baricitinib (Rx)

Brand and Other Names:Olumiant
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 2mg

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

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 years who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)

Adults: 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)

  • Rheumatoid arthritis
    • 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)

  • Rheumatoid arthritis
    • 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

  • Rheumatoid arthritis
    • Hgb ≥8 g/dL: Maintain dose
    • Hgb <8 g/dL: Avoid initiation or interrupt dosing until Hgb ≥8 g/dL

Renal impairment

  • Rheumatoid arthritis
    • Moderate (eGFR 30-60 mL/min/1.73 m2): Decrease to 1 mg/day
    • Severe (eGFR <30 mL/min/1.73 m2): Not recommended (not studied)
  • COVID-19
    • 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

  • Rheumatoid arthritis
    • Mild or moderate: No dose adjustment required
    • Severe: Not recommended
  • 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)

  • Rheumatoid arthritis
    • Coadministration with baricitinib and OAT3 inhibitor (eg, probenecid): Decrease baricitinib to 1 mg/day
  • 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

Rheumatoid arthritis

  • Do not initiate if ALC <500 cells/mm3, ANC <1000 cells/mm3, or Hgb level <8 g/dL
  • Avoid in patients with active, serious infection, including localized infections
  • Before initiating, test patients for latent tuberculosis (TB); if positive, consider treating for TB prior to initiating
  • Not recommended for use in combination with other janus kinase (JAK) inhibitors, biologic DMARDs, or with potent immunosuppressants (eg, azathioprine, cyclosporine)

COVID-19

  • Evaluate baseline eGFR, liver enzymes, and CBC count to determine treatment suitability and dose
  • Closely monitor 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

Dosage Forms & Strengths

tablet

  • 1mg
  • 2mg

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 years who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)

<2 years: Not authorized

2 to <9 years: 2 mg PO qDay

≥9 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

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Interactions

Interaction Checker

and baricitinib

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    Interactions Found

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (52)

              • 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.

              • 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.

              • 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.

              • 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.

              • 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.

              • 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.

              • 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 (4)

              • 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. .

              Minor (0)

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                Adverse Effects

                >10%

                Upper respiratory tract infections (16.3%)

                1-10%

                Nausea (2.7%)

                Increased LFTs (1-2%)

                Platelet elevations (1-2%)

                Herpes zoster infection (1%)

                <1%

                Acne (<1%)

                Herpes simplex infection (0.8%)

                Neutropenia (0.3%)

                Postmarketing Reports

                Immune System Disorders: Drug hypersensitivity (eg, rash, urticaria, angioedema)

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                Warnings

                Black Box Warnings

                Serious infections

                • Baricitinib increases risk for developing serious infections that may lead to hospitalization or death
                • Most patients who developed these infections were taking concomitant immunosuppressants (eg, methotrexate, corticosteroids)
                • If a serious infection develops, interrupt dosing until the infection is controlled
                • Reported infections include:
                  • Active TB, which may present with pulmonary or extrapulmonary disease; test patients for latent TB before initiating and during therapy; treatment for latent infection should be considered 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

                Malignancies

                • Lymphoma and other malignancies observed

                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

                Contraindications

                None

                Cautions

                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 (see Black Box Warnings and Dosing Considerations)

                Reactions such as angioedema, urticaria, and rash, including serious reactions, that may reflect drug hypersensitivity, reported; if a serious hypersensitivity reaction occurs, promptly discontinue therapy while evaluating potential causes of the reaction

                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 (see Black Box Warnings)

                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

                Malignancies were observed in clinical studies; non-melanoma skin cancers (NMSCs) reported; periodic skin examination is recommended for patients who are at increased risk for skin cancer

                Perform screening for viral hepatitis in accordance with clinical guidelines before starting therapy; unknown impact on chronic viral hepatitis reactivation

                Increased incidence of thrombosis, including DVT and PE, observed compared with placebo; caution in patients at increased risk of thrombosis (see Black Box Warnings)

                Gastrointestinal perforation reported in clinical studies, although the 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

                Prompt investigation of cause of liver enzyme elevation recommended to identify potential cases of drug-induced liver injury; if increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt therapy until this diagnosis is excluded

                Increased risk of serious heart-related problems and cancer

                • On September 1st, 2021, FDA is requiring revisions to warnings for baricitinib to include information about the risks of serious heart-related events, cancer, blood clots, and death
                • Revisions are based on results from completed trial show a higher occurrence of serious heart-related events and cancer in tofacitinib-treated group (both doses) compared to TNF inhibitor-treated group; results also showed an increased risk of blood clots and death with lower doses of tofacitinib
                • Not studied in trials, so risks have not been adequately evaluated; however, owing to similar mechanisms of action, FDA considers baricitinib may have similar risks
                • Consider the benefits and risks for the individual patient before initiating or continuing treatment, especially the following patients:
                  • Who are current or past smokers
                  • Who have other cardiovascular risk factors
                  • Who have developed a malignancy
                  • Who have a known malignancy other than a successfully treated nonmelanoma skin cancer
                • Reserve JAK inhibitors (eg, tofacitinib) if patients have an inadequate response or intolerance to ≥1 TNF blockers
                • Counsel patients about the benefits and risks of these medicines and advise them to seek emergency medical attention if they experience signs and symptoms of a heart attack, stroke, or blood clot

                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
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                Pregnancy

                Pregnancy

                Data in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage

                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 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.

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                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

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                Administration

                Oral Administration

                May take with or without food

                Unable to swallow whole tablet

                • 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 10 mL of water and administer entire contents to patient
                • 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 15 mL of water, withdraw entire content into syringe and administer to patient
                • Nasogastric 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 sufficient amount (minimum of 15 mL) of 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: Not known if powder may constitute a reproductive hazard to preparer; use proper control measures (eg, ventilated enclosure) or personal protective equipment (ie, N95 respirator)
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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Olumiant oral
                -
                2 mg tablet

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

                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.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.