Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with Olumiant 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 Olumiant should be interrupted if the patient is not responding to therapy. Do not resume Olumiant until the infection is controlled.
Tuberculosis - Monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.
Viral Reactivation - Viral reactivation, including cases of herpes virus reactivation (e.g. herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.
Patients with positive hepatitis B surface antibody and hepatitis B core antibody, without hepatitis B surface antigen; such patients should be monitored for expression of hepatitis B virus (HBV) DNA. Should HBV DNA be detected, consult with a hepatologist. Perform screening for viral hepatitis in accordance with clinical guidelines before starting therapy with Olumiant.
Non-melanoma skin cancers - Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
Neutropenia - Avoid initiation or interrupt Olumiant treatment in patients with an ANC less than 1000 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.
Lymphopenia - Avoid initiation or interrupt Olumiant treatment in patients with an ALC less than 500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.
Anemia - Avoid initiation or interrupt Olumiant treatment in patients with hemoglobin less than 8 g/dL. Evaluate at baseline and thereafter according to routine patient management.
Liver Enzyme Elevations - Evaluate 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 Olumiant until this diagnosis is excluded.
Lipid Elevations - Assessment of lipid parameters should be performed approximately 12 weeks following Olumiant initiation.
Because elderly patients are more likely to have decreased renal function, which will result in increased exposure of baricitinib, care should be taken in dose selection, and it may be useful to monitor renal function.
Reference: 1. Data on file. Lilly USA, LLC. DOF-BA-US-0001. 2. Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.