Jeljanz 5 mg (Tofacitinib Citrate)

Adult dose

Recommended dosage for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis The recommended dose of this medicine is 5 mg twice daily. Patients receiving the following drugs: -Strong CYP3A4 inhibitors (e.g., ketoconazole), or -One or more concomitant drugs that cause both moderate CYP3A4 inhibition and strong CYP2C19 inhibition (e.g., fluconazole) 5 mg once daily Patients with the following conditions: -Moderate or severe renal impairment -Moderate hepatic impairment* [See Section ‘5. General Precautions’] 5 mg once daily ALC less than 500 cells/mm3 (confirmed by repeat testing) Discontinue treatment ANC 500-1,000 cells/mm3 Temporarily interrupt treatment. When the ANC is greater than 1,000 cells/mm3, resume this medicine at 5 mg twice daily. ANC less than 500 cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2 g/dL or level below 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal Recommended dosage for ulcerative colitis Administer 10 mg twice daily for at least 8 weeks, then administer 5 mg or 10 mg twice daily according to treatment response. [See Section ‘12. Information for Healthcare Professionals’] Use the minimum effective dose for maintenance therapy. Discontinue treatment if adequate therapeutic benefit is not achieved after administration of this medicine at 10 mg twice daily for 16 weeks. Patients receiving the following drugs: -Strong CYP3A4 inhibitors (e.g., ketoconazole), or -One or more concomitant drugs that cause both moderate CYP3A4 inhibition and strong CYP2C19 inhibition (e.g., fluconazole) If receiving this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this medicine at 5 mg twice daily, reduce the dose to 5 mg once daily. Patients with the following conditions: -Moderate or severe renal impairment -Moderate hepatic impairment [See Section ‘5. General Precautions’] If receiving this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this medicine at 5 mg twice daily, reduce the dose to 5 mg once daily. ALC less than 500 cells/mm3 (confirmed by repeat testing) Discontinue treatment ANC 500-1,000 cells/mm3 If receiving this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. When the ANC is greater than 1,000 cells/mm3, increase the dose back to 10 mg twice daily according to clinical response. If previously receiving this medicine at 5 mg twice daily, temporarily interrupt treatment. When the ANC is greater than 1,000 cells/mm3, resume this medicine at 5 mg twice daily. ANC less than 500 cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2 g/dL or level below 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal For patients with risk factors for venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy, 10 mg is not recommended for maintenance therapy, regardless of the availability of alternative treatments. [Interactions] For patients receiving 5 mg tablets or an equivalent weight-based dose twice daily who are also receiving strong cytochrome P450 (CYP) 3A4 inhibitors (e.g., ketoconazole), and for patients receiving one or more concomitant drugs that cause both moderate CYP3A4 inhibition and strong CYP2C19 inhibition (e.g., fluconazole), the total daily dose of this medicine should be reduced to 5 mg once daily as a film-coated tablet or the equivalent weight-based dose once daily.

Child dose

Aged 2 years and under 18 years, body weight 10 - < 20 kg: 3.2 mg (3.2 mL oral solution) twice daily Aged 2 years and under 18 years, body weight 20 - < 40 kg: 4 mg (4 mL oral solution) twice daily Aged 2 years and under 18 years, body weight ≥ 40 kg: 5 mg (5 mL oral solution or 5 mg film-coated tablet) twice daily Patients weighing 40 kg or more who receive tofacitinib oral solution 5 mL twice daily may be switched to tofacitinib 5 mg tablets twice daily. Patients weighing less than 40kg cannot be switched from tofacitinib oral solution to tablets. No dose adjustment is required when coadministered with methotrexate. It is recommended that treatment with this medicine not be initiated in pediatric patients with an absolute lymphocyte count (ALC) below 750cells/mm3. ALC 750 or greater Maintain the dose ALC 500-750 If a decrease within this range persists (2 consecutive values within this range on routine testing), the dose should be reduced or treatment discontinued. For patients receiving this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. For patients receiving this medicine at 5 mg twice daily, discontinue treatment. Resume treatment as clinically appropriate when the ALC exceeds 750. ALC below 500 If the laboratory value is confirmed by repeat testing within 7 days, discontinue treatment. It is recommended that treatment not be initiated in pediatric patients with an absolute neutrophil count (ANC) below 1,200 cells/mm3. ANC greater than 1,000 Maintain the dose. ANC 500-1,000 If a decrease within this range persists (2 consecutive values within this range on routine testing), the dose should be reduced or treatment discontinued. For patients receiving this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. For patients receiving this medicine at 5 mg twice daily, discontinue treatment. Resume treatment as clinically appropriate when the ANC exceeds 1,000. ANC below 500 If the laboratory value is confirmed by repeat testing within 7 days, discontinue treatment. It is recommended that treatment not be initiated in pediatric patients with hemoglobin below 10 g/dL. Decrease of 2 g/dL or less and level of 9.0 g/dL or greater Maintain the dose. Decrease of 2 g/dL or more or level below 8.0 g/dL (confirmed by repeat testing) Temporarily interrupt treatment until the hemoglobin level returns to normal.

This medication modulates the immune system, which may weaken resistance to infections. Therefore, there is an increased risk of serious infections such as pneumonia, tuberculosis, and shingles while taking this medication. Before starting this medication, a tuberculosis test must be conducted, and if latent tuberculosis is found, treatment must be completed first. If any signs of infection occur, consult a physician immediately and discontinue use if necessary. This medication may increase the risk of serious cardiovascular issues such as heart attack or stroke in patients over 50 years old with cardiovascular disease risk factors. Therefore, extra caution is required for these patients, and it is recommended to avoid the 10 mg dosage. Additionally, patients taking this medication may have an increased risk of malignancies such as lymphoma or lung cancer, so those with a history of cancer or long-term smokers should use it cautiously. There may also be an increased risk of thrombosis, i.e., the formation of blood clots within blood vessels, so if symptoms such as leg pain or swelling, or sudden shortness of breath occur, medical attention should be sought immediately. There can be blood-related issues like abnormal liver function, decreased white blood cells, or anemia, thus regular blood tests and liver function tests are necessary. Women who are pregnant or may become pregnant should not take this medication, and patients with lactose intolerance should not use it. Patients should complete vaccinations before starting and during treatment with this medication under the guidance of a healthcare provider, and live vaccines should not be administered. Elderly patients, diabetes patients, and those with compromised liver or kidney function must exercise special caution when using this medication. During the treatment, regularly observe for any symptoms of infection, cardiovascular symptoms, skin changes, blood test results, and immediately consult healthcare professionals if any abnormalities are detected.

• serious infections
• pneumonia
• active tuberculosis
• candidiasis
• interstitial plasma cell pneumonia
• invasive fungal infections
• bacterial infections
• viral infections
• herpes virus infections
• pulmonary disease

This medication should be stored in a tightly sealed container to protect it from air and moisture, ideally at a temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's efficacy and safety.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle