Topaz tablet 10 mg (Tofacitinib Citrate)

Adult dose

2. 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 1. [Table 1] Recommended dosage of this drug for patients with ulcerative colitis Adults Administer 10 mg twice daily for at least 8 weeks, then administer 5 mg or 10 mg twice daily according to treatment response. [See ‘12. Information for healthcare professionals’] Use the lowest effective dose for maintenance therapy. Discontinue treatment if adequate therapeutic benefit is not achieved after administering 10 mg 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 this drug at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this drug at 5 mg twice daily, reduce the dose to 5 mg once daily. Patients with: • Moderate or severe renal impairment • Moderate hepatic impairment* [See 5. General Precautions] If receiving this drug at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this drug 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 drug 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 again to 10 mg twice daily according to clinical response. If receiving this drug at 5 mg twice daily, temporarily interrupt treatment. When the ANC is greater than 1,000 cells/mm3, resume this drug 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, 10mg is not recommended for maintenance therapy, regardless of the availability of other treatment options.

This medication may increase the risk of serious infections, so the patient’s infection status must be confirmed before administration. Especially, latent tuberculosis screening should be performed, and treatment should be initiated if latent tuberculosis is present. If symptoms of infection develop, the administration of this medication should be discontinued immediately, and appropriate treatment should be applied. Caution is required for elderly patients over 65 years or those with cardiovascular disease risk, as this medication may increase the risk of cardiovascular adverse events or thrombosis in some patients. Additionally, this medication may increase the risk of malignancy; therefore, careful consideration is necessary for patients with a history of malignancy or risk factors. This medication suppresses the immune system; thus, it should be avoided in combination with other immunosuppressants. Pregnant women or women of childbearing potential should not use this medication, and effective contraception should be ensured during administration. Nursing mothers are also advised to discontinue breastfeeding when using this medication. Regular blood tests (lymphocyte, neutrophil, hemoglobin levels, etc.), liver function, and lipid levels should be monitored before and during treatment. The dosage for patients with liver or kidney impairment needs adjustment, and the medication should not be administered to patients with severe liver impairment. This medication may interact with certain drugs; thus, consult healthcare providers if co-administering any medications. Vaccination should be completed before administering this medication, and live vaccines should not be used during treatment. Patients should be closely monitored for symptoms of infection, dyspnea, skin rash, or thrombosis symptoms during the course of this medication. There are no specific antidotes for an overdose; therefore, consult healthcare professionals immediately for proper management. This medication should be kept out of reach of children and should not be transferred to other containers.

• Serious infections
• lung diseases
• active tuberculosis
• yeast infections
• interstitial plasma cell pneumonia
• bacterial infections
• viral infections
• herpes virus infections
• pneumonia
• influenza

This medication should be stored in a tightly sealed container, avoiding exposure to air or moisture, and should be kept at room temperature between 1 and 30 degrees Celsius for safety. Proper storage will maintain the drug's effectiveness for an extended period.

Appearance

Blue round film-coated tablet

Package unit

30 tablets/bottle