Zeltopa Tablet 5 mg (Tofacitinib Citrate)

Adult dose

Recommended dosage for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis The recommended dose of this medicine 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 For the following patients: -Patients with moderate or severe renal impairment -Patients with 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 ANC exceeds 1,000 cells/mm3, resume this medicine at 5 mg twice daily. ANC below 500 cells/mm3 Discontinue treatment Decrease in hemoglobin level 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 Administer 10 mg of this medicine 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 10 mg 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 10 mg of this medicine twice daily, reduce the dose to 5 mg twice daily. If receiving 5 mg of this medicine twice daily, reduce the dose to 5 mg once daily. For the following patients: -Patients with moderate or severe renal impairment -Patients with moderate hepatic impairment [see section ‘5. General Precautions’] If receiving 10 mg of this medicine twice daily, reduce the dose to 5 mg twice daily. If receiving 5 mg of this medicine 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 10 mg of this medicine twice daily, reduce the dose to 5 mg twice daily. When ANC exceeds 1,000 cells/mm3, increase the dose again to 10 mg twice daily according to clinical response. If previously receiving 5 mg of this medicine twice daily, temporarily interrupt treatment. When ANC exceeds 1,000 cells/mm3, resume this medicine at 5 mg twice daily. ANC below 500 cells/mm3 Discontinue treatment Decrease in hemoglobin level 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), 10mg is not recommended for maintenance therapy, regardless of the availability of alternative treatments.

This medication may affect the immune system, increasing the risk of infections. Serious infections such as pneumonia, tuberculosis, and fungal infections may occur, so it is crucial to check for infections before and during treatment. In addition, if any symptoms of infection arise during treatment, immediate consultation with medical staff is necessary, and treatment should be discontinued if infections are severe. This medication may raise the risk of cardiovascular disease, particularly in patients over 50 or those with risk factors such as heart disease, hypertension, or diabetes. Some patients may experience thrombosis, characterized by symptoms such as leg pain, swelling, or shortness of breath, requiring immediate medical attention. The risk of malignancy, especially lymphoma and lung cancer, may increase, necessitating caution in patients with a history of cancer, smokers, or the elderly. Regular liver function tests are important as liver abnormalities may occur. Blood tests are also necessary, and if lymphocyte, neutrophil, or hemoglobin levels are too low, this medication should not be used or its use should be discontinued. This medication should not be administered to pregnant women or women of childbearing potential; pregnancy status must be confirmed before administration. It should not be used with live vaccines, and vaccinations should ideally be completed before commencing this treatment. Cases of gastrointestinal perforation, fractures, and allergic reactions have also been reported, so any abnormal symptoms should be reported to healthcare providers immediately. It is crucial for the administering physician to consider the patient's overall health status, medical history, and current medications.

• Serious infections
• pneumonia
• shingles
• urinary tract infection
• sinusitis
• bronchitis
• rhinitis
• pharyngitis
• tuberculosis
• diverticulitis

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to ensure the drug's efficacy and safety are preserved.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle