Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in rheumatoid arthritis patients receiving baricitinib.1

Avoid use of baricitinib in patients with an active, serious infection, including localized infections.1

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with baricitinib. Interrupt baricitinib if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with baricitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should be closely monitored, and baricitinib should be interrupted if the patient is not responding to therapy.1

Do not resume baricitinib until the infection is controlled.1

Treatment with baricitinib was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5 times upper limit of normal (ULN) and increases of AST ≥10 times the ULN were observed in patients in baricitinib clinical trials.1

Evaluate liver enzymes at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is 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 baricitinib until this diagnosis is excluded.1

Treatment with baricitinib was associated with increases in lipid parameters, including

• total cholesterol
• low-density lipoprotein (LDL), and
• high-density lipoprotein (HDL).1

Assessment of lipid parameters should be performed approximately 12 weeks following baricitinib initiation. Manage patients according to applicable clinical guidelines for the management of hyperlipidemia.1