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Omvoh (mirikizumab-mrkz)
mirikizumab
Adult Dosing .
Dosage forms: INJ (pen, SC): 100 mg per injection, 200 mg per injection; INJ (pre-filled syringe, SC): 100 mg per mL, 200 mg per 2 mL; INJ (vial, IV): various
Special Note
- [formulation clarification]
- Info: nonproprietary name = mirikizumab-mrkz
ulcerative colitis, moderate-severe
- [200 mg SC q4wk]
- Start: 300 mg IV x1 at wk 0, 4, 8, then 200 mg SC q4wk starting at wk 12
Crohn dz, moderate-severe
- [300 mg SC q4wk]
- Start: 900 mg IV x1 at wk 0, 4, 8, then 300 mg SC q4wk starting at wk 12
renal dosing
- [see below]
- CrCl 30-89: 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
- immunosuppressive effects
- caution advised w/ drugs metabolized by CYP450 enzymes, especially w/ narrow therapeutic index; chronic inflammatory conditions may alter metabolic enzyme formation; tx w/ immune modulators may reverse this effect, resulting in altered levels of concomitant drugs
Contraindicated
- adenovirus vaccine, live
- BCG live intravesical
- chikungunya vaccine, live
- cholera vaccine, live
- dengue vaccine, live
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- rotavirus vaccine, live
- smallpox vaccine, live
- talimogene laherparepvec
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- cladribine oral
- etrasimod
- infliximab
- natalizumab
- pimecrolimus topical
- rabies vaccine
- upadacitinib
Monitor/Modify Tx
- anthrax vaccine
- carfilzomib
- chikungunya vaccine
- COVID-19 vaccine
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- everolimus
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- influenza H5N1 vaccine
- influenza vaccine
- Japanese encephalitis vaccine
- meningococcal vaccine
- pneumococcal vaccine
- poliovirus vaccine
- respiratory syncytial virus vaccine
- sipuleucel-T
- smallpox/mpox vaccine, live
- temsirolimus
- tick-borne encephalitis vaccine
- typhoid vaccine
Caution Advised
- abatacept
- abemaciclib
- abrocitinib
- acalabrutinib
- adalimumab
- afamitresgene autoleucel
- aldesleukin
- alemtuzumab
- anakinra
- anifrolumab
- anti-thymocyte globulin
- atidarsagene autotemcel
- avacopan
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- baricitinib
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- belinostat
- bendamustine
- betamethasone
- bimekizumab
- blinatumomab
- bortezomib
- brentuximab vedotin
- brexucabtagene autoleucel
- brodalumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- busulfan
- cabazitaxel
- canakinumab
- carboplatin
- carmustine
- certolizumab pegol
- chlorambucil
- ciltacabtagene autoleucel
- cisplatin
- cladribine injection
- clobetasol ophthalmic
- clofarabine
- copanlisib
- corticotropin
- cortisone
- crovalimab
- cyclophosphamide
- cyclosporine
- cytarabine
- dactinomycin
- danicopan
- daratumumab
- daunorubicin
- decitabine
- deflazacort
- deucravacitinib
- deuruxolitinib
- dexamethasone
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- dinutuximab
- diroximel fumarate
- docetaxel
- doxorubicin
- dupilumab
- duvelisib
- eculizumab
- efgartigimod alfa
- elivaldogene autotemcel
- elotuzumab
- elranatamab
- emapalumab
- epcoritamab
- epirubicin
- eribulin
- etanercept
- etoposide
- fingolimod
- floxuridine
- fludarabine
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluorouracil
- fluticasone furoate
- fluticasone propionate
- fruquintinib
- gemcitabine
- gemtuzumab ozogamicin
- glofitamab
- golimumab
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- inebilizumab
- inotuzumab ozogamicin
- iptacopan
- irinotecan
- isatuximab
- ixabepilone
- ixekizumab
- lebrikizumab
- leflunomide
- lenalidomide
- lifileucel
- lisocabtagene maraleucel
- lomustine
- loncastuximab tesirine
- loteprednol ophthalmic
- lymphocyte immune globulin, anti-thymocyte globulin
- melphalan
- mercaptopurine
- methotrexate
- methylprednisolone
- mitoxantrone
- mogamulizumab
- momelotinib
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- nadofaragene firadenovec intravesical
- nelarabine
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- ofatumumab
- omacetaxine mepesuccinate
- oxaliplatin
- ozanimod
- paclitaxel
- panobinostat
- pegcetacoplan
- pentostatin
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponatinib
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- procarbazine
- quizartinib
- ravulizumab
- regorafenib
- rilonacept
- risankizumab
- ritlecitinib
- rituximab
- romidepsin
- ropeginterferon alfa-2b
- rozanolixizumab
- ruxolitinib
- ruxolitinib topical
- sarilumab
- satralizumab
- secukinumab
- selinexor
- siltuximab
- siponimod
- sirolimus
- sirolimus albumin-bound
- spesolimab
- sulfasalazine
- sutimlimab
- tacrolimus
- tafasitamab
- talquetamab
- tarlatamab
- teclistamab
- temozolomide
- teplizumab
- teriflunomide
- thioguanine
- thiotepa
- tildrakizumab
- tisagenlecleucel
- tocilizumab
- tofacitinib
- topotecan
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vamorolone
- vedolizumab
- venetoclax
- vilobelimab
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- zanubrutinib
- zilucoplan
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- anaphylaxis (IV use)
- infection, serious
- hepatotoxicity
- hepatic injury
Common Reactions
- infection
- URI
- injection site rxn
- 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 w/ 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 pts or encourage pts 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: catabolism; CYP450: unknown
Excretion: unknown; Half-life: 9.3 days
Subclass: Inflammatory Bowel Disease (IBD) ; Interleukin-23 (IL-23) Antagonists
Mechanism of Action
selectively binds to p19 subunit of IL-23 and inhibits IL-23 cytokine-induced responses incl. release of pro-inflammatory cytokines and chemokines (monoclonal antibody)
Formulary .
No Formulary Selected
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