Tophacia Tablet (Tofacitinib)

Adult dose

Do not initiate this drug in adult patients with an absolute lymphocyte count (ALC; absolute lymphocyte count) below 500 cells/mm3, an absolute neutrophil count (ANC; absolute neutrophil count) below 1,000 cells/mm3, or a hemoglobin level below 9 g/dL. This drug may be taken orally with or without food. The recommended dose for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis is 5mg twice daily. Recommended dose of this drug for patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: Adults: 5 mg twice daily Patients receiving the following medications: - A strong CYP3A4 inhibitor (e.g., ketoconazole), or - A moderate CYP3A4 inhibitor and a strong CYP2C19 inhibitor (e.g., fluconazole) 5 mg once daily For patients with: - Moderate or severe renal impairment - Moderate hepatic impairment* [See section ‘5. 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 exceeds 1,000 cells/mm3, resume this drug at 5 mg twice daily. ANC below 500 cells/mm3 Discontinue treatment A decrease in hemoglobin of more than 2 g/dL or a level below 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal Recommended dosage for ulcerative colitis: Adults 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 treatment. Discontinue treatment if adequate therapeutic benefit is not achieved after administering this drug at 10 mg twice daily for 16 weeks. Patients receiving the following medications: - A strong CYP3A4 inhibitor (e.g., ketoconazole), or - A moderate CYP3A4 inhibitor and a strong CYP2C19 inhibitor (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. For patients with: - Moderate or severe renal impairment - Moderate hepatic impairment [See section ‘5. 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 below 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 back 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 below 500 cells/mm3 Discontinue treatment A decrease in hemoglobin of more than 2 g/dL or a level below 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal A maintenance dose of 10mg is not recommended for patients with risk factors for venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy, regardless of the availability of alternative treatments. For patients receiving 5 mg tablets or an equivalent weight-based dose twice daily who are also receiving a strong cytochrome P450 (CYP) 3A4 inhibitor (e.g., ketoconazole), and for patients receiving one or more concomitant medications that cause both moderate CYP3A4 inhibition and strong CYP2C19 inhibition (e.g., fluconazole), the total daily dose of this drug should be reduced to one 5 mg film-coated tablet once daily or the equivalent weight-based dose once daily.

Child dose

Do not initiate this drug in pediatric patients with an absolute lymphocyte count (ALC) below 750 cells/mm3, an absolute neutrophil count (ANC) below 1,200cells/ mm3, or a hemoglobin level below 10 g/dL.

This medication affects the immune system, significantly increasing the risk of serious infections. Therefore, thorough checks for tuberculosis and signs of infection should be conducted before and during treatment with this medication. If symptoms of infection appear, the treatment should be stopped immediately and healthcare providers should be consulted. This medication may increase mortality in patients aged 50 and older with cardiovascular risks; therefore, elderly patients or those with a history of cardiovascular disease should use it cautiously. As there is a risk of malignancy, caution is required for patients who have a history of cancer or risk factors. Due to the risk of thromboembolism, patients with a history of thromboembolism or risk factors should avoid or be closely monitored while using this medication. Patients with impaired liver function need dose adjustment, and those with severe liver dysfunction should not take this medication. This medication is contraindicated in women who are pregnant or may become pregnant. Regular clinical tests to monitor blood cell counts, liver enzymes, lipid levels, and kidney function should be performed, and any abnormal findings should be discussed with healthcare providers. Additionally, this medication should not be administered with live vaccines, and vaccinations should be completed before taking this medication. Extra care should be taken to prevent infections during treatment, and if new symptoms arise, immediate consultation with a physician is recommended.

• serious infections
• pneumonia
• shingles
• urinary tract infections
• soft tissue infections
• gastroenteritis
• diverticulitis
• sepsis
• tuberculosis
• cryptococcal meningitis

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is advisable to maintain storage temperatures between 1°C and 30°C. This will help to preserve the medication's effectiveness for a longer period.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle