Janssen XR Extended-Release Tablet 11 mg (Tofacitinib Citrate)

Adult dose

To ensure accurate dosing, swallow this medicine whole; do not crush, split, or chew it. This medicine may be taken orally with or without food. Patients taking Xeljanz tablets 5 mg twice daily may switch to Xeljanz XR extended-release tablets 11 mg once daily beginning the day after their last dose of Xeljanz tablets 5 mg. Patients taking Xeljanz XR extended-release tablets 11 mg once daily may switch to Xeljanz tablets 5 mg twice daily beginning the day after their last dose of Xeljanz XR extended-release tablets 11 mg. Xeljanz XR extended-release tablets 11 mg once daily have been demonstrated to be pharmacokinetically equivalent to Xeljanz tablets 5 mg twice daily. The recommended dose for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis is 11 mg once daily. Adults: Administer Xeljanz XR extended-release tablets 11mg once daily. Patients receiving a strong CYP3A4 inhibitor (e.g., ketoconazole), or a moderate CYP3A4 inhibitor and a strong CYP2C19 inhibitor (e.g., fluconazole): Reduce the dose to Xeljanz tablets 5 mg once daily. Patients with moderate or severe renal impairment, or moderate hepatic impairment: Reduce the dose to Xeljanz tablets 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 ANC is greater than 1,000 cells/mm3, resume treatment with Xeljanz XR extended-release tablets 11mg once daily. ANC less than 500 cells/mm3: Discontinue treatment. Decrease in hemoglobin of more than 2 g/dL or hemoglobin level less than 8.0 g/dL: Temporarily interrupt treatment until the hemoglobin level normalizes. Do not initiate treatment with this medicine in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3, an absolute neutrophil count (ANC) less than 1,000 cells/mm3, or a hemoglobin level less than 9 g/dL.

This medication may increase the risk of serious infections, so latent tuberculosis testing and infection status must be confirmed before administration. If infection occurs, this medication should be discontinued immediately and appropriate treatment should be initiated. Elderly patients over 65 years or those with cardiovascular risk factors should use this medication with caution, and particularly, the 10mg dosage should not be used for safety. There may also be an increased risk of malignant tumors, so patients with a history of cancer or smoking should be administered carefully. There is also a possibility of thrombosis, so if symptoms of thrombosis appear, this medication should be discontinued immediately and a healthcare professional consulted. Patients with impaired liver or kidney function require dosage adjustment, and it should not be administered to patients with severe liver dysfunction. Lymphocyte, neutrophil, and hemoglobin levels should be monitored regularly, and if abnormalities are found, dosage adjustment or discontinuation should be considered. This medication must not be used in combination with other potent immunosuppressants or biologics. Pregnant women or those who may become pregnant should not take this medication, and vaccinations should be brought up to date prior to administration. Additionally, this medication contains sorbitol, so caution is needed in certain patients. During treatment with this medication, careful observation for symptoms of infection, thrombosis, skin abnormalities, and respiratory distress is essential.

• serious infections
• pneumonia
• herpes zoster
• urinary tract infection
• sinusitis
• bronchitis
• nasopharyngitis
• pharyngitis
• tuberculosis
• diverticulitis

This medication can be sensitive to air or moisture, so it should be stored in a tightly closed container. It's important to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature to preserve the medication’s efficacy.

Appearance

Pink oval tablet with a hole on one side

Package unit

30 tablets/bottle