G-K Tablet 5mg (Tofacitinib)

Adult dose

Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: The recommended dose is 5mg 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 or 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 exceeds 1,000 cells/mm3, resume this drug at 5 mg twice daily. ANC below 500 cells/mm3: Discontinue treatment A decrease in hemoglobin of more than 2 g/dL or a level below 8.0 g/dL: Temporarily interrupt treatment until the hemoglobin level returns to normal 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. Use the lowest effective dose for maintenance treatment. Discontinue treatment if adequate therapeutic benefit is not achieved after administering this drug at 10 mg twice daily for 16 weeks. 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 drug at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this drug 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 drug at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this drug 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 receiving this drug at 10 mg twice daily, reduce the dose to 5 mg twice daily. When the ANC exceeds 1,000 cells/mm3, increase the dose back to 10 mg twice daily according to clinical response. If previously receiving this drug at 5 mg twice daily, temporarily interrupt treatment. When the ANC exceeds 1,000 cells/mm3, resume this drug at 5 mg twice daily. ANC below 500 cells/mm3: Discontinue treatment A decrease in hemoglobin of more than 2 g/dL or a level below 8.0 g/dL: Temporarily interrupt treatment until the hemoglobin level returns to normal For patients receiving 5 mg tablets or an equivalent weight-based dose twice daily who are also receiving a strong cytochrome P450 (CYP) 3A4 inhibitor (e.g., ketoconazole), and for patients receiving one or more concomitant medications that cause both moderate CYP3A4 inhibition and strong CYP2C19 inhibition (e.g., fluconazole), the total daily dose of this drug should be reduced to one 5 mg film-coated tablet once daily or the equivalent weight-based dose once daily.

Child dose

Do not initiate this drug in pediatric patients with an absolute lymphocyte count (ALC) below 750 cells/mm3, an absolute neutrophil count (ANC) below 1,200 cells/mm3, or a hemoglobin level below 10 g/dL.

This drug poses a high risk of serious infections. If infection symptoms occur, administration should be stopped immediately and healthcare personnel should be consulted. A test for latent tuberculosis must be conducted before, during, and after treatment, and treatment should only be initiated after latent tuberculosis has been resolved. For patients over 50 years of age with cardiovascular risk factors, careful consideration is required when using this medication due to potential cardiovascular issues. The risk of malignancy may be increased; hence, patients with a history of cancer or smoking should use this medication with caution. There is a risk of thrombosis, and if there is a history of thrombosis or symptoms occur, administration should be stopped immediately and a medical evaluation should be undertaken. This drug is not to be administered to patients with severely compromised liver function, and regular testing is necessary if liver function abnormalities exist. Pregnant women or women who may become pregnant should not take this medication. Individuals with allergic reactions or hypersensitivity should avoid use, and administration should be stopped immediately if any adverse reactions occur. Vaccinations with live vaccines should be avoided during treatment, and it is preferable to complete vaccinations before treatment. Regular blood tests and liver function tests should be conducted to check for abnormalities. Special caution should be taken with elderly patients, those with diabetes, and immunocompromised individuals. There is a risk of gastrointestinal perforation, so patients with a history of gastrointestinal disease should consult healthcare personnel before use. This medication may elevate lipid levels, so patients requiring lipid management should undergo regular blood tests. Report any infection symptoms or unusual signs to healthcare personnel immediately during treatment.

• serious infections
• lung diseases
• active tuberculosis
• candidiasis
• interstitial plasma cell pneumonia
• bacterial infections
• viral infections
• herpes virus infections
• pneumonia
• influenza

Store this medication in a tightly closed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. This will help preserve the drug's effectiveness and safety for a longer period.

Appearance

White, round film-coated tablet

Package unit

30 tablets/bottle