Olumiant 2 mg Tablets (Baricitinib)

Adult dose

Do not initiate treatment in patients with an absolute lymphocyte count (ALC) below 500 cells/mm3, an absolute neutrophil count (ANC) below 1000 cells/mm3, or a hemoglobin level below 8 g/dL. Rheumatoid arthritis: The recommended dose of this drug is 4 mg once daily. A dose of 2 mg once daily is recommended for patients at increased risk of venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy; patients aged 65 years or older; and patients with a history of chronic or recurrent infections. For patients whose disease activity is not adequately controlled with 2 mg once daily, 4 mg once daily may be considered. A dose of 2 mg once daily should also be considered for patients whose disease activity is persistently controlled with 4 mg once daily and for whom dose tapering is appropriate. Atopic dermatitis, adults: The recommended dose of this drug is 4 mg once daily. A dose of 2 mg once daily is recommended for patients at increased risk of venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy; patients aged 65 years or older; and patients with a history of chronic or recurrent infections. For patients whose disease activity is not adequately controlled with 2 mg once daily, 4 mg once daily may be considered. A dose of 2 mg once daily should also be considered for patients whose disease activity is persistently controlled with 4 mg once daily and for whom dose tapering is appropriate. This drug may be administered alone or in combination with topical corticosteroids. The efficacy of this drug may be increased when administered in combination with topical corticosteroids. Topical calcineurin inhibitors may be used, but only on sensitive areas such as the face, neck, skin folds, and genital area. Discontinuation of treatment should be considered for patients who show no evidence of therapeutic benefit after 8 weeks of treatment. Alopecia areata: The recommended dose of this drug is 4mg once daily. A dose of 2 mg once daily is recommended for patients at increased risk of venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy; patients aged 65 years or older; and patients with a history of chronic or recurrent infections. For patients whose disease activity is not adequately controlled with 2 mg once daily, 4 mg once daily may be considered. A dose of 2 mg once daily should also be considered for patients whose disease activity is persistently controlled with 4mg once daily and for whom dose tapering is appropriate. Once a stable response is achieved, it is recommended that treatment be continued for at least several months to avoid relapse. The benefit-risk balance of treatment should be reassessed periodically for each patient. Discontinuation of treatment should be considered for patients who show no evidence of therapeutic benefit after 36 weeks of treatment. For adult patients receiving a strong organic anion transporter 3 (OAT3) inhibitor such as probenecid, or with creatinine clearance of 30-60mL/min, the recommended dose of this drug is 2mg once daily. The recommended dose for adult patients with creatinine clearance of 30-60mL/min is 2 mg once daily. Do not administer this drug to patients with creatinine clearance below 30mL/min. No dose adjustment is required in patients with mild or moderate hepatic impairment. Administration of this drug is not recommended in patients with severe hepatic impairment. Clinical experience in patients over 75 years of age is very limited. This drug is administered orally with or without food.

Child dose

Children with atopic dermatitis (aged 2 years to under 18 years): The recommended dose of this drug for patients weighing 30kg or more is 4mg once daily. Children with atopic dermatitis (aged 2 years to under 18 years): A dose of 2mg once daily is recommended for patients weighing 10kg or more and less than 30kg. Discontinuation of treatment should be considered for patients who show no evidence of therapeutic benefit after 8 weeks of treatment. Children with juvenile idiopathic arthritis (JIA) (aged 2 years to under 18 years): The recommended dose of this drug for patients weighing 30kg or more is 4mg once daily. Children with juvenile idiopathic arthritis (JIA) (aged 2 years to under 18 years): A dose of 2mg once daily is recommended for patients weighing 10kg or more and less than 30kg. Discontinuation of treatment should be considered for patients who show no evidence of therapeutic benefit after 12 weeks of treatment. Pediatric patients receiving a strong organic anion transporter 3 (OAT3) inhibitor such as probenecid, or with creatinine clearance of 30-60mL/min: 2mg once daily for patients weighing 30kg or more. Pediatric patients receiving a strong organic anion transporter 3 (OAT3) inhibitor such as probenecid, or with creatinine clearance of 30-60mL/min: 1mg once daily for patients weighing 10kg or more and less than 30kg. Pediatric patients with creatinine clearance of 30-60mL/min: 2mg once daily for patients weighing 30kg or more. Pediatric patients with creatinine clearance of 30-60mL/min: 1mg once daily for patients weighing 10kg or more and less than 30kg. For pediatric patients who cannot swallow tablets, this drug may be administered dispersed in water. This drug should be dispersed only in water. Disperse only the number of tablets required for the dose. If the entire suspension is not taken for any reason, do not take an additional dose; wait until the next scheduled dose. See the precautions for use for instructions on dispersing this drug before administration.

This drug may increase the risk of infection, so caution is required, especially in patients with active infections or those with compromised immunity. Elderly patients and those with diabetes have a higher frequency of infection, and these patients should use this drug with greater care. This drug may increase the risk of mortality and cardiovascular adverse effects in patients aged 50 and older with high cardiovascular risk, thus requiring careful judgment in these patients when using this drug. There is a risk of malignancies, particularly lung cancer and lymphoma; hence, long-term smokers or those with a history of malignancies should have a thorough consultation before using this medication. Due to the risk of thrombosis, patients with a history of thrombosis or risk factors should either avoid or use this medication with caution, and consult a doctor immediately if any symptoms arise. It is essential to check for tuberculosis infection, and this drug should not be administered to patients with active tuberculosis. Pregnant women, women who may become pregnant, and breastfeeding women should not use this drug, and fertile women should employ effective contraception during and after treatment for some time. As this drug has immunosuppressive effects, it is advisable to avoid co-administration with other immunosuppressants to decrease the risk of infection. During use, regular blood tests and liver function tests should be performed to monitor for possible adverse effects. Additionally, this drug can cause side effects such as elevated liver transaminases, increased lipid levels, neutropenia, headache, gastrointestinal disturbances, and precautions should be taken if symptoms occur. This drug does not significantly affect driving or operating machinery, but caution may be needed depending on the physical condition. In case of overdose, immediately visit a medical institution for appropriate treatment, and follow the prescribing physician’s instructions regarding dosage. This drug should be kept out of reach of children and should not be transferred to other containers.

• Increased LDL cholesterol
• upper respiratory infection
• headache
• simple herpes
• urinary tract infection
• pneumonia
• folliculitis
• thrombocytosis
• neutropenia
• facial swelling

This medication may be sensitive to air or moisture; therefore, it should be stored in a sealed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a longer period.

Appearance

Light pink oval film-coated tablet with “Lilly” embossed on one side and “2” embossed on the other side.

Package unit

28 tablets (14 tablets/PTPX2) per box