Olumiant 1 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 medicine 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. A dose of 4 mg once daily may be considered in patients whose disease activity is not adequately controlled with 2 mg once daily. A dose of 2 mg once daily should also be considered for patients whose disease activity remains controlled with 4 mg once daily and for whom dose tapering is appropriate. Atopic dermatitis, adults: The recommended dose of this medicine 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. A dose of 4 mg once daily may be considered in patients whose disease activity is not adequately controlled with 2 mg once daily. A dose of 2 mg once daily should also be considered for patients whose disease activity remains controlled with 4 mg once daily and for whom dose tapering is appropriate. Atopic dermatitis: This medicine may be administered alone or in combination with topical corticosteroids. Its efficacy may be enhanced 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 in patients who show no evidence of therapeutic benefit after 8 weeks of treatment. Alopecia areata: The recommended dose of this medicine 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. A dose of 4 mg once daily may be considered in patients whose disease activity is not adequately controlled with 2 mg once daily. A dose of 2mg once daily should also be considered for patients whose disease activity remains 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 regularly on an individual basis. Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 36 weeks of treatment. The recommended dose of this medicine for adults receiving strong organic anion transporter 3 (OAT3) inhibitors, such as probenecid, or with a creatinine clearance of 30-60mL/min is 2mg once daily. The recommended dose for adults with a creatinine clearance of 30-60mL/min is 2 mg once daily. This medicine should not be administered to patients with a creatinine clearance below 30mL/min. No dose adjustment is required in patients with mild or moderate hepatic impairment. Administration of this medicine is not recommended in patients with severe hepatic impairment. Clinical experience in patients aged 75 years or older is very limited. This medicine is administered orally, with or without food.

Child dose

Atopic dermatitis, pediatric patients (2 years to under 18 years): The recommended dose of this medicine for patients weighing 30kg or more is 4mg once daily. Atopic dermatitis, pediatric patients (2 years to under 18 years): A dose of 2mg once daily is recommended for patients weighing 10kg or more and less than 30kg. Juvenile idiopathic arthritis (JIA) (2 years to under 18 years): The recommended dose of this medicine for patients weighing 30kg or more is 4mg once daily. Juvenile idiopathic arthritis (JIA) (2 years to under 18 years): A dose of 2mg once daily is recommended for patients weighing 10kg or more and less than 30kg. Juvenile idiopathic arthritis (JIA): Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 12 weeks of treatment. Recommended dose for pediatric patients receiving strong organic anion transporter 3 (OAT3) inhibitors, such as probenecid, or with a creatinine clearance of 30-60mL/min: 2mg once daily for patients weighing 30kg or more. Recommended dose for pediatric patients receiving strong organic anion transporter 3 (OAT3) inhibitors, such as probenecid, or with a creatinine clearance of 30-60mL/min: 1mg once daily for patients weighing 10kg or more and less than 30kg. Pediatric patients with a creatinine clearance of 30-60mL/min: 2mg once daily for patients weighing 30kg or more. Pediatric patients with a 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 medicine may be dispersed in water for administration. This medicine should be dispersed only in water. Disperse only the number of tablets needed 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. Refer to the precautions for use for instructions on dispersing this medicine before administration.

This medication may affect the immune system and increase the risk of infections. Therefore, it is important to consult a doctor before using this medication if there is an active infection or a history of chronic infection. If any signs of infection appear, notify medical personnel immediately and discontinue the medication if necessary. Special caution is required for the elderly or patients with diabetes, as the risk of infection is higher in these individuals. This medication may increase mortality and cardiovascular adverse reactions in patients at risk of cardiovascular diseases, so it should be used cautiously in individuals aged 65 and older or those with cardiovascular risk factors. Additionally, it may elevate the risk of malignant tumors, particularly lung cancer and lymphoma; therefore, long-term smokers or those with a history of malignancy should consult thoroughly before using this medication. There is also a risk of thrombosis; therefore, patients with a history or risk factors for thrombosis should use this medication with caution, and if symptoms of thrombosis appear, treatment should be discontinued immediately and medical advice sought. This medication should not be used if tuberculosis is suspected or if there is active tuberculosis; in cases of latent tuberculosis, anti-tuberculosis therapy should be considered before treatment. It should not be administered to patients with specific low blood counts (such as neutrophils, lymphocytes, or hemoglobin levels) or to patients with severe renal impairment, pregnant or breastfeeding women. Various adverse reactions such as infection risk, liver dysfunction, hematological abnormalities, and elevated lipid levels may occur, hence regular examinations are necessary. Notably, blood lipid and liver function tests should be performed at 12 weeks after starting treatment, and appropriate management should be conducted if necessary. The immunosuppressive effects may be excessive when used in conjunction with other immunosuppressants, so caution is advised for co-administration. This medication should not be used during pregnancy as it may harm the fetus, and women of childbearing potential should use effective contraception during and for a certain period after treatment. Breastfeeding women should avoid using this medication and consider discontinuing breastfeeding or the drug. There is limited data on safety and efficacy in pediatric and elderly populations, and this should also be considered. No specific toxic signs have been reported in cases of overdose, but adverse reactions should be monitored closely. This medication can be taken by dispersing the tablet in water, and it is advisable to take it promptly after dispersion. Keep this medication out of the reach of children, and avoid transferring it to other containers.

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

Store this medication in a tightly closed container to protect it from air or moisture. It is advisable to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

A very light pink, round, film-coated tablet, imprinted with “Lilly” on one side and “1” on the other side.

Package unit

28 tablets/box [(14 tablets/PTP) X 2]