Tozeljs 5 mg (Tofacitinib Citrate)

Adult dose

1. Precautions for administration 1) Do not initiate treatment with this medicine in patients with an absolute lymphocyte count (ALC) below 500 cells/mm3, an absolute neutrophil count (ANC) below 1,000 cells/mm3, or a hemoglobin level below 9 g/dL. 2) Patients should be closely monitored for infections, including tuberculosis, before, during, and after treatment with this medicine. In patients who develop a serious infection, treatment with this medicine should be interrupted until the infection is controlled. 3) Temporary interruption of treatment with this medicine may be necessary to manage lymphopenia, neutropenia, and anemia. 4) This medicine may be taken orally with or without food. 2. Recommended dosage for rheumatoid arthritis and psoriatic arthritis The recommended dose of this medicine is 5 mg twice daily. The recommended adult dose 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. Table 1: Recommended dosage of this medicine for patients with rheumatoid arthritis1 and psoriatic arthritis2 This medicine 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 below 500 cells/mm3 (confirmed by repeat testing) Interrupt treatment ANC 500-1,000 cells/mm3 Temporarily interrupt treatment. When the ANC exceeds 1,000 cells/mm3, resume treatment with this medicine at 5 mg twice daily. ANC below 500 cells/mm3 Interrupt treatment A decrease in hemoglobin level of more than 2 g/dL or a level below 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal 1 In patients with rheumatoid arthritis, this medicine is administered alone or in combination with methotrexate and other non-biologic antirheumatic drugs. 2 In patients with psoriatic arthritis, this medicine is administered in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs). The efficacy of this medicine as monotherapy in patients with psoriatic arthritis has not been studied.

This drug suppresses the immune system, hence there is an increased risk of serious infections. Especially, serious infections such as pulmonary tuberculosis, fungal infections, and viral infections may occur; therefore, careful monitoring for infection is essential prior to and during treatment. If an infection occurs, the use of this drug should be stopped immediately, and appropriate treatment should be provided. Special caution is required for elderly patients aged 65 years and older or those with cardiovascular risk factors, and the administration of this drug should be decided with caution. Additionally, this drug can increase the risk of cardiovascular diseases, thrombosis, and malignancies, so patients with these histories or risk factors should consult a specialist before use. Patients with low white blood cell counts, lymphocyte counts, or hemoglobin levels should not receive this drug, and regular monitoring of blood counts is required during treatment. Dose adjustment is necessary for patients with impaired liver and kidney function, and this drug should not be used in patients with severe liver impairment. It is advisable not to combine this drug with other immunosuppressants or biologics, as such combinations may further increase the risk of infections. Women who are pregnant or may become pregnant should not use this drug, and effective contraception should be employed during treatment. Live vaccinations should be avoided while using this drug, and necessary vaccinations should be completed before commencing treatment. If any unusual symptoms such as fever, cough, shortness of breath, skin rash, swelling, or pain occur during treatment, medical personnel should be notified immediately. This drug may elevate liver enzymes and lipid levels, so regular blood tests are necessary, and appropriate actions should be taken if abnormal findings are observed. Immediate treatment should be sought if symptoms of thrombosis (e.g., leg pain, swelling, sudden shortness of breath) occur, and the use of this drug should be discontinued. This drug must be taken according to the exact dosage and administration as directed by a physician, and should not be stopped or altered arbitrarily.

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

This drug must be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle