Drug Interactions between baricitinib and hydrocortisone

MONITOR CLOSELY: Coadministration of baricitinib or tofacitinib with other immuno- or myelosuppressive agents may potentiate the risk of infections as well as lymphoma and other malignancies. Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving baricitinib and tofacitinib, most of whom were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Lymphoma and other malignancies have also been observed with tofacitinib use, with or without concomitant immunosuppressants. Epstein Barr virus-associated posttransplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with tofacitinib and concomitant immunosuppressive agents (basiliximab, high-dose corticosteroids, and mycophenolic acid) relative to cyclosporine plus the same induction regimen (2.3% vs. 0%). The most common serious infections reported with baricitinib treatment include pneumonia, herpes zoster, and urinary tract infection. Opportunistic infections include tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus. Lymphoma and other malignancies have also been observed with baricitinib use, with or without concomitant immunosuppressants.

MANAGEMENT: Close monitoring for the development of infection is recommended if baricitinib or tofacitinib is used in combination with other immuno- or myelosuppressive agents, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. Lymphocyte and neutrophil counts as well as hemoglobin should be evaluated at baseline and regularly during therapy, and the baricitinib or tofacitinib dosage adjusted as necessary in accordance with the product labeling. Patients should be advised to contact their physician if they develop signs and symptoms of infection such as fever, chills, diarrhea, sore throat, muscle aches, shortness of breath, blood in phlegm, weight loss, red or inflamed skin, body sores, and pain or burning during urination. If a serious infection, an opportunistic infection, or sepsis develops, baricitinib should be interrupted until the infection is controlled.

MONITOR Baricitinib and tofacitinib, both Janus kinase (JAK) inhibitors, have been associated with an increased risk of diverticulitis (DV) and gastrointestinal (GI) perforation, particularly in patients with risk factors (e.g., history of diverticulosis or diverticulitis, concomitant use of other agents associated with DV). Cases of DV and GI perforation have been reported in patients receiving baricitinib concomitantly with other agents linked to an increased risk of DV, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and opioids. The mechanism of this interaction and the role of JAK inhibition, if any, has not been determined.

MANAGEMENT: Caution is recommended when using baricitinib or tofacitinib in patients with a history of diverticular disease and in patients receiving long-term concomitant treatment with drugs associated with an increased risk of DV and/or GI perforation, such as aspirin, NSAIDs, corticosteroids, and opioids. Patients should be advised to contact their healthcare provider if they experience signs of DV or GI perforation, such as severe abdominal pain, fever, nausea, or vomiting.

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