دواعي استعمال رينفوك 15مجم 30 قرص

Upadacitinib 15 mg prolonged-release tablets, pack of 30; selective JAK inhibitor for immune-mediated inflammatory diseases.

• Moderately to severely active rheumatoid arthritis with inadequate response or intolerance to one or more TNF blockersالفئة: AdultsDailyMed (US National Library of Medicine)
• Active psoriatic arthritis with inadequate response or intolerance to one or more TNF blockersالفئة: Adults and children 2 years and older (tablet for 30 kg and greater)DailyMed (US National Library of Medicine)
• Refractory moderate to severe atopic dermatitis not adequately controlled with other systemic drugsالفئة: Adults and children 12 years and olderDailyMed (US National Library of Medicine)
• Moderately to severely active ulcerative colitisالفئة: AdultsDailyMed (US National Library of Medicine)
• Moderately to severely active Crohn's diseaseالفئة: AdultsDailyMed (US National Library of Medicine)
• Active ankylosing spondylitisالفئة: AdultsDailyMed (US National Library of Medicine)
• Active non-radiographic axial spondyloarthritis with objective signs of inflammationالفئة: AdultsDailyMed (US National Library of Medicine)
• Active polyarticular juvenile idiopathic arthritisالفئة: Patients 2 years and olderDailyMed (US National Library of Medicine)
• Giant cell arteritisالفئة: AdultsDailyMed (US National Library of Medicine)

• Common (at least 1%) in RA/PsA/AS/nr-axSpA: upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne and headache.نشرة دولية لنفس المنتج · DailyMed (US National Library of Medicine)

• Known hypersensitivity to upadacitinib or any excipient.نشرة دولية لنفس المنتج · DailyMed (US National Library of Medicine)

• Boxed warning: serious bacterial, fungal, viral and opportunistic infections including tuberculosis; test for latent TB before and during therapy and interrupt treatment for serious infection.نشرة دولية لنفس المنتج · DailyMed (US National Library of Medicine)
• Boxed warning: higher all-cause mortality, malignancies (including lymphoma and lung cancer), major adverse cardiovascular events and thrombosis observed with another JAK inhibitor versus TNF blockers in RA patients.نشرة دولية لنفس المنتج · DailyMed (US National Library of Medicine)
• Serious hypersensitivity reactions, gastrointestinal perforations, hypoglycaemia in patients with diabetes and laboratory abnormalities (neutropenia, lymphopenia, anaemia, lipid and liver-enzyme elevations).نشرة دولية لنفس المنتج · DailyMed (US National Library of Medicine)
• Embryo-fetal toxicity: use effective contraception during treatment and for 4 weeks after the last dose; avoid live vaccines.نشرة دولية لنفس المنتج · DailyMed (US National Library of Medicine)

• Strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, grapefruit)Increase upadacitinib exposure; dose adjustments apply for AD, UC and CD; avoid grapefruit.DailyMed (US National Library of Medicine)
• Strong CYP3A4 inducers (e.g. rifampin)Decrease upadacitinib exposure; coadministration not recommended.DailyMed (US National Library of Medicine)

• Human data are insufficient; animal studies showed skeletal and cardiovascular malformations, so upadacitinib may cause fetal harm.نشرة دولية لنفس المنتج · DailyMed (US National Library of Medicine)
• Breastfeeding is not recommended during treatment and for 6 days after the last dose.نشرة دولية لنفس المنتج · DailyMed (US National Library of Medicine)

• Before starting: TB, viral hepatitis, complete blood count, hepatic function and pregnancy status; avoid starting or interrupt if ALC below 500, ANC below 1000 cells/mm3 or haemoglobin below 8 g/dL; check lipids about 12 weeks after initiation.نشرة دولية لنفس المنتج · DailyMed (US National Library of Medicine)

• Inhibits JAK enzymes, preventing phosphorylation and activation of STATs; greater potency at JAK1 than JAK2/JAK3/TYK2 in cellular assays.