Jongkundang Tofacitinib Tablet 5 mg

Adult dose

Recommended dosage for rheumatoid arthritis and psoriatic arthritis The recommended dose of this medicine is 5 mg twice daily. The recommended adult dosage for patients receiving CYP2C19 and/or CYP3A4 inhibitors, patients with moderate or severe renal impairment, patients with moderate hepatic impairment, and patients with lymphopenia, neutropenia, or anemia is shown in Table 1. Adults: 5 mg twice daily Patients receiving the following medicines: -Strong CYP3A4 inhibitors (e.g., ketoconazole), or -Moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) 5 mg once daily Patients with: -Moderate or severe renal impairment -Moderate hepatic impairment* [See section ‘5. General Precautions’] 5 mg once daily ALC less than 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 medicine at 5 mg twice daily. ANC less than 500 cells/mm3 Discontinue treatment Hemoglobin decrease of more than 2 g/dL or below 8.0 g/dL Temporarily interrupt treatment until hemoglobin levels return to normal

This medication regulates the immune system, which may increase the risk of serious infections. If there is a history of latent tuberculosis, such as pulmonary tuberculosis, treatment should occur prior to starting this medication, and tuberculosis infection monitoring should be conducted during treatment. Additionally, during treatment, severe infection symptoms such as pneumonia, herpes zoster, and urinary tract infections may appear, requiring immediate consultation with healthcare professionals upon symptom emergence. There may also be an increased risk of cardiovascular mortality in elderly patients over 65 or those with a history of cardiovascular disease. There is a potential for the development of malignant tumors; therefore, patients with a past history of cancer or a history of smoking should use this medication with caution. There is a risk of thrombosis; if symptoms like pain in the legs, swelling, or difficulty breathing appear, the medication should be stopped immediately, and the patient should go to the hospital. Women who are pregnant or may become pregnant should not take this medication and should use effective contraception during treatment. Patients with severe liver or kidney dysfunction should not use this medication, and dosage adjustments are required in cases of mild to moderate dysfunction. The risk of infection may increase when this drug is used in conjunction with other potent immunosuppressants or biological agents. Prior to administration, a blood test should be performed to check white blood cell count, lymphocyte count, hemoglobin levels, and regular testing is required during treatment. Liver function tests and lipid level tests should also be conducted periodically during treatment, and proper actions should be taken if abnormalities occur. Additionally, while taking this medication, live vaccines should be avoided, and any necessary vaccinations should be completed beforehand for safety. In cases of overdose, no specific antidote is available; hence immediate hospital treatment should be sought based on symptoms. This medication should be stored out of reach of children and should not be transferred to other containers.

• serious infections
• lung disease
• active tuberculosis
• yeast infections
• interstitial plasmacytic pneumonia
• bacterial infections
• viral infections
• herpes virus infections
• pneumonia
• shingles

This medication should be stored in a tightly closed container to prevent air or moisture ingress. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This ensures the effect of the medication is safely preserved.

Appearance

White, round, film-coated tablets

Package unit

30 tablets/bottle