Tomato Tablet 10 mg (Tofacitinib Citrate)

Adult dose

1. Precautions for administration 1) Do not initiate treatment with 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 treatment with this medicine may be necessary to manage lymphopenia, neutropenia, and anemia. 4) This medicine may be administered orally with or without food. 2. Recommended dosage for ulcerative colitis The recommended adult dosage 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 is 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. 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 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 the following conditions: • 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. Once 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 interrupt treatment. Once the ANC is above 1,000 cells/mm3, resume this medicine at 5 mg twice daily. ANC below 500 cells/mm3 Discontinue treatment Hemoglobin level decreases by more than 2 g/dL or is 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 other treatment options.

This medication has immunosuppressive effects, which may increase the risk of infections. Serious infections such as pneumonia, tuberculosis, and shingles may occur, so infection symptoms should be closely monitored before and during administration. If a serious infection occurs, this medication should be discontinued. Additionally, patients over 50 years old with cardiovascular risk factors may have an increased risk of cardiovascular side effects such as myocardial infarction and stroke, warranting caution. This medication may also increase the risk of malignancies, so patients with a history of cancer or smoking should use it with caution. There is a risk of thrombosis, so if symptoms of thrombosis appear, medication should be discontinued immediately, and consultation with healthcare professionals is necessary. Women who are pregnant or may become pregnant should not use this medication, and effective contraception should be employed during treatment. Safety in children or patients under 18 years old has not been established. Patients with moderate to severe liver or kidney impairment need dose adjustments, and patients with severe liver impairment should not use this medication. It is advisable not to use this medication in conjunction with other potent immunosuppressants or biological agents. Prior to administration, tuberculosis screening and viral infection testing should be performed, and vaccinations should be completed according to the latest guidelines. Regular blood tests, liver function tests, and lipid checks should be performed during treatment to monitor for adverse reactions. In cases of overdose, there is no specific antidote, so treatment should be provided based on symptoms. This medication should be kept out of reach of children and should not be transferred to another container.

• pulmonary disease
• active tuberculosis
• yeast infection
• interstitial plasma cell pneumonia
• invasive fungal infection
• bacterial infection
• viral infection
• herpes virus infection
• pneumonia
• influenza

This medication should be stored in a tightly closed container to prevent air and moisture ingress, and it is recommended to be kept at room temperature between 1°C and 30°C. Proper storage helps maintain the efficacy of the medication for a longer period.

Appearance

Blue circular film-coated tablets

Package unit

30 tablets/bottle