Topjact Tablet 5 mg (Tofacitinib Citrate)

Adult dose

Do not initiate treatment with this medicine in adult 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. The recommended dose of this medicine is 5 mg twice daily. Patients receiving any of 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 any of the following: -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 is above 1,000 cells/mm3, restart this medicine at 5 mg twice daily. ANC below 500 cells/mm3 Interrupt treatment Decrease in hemoglobin level of more than 2 g/dL or hemoglobin level below 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal Administer 10 mg twice daily for at least 8 weeks, then administer 5 mg or 10 mg twice daily according to treatment response. [See section ‘12. Information for Professionals’] Use the lowest effective dose for maintenance therapy. Discontinue treatment if adequate therapeutic benefit is not observed after administering this medicine at 10 mg twice daily for 16 weeks. Patients receiving any of the following medicines: -Strong CYP3A4 inhibitors (e.g., ketoconazole), or -Moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole) If receiving this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this medicine at 5 mg twice daily, reduce the dose to 5 mg once daily. Patients with any of the following: -Moderate or severe renal impairment -Moderate hepatic impairment [See section ‘5. General Precautions’] If receiving this medicine at 10 mg twice daily, reduce the dose to 5 mg twice daily. If receiving this medicine at 5 mg twice daily, reduce the dose to 5 mg once daily. ALC below 500 cells/mm3 (confirmed by repeat testing) Interrupt treatment ANC 500-1,000 cells/mm3 If this medicine was administered at 10 mg twice daily, reduce the dose to 5 mg twice daily. When the ANC is above 1,000 cells/mm3, increase the dose again to 10 mg twice daily according to clinical response. If this medicine was previously administered at 5 mg twice daily, temporarily interrupt treatment. When the ANC is above 1,000 cells/mm3, restart this medicine at 5 mg twice daily. ANC below 500 cells/mm3 Interrupt treatment Decrease in hemoglobin level of more than 2 g/dL or hemoglobin level below 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal For patients with risk factors for venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy, 10mg is not recommended for maintenance therapy, regardless of the availability of other treatment options.

This medication is associated with a high risk of serious infections; if symptoms of infection appear, treatment should be stopped immediately and appropriate therapy initiated. Before initiating treatment, latent tuberculosis screening must be performed, and appropriate therapy should be instituted if latent tuberculosis is detected. Patients aged 65 years or older or those with cardiovascular risk factors require particular caution when using this medication. This drug may increase the risk of cardiovascular mortality and thrombosis; hence, patients with relevant risks should avoid its use or should use it with careful judgment. There is a risk of malignancy; patients with a history of cancer or risk factors should consult their physician to determine whether to proceed with treatment. Pregnant women or those who may become pregnant should not take this medication. Patients with severely impaired liver or kidney function should not use this drug, and those with mild to moderate impairment may require dose adjustments. Before and during treatment, blood tests to regularly monitor lymphocytes, neutrophils, hemoglobin levels, and liver function must be conducted. As this drug suppresses immunity, live vaccinations should be avoided, and if necessary, vaccination plans should be discussed with a physician. During treatment, signs of infection, symptoms of thrombosis, liver function abnormalities, and skin changes should be monitored carefully, and any unusual symptoms should be reported to medical staff immediately. This drug poses a risk of gastrointestinal perforation, thus urgent evaluation should occur if abdominal pain or similar symptoms appear. Additional caution is warranted for the elderly, smokers, and diabetic patients when using this medication. Regular health check-ups and management as per physician’s directions are critical during the medication course.

Severe infections, pulmonary diseases, active tuberculosis, candidiasis, interstitial plasmacytic pneumonia, bacterial infections, viral infections, herpes virus infections, pneumonia, influenza, shingles, urinary tract infections, sinusitis, bronchitis, rhinitis, pharyngitis, tuberculosis, diverticulitis, pyelonephritis, soft tissue infections, herpes simplex, viral gastroenteritis, viral infections, sepsis, central nervous system tuberculosis, cryptococcal meningitis, urosepsis, disseminated tuberculosis, necrotizing fasciitis, bacteremia, staphylococcemia, Pneumocystis pneumonia, streptococcal pneumonia, bacterial pneumonia, encephalitis, atypical mycobacterial infections, Mycobacterium avium complex infections, cytomegalovirus infections, bacterial arthritis, anemia, leukopenia, lymphocytopenia, neutropenia, drug hypersensitivity reactions, hyperlipidemia, dyslipidemia, dehydration, insomnia, headache, paresthesia, hypertension, venous thromboembolism, cough, dyspnea, sinus congestion, abdominal pain, vomiting, diarrhea, nausea, gastritis, dyspepsia, fatty liver disease, rash, acne, erythema, itching, arthralgia, musculoskeletal pain, joint swelling, tendinitis, fever, peripheral edema, fatigue, increased gamma-glutamyl transferase, increased serum cholesterol, weight gain, increased serum creatine phosphokinase, elevated liver enzymes, increased aminotransferases, abnormal liver function tests, increased serum creatinine, elevated low-density lipoproteins, ligament sprain, muscle tension, facial edema, asthenia, chest discomfort, generalized edema, facial swelling, acute pyelonephritis, peritonsillar abscess, fungal sinusitis, synovitis, rheumatoid nodules, mononeuropathy, dizziness, post-herpetic neuralgia, constipation, oral ulceration, tachycardia, prostate cancer, dysuria, interstitial lung disease, wet cough, deep vein thrombosis, alopecia, dermatitis, eczema, skin disorders, weight loss, exacerbation of ulcerative colitis, gastroesophageal reflux disease, amenorrhea, atrophic vaginitis, cervical polyps, cervical inflammation, irregular menstruation, onycholysis, skin hyperpigmentation, increased appetite, essential thrombocythemia, uterine leiomyomas, pain, fractures, angioedema, urticaria, anaphylaxis, aseptic meningitis, varicella-zoster virus infection, drug-induced liver injury, liver injury, pulmonary embolism, deep venous thrombosis, arterial thrombosis, lymphoma, solid tumors, lung cancer, breast cancer, stomach cancer, rectal cancer, renal cell carcinoma, prostate cancer, malignant melanoma, Epstein-Barr virus-related post-transplant lymphoproliferative disorder

This medication must be stored in a tightly closed container to protect it from air and moisture. It is important to keep the storage temperature between 1 and 30 degrees Celsius for optimal efficacy and safe use.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle - 30 tablets/bottle