Geltofa 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) Monitor closely for infections, including tuberculosis, before, during, and after treatment with this medicine. In patients who develop a serious infection, treatment with this medicine should be interrupted 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 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 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 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), major adverse cardiovascular events (MACE), and malignancy, 10mg is not recommended for maintenance therapy, regardless of the availability of alternative treatments.

This medication may affect the immune system, making patients more susceptible to infections. Therefore, screening for latent infections, such as tuberculosis, should be conducted before administering this drug. Patients should notify their healthcare provider immediately if infection symptoms arise and discontinue use of the drug until the infection is controlled. Special caution is needed for patients over 50 years old or those at risk for cardiovascular diseases, as there may be an increased risk of cardiac issues and thrombosis. This drug may also increase the risk of malignancies; hence, patients with a history of cancer or smoking should use it with caution. Women who are pregnant or may become pregnant should not take this drug and should use effective contraception during treatment. This medication should not be administered to patients with severely impaired liver or kidney function. Caution is advised against using this drug in combination with other immunosuppressants due to an increased risk of infections. Regular blood tests and liver function tests should be performed during treatment, and treatment should be discontinued or dosage adjusted if lymphocyte, neutrophil, or hemoglobin levels fall below certain thresholds. Moreover, this medication may increase lipid levels, so regular checks for hyperlipidemia management are required. Live vaccinations should be avoided during treatment, and vaccinations should be completed before starting this medication. If hypersensitivity or allergic reactions occur, the patient should immediately stop taking the medication and consult healthcare professionals. Caution should also be exercised when administered to the elderly, patients with diabetes, and those with a history of interstitial lung disease. In cases of overdose, there is no specific antidote, so appropriate treatment should be administered based on symptoms, and the medication should be stored out of reach of children.

• Serious infections
• pulmonary diseases
• active tuberculosis
• yeast infections
• interstitial plasma cell pneumonia
• bacterial infections
• viral infections
• herpes virus infections
• pneumonia
• influenza

Store this medication in a tightly closed container to protect it from air and moisture, ideally at room temperature between 1°C and 30°C. Proper storage maintains the drug's efficacy and prevents degradation.

Appearance

Blue round film-coated tablet

Package unit

30 tablets/bottle