Hypothetical female Omvoh patient standing in front of yellow background

Dosing

FOR ADULTS WITH MODERATE TO SEVERE UC OR CD¹

Indication-specific dosing¹

Omvoh dosing begins with IV infusions during induction and transitions to self-injections for maintenance¹
Patients can take Omvoh with preﬁlled pens or preﬁlled syringes for maintenance dosing¹

Omvoh is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject after training in proper technique.¹

Omvoh Induction and Maintenance Dosing¹

Schedule of IV infusion dosing and subcutaneous injection manitenance for Omvoh ulcerative colitis and crohn's disease patients — Dosing and administration schedule for Omvoh infusion:

For UC, induction dosage is IV infusions^a of Omvoh 300 mg at Weeks 0, 4, and 8.

For CD, induction dosage is IV infusions^b of Omvoh 900 mg at Weeks 0, 4, and 8.

Dosing and administration of Omvoh for maintenance with subcutaneous injections starting at Week 12 and every 4 weeks thereafter:

For UC, Omvoh 200 mg via 2 injections (each of 100 mg).

For CD, Omvoh 300 mg via 2 injections (1 injection of 100 mg and 1 injection of 200 mg administered in any order).

^aFor at least 30 minutes.¹
^bFor at least 90 minutes.¹

See the Prescribing Information for dosage and administration instructions, and refer to the Instructions for Use included with the devices.

SELECT IMPORTANT SAFETY INFORMATION
Pretreatment Evaluations
Prior to initiating treatment with Omvoh, evaluate patients for tuberculosis infection, obtain liver enzymes and bilirubin levels, and complete all age-appropriate vaccinations according to current immunization guidelines.¹

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CD=Crohn's disease; IV=intravenous; UC=ulcerative colitis.

Reference:

Omvoh. Prescribing Information. Lilly USA, LLC.

IMPORTANT SAFETY INFORMATION for Omvoh (mirikizumab-mrkz)

Warning:

CONTRAINDICATIONS - Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.

WARNINGS AND PRECAUTIONS

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. If a severe hypersensitivity reaction occurs, discontinue Omvoh immediately and initiate appropriate treatment.

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. 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.

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 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 history of active TB, or were diagnosed with latent TB at screening.

Hepatotoxicity

Drug-induced liver injury 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.

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, 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.

ADVERSE REACTIONS

Most common adverse reactions associated with Omvoh (≥2% of subjects and at a higher frequency than placebo) in ulcerative colitis treatment are upper respiratory tract infections and arthralgia during the induction study (UC-1), and upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection during the maintenance study (UC-2).

Most common adverse reactions associated with Omvoh in the Crohn’s disease study (CD-1) (≥5% of subjects and at a higher frequency than placebo) are upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests.

Omvoh injection is available as a 300mg/15 mL solution in a single-dose vial for intravenous infusion, and as a 100 mg/mL solution or a 200 mg/2 mL solution in a single dose prefilled pen or prefilled syringe for subcutaneous injection. Refer to the Prescribing Information for dosing information.

MR HCP ISI CD APP

Please see Prescribing Information and Medication Guide for Omvoh. Please see Instructions for Use included with the device.

INDICATIONS

Ulcerative Colitis
Omvoh is an interleukin-23 antagonist indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

Crohn's Disease
Omvoh is an interleukin-23 antagonist indicated for the treatment of moderately to severely active Crohn's disease (CD) in adults.