Topazant 5 mg (Tofacitinib Citrate)

Adult dose

Recommended dosage for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis The recommended dosage of this medicine is 5 mg per dose, administered twice daily. The recommended adult dosages 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 are shown in Table 1. [Table 1] Recommended dosage of this medicine for patients with rheumatoid arthritis1, psoriatic arthritis2, and ankylosing spondylitis3 This medicine Adults 5 mg per dose, administered 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, 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 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 Recommended dosage for ulcerative colitis The recommended adult dosages 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 are shown in Table 2. [Table 2] Recommended dosage of this medicine for patients with ulcerative colitis Ulcerative colitis This medicine 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. [See section ‘12. Information for Healthcare Professionals’] Use the lowest effective dose for maintenance therapy. Discontinue treatment if adequate therapeutic benefit is not achieved 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. Patients with: -Moderate or severe renal impairment -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 receiving this medicine at 10 mg per dose twice daily, reduce the dose to 5 mg per dose twice daily. When the ANC exceeds 1,000 cells/mm3, increase the dose back to 10 mg per dose twice daily according to clinical response. If previously receiving this medicine at 5 mg per dose twice daily, temporarily interrupt treatment. When the 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, 10 mg is not recommended for maintenance therapy, regardless of the availability of alternative treatments.

This medication modulates the immune system and may reduce resistance to infections. Therefore, the risk of serious infections such as pneumonia, tuberculosis, and shingles may increase while taking this medication. Caution is particularly necessary when used with immunosuppressants as the risk of infection may further increase. If symptoms of infection arise, it may be necessary to consult a doctor immediately and possibly discontinue the medication. In patients over 50 years with cardiovascular risk factors, there may be an increased risk of cardiovascular adverse reactions and death such as myocardial infarction or stroke. Therefore, patients with these risk factors should use it cautiously, and the 10 mg dosage is not administered to certain patients. This medication can increase the risk of malignancies such as lymphomas, lung cancer, and skin cancers. Caution is especially warranted in elderly patients, those with a history of smoking, or those with a history of malignancies. Patients with very low lymphocyte or neutrophil counts or low hemoglobin should not use this medication, and regular blood tests should be conducted to monitor their condition during use. This medication can affect liver function, potentially leading to increased liver enzyme levels, so dose adjustments or restrictions may be necessary for patients with liver impairment or reduced liver function. Additionally, this medication may increase the risk of thrombosis (blood clot formation), so patients with a history of thrombosis or risk factors should avoid or be very cautious with its administration. Pregnant women or those who could become pregnant should not take this medication, nor should patients with certain genetic metabolic disorders like lactose intolerance. Before taking, test for infections and tuberculosis should be conducted, and vaccinations should be completed before starting this medication. Live vaccines should not be used concurrently with this medication, and contact with live vaccine recipients should be avoided during treatment. While taking this medication, side effects such as headache, dyspepsia, rash, hypertension, and fatigue may occur, so if symptoms are severe or adverse reactions are suspected, consult a doctor immediately.

• serious infections
• lung disease
• active tuberculosis
• candidiasis
• interstitial plasma cell pneumonia
• bacterial infections
• viral infections
• herpes virus infections
• pneumonia
• influenza

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle