Alternate Drug.measles mumps and rubella vaccine, liveSerious - Use Alternative (1)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, liveSerious - Use Alternative (1)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.mechlorethamineMonitor Closely (1)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. .meclofenamateSerious - Use Alternative (1)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 acidSerious - Use Alternative (1)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.natalizumabSerious - Use Alternative (1)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.nateglinideSerious - Use Alternative (1)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.nitazoxanideSerious - Use Alternative (1)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.ocrelizumabSerious - Use Alternative (1)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.oxaprozinSerious - Use Alternative (1)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 benzathineSerious - Use Alternative (1)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.pimecrolimusSerious - Use Alternative (1)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.pioglitazoneSerious - Use Alternative (1)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.pretomanidSerious - Use Alternative (1)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.probenecidSerious - Use Alternative (1)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.rilonaceptSerious - Use Alternative (1)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.rituximabSerious - Use Alternative (1)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-hyaluronidaseSerious - Use Alternative (1)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, liveSerious - Use Alternative (1)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.siltuximabSerious - Use Alternative (1)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, liveSerious - Use Alternative (1)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.tacrolimusSerious - Use Alternative (1)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.telmisartanSerious - Use Alternative (1)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.tisagenlecleucelSerious - Use Alternative (1)baricitinib, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.tocilizumabSerious - Use Alternative (1)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.tofacitinibSerious - Use Alternative (1)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.trastuzumabMonitor Closely (1)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 deruxtecanMonitor Closely (1)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. .Serious - Use Alternative (1)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 liveSerious - Use Alternative (1)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.ublituximabMonitor Closely (1)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 coadministeredupadacitinibContraindicated (1)baricitinib, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.valsartanSerious - Use Alternative (1)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 liveSerious - Use Alternative (1)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.vedolizumabSerious - Use Alternative (1)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 vaccineSerious - Use Alternative (1)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 liveSerious - Use Alternative (1)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. >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) 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