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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 pts w/ RA occur in combo w/ immunosuppressants; screen for latent TB infection before and during baricitinib tx, in all pts except those w/ COVID-19; initiate latent TB tx before baricitinib tx in pts w/ RA; baricitinib should not be given to pts w/ active TB; weigh risk/benefit in pts w/ chronic or recurrent infection; monitor closely for infection s/sx during and after tx, incl. TB development in pts w/ negative latent TB screen prior to tx start; D/C baricitinib if serious infection develops
Mortality
higher rate of mortality, incl. sudden cardiovascular death, observed in RA pts 50 yo and older w/ at least 1 cardiovascular risk factor treated w/ another JAK inhibitor (tofacitinib) vs. TNF blockers in a large, randomized, post-marketing study
Malignancies
lymphoma and other malignancies observed w/ baricitinib; higher rate of malignancies, excluding non-melanoma skin CA, observed in RA pts treated w/ 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, incl. cardiovascular death, non-fatal MI, and non-fatal stroke, observed in RA pts 50 yo and older w/ at least 1 cardiovascular risk factor treated w/ another JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; D/C baricitinib in pts that experienced MI or stroke
Thrombosis
thrombosis, incl. DVT, PE, and arterial thrombosis have occurred during baricitinib tx, sometimes fatal; higher rate of thrombosis observed in RA pts 50 yo and older w/ at least 1 cardiovascular risk factor on another JAK inhibitor (tofacitinib) vs. TNF blockers; avoid baricitinib in pts w/ thrombosis risk; D/C baricitinib and promptly evaluate pts w/ thrombosis sx
Adult Dosing .
Dosage forms: TAB: 1 mg, 2 mg, 4 mg
rheumatoid arthritis, mod-severe
- [2 mg PO qd]
- Info: use alone or w/ methotrexate or other non-biologic DMARDs; see pkg insert for toxicity-related dose adjustments
COVID-19
- [4 mg PO qd]
- Info: for hospitalized pts requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO); may give w/ remdesivir; cont. 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 pts w/ 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, COVID-19
- [FDA emergency use authorization (EUA)]
- Info: for hospitalized pts 2 yo and older w/ 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; avail. 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 pts requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO), per FDA EUA; may give w/ remdesivir; cont. 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 pts requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO), per FDA EUA; may give w/ remdesivir; cont. 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