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Olumiant
baricitinib
Black Box Warnings .
Serious Infections
incr. risk of serious infection leading to hospitalization or death; pulmonary and extrapulmonary TB, invasive fungal infections, and other opportunistic infections observed; most infections in patients with RA occur in combo with immunosuppressants; screen for latent TB infection before and during baricitinib tx, in all patients except those with COVID-19; initiate latent TB tx before baricitinib tx in patients with RA; baricitinib should not be given to patients with active TB; weigh risk/benefit in patients with chronic or recurrent infection; monitor closely for infection signs/symptoms during and after tx, including TB development in patients with negative latent TB screen prior to tx start; D/C baricitinib if serious infection develops
Mortality
higher rate of mortality, including sudden cardiovascular death, observed in RA patients 50 yo and older with at least 1 cardiovascular risk factor treated with another JAK inhibitor (tofacitinib) vs. TNF blockers in a large, randomized, post-marketing study
Malignancies
lymphoma and other malignancies observed with baricitinib; higher rate of malignancies, excluding non-melanoma skin CA, observed in RA patients treated with another JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers
Major Adverse Cardiovascular Events
higher rate of major adverse cardiovascular events, including cardiovascular death, non-fatal MI, and non-fatal stroke, observed in RA patients 50 yo and older with at least 1 cardiovascular risk factor treated with another JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; D/C baricitinib in patients that experienced MI or stroke
Thrombosis
thrombosis, including DVT, PE, and arterial thrombosis have occurred during baricitinib tx, sometimes fatal; higher rate of thrombosis observed in RA patients 50 yo and older with at least 1 cardiovascular risk factor on another JAK inhibitor (tofacitinib) vs. TNF blockers; avoid baricitinib in patients with thrombosis risk; D/C baricitinib and promptly evaluate patients with thrombosis symptoms
Adult Dosing .
Dosage forms: TAB: 1 mg, 2 mg, 4 mg
rheumatoid arthritis, moderate-severe
- [2 mg PO qd]
- Info: use alone or with methotrexate or other non-biologic DMARDs; see pkg insert for toxicity-related dose adjustments
COVID-19
- [4 mg PO qd]
- Info: for hospitalized patients requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO); may give with remdesivir; continue for 14 days or until hospital discharge, whichever comes first; see pkg insert for toxicity-related dose adjustments
alopecia areata, severe
- [2-4 mg PO qd]
- Info: may incr. dose to 4 mg PO qd if inadequate response or in patients with nearly complete or complete scalp hair loss; decr. dose to 2 mg PO qd after adequate response; see pkg insert for toxicity-related dose adjustments
atopic dermatitis, moderate-severe refractory (off-label)
- [2-4 mg PO qd]
- Info: see pkg insert for toxicity-related dose adjustments; refer to AAAAI/ACAAI guidelines
renal dosing
- [COVID-19]
- eGFR 30-59: 2 mg qd; eGFR 15-29: 1 mg qd; eGFR <15: avoid use
- HD/PD: avoid use
- [alopecia areata]
- eGFR 30-59: decr. usual dose by 50%; eGFR <30: avoid use
- HD/PD: not defined
- [all other indications]
- eGFR 30-59: 1 mg qd; eGFR <30: avoid use
- HD/PD: not defined
hepatic dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined
Peds Dosing .
- Dosage forms: TAB: 1 mg, 2 mg, 4 mg
Special Note
- [FDA emergency use authorization (EUA)]
- Info: for hospitalized patients 2 yo and older with suspected or confirmed COVID-19 requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO); not FDA approved for COVID-19; optimal tx duration unknown; available from Lilly's Authorized Distributors of Record at www.lillytrade.com; for clinical trial eligibility and enrollment info, check www.clinicaltrials.gov
- [strength clarification]
- Info: 4 mg tab only available through FDA EUA
- [mandatory reporting for EUA]
- Info: serious medication errors and adverse events must be reported to FDA MedWatch (www.fda.gov/medwatch/report.htm or 1-800-FDA-1088) and Eli Lilly and Company (1-855-545-5921)
COVID-19
- [2-8 yo]
- Dose: 2 mg PO qd; Info: for hospitalized patients requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO), per FDA EUA; may give with remdesivir; continue for 14 days or until hospital discharge, whichever comes first; see EUA for toxicity-related dose adjustments
- [9 yo and older]
- Dose: 4 mg PO qd; Info: for hospitalized patients requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO), per FDA EUA; may give with remdesivir; continue for 14 days or until hospital discharge, whichever comes first; see EUA for toxicity-related dose adjustments
renal dosing
- [2-8 yo]
- eGFR 30-59: 1 mg qd; eGFR <30: avoid use
- HD/PD: avoid use
- [9 yo and older]
- eGFR 30-59: 2 mg qd; eGFR 15-29: 1 mg qd; eGFR <15: avoid use
- HD/PD: avoid use
hepatic dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- acute kidney injury
- eGFR <30 (COVID-19 use in patients 2-8 yo)
- eGFR <30 (RA or alopecia use)
- eGFR <15 (COVID-19 use in patients 9 yo and older)
- baseline Hgb <8
- baseline lymphocytes <500 (RA or alopecia use)
- baseline lymphocytes <200 (COVID-19 use)
- baseline ANC <1000 (RA or alopecia use)
- baseline ANC <500 (COVID-19 use)
- infection, active (RA or alopecia use)
- TB infection, active
- thrombosis risk
- avoid: breastfeeding during tx and x4 days after D/C
- caution: patients of childbearing potential
- caution: eGFR 30-59 (COVID-19 use in patients 2-8 yo)
- caution: eGFR 30-59 (RA or alopecia use)
- caution: eGFR 15-59 (COVID-19 use in patients 9 yo and older)
- caution: infection, active (COVID-19 use)
- caution: opportunistic infection history
- caution: infection, chronic
- caution: infection, recurrent
- caution: infection risk
- caution: TB infection, latent
- caution: TB infection risk
- caution: lung disease history, chronic
- caution: herpes zoster history
- caution: HBV infection
- caution: HBV infection history
- caution: HCV infection
- caution: malignancy
- caution: GI perforation risk
- caution: diabetes mellitus
- caution: cardiovascular disease
- caution: cardiovascular disease risk
- caution: smokers
- caution: past smokers
Drug Interactions .
Overview
baricitinib
JAK inhibitor
- OAT3 substrate
- immunomodulatory effects
- myelosuppressive effects
- thrombogenic effects
- FDA Emergency Use Authorization for COVID-19: clinical drug interaction studies not available with other JAK Inhibitors or DMARDs
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
- abatacept
- abrocitinib
- adalimumab
- anakinra
- anti-thymocyte globulin
- azathioprine
- basiliximab
- belatacept
- belimumab
- canakinumab
- certolizumab pegol
- chloramphenicol
- cladribine oral
- cyclosporine
- deferiprone
- delgocitinib topical
- deuruxolitinib
- etanercept
- etrasimod
- everolimus
- fexinidazole
- ganciclovir
- golimumab
- infliximab
- lymphocyte immune globulin, anti-thymocyte globulin
- mycophenolate mofetil
- mycophenolic acid
- natalizumab
- pacritinib
- pimecrolimus topical
- primaquine
- rabies vaccine
- radium Ra 223 dichloride
- rilonacept
- ritlecitinib
- ropeginterferon alfa-2b
- rozanolixizumab
- ruxolitinib topical
- sarilumab
- sirolimus
- tacrolimus
- tocilizumab
- tranexamic acid
- upadacitinib
- vaccinia immune globulin
- valganciclovir
- voclosporin
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- ado-trastuzumab emtansine
- afamitresgene autoleucel
- aflibercept
- albendazole
- aldesleukin
- alemtuzumab
- allopurinol
- aminocaproic acid
- angiotensin II
- anthrax immune globulin
- anthrax vaccine
- anti-inhibitor coagulant complex
- antihemophilic factor (factor VIII)/von Willebrand factor complex
- arsenic trioxide
- asciminib
- asparaginase
- atidarsagene autotemcel
- auranofin
- avatrombopag
- axicabtagene ciloleucel
- axitinib
- azacitidine
- balsalazide
- bazedoxifene
- belantamab mafodotin
- belinostat
- bendamustine
- benznidazole
- betibeglogene autotemcel
- bevacizumab
- bexarotene
- binimetinib
- blinatumomab
- bortezomib
- bosutinib
- botulism immune globulin
- brentuximab vedotin
- brexucabtagene autoleucel
- brolucizumab
- busulfan
- C1 esterase inhibitor
- cabazitaxel
- cabotegravir
- cabozantinib
- calaspargase
- capecitabine
- carboplatin
- carfilzomib
- carmustine
- celecoxib
- chikungunya vaccine
- chlorambucil
- chorionic gonadotropin
- cidofovir
- ciltacabtagene autoleucel
- cisplatin
- cladribine injection
- clofarabine
- clozapine
- coagulation factor IX
- coagulation factor VIIa
- colchicine
- concizumab
- copanlisib
- copper histidinate
- COVID-19 vaccine
- crizotinib
- cyclophosphamide
- cytarabine
- cytomegalovirus immune globulin
- dacarbazine
- dactinomycin
- danazol
- dapsone
- daratumumab
- darbepoetin alfa
- dasatinib
- daunorubicin
- decitabine
- deferasirox
- deflazacort
- desogestrel (contraceptive)
- dexamethasone
- dexrazoxane
- diclofenac
- diclofenac topical
- dienogest (contraceptive)
- diflunisal
- dinutuximab
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- docetaxel
- dostarlimab
- doxorubicin
- drospirenone (contraceptive)
- drospirenone (hormone replacement)
- duvelisib
- ebola vaccine, live
- eflornithine
- elivaldogene autotemcel
- elranatamab
- eltrombopag
- enfortumab vedotin
- entrectinib
- epcoritamab
- epirubicin
- epoetin alfa
- eribulin
- estetrol (contraceptive)
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- ethynodiol (contraceptive)
- etodolac
- etonogestrel (contraceptive)
- etoposide
- etuvetidigene autotemcel
- exagamglogene autotemcel
- factor XIII concentrate
- fam-trastuzumab deruxtecan
- faricimab
- fedratinib
- fenofibrate
- fenofibric acid
- fenoprofen
- fibrinogen (human)
- fitusiran
- floxuridine
- flucytosine
- fludarabine
- fluorouracil
- fluphenazine
- flurbiprofen
- follitropin
- foscarnet
- fosfomycin injection
- fostamatinib
- fruquintinib
- gemcitabine
- gemfibrozil
- gemtuzumab ozogamicin
- givinostat
- glasdegib
- glofitamab
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B immune globulin
- hepatitis B vaccine
- human papillomavirus vaccine
- hydroxychloroquine
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- ibuprofen
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- imatinib
- imetelstat
- immune globulin
- indomethacin
- influenza H5N1 vaccine
- influenza vaccine
- inotuzumab ozogamicin
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- iodixanol
- iohexol
- iomeprol
- iopamidol
- iopromide
- iothalamate meglumine
- ioversol
- irinotecan
- isatuximab
- ivosidenib
- ixabepilone
- Japanese encephalitis vaccine
- ketoprofen
- ketorolac
- lazertinib
- leflunomide
- lenalidomide
- lenvatinib
- levonorgestrel (contraceptive)
- levonorgestrel (hormone replacement)
- lifileucel
- linezolid
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- lonafarnib
- loncastuximab tesirine
- lovotibeglogene autotemcel
- lurbinectedin
- luspatercept
- lusutrombopag
- lutetium Lu 177 dotatate
- lutetium Lu 177 vipivotide tetraxetan
- meclofenamate
- medroxyprogesterone (contraceptive)
- medroxyprogesterone (hormone replacement)
- mefenamic acid
- megestrol
- meloxicam
- melphalan
- meningococcal vaccine
- menotropins
- mercaptopurine
- meropenem
- mesalamine
- mesalamine rectal
- methotrexate
- methoxy polyethylene glycol-epoetin beta
- methyltestosterone
- midostaurin
- mitomycin
- mitotane
- mitoxantrone
- mogamulizumab
- momelotinib
- mosunetuzumab
- nabumetone
- naproxen
- necitumumab
- nelarabine
- nilotinib
- nintedanib
- niraparib
- nitisinone
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norethindrone (hormone replacement)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- obecabtagene autoleucel
- obinutuzumab
- ofatumumab
- olaparib
- olsalazine
- ospemifene
- oxaliplatin
- oxaprozin
- paclitaxel
- palbociclib
- pazopanib
- pegaspargase
- peginterferon alfa 2a
- peginterferon beta 1a
- pemetrexed
- penicillamine
- pentamidine
- pentostatin
- piroxicam
- pirtobrutinib
- pneumococcal vaccine
- polatuzumab vedotin
- poliovirus vaccine
- pomalidomide
- ponatinib
- porfimer
- pralatrexate
- pretomanid
- probenecid
- procarbazine
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- proguanil
- prothrombin complex concentrate (human)
- pyrimethamine
- quizartinib
- raloxifene
- ramucirumab
- ranibizumab
- respiratory syncytial virus vaccine
- Rho(D) immune globulin
- ribavirin
- ribociclib
- rifabutin
- rituximab
- romidepsin
- romiplostim
- rucaparib
- ruxolitinib
- sacituzumab govitecan
- satralizumab
- segesterone (contraceptive)
- selinexor
- sirolimus albumin-bound
- smallpox/mpox vaccine, live
- sodium tetradecyl sulfate
- sotatercept
- stiripentol
- streptozocin
- succimer
- sulfasalazine
- sulindac
- tafasitamab
- tagraxofusp
- talazoparib
- talquetamab
- tarlatamab
- tazemetostat
- teclistamab
- temozolomide
- temsirolimus
- teplizumab
- teriflunomide
- testosterone
- thalidomide
- thioguanine
- thiotepa
- tick-borne encephalitis vaccine
- tisagenlecleucel
- tivozanib
- tofacitinib
- tolmetin
- topotecan
- toremifene
- trabectedin
- trastuzumab
- treosulfan
- tretinoin
- trifluridine
- trimethoprim
- typhoid vaccine
- vaborbactam
- vadadustat
- valoctocogene roxaparvovec
- valproic acid
- vamorolone
- vancomycin
- varicella zoster immune globulin
- venetoclax
- vinblastine
- vincristine
- vinorelbine
- von Willebrand factor
- vorinostat
- zanubrutinib
- zidovudine
- ziv-aflibercept
- zopapogene imadenovec
Caution Advised
- anifrolumab
- avacopan
- beclomethasone inhaled
- beclomethasone nasal
- betamethasone
- bimekizumab
- brodalumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- clobetasol ophthalmic
- corticotropin
- cortisone
- crovalimab
- danicopan
- deucravacitinib
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- diroximel fumarate
- dupilumab
- eculizumab
- efgartigimod alfa
- elotuzumab
- emapalumab
- fingolimod
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- icotrokinra
- inebilizumab
- iptacopan
- ixekizumab
- lebrikizumab
- loteprednol ophthalmic
- methylprednisolone
- mirikizumab
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- nadofaragene firadenovec intravesical
- narsoplimab
- nipocalimab
- ocrelizumab
- ozanimod
- pegcetacoplan
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- ravulizumab
- regorafenib
- rilzabrutinib
- risankizumab
- secukinumab
- sibeprenlimab
- siltuximab
- siponimod
- spesolimab
- sutimlimab
- tildrakizumab
- tralokinumab
- triamcinolone
- ublituximab
- ustekinumab
- vedolizumab
- vilobelimab
- zilucoplan
Adverse Reactions .
Serious Reactions
- cardiovascular death risk
- cardiovascular event risk
- infection, severe
- opportunistic infection
- viral reactivation
- HBV reactivation
- neutropenia
- lymphopenia
- anemia
- malignancy
- lymphoma
- non-melanoma skin CA
- pulmonary embolism
- DVT
- arterial thrombosis
- hypersensitivity reaction
- GI perforation
Common Reactions
- URI
- headache
- acne
- nausea
- herpes viral infection
- UTI
- ALT or AST elevated
- cholesterol incr.
- CPK elevated
- Cr incr.
- neutropenia
Safety/Monitoring .
Monitoring Parameters
eGFR, hepatitis panel at baseline; CBC with diff, LFTs, TB test at baseline, then periodically; lipid panel 12wk after tx start; dermatologic exams if incr. skin CA risk
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available; possible risk of teratogenicity based on animal data at 11x MRHD
Pregnancy Reporting
report pregnancy to Eli Lilly and Co. at 1-800-545-5979
Individuals of Reproductive Potential
consider avoiding pregnancy by using effective contraception during tx in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x4 days after D/C; no human data available to assess risk of infant harm, though possible drug excretion into milk based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for baricitinib: unknown; CYP450: 3A4 substrate
Excretion: for baricitinib: urine 75% (69% unchanged), feces 20% (15% unchanged); Half-life: 10.8h (COVID-19 patients), 12-16h (RA or alopecia patients)
Subclass: Atopic Dermatitis, Systemic Nonsteroidal Agents ; Coronavirus ; Cosmetic, Dermatologic ; DMARDs, JAK Inhibitors ; JAK Inhibitors, Dermatologic
Mechanism of Action
for baricitinib: inhibits janus-associated kinases (JAK) 1, 2, and 3, leading to disruption of cytokine and growth factor signaling pathways
Formulary .
No Formulary Selected
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