OMVOHTM -mirikizumab-mrkz injection
Drug UPDATES: [Drug information (pdf)]
PACKAGE INSERT -Dosing: Click (+) next to Dosage and Administration section (drug info link)
Intravenous Infusion
- OMVOH for intravenous use is intended for administration by a healthcare provider using aseptic technique. Each vial is for single use only.
- 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.
- Using an 18 to 21 gauge needle withdraw 15 mL of OMVOH solution from the vial and transfer to an infusion bag ranging in size from 50 mL to 250 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection. Do not mix with other drugs. Do not dilute or infuse through the same intravenous line with solutions other than 0.9% Sodium Chloride or 5% Dextrose Injection.
- 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.
- Administer the infusion over at least 30 minutes.
- 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.
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
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. 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 - 6.0.
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.
OMVOHTM is an interleukin-23 antagonist indicated for the treatment of moderately to severely active ulcerative colitis in adults
History of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.
- 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)
- Drug information (pdf)
Most common adverse reactions (≥2%) are:
- Induction: upper respiratory tract infections and arthralgia.
- Maintenance: upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection. (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.
Revised: 4/2024
See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide. Drug information (pdf)
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
Induction Dosage
The recommended induction dosage of OMVOH is 300 mg administered by intravenous infusion over at least 30 minutes at Week 0, Week 4, and Week 8 [see Dosage and Administration (2.3)].
Maintenance Dosage
The recommended maintenance dosage of OMVOH is 200 mg administered by subcutaneous injection (given as two consecutive injections of 100 mg each) at Week 12, and every 4 weeks thereafter.
2.3 Preparation and Administration of OMVOH for Intravenous Infusion
- OMVOH for intravenous use is intended for administration by a healthcare provider using aseptic technique. Each vial is for single use only.
- 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.
- Using an 18 to 21 gauge needle withdraw 15 mL of OMVOH solution from the vial and transfer to an infusion bag ranging in size from 50 mL to 250 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection. Do not mix with other drugs. Do not dilute or infuse through the same intravenous line with solutions other than 0.9% Sodium Chloride or 5% Dextrose Injection.
- 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.
- Administer the infusion over at least 30 minutes.
- 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.
2.4 Preparation and Administration of OMVOH for Subcutaneous Injection
- A full maintenance dose will require 2 prefilled pens or 2 prefilled syringes.
- 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 pen or OMVOH prefilled syringe from the refrigerator and leave at room temperature for 30 minutes. Do not shake the prefilled pens or 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 every time. For example, if the first injection was in the abdomen, administer the second injection (to complete a full dose) in another area of the abdomen, or upper arm, or thigh. 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.
Intravenous Infusion:
- Injection: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial
Subcutaneous Injection:
- Injection: 100 mg/mL solution in a single-dose prefilled pen
- Injection: 100 mg/mL solution in a single-dose prefilled syringe
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 as:
| Strength | Pack Size | NDC Code | |
| For Intravenous Infusion | |||
| Single-dose Vial | 300 mg/15 mL (20 mg/mL) | Carton of 1 | 0002-7575-01 |
| For Subcutaneous Use | |||
| Single-dose Prefilled Pen | 100 mg/mL | Carton of 2 | 0002-8011-27 |
| Single-dose Prefilled Syringe | 100 mg/mL | Carton of 2 | 0002-8870-27 |
Each single-dose prefilled pen or prefilled syringe consists of a 1 mL glass syringe with a fixed 27-gauge ½ inch 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.
