvoh TM (mirikizumab-mrkz) injection 200 mg/2 mL For Subcutaneous Use Only This carton contains a total dose of 200 mg. Only one injection is required for a full dose. 1 x 200mg/2mL single dose prefilled pen Rx only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL – Omvoh 200 mg Prefilled Syringe
- PACKAGE LABEL – Omvoh Prefilled Syringe 200 mg Single Injection Dose Carton - Ulcerative Colitis NDC 0002-1442-11 omvoh TM (mirikizumab-mrkz) injection 200 mg/2 mL (100 mg/mL) For Subcutaneous Use Only This carton contains a total dose of 200 mg. Only one injection is required for a full dose. 1 x 200 mg/2 mL single-dose prefilled syringe Rx only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE LABEL – Omvoh 200 mg Prefilled Syringe
Overview
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.
Indications & 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 & 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 ) 2.1 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.
Warnings & 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 ) 5.1 Hypersensitivity 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. 5.2 Infections 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. 5.3 Tuberculosis 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. 5.4 Hepatotoxicity 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. 5.5 Immunizations Avoid use of live vaccines in patients treated with OMVOH. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy with OMVOH, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or non-live vaccines in patients treated with OMVOH.
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 ).
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. 6.1 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.
Drug Interactions
7.1 CYP450 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.
Storage & 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.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.