Jansinib Tablets 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) Closely monitor for infections, including tuberculosis, before, during, and after treatment with this medicine. In patients who develop a serious infection, interrupt treatment 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 administered orally with or without food. 2. Recommended dosage for ulcerative colitis The recommended adult dosage for patients taking 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 treatment. Discontinue treatment if adequate therapeutic benefit is not achieved after administration of 10 mg twice daily for 16 weeks. Patients taking any of the following medicines: • A strong CYP3A4 inhibitor (e.g., ketoconazole), or • A moderate CYP3A4 inhibitor and a strong CYP2C19 inhibitor (e.g., fluconazole) If taking this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. If taking 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 taking this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. If taking 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 taking 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 again to 10 mg twice daily according to clinical response. If taking this medicine at 5 mg twice daily, temporarily interrupt 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 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 carries a high risk of serious infections, and administration must be stopped immediately if symptoms of infection appear. Particularly, latent infections such as tuberculosis should be screened in advance, and treatment should be initiated when necessary. Moreover, it should be used cautiously in patients over 50 years old with cardiovascular risk factors, and certain doses should be avoided. Due to the risk of malignancy, caution is needed in patients with a history of cancer or risk factors. There is also a risk of thrombosis, so if symptoms of thrombosis appear, medical consultation should be sought immediately. This medication is not to be administered to patients with specific infections or severe liver and blood conditions, or to pregnant women. Patients suspected of having infections, immunocompromised patients, elderly individuals, and patients with diabetes should consult with medical staff prior to use. While administering, regular monitoring of infection, blood counts, liver function, and lipid levels is necessary, and any abnormal symptoms should be reported immediately. This medication should not be combined with other immunosuppressants and should be avoided for a certain period after live vaccine administration. Women who may become pregnant should use effective contraception during and for some time after treatment, and nursing mothers are advised to avoid use. Special precautions are required for children and the elderly, with increased infection risk in older patients. In case of overdose, as there is no specific antidote, notify the healthcare provider immediately and monitor symptoms. This medication should be stored out of reach of children and not transferred to other containers.

• serious infections
• pulmonary diseases
• active tuberculosis
• candidiasis
• interstitial plasmacytic pneumonia
• bacterial infections
• viral infections
• herpes virus infections
• pneumonia
• influenza

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is advisable to maintain room temperature between 1 degrees and 30 degrees.

Appearance

Blue round film-coated tablets

Package unit

30 tablets/bottle