Olumiant Special Precautions

Use of JAK inhibitors in patients 65 years of age and older: Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients 65 years of age and older, as observed in a large randomised study of tofacitinib (another JAK inhibitor), baricitinib should only be used in these patients if no suitable treatment alternatives are available.
Infections: Serious and sometimes fatal infections have been reported in patients receiving other JAK inhibitors.
Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections compared to placebo (see Adverse Reactions). In rheumatoid arthritis clinical studies, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy.
The risks and benefits of treatment with Baricitinib should be carefully considered prior to initiating baricitinib in patients with active, chronic or recurrent infections (see Dosage & Administration). If an infection develops, the patient should be monitored carefully and therapy should be temporarily interrupted if the patient is not responding to standard therapy. Treatment should not be resumed until the infection resolves.
As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes. In patients over 65 years of age, baricitinib should only be used if no suitable treatment alternatives are available.
Tuberculosis: Patients should be screened for tuberculosis (TB) before starting therapy. Baricitinib should not be given to patients with active TB. Anti-TB therapy should be considered prior to initiation of treatment in patients with previously untreated latent TB.
Haematological abnormalities: Absolute Neutrophil Count (ANC) <1 x 10⁹ cells/L, Absolute Lymphocyte Count (ALC) <0.5 x 10⁹ cells/L, and haemoglobin <8 g/dL were reported in clinical trials.
Treatment should not be initiated, or should be temporarily interrupted, in patients with an ANC <1 x 10⁹ cells/L, ALC <0.5 x 10⁹ cells/L or haemoglobin <8 g/dL observed during routine patient management (see Dosage & Administration).
The risk of lymphocytosis is increased in elderly patients with rheumatoid arthritis. Rare cases of lymphoproliferative disorders have been reported.
Viral reactivation: Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster, herpes simplex), were reported in clinical studies (see Adverse Reactions). In rheumatoid arthritis clinical studies, herpes zoster was reported more commonly in patients ≥65 years of age who had previously been treated with both biologic and synthetic conventional DMARDs. If a patient develops herpes zoster, treatment should be temporarily interrupted until the episode resolves.
Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with baricitinib. Patients with evidence of active hepatitis B or C infection were excluded from clinical trials. Patients, who were positive for hepatitis C antibody but negative for hepatitis C virus RNA, were allowed to participate. Patients with hepatitis B surface antibody and hepatitis B core antibody, without hepatitis B surface antigen, were also allowed to participate; such patients should be monitored for expression of hepatitis B virus (HBV) DNA. If HBV DNA is detected, a liver specialist should be consulted to determine if treatment interruption is warranted.
Vaccination: No data are available on the response to vaccination with live vaccines in patients receiving baricitinib. Use with live, attenuated vaccines during, or immediately prior to, baricitinib therapy is not recommended. Prior to initiating treatment, it is recommended that all patients, and particularly paediatric patients, be brought up to date with all immunisations in agreement with current immunisation guidelines.
Lipids: Dose dependent increases in blood lipid parameters were reported in patients treated with baricitinib (see Adverse Reactions). Elevations in low density lipoprotein (LDL) cholesterol decreased to pre-treatment levels in response to statin therapy in adults. In both paediatric and adult patients, lipid parameters should be assessed approximately 12 weeks following initiation of therapy and thereafter patients should be managed according to international clinical guidelines for hyperlipidaemia.
Hepatic transaminase elevations: Dose dependent increases in blood alanine transaminase (ALT) and aspartate transaminase (AST) activity were reported in patients treated with baricitinib (see Adverse Reactions).
Increases in ALT and AST to ≥5 and ≥10 x upper limit of normal (ULN) were reported in clinical trials. In rheumatoid arthritis clinical studies, combination with methotrexate resulted in increased frequency of hepatic transaminase elevations compared with baricitinib monotherapy (see Adverse Reactions).
If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, treatment should be temporarily interrupted until this diagnosis is excluded.
Malignancy: Immunomodulatory medicinal products may increase the risk of malignancies including lymphoma. Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including baricitinib.
In a large randomized active controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma and non-melanoma skin cancer (NMSC) was observed with tofacitinib compared to TNF inhibitors.
In patients over 65 years of age, patients who are current or past long-time smokers, or with other malignancy risk factors (e.g. current malignancy or history of malignancy) baricitinib should only be used if no suitable treatment alternatives are available.
Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
Venous thromboembolism: In a retrospective observational study of baricitinib in rheumatoid arthritis patients, a higher rate of venous thromboembolic events (VTE) was observed compared to patients treated with TNF inhibitors (see Adverse Reactions).
In a large randomized active controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a dose dependent higher rate of VTE including deep venous thrombosis (DVT) and pulmonary embolism (PE) was observed with tofacitinib compared to TNF inhibitors.
In patients with cardiovascular or malignancy risk factors (see also "Major adverse cardiovascular events (MACE)" as follows and "Malignancy" as previously mentioned) baricitinib should only be used if no suitable treatment alternatives are available.
In patients with known VTE risk factors other than cardiovascular or malignancy risk factors, baricitinib should be used with caution. VTE risk factors other than cardiovascular or malignancy risk factors include previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder.
Patients should be re evaluated periodically during baricitinib treatment to assess for changes in VTE risk.
Promptly evaluate patients with signs and symptoms of VTE and discontinue baricitinib in patients with suspected VTE, regardless of dose or indication.
Major adverse cardiovascular events (MACE): In a retrospective observational study of baricitinib in rheumatoid arthritis patients, a higher rate of MACE was observed compared to patients treated with TNF inhibitors.
In a large randomized active controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke, was observed with tofacitinib (another JAK inhibitor) compared with TNF inhibitors.
Therefore, in patients over 65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors, baricitinib should only be used if no suitable treatment alternatives are available.
Laboratory monitoring: See Table 9.

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Immunosuppressive medicinal products: Combination with biological DMARDs, biological immunomodulators or other Janus kinase (JAK) inhibitors is not recommended, as a risk of additive immunosuppression cannot be excluded.
In rheumatoid arthritis and juvenile idiopathic arthritis, data concerning use of baricitinib with potent immunosuppressive medicinal products other than methotrexate (e.g., azathioprine, tacrolimus, ciclosporin) are limited. Caution should be exercised when using such combinations (see Interactions).
In atopic dermatitis and alopecia areata, combination with ciclosporin or other potent immunosuppressants has not been studied and is not recommended (see Interactions).
Hypersensitivity: In post-marketing experience, cases of drug hypersensitivity associated with baricitinib administration have been reported. If any serious allergic or anaphylactic reaction occurs, treatment should be discontinued immediately.
Diverticulitis: Cases of diverticulitis and gastrointestinal perforation have been reported in clinical trials and from postmarketing sources (see Adverse Reactions). Baricitinib should be used with caution in patients with diverticular disease and especially in patients chronically treated with concomitant medicinal products associated with an increased risk of diverticulitis: nonsteroidal anti-inflammatory drugs, corticosteroids, and opioids. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation.
Excipients: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially "sodium-free".
Effects on ability to drive and use machines: Baricitinib has no or negligible influence on the ability to drive and use machines.