Mirikizumab

OMVOH

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What it isIL-23 p19 monoclonal antibody; ulcerative colitis and Crohn disease.

Why this oneIt was the first IL-23 agent approved specifically for ulcerative colitis.

What limits itScreen for tuberculosis before starting. Injection-site reactions; cost and access.

FDA-approved for

Ulcerative colitis (2023)
Crohn disease (2023)

FDA label

Read the full label on DailyMed ↗

FDA dosing	Population	Start	Target	Max
Moderately to severely active ulcerative colitis	Adults	Induction 300 mg IV q4wk (Weeks 0, 4, 8)	Maintenance 200 mg SC q4wk from Week 12	300 mg IV per induction dose
Moderately to severely active Crohn's disease	Adults	Induction 900 mg IV q4wk (Weeks 0, 4, 8)	Maintenance 300 mg SC q4wk from Week 12	900 mg IV per induction dose

Renal No dose adjustment for mild-moderate impairment (CrCl 30–89); severe not studied

Hepatic Undefined (not studied; consider other options in cirrhosis)

Instructions

Induction by IV infusion (UC ≥30 min; CD ≥90 min); do not give as IV push
Maintenance by SC injection (abdomen, thigh, or back of upper arm); may self-inject after training
Before treatment: evaluate for TB, obtain liver enzymes/bilirubin, complete age-appropriate vaccinations
Avoid live vaccines
If dose missed, give as soon as possible then resume q4wk

Cautions

Serious hypersensitivity reactions including anaphylaxis and infusion-related reactions
Infections — do not initiate during clinically important active infection
Tuberculosis — do not give with active TB; treat latent TB first
Hepatotoxicity/drug-induced liver injury — monitor liver enzymes and bilirubin
Avoid live vaccines

Adverse reactions

Upper respiratory tract infections
Injection site reactions
Arthralgia
Rash
Headache
Herpes viral infection
Elevated liver tests

Pregnancy Insufficient data; monoclonal antibody may cross placenta and cause immunosuppression in exposed infant; no adverse developmental effects in monkeys at 20x MRHD

Lactation No human milk data; IgG/monoclonal antibodies transferred in milk; weigh benefits vs. risk

NO BOXED WARNINGS

Principal riskScreen for tuberculosis