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Omvoh (mirikizumab-mrkz)
mirikizumab
Adult Dosing .
Dosage forms: INJ (SC pen): 100 mg per injection, 200 mg per injection; INJ (300 mg dose SC pen pack): 100 mg per injection x1 and 200 mg per injection x1; INJ (SC pre-filled syringe): 100 mg per mL, 200 mg per 2 mL; INJ (300 mg dose SC pre-filled syringe pack): 100 mg per mL x1 and 200 mg per 2 mL x1; INJ (IV vial): various
Special Note
- [drug name clarification]
- Info: nonproprietary name = mirikizumab-mrkz
ulcerative colitis, moderate-severe
- [200 mg SC q4wk]
- Start: 300 mg IV x1 on wk 0, 4, 8, then 200 mg SC q4wk starting on wk 12
Crohn disease, moderate-severe
- [300 mg SC q4wk]
- Start: 900 mg IV x1 on wk 0, 4, 8, then 300 mg SC q4wk starting on wk 12
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: not defined; Info: consider alternative tx if cirrhosis
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- infection, active
- TB infection, active
- caution: TB infection, latent
- caution: TB infection risk
- caution: infection, chronic
- caution: infection, recurrent
- caution: infection risk
- caution: cirrhosis
Drug Interactions .
Overview
mirikizumab
IL-23 antagonist
- immunomodulatory effects
- caution advised with drugs metabolized by CYP450 enzymes, especially with narrow therapeutic index; chronic inflammatory conditions may alter metabolic enzyme formation; tx with immune modulators may reverse this effect, resulting in altered levels of concomitant drugs
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis (IV use)
- infection, serious
- hepatotoxicity
- hepatic injury
Common Reactions
- infection
- URI
- injection site reaction
- arthralgia
- headache
- LFTs elevated
- rash
- herpes viral infection
- urticaria
Safety/Monitoring .
Monitoring Parameters
TB test before tx start; ALT, AST, bilirubin at baseline, then for at least 24wk of tx, then as clinically indicated
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available, though likely to cross placenta based on human data with other monoclonal antibodies; no known risk of teratogenicity based on animal data at 20x MRHD; possible risk of neonatal immunosuppression based on drug's mechanism of action; for infants exposed to mirikizumab in utero, monitor for serious infection for at least 2mo after birth
Pregnancy Registry
enroll patients or encourage patients to enroll in Omvoh Pregnancy Registry at 1-800-545-5979
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for mirikizumab: catabolism; CYP450: unknown
Excretion: for mirikizumab: unknown; Half-life: 9.3 days
Subclass: Inflammatory Bowel Disease (IBD) ; Interleukin-23 (IL-23) Antagonists
Mechanism of Action
for mirikizumab: selectively binds to p19 subunit of IL-23 and inhibits IL-23 cytokine-induced responses including release of pro-inflammatory cytokines and chemokines (monoclonal antibody)
Formulary .
No Formulary Selected
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