UPADA
UPADACITINIB · by SEARLE
Composition
Tab 15 mg: Upadacitinib 15 mg
Indications & Dosage
Rheumatoid arthritis, Psoriatic arthritis (specialist use only): Adult: 15 mg once daily, consider discontinuation of treatment if no response after 12 weeks. Ankylosing spondylitis, Non-radiographic axial spondyloarthritis (specialist use only): Adult: 15 mg once daily, consider discontinuation of treatment if no response after 16 weeks. Atopic eczema (specialist use only): Adult: 15 mg once daily, consider discontinuation of treatment if no response after 12 weeks, alternatively 30 mg once daily, consider discontinuation of treatment if no response after 12 weeks. Ulcerative colitis (specialist use only): Adult: Initially 45 mg once daily for 8 weeks, can be extended for an additional 8 weeks if an adequate therapeutic response is not achieved after 8 weeks, discontinue treatment if no response after 16 weeks. Maintenance: 15–30 mg once daily.
Contraindications
Absolute lymphocyte count less than 0.5x109 cells/litre. absolute neutrophil count less than 1x109 cells/litre. active serious infection including localised infection. active tuberculosis. haemoglobin less than 8 g/dL.
Precautions
Elderly; 65 years and over, chronic or recurrent infection, diverticular disease, history of serious or opportunistic infection, known malignancy, patients at high risk for deep-vein thrombosis or pulmonary embolism, risk of viral reactivation, tuberculosis exposure. Avoid in severe hepatic impairment. Caution in renal severe impairment; reduce dose in severe impairment. Evaluated for tuberculosis and viral hepatitis before treatment. Monitor for signs and symptoms of infection during and after treatment. Periodic skin examination in patients at increased risk of skin cancer. Monitor neutrophils, lymphocytes, and haemoglobin before and during treatment. Monitor hepatic transaminases before starting treatment. Monitor lipids 12 weeks after starting treatment, and then as clinically indicated.
Interactions
: CYP3A4 inhibitors, CYP2C19 inhibitor, BCG, Natalizumab, Tacrolimus, Leflunomide, Pimecrolimus, Roflumilast, Denosumab, Dasatinib, Ivacaftor, Sitaxsentan, Mifepristone, Fluconazole.
Pregnancy
Avoid
Lactation
Avoid
Side Effects
Abdominal pain, anaemia, cough, dyslipidaemia, fatigue, fever, headache, increased risk of infection, lymphopenia, nausea, neutropenia, skin reactions, weight increased deep vein thrombosis (discontinue), malignancy, meningitis bacterial, non-melanoma skin cancer, pulmonary embolism (discontinue), reactivation of infections. venous thromboembolism (discontinue).