Zeljanz 10 mg (Tofacitinib Citrate)

Adult dose

Administer 10 mg twice daily for a minimum of 8 weeks, then administer 5 mg or 10 mg twice daily according to treatment response. [See ‘12. Information for Healthcare Professionals’] Use the minimum effective dose for maintenance therapy. Discontinue treatment if an adequate therapeutic benefit is not observed after administering 10 mg twice daily for 16 weeks. For 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 10 mg of this medicine was administered 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 5 mg of this medicine was administered twice daily, temporarily interrupt treatment. When the ANC exceeds 1,000 cells/mm3, resume administration of 5 mg of this medicine 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 hemoglobin levels return 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.

Since this medication can modulate the immune system, there may be an increased risk of serious infections during treatment. Before using this medication, it is essential to undergo tuberculosis screening and latent tuberculosis treatment, and if symptoms of infection appear, the use of the medication must be stopped immediately. In patients aged 50 years or older with cardiovascular disease risk, serious cardiovascular adverse reactions such as myocardial infarction and stroke may increase, so caution is needed. This medication can increase the risk of malignancies, especially lymphoma and lung cancer, so patients with a history of cancer or smoking should use it with caution. There is also a risk of thrombosis, so patients with a history or risk factors for thrombosis should avoid the use of this medication or be monitored closely. Allergic reactions may occur, so patients with a history of allergies must inform healthcare providers immediately if any unusual symptoms arise during treatment. Pregnant women or those who may become pregnant should not take this medication and should ensure effective contraception during and for a period after treatment. For patients with moderate to severe liver or kidney impairment, dose adjustments are necessary, and this medication should not be used in patients with severe liver dysfunction. This medication should not be used in conjunction with other strong immunosuppressants or biological agents, as this could significantly increase the risk of infection. Regular blood tests, liver function tests, and lipid tests should be performed before and after administration to detect and manage adverse reactions early. During treatment, live vaccinations should be avoided, and vaccinations should be completed before administration for safety. Elderly patients over 65 years or those with diabetes, gastrointestinal diseases, or weakened immune systems require special caution during treatment. There is no specific antidote in case of overdose, so appropriate treatment should be obtained immediately at a medical institution. This medication should be stored out of the reach of children and should not be transferred to other containers.

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

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature to preserve the effectiveness of the medication for a long time.

Appearance

Blue round film-coated tablets

Package unit

28 tablets/bottle