Topasiz Tablet 10 mg (Tofacitinib Citrate)

Adult dose

1. Precautions for administration 1) 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 a hemoglobin level below 9 g/dL. 2) Patients should be closely monitored for infections, including tuberculosis, before, during, and after treatment with this medicine. If a serious infection occurs, discontinue this medicine until the infection is controlled. 3) Temporary interruption of this medicine may be necessary to manage lymphopenia, neutropenia, and anemia. 4) This medicine may be taken orally with or without food. 2. Recommended dosage for ulcerative colitis The recommended adult doses 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 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 ‘12. Information for healthcare professionals’] Use the lowest effective dose for maintenance therapy. Discontinue treatment if adequate therapeutic benefit is not achieved after administration of 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 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 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 back to 10 mg twice daily according to clinical response. If receiving this medicine at 5 mg twice daily, temporarily discontinue 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 level below 8.0 g/dL Temporarily discontinue treatment until the hemoglobin level returns to normal For patients with risk factors for venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy, 10mg is not recommended for maintenance therapy, regardless of the availability of alternative treatments.

This medication carries a high risk of serious infections; if symptoms of infection occur, treatment should be discontinued immediately, and medical attention should be sought. Before taking this medication, latent tuberculosis should be tested, and if present, appropriate treatment should precede therapy. Caution is warranted in elderly patients over 65 years or those at cardiovascular risk, as there may be an increased risk of cardiovascular adverse reactions and thrombosis. It may increase the risk of malignancy, so it should be used cautiously in patients with a history of cancer or a history of smoking. This medication should not be administered to patients with a low neutrophil count, lymphocyte count, or hemoglobin levels based on blood tests, and regular blood tests should be conducted to monitor for abnormalities. Patients with moderate or greater impairment of liver or kidney function may require dosage adjustment, and this medication should not be given to patients with severe liver impairment. Women who are pregnant or may become pregnant should not take this medication; effective contraception should be maintained during treatment. Nursing mothers are advised to discontinue breastfeeding or the medication since this drug may be secreted in breast milk. This drug should not be combined with other potent immunosuppressants or biologics, and careful attention should be paid to drug interactions. Patients should be closely monitored for various adverse reactions such as infections, cardiovascular issues, malignancies, thrombosis, and liver function abnormalities during treatment. Vaccination with live vaccines should be avoided during therapy, and immunizations should be completed before the initiation of therapy. After initiation, regular blood tests, liver function tests, and lipid panels should be conducted to continually monitor the patient's condition. In cases of overdose, since there is no specific antidote, the patient should seek medical attention immediately for appropriate treatment. Keep this medication out of reach of children and do not transfer to other containers.

• 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 avoid exposure to air or moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius. This will safely preserve the effectiveness of the medication.

Appearance

Blue round film-coated tablet

Package unit

30 tablets/bottle