Join Topa Tablet 5 Milligrams (Tofacitinib Citrate)

Adult dose

Recommended dosage for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis The recommended dosage of this drug is 5mg twice daily. Adults: 5 mg twice daily Patients receiving 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 or moderate hepatic impairment: 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 drug at 5 mg twice daily. ANC less than 500 cells/mm3: Discontinue treatment Hemoglobin level decrease of more than 2 g/dL or below 8.0 g/dL: Temporarily interrupt treatment until the hemoglobin level returns to normal Recommended dosage for ulcerative colitis Adults: 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 therapy. Discontinue treatment if an adequate therapeutic benefit is not observed after administration of 10 mg twice daily for 16 weeks. Patients receiving strong CYP3A4 inhibitors (e.g., ketoconazole), or moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (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 less than 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 again 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 less than 500 cells/mm3: Discontinue treatment Hemoglobin level decrease of more than 2 g/dL or 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 alternative treatments.

This drug modulates the immune system, therefore there is a heightened risk of serious infections occurring during its use. In particular, serious infections such as pneumonia, tuberculosis, and fungal infections may arise, and careful evaluation for infection should be conducted before and during treatment. If an infection occurs, the use of this medication should be discontinued until it is fully controlled. Additionally, this drug may increase the risk of cardiovascular diseases; thus, patients over 50 with cardiovascular risk factors like hypertension, diabetes, or a history of smoking should use it cautiously. The risk of malignant tumors, especially lymphoma or lung cancer, may increase, so patients with a history of cancer or a smoking history need special attention when using this drug. There is also a risk of thromboembolism; hence, those with a history of thrombosis or symptoms of thrombosis should consult healthcare professionals immediately. Dosage adjustments are necessary for patients with impaired liver and kidney function, and it should not be used in patients with severe liver dysfunction. Women who are pregnant or may become pregnant should not use this drug. Moreover, this drug should not be administered to patients with certain hereditary lactase deficiency. During treatment, regular blood counts, liver function tests, and lipid tests should be conducted to monitor adverse reactions. Live vaccines are not to be administered concurrently with this drug, and vaccinations should ideally be completed prior to starting treatment. This drug should not be combined with other potent immunosuppressants, and professional observation and monitoring as directed by a physician are required.

serious infections, lung disease, active tuberculosis, candidiasis, interstitial plasmacytic pneumonia, bacterial infections, viral infections, herpes virus infection, pneumonia, influenza, shingles, urinary tract infection, 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, pneumococcal pneumonia, bacterial pneumonia, encephalitis, atypical mycobacterial infections, Mycobacterium avium complex infections, cytomegalovirus infections, bacterial arthritis, non-melanoma skin cancer, anemia, leukopenia, lymphocytopenia, neutropenia, drug hypersensitivity reactions, hyperlipidemia, dyslipidemia, dehydration, insomnia, headache, paresthesia, hypertension, venous thromboembolism, cough, shortness of breath, sinus congestion, abdominal pain, vomiting, diarrhea, nausea, gastritis, dyspepsia, fatty liver, rash, acne, erythema, pruritus, arthralgia, musculoskeletal pain, joint swelling, tendinitis, fever, peripheral edema, fatigue, gamma-glutamyl transferase elevation, increased serum cholesterol, weight gain, increased serum creatine phosphokinase, increased liver enzymes, elevated aminotransferases, abnormal liver function tests, increased serum creatinine, increased low-density lipoprotein, ligament sprain, muscle tension, facial edema, asthenia, chest discomfort, generalized edema, facial swelling, acute pyelonephritis, peritonsillar abscess, fungal sinusitis, synovitis, rheumatoid nodules, mononeuritis, dizziness, postherpetic neuralgia, constipation, oral ulceration, tachycardia, prostate cancer, dysuria, interstitial lung disease, deep vein thrombosis, hair loss, dermatitis, eczema, skin disorders, weight loss, exacerbation of ulcerative colitis, gastroesophageal reflux disease, amenorrhea, atrophic vaginitis, cervical polyp, cervical inflammation, irregular menstruation, onycholysis, skin hyperpigmentation, increased appetite, essential thrombocythemia, uterine leiomyoma, pain, pulmonary embolism, deep vein thrombosis, lymphoma, solid tumors, lung cancer, breast cancer, gastric cancer, rectal cancer, renal cell carcinoma, prostate cancer, malignant melanoma, Epstein-Barr virus-associated post-transplant lymphoproliferative disorder, increased serum creatinine, increased serum creatine phosphokinase, liver damage, drug-induced liver injury, hypoglycemia, fractures, vascular edema, urticaria, anaphylaxis

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain the storage temperature between 1°C and 30°C.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle