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Omvoh ™ (mirikizumab-mrkz) injection
300 mg/15 mL, 100 mg/mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
How is the maintenance dose of subcutaneous Omvoh™ (mirikizumab-mrkz) administered?
For maintenance dosing, mirikizumab is available as a prefilled pen for subcutaneous administration. Patients may self-inject mirikizumab after being trained in subcutaneous injection technique.
Maintenance Dosing and Administration
Mirikizumab is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject mirikizumab after training in subcutaneous (SC) injection technique. Provide proper training to patients and/or caregivers on the SC injection technique of mirikizumab according to the “Instructions for Use” included with the packaged product.1
Maintenance Dosing Delivery Devices
Mirikizumab is available for subcutaneous (SC) injection as 100 mg/mL solution in a single-dose prefilled pen.1
Recommended Maintenance Dose
The recommended maintenance dosage of mirikizumab is 200 mg administered by subcutaneous (SC) injection (given as 2 consecutive injections of 100 mg each) at week 12, and every 4 weeks thereafter.1
A full maintenance dose will require 2 prefilled pens.1
Patients with loss of response during maintenance treatment may receive an additional 3 doses of 300 mg intravenous (IV) infusion of mirikizumab given every 4 weeks. If therapeutic benefit is achieved, patients may resume mirikizumab subcutaneous (SC) dosing every 4 weeks.1
Injection Sites
Sites for injection include the
- abdomen
- thigh, and
- back of the upper arm.1
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.1
Do not inject into areas where the skin is tender, bruised, erythematous, or indurated.1
Preparation and Use
Before injection, remove the mirikizumab prefilled pen from the refrigerator and leave at room temperature for 30 minutes. Do not shake the prefilled pens.1
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 mirikizumab if it is cloudy or there are visible particles.1
Mirikizumab does not contain preservatives. Therefore, discard any unused product. Do not reuse.1
Storage and Handling
The following are the storage and handling instructions for mirikizumab.1
- Store refrigerated at 2°C to 8°C (36°F to 46°F).1
- Do not freeze. Do not use mirikizumab if it has been frozen.1
- Do not shake.1
- Keep mirikizumab in the original carton to protect it from light until the time of use.1
- Mirikizumab is sterile and preservative-free. Discard any unused portion.1
- If needed, the prefilled pen 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 mirikizumab has been stored at room temperature, do not return to the refrigerator. If these conditions are exceeded, mirikizumab must be discarded.1
- The vial and prefilled pen are not made with dry natural rubber latex.1
Enclosed Prescribing Information
Reference
1Omvoh [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
Date of Last Review: May 30, 2023