Jak Munjeong 10 mg (Tofacitinib Citrate)

Adult dose

This medicine may be taken orally with or without food. 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 minimum effective dose for maintenance therapy. Discontinue treatment if adequate therapeutic benefit is not observed after administration of 10 mg twice daily for 16 weeks. Patients receiving any of 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. In the following patients: • Patients with moderate or severe renal impairment • Patients with 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 less than 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 exceeds 1,000 cells/mm3, increase the dose again to 10 mg twice daily according to clinical response. If receiving this medicine at 5 mg twice daily, temporarily interrupt treatment. When the ANC exceeds 1,000 cells/mm3, resume this medicine at 5 mg twice daily. ANC less than 500 cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2 g/dL or hemoglobin level less than 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 works by modulating the immune system, which increases the risk of serious infections. Therefore, before administration, latent infections such as tuberculosis should be checked, and treatment should be discontinued until the infection is under control. Caution should be exercised when using this medication in elderly patients over 65 years or those with cardiovascular risk factors. This drug may increase the risk of cardiovascular disease, thrombosis, and malignancies, so it should be administered with caution to patients with relevant medical history. Patients with active infections, severe liver impairment, low blood cell counts, and pregnant or potentially pregnant women should not use this drug. During treatment, symptoms of infection, blood test values, liver function, and lipid levels should be monitored regularly, and medical consultation should be sought immediately if any abnormal symptoms occur. It is safest not to use this drug in combination with other immunosuppressants or biological agents. Pregnant women should avoid use as it may harm the fetus and should use effective contraception during treatment. Breastfeeding mothers should consider discontinuing breastfeeding or stopping the medication as it may be excreted in breast milk. For children's safety, store out of reach of children, and in case of overdose, seek medical attention immediately.

• serious infections
• lung diseases
• active tuberculosis
• candidiasis
• interstitial plasma cell 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 sealed container. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius to safely preserve the drug's effectiveness.

Appearance

Blue round film-coated tablets

Package unit

30 tablets/bottle