Piestopacitinib 10 mg Tablets (Topacitilib Citrate)

Adult dose

Do not initiate treatment with this drug 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. Temporary interruption of treatment with this drug may be necessary to manage lymphopenia, neutropenia, and anemia. This drug may be administered orally with or without food. 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 adequate therapeutic benefit is not observed after administering this drug at 10 mg twice daily for 16 weeks. Patients receiving the following drugs: • 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. In the following patients: • Patients with moderate or severe renal impairment • Patients with moderate hepatic impairment* [See section 5. General precautions] 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 below 500 cells/mm3 (confirmed by repeat testing) Interrupt 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 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 below 500 cells/mm3 Interrupt treatment Hemoglobin level decreases by more than 2 g/dL or is below 8.0 g/dL Temporarily interrupt treatment until the hemoglobin level returns to normal. A maintenance dose of 10 mg is not recommended in patients with risk factors for venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy, regardless of the availability of alternative therapies.

This medication presents a high risk of serious infections; if symptoms of infection appear, treatment should be stopped immediately and appropriate therapy should be initiated. Testing for latent tuberculosis should be performed before and during treatment, and treatment must be conducted if latent tuberculosis is detected. Patients over 65 years of age or those with cardiovascular risk factors should use this medication with caution, and especially, dosing 10 mg twice daily may be restricted for certain patients. There is a risk of malignancy and lymphoma, so patients with a history of cancer or smoking should be cautious. There is a potential for thrombosis, thus if symptoms of thrombosis occur, use of the medication should be stopped immediately and a medical consultation should be sought. This medication is not indicated for patients with certain infections, liver dysfunction, low blood counts, or pregnant women. Patients at high risk for infections or the elderly, diabetic patients, etc., should be carefully evaluated before use. During treatment, regular monitoring for infections, blood tests, liver function, and lipid levels is necessary, and any abnormal symptoms should be reported to healthcare professionals immediately. Live vaccines should not be administered alongside this medication, and it is advisable to complete the latest vaccinations before use. Pregnant women or those who may become pregnant should not take this medication, and effective contraception should be practiced during and for a period after treatment. Breastfeeding women are also advised to discontinue nursing while taking this medication. This medication should not be combined with other immunosuppressants or biological agents and should be discussed with a physician due to potential drug interactions. There are no specific antidotes for overdose, so immediate medical attention should be sought to receive appropriate treatment. This medication should be stored out of reach of children and should not be transferred to another container for safety.

Severe infections, active tuberculosis with pulmonary disease or other diseases outside the lung, candidiasis, interstitial plasma cell pneumonia, bacterial infections, viral infections, herpes virus infections, pneumonia, influenza, herpes zoster, urinary tract infections, sinusitis, bronchitis, rhinitis, pharyngitis, tuberculosis, diverticulitis, pyelonephritis, soft tissue infections, herpes simplex, viral gastroenteritis, sepsis, central nervous system tuberculosis, cryptococcal meningitis, urinary sepsis, disseminated tuberculosis, necrotizing fasciitis, bacteremia, staphylococcal bacteremia, 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, sensory abnormalities, hypertension, venous thromboembolism, cough, dyspnea, 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, increased gamma-glutamyl transferase, elevated blood cholesterol, weight gain, increased blood creatine phosphokinase, increased liver enzymes, elevated aminotransferases, abnormal liver function tests, increased blood creatinine, increased low-density lipoprotein, ligament sprain, muscle tension, exacerbation of ulcerative colitis, gastroesophageal reflux disease, amenorrhea, atrophic vaginitis, cervical polyps, cervical inflammation, irregular menstruation, onycholysis, skin hyperpigmentation, increased appetite, essential thrombocythemia, uterine leiomyoma, ineffective medications, fractures, angioedema, urticaria, anaphylaxis, hypoglycemia

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

Appearance

Blue round film-coated tablet

Package unit

30 tablets/bottle