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OLUMIANT is a brand name for Baricitinib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 01/2024 7 WARNINGS AND PRECAUTIONS, Malignancies 06/2022 7 WARNINGS AND PRECAUTIONS, Major Adverse Cardiovascular Events 06/2022 7 WARNINGS AND PRECAUTIONS, Thrombosis 06/2022 7 WARNINGS AND PRECAUTIONS, Laboratory Parameters, Creatine phosphokinase 01/2024 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests, Renal 01/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
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). Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Olumiant (baricitinib) tablets Page 5 of 55 If a serious infection develops, interrupt OLUMIANT until the infection is controlled.
Reported infections include: • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before initiating OLUMIANT and during therapy. Treatment for latent infection should be initiated prior to OLUMIANT use.
• Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. • Bacterial, viral, and other infections due to opportunistic pathogens.
Treatment with OLUMIANT should not be initiated in patients with active infections including chronic or localized infection. The risks and benefits of treatment with OLUMIANT should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with OLUMIANT, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy (see 7 WARNINGS AND PRECAUTIONS, Infections).
MALIGNANCIES Lymphoma and other malignancies have been reported in patients receiving OLUMIANT. An increase in malignancies, including lung cancer, were observed in rheumatoid arthritis (RA) patients 50 years and older with at least one additional cardiovascular (CV) risk factor who were treated with another Janus kinase (JAK) inhibitor compared to tumour necrosis factor (TNF) inhibitors.
Caution should be applied when using OLUMIANT in geriatric patients, patients who are current or past smokers, and patients with other malignancy risk factors (see 7 WARNINGS AND PRECAUTIONS, Malignancies). MAJOR ADVERSE CARDIOVASCULAR EVENTS In a retrospective observational study of OLUMIANT in RA patients, a higher rate of major adverse cardiovascular events was observed in OLUMIANT treated patients compared to patients treated with TNF inhibitors.
, Malignancies 06/2022 7 WARNINGS AND PRECAUTIONS, Major Adverse Cardiovascular Events 06/2022 7 WARNINGS AND PRECAUTIONS, Thrombosis 06/2022 7 WARNINGS AND PRECAUTIONS, Laboratory Parameters, Creatine phosphokinase 01/2024 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests, Renal 01/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In a clinical trial with another JAK inhibitor compared to TNF inhibitors, major adverse cardiovascular events, including non-fatal myocardial infarction, were observed more frequently in RA patients who were 50 years and older with at least one additional CV risk factor.
Caution should be applied when using OLUMIANT in geriatric patients, patients who are current or past smokers, and patients with other CV risk factors (see 7 WARNINGS AND PRECAUTIONS, Major Adverse Cardiovascular Events). THROMBOSIS Thrombosis, including deep venous thrombosis and pulmonary embolism, has been observed at an increased incidence in patients treated with OLUMIANT compared to placebo.
In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In a retrospective observational study of OLUMIANT in RA patients, a higher rate of venous thrombosis was observed when compared with TNF inhibitors.
RA patients with at least one CV risk factor had a higher rate of all-cause mortality and thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis in a clinical trial with another JAK inhibitor compared to TNF inhibitors.
Consider the risks and benefits prior to treating patients who may be at increased risk. Discontinue OLUMIANT and promptly evaluate patients with symptoms of thrombosis (see 7 WARNINGS Olumiant (baricitinib) tablets Page 6 of 55 AND PRECAUTIONS, Thrombosis).
4 Drug-Drug Interactions). • Monitor complete blood counts during treatment and modify dosage as recommended (see Hematology). 5 x 109 cells/L, absolute neutrophil count (ANC) less than 1 x 109 cells/L, or hemoglobin levels less than 80 g/L (see Hematology and 8 ADVERSE REACTIONS).
• OLUMIANT should not be initiated in patients with active serious infection, including localized infections. OLUMIANT should be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis (see Infections).
• The use of OLUMIANT with live vaccines is not recommended (see Immunization). • Treatment for latent tuberculosis infection should be initiated prior to OLUMIANT use (see Infections). • Prior to initiating OLUMIANT, screening for viral hepatitis is recommended (see Infections).
• Prior to initiating OLUMIANT, consider the risks and benefits of therapy in geriatric patients, patients who are current or past smokers, patients with other CV risk factors, patients with a known malignancy, or patients at increased risk of thrombosis, and when considering continuing OLUMIANT in patients who develop a malignancy, major CV events, or thrombosis (see Malignancies, Major Adverse Cardiovascular Events, and Thrombosis).
Discontinue OLUMIANT and promptly evaluate patients with symptoms of thrombosis (see Thrombosis). 2 Breast-feeding). • Caution should be used when using OLUMIANT in patients 65 years of age or older. 4 Geriatrics). • OLUMIANT is not recommended for use in patients with severe hepatic impairment (see Special Populations and Conditions).
Liver enzymes should be evaluated before initiating OLUMIANT. If increases in liver enzymes are observed during therapy and drug induced liver injury […]