Topasize Tablet 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 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 once daily Patients with: -Moderate or severe renal impairment -Moderate hepatic impairment* [See Section ‘5. General Precautions’] 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 exceeds 1,000 cells/mm3, resume this drug at 5 mg twice daily. ANC less than 500 cells/mm3 Discontinue treatment Hemoglobin level decrease of more than 2 g/dL or below 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal Ulcerative colitis Administer 10 mg 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 an adequate therapeutic benefit is not observed after administration of 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 Section ‘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 exceeds 1,000 cells/mm3, increase the dose again to 10 mg twice daily according to clinical response. If previously receiving this drug at 5 mg twice daily, temporarily interrupt treatment. When the ANC exceeds 1,000 cells/mm3, resume this drug at 5 mg twice daily. ANC less than 500 cells/mm3 Discontinue treatment Hemoglobin level decrease of more than 2 g/dL or 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 should be used with caution in patients who are susceptible to infections. Serious infections can occur during treatment; therefore, symptoms of infection must be closely monitored. If latent tuberculosis is present, appropriate treatment should be received before starting this medication, and the risk of tuberculosis should be continuously checked during treatment. Caution is also required for patients aged over 50 and those with cardiovascular risk factors, as the risk of mortality and cardiovascular adverse reactions may increase. Patients with a history of malignancies, particularly lymphoma and lung cancer, need to consult thoroughly before using this medication. The risk of thrombotic events may increase; hence, patients with a history of thrombosis or risk factors should avoid or be closely monitored while using this medication. Hepatic and renal function impairment may lead to elevated blood concentrations of this medication, necessitating dose adjustments. Patients with low neutrophil count, lymphocyte count, or hemoglobin levels should not receive this medication, or regular blood tests may be required during treatment. Pregnant women or those who may become pregnant should not use this medication. This medication contains lactose and should not be administered to patients with lactose intolerance. Live vaccinations should be avoided during treatment, and vaccinations should be completed according to the latest guidelines before administration. If allergic reactions or hypersensitivity occur while taking this medication, treatment should be stopped immediately and healthcare professionals consulted. Given the risk of gastrointestinal perforation, caution is needed for patients with a history of gastrointestinal diseases, and new abdominal symptoms should prompt prompt evaluation. This medication may elevate lipid levels, thus requiring regular blood tests to manage. Prolonged use may increase the risk of fractures, and patients at risk of fractures should be cautious. During treatment, patient's status should be regularly monitored, and healthcare professionals should be notified immediately of any abnormal symptoms.

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

This medication should be stored in a sealed container away from air or moisture, preferably at room temperature between 1 to 30 degrees Celsius. Proper storage conditions will help maintain the drug's efficacy for an extended period.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle