Samsung Tofacitinib Tablets 10 mg (Tofacitinib Citrate)

Adult dose

Adults 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. Discontinue treatment if adequate therapeutic benefit is not achieved after administering 10 mg twice daily for 16 weeks. Patients receiving the following drugs: • Strong CYP3A4 inhibitors (e.g., ketoconazole), or • Moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) If receiving 10 mg of this drug twice daily, reduce the dose to 5 mg twice daily. If receiving 5 mg of this drug 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 10 mg of this drug twice daily, reduce the dose to 5 mg twice daily. If receiving 5 mg of this drug 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 drug twice daily, reduce the dose to 5 mg twice daily. When ANC exceeds 1,000 cells/mm3, increase again to 10 mg of this drug twice daily according to clinical response. If receiving 5 mg of this drug twice daily, temporarily interrupt treatment. When ANC exceeds 1,000 cells/mm3, resume 5 mg of this drug twice daily. ANC below 500 cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2 g/dL or hemoglobin below 8.0 g/dL Temporarily interrupt treatment until hemoglobin levels return to normal

This medication suppresses the immune system, increasing the risk of serious infections. If infections occur, treatment must be discontinued immediately, as they can lead to hospitalization or even death. A latent tuberculosis test must be conducted before starting this medication, and if latent tuberculosis is present, treatment must be received first. Additionally, this medication may increase the risk of cardiovascular adverse reactions and mortality in patients over 50 years of age with cardiovascular risk factors, such as myocardial infarction and stroke. The risk of malignancy may also be increased, so it should be used with caution in individuals with a history of cancer or smoking. There is a risk of thrombosis (blood clotting), so special caution should be exercised in patients with a history of thrombosis, and treatment should be suspended immediately if symptoms of thrombosis appear. This medication should not be used in patients with low specific blood counts (neutrophils, lymphocytes, hemoglobin) or with severely impaired liver or kidney function. Women who are pregnant or may become pregnant should not take this medication and must ensure effective contraception while taking it. While taking this medication, watch closely for symptoms of infection, skin changes, respiratory difficulties, and symptoms of thrombosis. Also, it is safer not to use this medication with other immunosuppressants or biologics. Regular blood tests and liver and kidney function tests should be performed before and during treatment, and should be discussed with a physician if any abnormalities are found. This medication cannot be used with live vaccines, so consult with the prescribing physician before vaccinations. In case of overdose, as there is no specific antidote, seek immediate medical attention for appropriate treatment. Store out of the reach of children and do not transfer to another container.

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

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It is best to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's effectiveness and safety.

Appearance

Blue circular film-coated tablet

Package unit

30 tablets/bottle