Topazcel Tablet 5 mg (Tofacitinib Citrate)

Adult dose

Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: The recommended dose is 5mg 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 once daily Patients with: -Moderate or severe renal impairment -Moderate hepatic impairment* [See Section ‘5. General Precautions’] 5 mg once daily ALC below 500 cells/mm3 (confirmed by repeat testing) Discontinue treatment ANC 500-1,000 cells/mm3 Temporarily interrupt treatment. When the ANC is above 1,000 cells/mm3, resume this medicine at 5 mg twice daily. ANC below 500 cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2 g/dL or hemoglobin below 8.0 g/dL Temporarily interrupt treatment until hemoglobin 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 adequate therapeutic benefit is not achieved after 16 weeks of this medicine at 10 mg twice daily. 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 twice daily, reduce the dose to 5 mg twice daily. If receiving this medicine 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 medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this medicine at 5 mg twice daily, reduce the dose to 5 mg once daily. ALC below 500 cells/mm3 (confirmed by repeat testing) Discontinue treatment ANC 500-1,000 cells/mm3 If receiving this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. When the ANC is above 1,000 cells/mm3, increase the dose again to 10 mg twice daily according to clinical response. If previously receiving this medicine at 5 mg twice daily, temporarily interrupt treatment. When the ANC is above 1,000 cells/mm3, resume this medicine at 5 mg twice daily. ANC below 500 cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2 g/dL or hemoglobin below 8.0 g/dL Temporarily interrupt treatment until hemoglobin returns to normal For patients with risk factors for venous thromboembolism (VTE), 10 mg is not recommended for maintenance therapy, regardless of the availability of other treatment options. Do not initiate this medicine in patients with an absolute lymphocyte count (ALC) below 500 cells/mm3, an absolute neutrophil count (ANC) below 1,000 cells/mm3, or hemoglobin below 9 g/dL.

This medication carries a high risk of serious infections; if symptoms of infection appear, discontinue use immediately and consult a physician. Especially, latent infections such as tuberculosis must be carefully tested before and during treatment, and if latent tuberculosis is confirmed, appropriate treatment must be received first. For patients over 65 years old or those with cardiovascular risk factors, this medication may increase the risk of cardiovascular mortality and thrombosis, so it should be used with caution. This medication may increase the risk of malignancy; therefore, patients with a history of malignancy or risk factors should definitely consult a physician. Regular blood tests should be performed to check lymphocyte, neutrophil, and hemoglobin levels, with dose adjustments or discontinuation needed if abnormalities occur. Liver function tests should also be carried out regularly, and appropriate action should be taken if liver enzyme levels rise. This medication may increase lipid levels, so cholesterol management is necessary, and serum creatinine levels should also be checked periodically. It should not be used by patients with active infections, severe liver dysfunction, patients with very low blood cell counts, or women who are pregnant or may become pregnant. Live vaccine vaccinations must be completed before starting this medication, and during treatment, avoid live vaccine vaccinations or contact with vaccinated individuals. This medication poses a risk of gastrointestinal perforation; therefore, patients with a history of gastrointestinal disorders should be cautious and have any new abdominal symptoms examined immediately. If symptoms of thrombosis occur, discontinue medication immediately and seek medical evaluation. If adverse reactions such as skin rashes, allergic reactions, severe fatigue, or difficulty breathing occur while taking this medication, inform medical personnel immediately. Regular checks and safe use of this medication according to the physician’s instructions are necessary.

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

This medicine may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Also, avoid very hot or very cold places, and it is important to store it at room temperature between 1 degree and 30 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle