Tomato Tablet 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. Adults: 5 mg twice daily Patients receiving a strong CYP3A4 inhibitor (e.g., ketoconazole) or a moderate CYP3A4 inhibitor and a strong CYP2C19 inhibitor (e.g., fluconazole): 5 mg once daily Patients with moderate or severe renal impairment or moderate hepatic impairment: 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 hemoglobin level below 8.0 g/dL: Temporarily interrupt treatment until the hemoglobin level returns to normal Recommended dosage for ulcerative colitis Adults: Administer 10 mg twice daily for at least 8 weeks, then administer 5 mg or 10 mg twice daily depending on treatment response. Use the lowest 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. For patients receiving a strong CYP3A4 inhibitor (e.g., ketoconazole) or a moderate CYP3A4 inhibitor and a strong CYP2C19 inhibitor (e.g., fluconazole), who are taking this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. For patients receiving a strong CYP3A4 inhibitor (e.g., ketoconazole) or a moderate CYP3A4 inhibitor and a strong CYP2C19 inhibitor (e.g., fluconazole), who are taking this medicine at 5 mg twice daily, reduce the dose to 5 mg once daily. For patients with moderate or severe renal impairment or moderate hepatic impairment who are taking this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. For patients with moderate or severe renal impairment or moderate hepatic impairment who are taking 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 taking 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 the patient was previously taking 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 hemoglobin 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.

This medication carries a high risk of serious infections, including pneumonia, shingles, and urinary tract infections; therefore, if signs of infection appear, immediate consultation with healthcare providers is essential. Patients with tuberculosis must be screened for latent tuberculosis prior to administration, and appropriate treatment must be received if latent tuberculosis is confirmed. Caution is advised in elderly patients over 65 or those with cardiovascular risk factors, as the risk of mortality and cardiovascular adverse reactions may increase with use. This medication may increase the risk of lymphoma and other malignancies; hence, it should be administered with caution in patients with a history of cancer. There is a risk of thrombosis, i.e., formation of clots within blood vessels, so if symptoms occur, it is imperative to discontinue use and seek evaluation from a healthcare provider. Pregnant women or those who could become pregnant, as well as patients with hypersensitivity to any components of this medication, should not use it. Patients with severely impaired liver or kidney function should also consult a specialist, as administration may be prohibited or require dosage adjustment. This medication suppresses the immune system, so vaccinations should ideally be completed before use, and live vaccines should be avoided during treatment. Periodic blood tests should be performed to monitor lymphocyte, neutrophil, and hemoglobin levels; if these levels are excessively low, use may need to be halted or adjusted. During treatment, liver enzymes and lipid levels may rise, so regular monitoring is necessary, with appropriate action taken if abnormal findings are detected. There is a risk of gastrointestinal perforation, so if symptoms like abdominal pain arise, immediate examination is required, and patients with a history of gastrointestinal disease should be particularly cautious. The risk of fractures may increase, so patients at high risk for fractures should consider this when using the medication. Hypersensitivity reactions may occur, and if any allergy symptoms appear, use should be immediately discontinued and the healthcare provider notified.

• serious infections
• pneumonia
• herpes zoster
• urinary tract infections
• sinusitis
• bronchitis
• rhinopharyngitis
• pharyngitis
• tuberculosis
• diverticulitis

Store this medication in a tightly sealed container to prevent air and moisture. It is advisable to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle