Topra Tablet 5 mg (Tofacitinib Citrate)

Adult dose

Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: The recommended dose of this medicine is 5mg per dose, twice daily. Patients receiving the following medicines: -Strong CYP3A4 inhibitors (e.g., ketoconazole), or -Moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) 5 mg per dose, once daily In the following patients: -Patients with moderate or severe renal impairment -Patients with moderate hepatic impairment* [See section ‘5. General Precautions’] 5 mg per dose, once daily ALC less than 500 cells/mm3 (confirmed by repeat testing) Discontinue treatment ANC 500-1,000 cells/mm3 Temporarily interrupt treatment. When ANC exceeds 1,000 cells/mm3, resume this medicine 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 level below 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal Ulcerative colitis: 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. [See section ‘12. Information for Healthcare Professionals’] Use the lowest effective dose for maintenance therapy. Discontinue treatment if adequate therapeutic benefit is not observed after administering this medicine at 10 mg per dose twice daily for 16 weeks. Patients receiving the following medicines: -Strong CYP3A4 inhibitors (e.g., ketoconazole), or -Moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) If receiving this medicine at 10 mg per dose twice daily, reduce the dose to 5 mg per dose twice daily. If receiving this medicine at 5 mg per dose twice daily, reduce the dose to 5 mg once daily. In the following patients: -Patients with moderate or severe renal impairment -Patients with moderate hepatic impairment [See section ‘5. General Precautions’] If receiving this medicine at 10 mg per dose twice daily, reduce the dose to 5 mg per dose twice daily. If receiving this medicine at 5 mg per dose 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 this medicine has been administered at 10 mg per dose twice daily, reduce the dose to 5 mg per dose twice daily. When ANC exceeds 1,000 cells/mm3, increase the dose again to 10 mg per dose twice daily according to clinical response. If this medicine has previously been administered at 5 mg per dose twice daily, temporarily interrupt treatment. When ANC exceeds 1,000 cells/mm3, resume this medicine 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 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 alternative treatments.

This drug modulates the immune system, which may increase the risk of infections. Serious infections such as pneumonia, tuberculosis, and herpes zoster may occur, so thorough monitoring for infections is necessary before and during treatment. If a serious infection occurs, discontinue this medication immediately. This medication may increase the risk of death due to cardiovascular issues in patients aged 50 and above, so caution is required for those at risk for heart disease. Additionally, it may increase the risk of cancer; therefore, patients with a history of cancer or smoking history should use it cautiously. If blood leukocyte or lymphocyte counts are low, taking this drug may increase the risk of infections, thus regular blood tests are necessary. There are also risks of thrombosis, including pulmonary embolism or deep vein thrombosis, so patients should promptly inform healthcare providers if thrombosis symptoms appear. For patients with liver or kidney dysfunction, dosage adjustments may be necessary, and it should not be administered in patients with severe liver disease. Women who are pregnant or could become pregnant should not take this medication. This drug contains lactose; therefore, patients with lactose intolerance should avoid this medication. Vaccination must be up to date before taking this medication, and it should not be administered concomitantly with live vaccines. While taking this medication, side effects like headache, dyspepsia, skin rash, and fatigue may occur, so any unusual symptoms should be discussed with healthcare providers. Regular blood tests and liver function tests are critical to monitor for abnormalities. This drug affects immune functions, so rapid response is necessary in case of infections or other adverse reactions.

• 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 to prevent exposure to air or moisture. It is best stored at room temperature between 1 to 30 degrees Celsius.

Appearance

White, round film-coated tablet

Package unit

30 tablets/bottle