Dosing & Uses
Dosage Forms & Strengths
tablet
- 1mg
- 2mg
- 4mg
Rheumatoid Arthritis
Indicated for adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies
May be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs)
2 mg PO qDay
Alopecia Areata
Indicated for adults with severe alopecia areata
2 mg PO qDay; increase to 4 mg qDay if inadequate response
With nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider 4 mg qDay
Once adequate response achieved with 4 mg/day, decrease to 2 mg/day
COVID-19
Indicated for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults who require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)
4 mg PO qDay
Recommended treatment duration is 14 days or until hospital discharge, whichever comes first
Dosage Modifications
Absolute lymphocyte count (ALC)
-
RA or alopecia areata
- ALC ≥500 cells/mm3: Maintain dose
- ALC <500 cells/mm3: Avoid initiation or interrupt dosing until ALC ≥500 cells/mm3
-
COVID-19
- ALC ≥200 cells/mm3: Maintain dose
- ALC <200 cells/mm3: Avoid initiation or interrupt dosing until ALC ≥200 cells/mm3
Absolute neutrophil count (ANC)
-
RA or alopecia areata
- ANC ≥1000 cells/mm3: Maintain dose
- ANC <1000 cells/mm3: Avoid initiation or interrupt dosing until ANC ≥1000 cells/mm3
-
COVID-19
- ANC ≥500 cells/mm3: Maintain dose
- ANC <500 cells/mm3: Avoid initiation or interrupt dosing until ANC ≥500 cells/mm3
Anemia
-
RA or alopecia areata
- Hgb ≥8 g/dL: Maintain dose
- Hgb <8 g/dL: Avoid initiation or interrupt dosing until Hgb ≥8 g/dL
Renal impairment
-
RA
- Mild (eGFR 60 to <90 mL/min/1.73 m2): No dose adjustment required
- Moderate (eGFR 30 to <60 mL/min/1.73 m2): Decrease to 1 mg/day
- Severe (eGFR <30 mL/min/1.73 m2): Not recommended (not studied)
-
Alopecia areata
- Mild (eGFR 60 to <90 mL/min/1.73 m2): No dose adjustment required
- Moderate (eGFR 30 to <60 mL/min/1.73 m2): Reduce dose by 50%
- Severe (eGFR <30 mL/min/1.73 m2): Not recommended
-
COVID-19
- Mild (eGFR 60 to <90 mL/min/1.73 m2): No dose adjustment
- Moderate (eGFR 30 to <60 mL/min/1.73 m2): Decrease to 2 mg/day
- Severe (eGFR 15 to <30 mL/min/1.73 m2): Decrease to 1 mg/day
- eGFR <15 mL/min/1.73 m2, patients on dialysis, have end-stage renal disease, or have acute kidney injury: Not recommended
Hepatic impairment
-
RA or alopecia areata
- Interrupt if ALT/AST increased and drug-induced liver injury (DILI) suspected, until DILI diagnosis excluded
- Mild or moderate: No dose adjustment required
- Severe: Not recommended
-
COVID-19
- Interrupt if ALT/AST increased and DILI suspected, until DILI diagnosis excluded
- Increased ALT/AST: Consider interruption until the diagnosis of drug-induced liver injury is excluded
- Severe: Not studied; use only if benefits outweigh risks
Coadministration with strong organic anion transporter 3 (OAT3) inhibitors (eg, probenecid)
- If recommended dose is 4 mg/day, reduce to 2 mg/day
- If recommended dose is 2 mg/day, reduce to 1 mg/day
- If recommended dose is 1 mg/day, consider discontinuing probenecid
Dosing Considerations
Consider following evaluations before initiating
- Active and latent tuberculosis (TB) infection: Do not give to patients with active TB; if latent infection positive in patients with rheumatoid arthritis, consider treatment for TB before initiating
- Screen for viral hepatitis in accordance with clinical guidelines
- Baseline hepatic and renal function: Assess baseline values and monitor for laboratory changes; modify dosage based on hepatic and renal impairment, and laboratory abnormalities
Complete blood cell count (CBC)
- Assess baseline to determine whether treatment can be initiated
- Rheumatoid arthritis: Not recommended with ALC <500 cells/μL, ANC <1000 cells/μL, or hemoglobin level <8 g/dL
- COVID-19: Not recommended with ALC <200 cells/μL, ANC <500 cells/μL
- Monitor CBC during treatment and modify dosage as recommended
RA or alopecia areata
- Avoid in patients with active, serious infection, including localized infections; if serious infection occurs, withhold treatment
- Update immunizations in agreement with current immunization guidelines before initiating
- Limitations of use: Not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic DMARDs, or with potent immunosuppressants (eg, azathioprine, cyclosporine)
Dosage Forms & Strengths
tablet
- 1mg
- 2mg
- 4mg
COVID-19 (EUA)
November 19, 2020: Emergency use authorization (EUA) issued by the FDA for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized patients aged 2 to <18 years who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)
<2 years: Not authorized
2 to <9 years: 2 mg PO qDay
9 to <18 years: 4 mg PO qDay
Recommended treatment duration is 14 days or until hospital discharge, whichever comes first; optimal treatment duration unknown
Dosage Modifications
Absolute lymphocyte count (ALC)
-
COVID-19
- ALC ≥200 cells/mm3: Maintain dose
- ALC <200 cells/mm3: Avoid initiation or interrupt dosing until ALC ≥200 cells/mm3
Absolute neutrophil count (ANC)
-
COVID-19
- ANC ≥500 cells/mm3: Maintain dose
- ANC <500 cells/mm3: Avoid initiation or interrupt dosing until ANC ≥500 cells/mm3
Renal impairment
-
COVID-19 (2-9 years)
- eGFR ≥60 mL/min/1.73 m2: No dose adjustment
- eGFR 30 to <60 mL/min/1.73 m2: Decrease to 1 mg/day
- eGFR 15 to <30 mL/min/1.73 m2: Not recommended
- eGFR <15 mL/min/1.73 m2, patients on dialysis, have end-stage renal disease, or have acute kidney injury: Not recommended
-
COVID-19 (≥9 years)
- eGFR ≥60 mL/min/1.73 m2: No dose adjustment
- eGFR 30 to <60 mL/min/1.73 m2: Decrease to 2 mg/day
- eGFR 15 to <30 mL/min/1.73 m2: Decrease to 1 mg/day
- eGFR <15 mL/min/1.73 m2, patients on dialysis, have end-stage renal disease, or have acute kidney injury: Not recommended
Hepatic impairment
-
COVID-19
- Increased ALT/AST: Consider interruption until the diagnosis of drug-induced liver injury is excluded
- Severe: Not studied; use only if benefits outweigh the risks
Coadministration with strong organic anion transporter 3 (OAT3) inhibitors (eg, probenecid)
-
COVID-19
- If recommended dose is 4 mg/day, reduce to 2 mg/day
- If recommended dose is 2 mg/day, reduce to 1 mg/day
- If recommended dose is 1 mg/day, consider discontinuing probenecid
Dosing Considerations
COVID-19
- Evaluate baseline eGFR, liver enzymes, and CBC count to determine treatment suitability and dose
- Closely monitor patients with abnormal baseline and post-baseline laboratory values
- Not recommended with known active TB
- Data are limited in patients receiving systemic corticosteroids
- Has not been studied in combination with other JAK inhibitors or with biologic DMARDs (biologic treatments targeting cytokines, B-cells, or T-cells)
-
EUA for patients hospitalized or in ACS
- Authorized for emergency use to treat certain hospitalized patients with COVID-19
- Authorization clarifies that individuals determined as being appropriate for acute inpatient hospitalization and who are admitted or transferred to an alternate care site (ACS) that can provide acute care that is comparable to general inpatient hospital care are within the terms and conditions of the EUA
- An ACS is intended to provide additional hospital surge capacity and capability for communities overwhelmed by patients with COVID-19
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- upadacitinib
baricitinib, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
Serious - Use Alternative (58)
- abatacept
baricitinib, abatacept. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- adalimumab
baricitinib, adalimumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- adenovirus types 4 and 7 live, oral
baricitinib decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines with baricitinib. Update immunizations in agreement with current immunization guidelines before initiating baricitinib.
- ado-trastuzumab emtansine
baricitinib, ado-trastuzumab emtansine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- anakinra
baricitinib, anakinra. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- axicabtagene ciloleucel
baricitinib, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- azathioprine
baricitinib, azathioprine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- balsalazide
balsalazide will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- BCG vaccine live
baricitinib decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines with baricitinib. Update immunizations in agreement with current immunization guidelines before initiating baricitinib.
- brexucabtagene autoleucel
baricitinib, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- canakinumab
baricitinib, canakinumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- certolizumab pegol
baricitinib, certolizumab pegol. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- ciltacabtagene autoleucel
baricitinib, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cyclosporine
baricitinib, cyclosporine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- deferiprone
baricitinib, deferiprone. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- diflunisal
diflunisal will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- etanercept
baricitinib, etanercept. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- ethacrynic acid
ethacrynic acid will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- fingolimod
baricitinib, fingolimod. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- golimumab
baricitinib, golimumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- idecabtagene vicleucel
baricitinib, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- infliximab
baricitinib, infliximab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- influenza virus vaccine quadrivalent, intranasal
baricitinib decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines with baricitinib. Update immunizations in agreement with current immunization guidelines before initiating baricitinib.
- irbesartan
irbesartan will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- ketorolac
ketorolac will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- lisocabtagene maraleucel
baricitinib, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- measles mumps and rubella vaccine, live
baricitinib decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines with baricitinib. Update immunizations in agreement with current immunization guidelines before initiating baricitinib.
- measles, mumps, rubella and varicella vaccine, live
baricitinib decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines with baricitinib. Update immunizations in agreement with current immunization guidelines before initiating baricitinib.
- meclofenamate
meclofenamate will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- mefenamic acid
mefenamic acid will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- natalizumab
baricitinib, natalizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- nateglinide
nateglinide will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- nitazoxanide
nitazoxanide will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- ocrelizumab
baricitinib and ocrelizumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- oxaprozin
oxaprozin will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- penicillin G benzathine
penicillin G benzathine will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- pimecrolimus
baricitinib, pimecrolimus. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- pioglitazone
pioglitazone will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- pretomanid
pretomanid will increase the level or effect of baricitinib by Other (see comment). Avoid or Use Alternate Drug. In vitro studies demonstrated that pretomanid significantly inhibits OAT3; monitor for increased adverse effects and consider dosage reduction for OAT3 substrates.
- probenecid
probenecid will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- rilonacept
baricitinib, rilonacept. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- rituximab
baricitinib, rituximab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- rituximab-hyaluronidase
baricitinib, rituximab-hyaluronidase. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- rotavirus oral vaccine, live
baricitinib decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines with baricitinib. Update immunizations in agreement with current immunization guidelines before initiating baricitinib.
- siltuximab
baricitinib, siltuximab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- smallpox (vaccinia) vaccine, live
baricitinib decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines with baricitinib. Update immunizations in agreement with current immunization guidelines before initiating baricitinib.
- tacrolimus
baricitinib, tacrolimus. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- telmisartan
telmisartan will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- tisagenlecleucel
baricitinib, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tocilizumab
baricitinib, tocilizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- tofacitinib
baricitinib, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- trastuzumab deruxtecan
baricitinib, trastuzumab deruxtecan. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- typhoid vaccine live
baricitinib decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines with baricitinib. Update immunizations in agreement with current immunization guidelines before initiating baricitinib.
- valsartan
valsartan will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- varicella virus vaccine live
baricitinib decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines with baricitinib. Update immunizations in agreement with current immunization guidelines before initiating baricitinib.
- vedolizumab
baricitinib, vedolizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- yellow fever vaccine
baricitinib decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines with baricitinib. Update immunizations in agreement with current immunization guidelines before initiating baricitinib.
- zoster vaccine live
baricitinib increases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines with baricitinib. Update immunizations in agreement with current immunization guidelines before initiating baricitinib.
Monitor Closely (5)
- ifosfamide
ifosfamide, baricitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor.
- mechlorethamine
mechlorethamine, baricitinib. immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections. .
- trastuzumab
trastuzumab, baricitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, baricitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- ublituximab
ublituximab and baricitinib both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
Minor (0)
Adverse Effects
>10%
RA
- Upper respiratory tract infections (16.3%)
COVID-19
- ALT ≥3 x ULN (18.1%)
- AST ≥3 x ULN (11.8%)
1-10%
RA
- Increased ALT/AST (1.3-4.7%)
- Nausea (2.7-2.8%)
- Platelet elevations (1-2%)
- Herpes zoster infection (1-1.4%)
- Herpes simplex infection (0.8-1.4%)
COVID-19
- *Reported incidence less than placebo
- Thrombocytosis >600,000 cells/mm3 (7.9%)
- CPK >5 x ULN (4.5%)*
- Neutropenia <1000 cells/mm3 (2.2%)
- Deep vein thrombosis (1.5%)
- Pulmonary embolism (1.5%)
- Urinary tract infection (1.5%)
<1%
RA
- Acne (<1%)
- Neutropenia (0.3%)
Postmarketing Reports
Immune system disorders: Drug hypersensitivity (eg, rash, urticaria, angioedema)
Warnings
Black Box Warnings
Serious infections
- May increase risk for developing serious infections which may lead to hospitalization or death
- Most patients with rheumatoid arthritis who developed these infections were taking concomitant immunosuppressants (eg, methotrexate, corticosteroids)
- If a serious infection develops, interrupt dosing until infection is controlled
-
Reported infections include:
- Active TB, which may present with pulmonary or extrapulmonary disease; do not administer to patients with active TB
- Except those with COVID-19, test for latent TB before initiating and during therapy; consider treating for latent infection before initiating
- Invasive fungal infections, including candidiasis and pneumocystosis; patients with invasive fungal infections may present with disseminated, rather than localized, disease
- Bacterial, viral, and other infections due to opportunistic pathogens
- Consider risks and benefits before initiating therapy in patients with chronic or recurrent infection
- Closely monitor for developing signs and symptoms of infection during and after treatment, including the possible development of TB in patients who tested negative for latent TB before initiating baricitinib
Mortality and cardiovascular risk
- Higher rate of all-cause mortality observed, including sudden cardiovascular (CV) death, with another JAK inhibitor when compared with TNF blockers in a large, randomized, postmarketing safety study in patients with rheumatoid arthritis aged ≥50 years with ≥1 CV factor
-
CV risk
- Also, higher rate of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction (MI), and stroke, observed when compared with TNF blockers
- Patients who are current or past smokers are at additional increased risk
- Discontinue in patients that have experienced MI or stroke
Malignancies
- Higher rate of lymphoma and other malignancies (excluding nonmelanoma skin cancer) observed in patients with RA arthritis treated with another JAK inhibitor, when compared with TNF blockers
- Patients who are current or past smokers are at additional increased risk
Thrombosis
- Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), observed at an increased incidence in patients treated with baricitinib compared with placebo
- Additionally, cases of arterial thrombosis reported; many of these adverse events were serious and some resulted in death
- Patients with symptoms of thrombosis should be promptly evaluated
- Higher rate of thrombosis observed in patients with RA (aged ≥50 yr) with ≥1 CV risk factor treated with another JAK compared with TNF blockers; avoid in patients at risk
- Discontinue in patients with symptoms of thrombosis
Contraindications
None
Cautions
Hypersensitivity reactions (eg, angioedema, urticaria, rash) observed, including serious reactions; if serious hypersensitivity reaction occurs, promptly discontinue therapy while evaluating potential causes
Malignancies were observed in clinical studies; non-melanoma skin cancers reported; periodic skin examination is recommended for patients who are at increased risk for skin cancer
Higher rate for all-cause mortality and for MACE (defined as CV death, myocardial infarction, and stroke) reported with another JAK inhibitor compared with TNF blockers in patients who have RA and ≥1 CV risk
Increased incidence of thrombosis, including DVT and PE, observed compared with placebo; avoid therapy in patients who may be at increased risk of thrombosis
Gastrointestinal perforation reported in clinical studies, although role of JAK inhibition in these events is unknown
May increase incidence of neutropenia, lymphopenia, anemia, or elevated LFTs or lipids; monitor laboratory values at baseline and periodically during treatment
Promptly investigate cause of liver enzyme elevation recommended to identify potential cases of drug-induced liver injury; interrupt therapy if increased ALT or AST observed and drug-induced liver injury is suspected, until this diagnosis is excluded
Infection risk
- In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment; there is limited information regarding use in patients with COVID-19 and concomitant active serious infections; risks and benefits of treatment in COVID-19 patients with other concurrent infections should be considered
- Serious and sometimes fatal infections may develop owing to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens reported; may cause reactivation of latent TB or viral infections
- Perform screening for viral hepatitis in accordance with clinical guidelines before starting therapy; unknown impact on chronic viral hepatitis reactivation
- Consider risks and benefits before initiating in patients with chronic or recurrent infection, history of serious or opportunistic infection, underlying conditions predisposing them to infection, or patients who have been exposed to tuberculosis or have resided or traveled in areas of endemic tuberculosis or mycoses
- Consider TB therapy for patients with a negative test for latent TB but who have risk factors for TB infection; consultation with a physician with expertise in TB recommended to aid in decision about whether initiating anti-TB therapy is appropriate
- If a new infection develops during treatment, promptly initiate diagnostic tests appropriate for an immunocompromised patient; if necessary, initiate appropriate antimicrobial therapy and closely monitor; interrupt baricitinib therapy if patient unresponsive to treatment
- If herpes zoster occurs, interrupt treatment until episode resolves
Drug interaction overview
- Avoid use of live vaccines; update immunizations in agreement with current immunization guidelines before initiating
- Coadministration with strong OAT3 inhibitors may increase baricitinib systemic exposure; dosage modification recommended
Pregnancy & Lactation
Pregnancy
Report pregnancies to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979)
Based on findings from animal reproduction studies, therapy may cause fetal harm during pregnancy; available data from clinical trials and postmarketing reports of exposure in pregnancy are insufficient to inform a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes
There are no human data on chronic baricitinib exposure throughout pregnancy; there are risks to mother and the fetus associated with rheumatoid arthritis in pregnancy; consider risks and benefits with chronic use during pregnancy
Published data suggest that increased disease activity is associated with risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis; adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth
Based on animal studies, therapy may cause fetal harm when administered during pregnancy; consider pregnancy planning and prevention for females of reproductive potential
Animal studies
- In animal embryo-fetal development studies, oral baricitinib administration to pregnant rats and rabbits at exposures equal to and greater than ~20 and 84 times the maximum recommended human dose (MRHD), respectively, resulted in reduced fetal body weights, increased embryo lethality (rabbits only), and dose-related increases in skeletal malformations
Lactation
Unknown if distributed in human breast milk
Baricitinib is present in the milk of lactating rats
Owing to species-specific differences in lactation physiology, the clinical relevance of these data are not clear
Because of the potential for serious adverse reactions in nursing infants, advise women with rheumatoid arthritis not to breastfeed while taking baricitinib
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Janus kinases (JAKs) pathways inhibitor; JAK consists of a group of intracellular tyrosine kinases that transmit signals from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoieses and immune cell function
Within the signaling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which modulate intracellular activity including gene expression; baricitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs
Absorption
Absolute bioavailability: 80%
Peak plasma time: 1 hr
Steady-state achieved: 2-3 days
Distribution
Protein bound: 50% to plasma proteins and 45% to serum proteins
Vd: 76 L
Substrate of the P-gp, BCRP, OAT3 and MATE2-K transporters, which play roles in drug distribution
Metabolism
~6% of the orally administered baricitinib dose is identified as metabolites (3 from urine and 1 from feces), with CYP3A4 identified as the main metabolizing enzyme
No metabolites of baricitinib were quantifiable in plasma
Elimination
Half-life: 12 hr
Total body clearance: 8.9 L/hr
Excretion: 75% (69% unchanged) urine; 20% (15% unchanged) feces
Administration
Oral Administration
May take with or without food
Unable to swallow whole tablet
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Oral
- Disperse tablet(s) for required dose in container with ~10 mL (5 mL minimum) of room temperature water by gently swirling contents; take immediately
- Rinse container with an additional 5-10 mL of water and administer entire contents to patient
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Gastrostomy feeding tube
- Disperse tablet(s) for required dose in container with ~15 mL (10 mL minimum) of room temperature water by gently swirling contents; ensure tablets are sufficiently dispersed to flow through syringe tip
- Withdraw entire contents from container into an appropriate syringe and immediately administer through gastric tube
- Rinse container with an additional 10-15 mL of water, withdraw entire content into syringe and administer to patient
-
Nasogastric or orogastric feeding tube
- Disperse tablet(s) for required dose in container with ~30 mL of room temperature water by gently swirling contents; ensure tablets are sufficiently dispersed to flow through syringe tip
- Withdraw entire contents from container into an appropriate syringe and immediately administer through nasogastric tube
- To avoid clogging small diameter tubes (<12 Fr), the syringe can be held horizontally and shaken during administration
- Rinse container with enough (minimum of 15 mL) room temperature water, withdraw contents into syringe, and administer through nasogastric tube
Storage
Tablets: Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
Dispersed tablets in water: Stable for up to 4 hr
Handling
- Intact tablet: Not hazardous
- Crushed tablets: Unknown if powder may constitute a reproductive hazard to preparer; use proper control measures (eg, ventilated enclosure) or personal protective equipment (ie, N95 respirator)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Olumiant oral - | 2 mg tablet |  |
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Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
