Zackmunjeong 5 mg (Tofacitinib Citrate)

Adult dose

1) Do not initiate treatment with this medicine in adult 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 develops, treatment 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. 5) Treatment with this medicine should be initiated and monitored by a specialist experienced in the diagnosis and treatment of the disease. Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: The recommended dose is 5 mg twice daily. Adults with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: 5 mg twice daily Patients receiving a strong CYP3A4 inhibitor (e.g., ketoconazole), or a moderate CYP3A4 inhibitor and a strong CYP2C19 inhibitor (e.g., fluconazole): 5 mg once daily Patients with moderate or severe renal impairment: 5 mg once daily Patients with moderate hepatic impairment*: 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 is above 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 normalizes Adults with ulcerative colitis: 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. If adequate therapeutic benefit is not observed after administering this medicine at 10 mg twice daily for 16 weeks, discontinue treatment. Patients receiving a strong CYP3A4 inhibitor (e.g., ketoconazole), or a moderate CYP3A4 inhibitor and a strong CYP2C19 inhibitor (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 or moderate hepatic impairment: 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: For patients 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 again to 10 mg twice daily according to clinical response. For patients previously receiving 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 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 normalizes 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 alternative treatments.

This medication modulates the immune system and may increase the risk of infections by suppressing immune function. Particularly, significant infections like pneumonia, tuberculosis, and shingles may occur, so infection status should be carefully checked before and during administration. If a severe infection occurs, the medication should be discontinued and appropriate treatment initiated. Additionally, this medication can increase the likelihood of serious cardiovascular issues such as myocardial infarction and stroke in patients older than 50, especially those at high risk for cardiovascular diseases. There is also an increased risk of malignancies, especially cancers like lymphoma or lung cancer, so patients with a history of cancer or a smoking history should use this medication cautiously. The risk of blood clots may also be present, so patients with a history of thrombosis or many cardiovascular risk factors should avoid this medication or require strict medical supervision. Patients with impaired liver or kidney function, those with very low blood cell counts, pregnant women or women of childbearing potential, and patients allergic to this drug should not receive it. Regular blood tests, liver function tests, and lipid tests should be performed during administration, and any unusual symptoms should be reported to healthcare professionals immediately. It is recommended to complete vaccinations before starting this medication, and live vaccines should not be administered alongside this drug. There have also been reports of side effects including gastrointestinal perforation, interstitial lung disease, fractures, and hypersensitivity reactions; prompt medical consultation is necessary if related symptoms occur. This medication must be used carefully according to the doctor's instructions, considering the patient's condition and risk factors.

• Serious infections
• pneumonia
• active tuberculosis other than the lung
• candidiasis
• interstitial plasma cell pneumonia
• bacterial infections
• viral infections
• herpes virus infections
• pulmonary embolism
• deep vein thrombosis

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is safe to store at room temperature between 1 and 30 degrees Celsius. Storing it this way can help maintain the drug's effectiveness for an extended period.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle