Jansinib Tablets 5 mg (Tofacitinib Citrate)

Adult dose

Recommended dosage for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis The recommended dosage of this drug is 5 mg per dose, administered twice daily. The recommended adult dosage for patients receiving CYP2C19 and/or CYP3A4 inhibitors, patients with moderate or severe renal impairment, patients with moderate hepatic impairment, and patients with lymphopenia, neutropenia, or anemia is shown in Table 1. [Table 1] Recommended dosage of this drug for patients with rheumatoid arthritis1, psoriatic arthritis2, and ankylosing spondylitis3 Adults 5 mg per dose, administered twice daily Patients receiving the following drugs: -Strong CYP3A4 inhibitors (e.g., ketoconazole), or -Moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) 5 mg per dose, administered once daily Patients with: -Moderate or severe renal impairment -Moderate hepatic impairment* [See section ‘5. General Precautions’] 5 mg per dose, administered 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 drug at 5 mg per dose twice daily. ANC less than 500 cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2 g/dL or hemoglobin less than 8.0 g/dL Temporarily interrupt treatment until hemoglobin levels return to normal 1 In patients with rheumatoid arthritis, this drug is administered alone or in combination with methotrexate and other nonbiologic disease-modifying antirheumatic drugs. 2 In patients with psoriatic arthritis, this drug is administered in combination with nonbiologic disease-modifying antirheumatic drugs (DMARDs). The efficacy of this drug as monotherapy in patients with psoriatic arthritis has not been studied. 3 Clinical improvement in ankylosing spondylitis was observed within 16 weeks after starting treatment with this drug. For patients who do not show clinical improvement within this period, carefully consider whether to continue treatment. Recommended dosage for ulcerative colitis The recommended adult dosage for patients receiving CYP2C19 and/or CYP3A4 inhibitors, patients with moderate or severe renal impairment, patients with moderate hepatic impairment, and patients with lymphopenia, neutropenia, or anemia is shown in Table 2. [Table 2] Recommended dosage of this drug for patients with ulcerative colitis Ulcerative colitis Adults Administer 10 mg per dose twice daily for at least 8 weeks, then administer 5 mg or 10 mg twice daily according to treatment response. Use the lowest effective dose for maintenance therapy. Discontinue treatment if an adequate therapeutic benefit is not achieved after administering 10 mg per dose twice daily for 16 weeks. Patients receiving the following drugs: -Strong CYP3A4 inhibitors (e.g., ketoconazole), or -Moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) If receiving 10 mg per dose twice daily, reduce the dosage to 5 mg per dose twice daily. If receiving 5 mg per dose twice daily, reduce the dosage to 5 mg once daily. Patients with: -Moderate or severe renal impairment -Moderate hepatic impairment [See section ‘5. General Precautions’] If receiving 10 mg per dose twice daily, reduce the dosage to 5 mg per dose twice daily. If receiving 5 mg per dose twice daily, reduce the dosage 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 10 mg per dose twice daily, reduce the dosage to 5 mg per dose twice daily. When the ANC is greater than 1,000 cells/mm3, increase the dosage back to 10 mg per dose twice daily according to clinical response. If previously receiving 5 mg per dose twice daily, temporarily interrupt treatment. When the ANC is greater than 1,000 cells/mm3, resume this drug at 5 mg per dose twice daily. ANC less than 500 cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2 g/dL or hemoglobin less than 8.0 g/dL Temporarily interrupt treatment until hemoglobin levels return 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.

This medication carries a high risk of serious infections; if symptoms of infection occur, it should be stopped immediately and treated. Before and during treatment, latent tuberculosis testing must be performed, and if latent tuberculosis is present, treatment must be completed prior to starting this medication. It should be used cautiously in elderly patients over 65 years old or those with cardiovascular risk factors, particularly at the 10 mg dosage limit for certain patients. This medication may increase the risk of malignancy, thus caution is needed in patients with a history of cancer or smoking history. There is also a risk of thrombosis, and if there is a history of thrombosis or symptoms develop, treatment should be stopped immediately and medical consultation sought. Pregnant women, women capable of becoming pregnant, patients with severe liver impairment, and those with significant blood abnormalities should not use this medication. Regular blood tests, liver function tests, and lipid tests should be conducted pre and post-treatment to identify any abnormalities early. During treatment, live vaccine administration should be avoided, and necessary vaccinations should be completed in advance. Any signs of infection, allergic reactions, liver function abnormalities, or blood level changes should be reported to a healthcare provider immediately. This medication can affect immune function, making patients vulnerable to infections, and such risks should always be taken into account.

• Serious infections
• pneumonia
• active tuberculosis other than the lungs
• candidiasis
• interstitial plasma cell pneumonia
• bacterial infections
• viral infections
• herpes virus infections
• pulmonary embolism
• deep vein thrombosis

This medication should be stored in a tightly closed container to avoid exposure to air or moisture, and it is safe to store at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness for a long time.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle