سعر امجيفيتا 40 مجم 0.8 مل 2 سرنجة 2024

Amgevita (adalimumab biosimilar, Amgen) 40 mg/0.8 mL solution for subcutaneous injection, pack of 2 pre-filled syringes; a TNF-alpha inhibitor used for rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis.

• Moderate to severe active rheumatoid arthritis (with methotrexate or as monotherapy)Population: AdultsEuropean Medicines Agency (EMA)
• Polyarticular juvenile idiopathic arthritisPopulation: Patients from 2 yearsEuropean Medicines Agency (EMA)
• Enthesitis-related arthritisPopulation: Patients from 6 yearsEuropean Medicines Agency (EMA)

• Most commonly reported: infections (e.g. nasopharyngitis, upper respiratory tract infection, sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.International label, same product · European Medicines Agency (EMA)

• Hypersensitivity to adalimumab or to any of the excipients.International label, same product · European Medicines Agency (EMA)
• Active tuberculosis or other severe infections such as sepsis and opportunistic infections.International label, same product · European Medicines Agency (EMA)
• Moderate to severe heart failure (NYHA class III/IV).International label, same product · European Medicines Agency (EMA)

• Boxed warning (US): increased risk of serious infections leading to hospitalisation or death, including tuberculosis, bacterial sepsis, invasive fungal and opportunistic infections; test for latent TB before starting and monitor for active TB during treatment; discontinue if a serious infection or sepsis develops.International label, same formulation · DailyMed (U.S. National Library of Medicine)
• Boxed warning (US): lymphoma and other malignancies, some fatal, in children and adolescents treated with TNF blockers; hepatosplenic T-cell lymphoma in adolescents and young adults with inflammatory bowel disease.International label, same formulation · DailyMed (U.S. National Library of Medicine)
• Serious infections including tuberculosis: screen all patients for active and latent TB before starting; do not start in active infection; monitor closely for infections during and after treatment.International label, same product · European Medicines Agency (EMA)

• Anakinra; abataceptIncreased risk of serious infections without added clinical benefit; combination not recommended.European Medicines Agency (EMA)
• Live vaccinesAvoid live vaccines during treatment.DailyMed (U.S. National Library of Medicine)
• MethotrexateMethotrexate reduces the apparent clearance of adalimumab, but no dose adjustment of either drug is needed.DailyMed (U.S. National Library of Medicine)

• Prospectively collected data from about 2,100 adalimumab-exposed pregnancies showed no increased rate of malformations; use in pregnancy only if clearly needed. Women of childbearing potential should consider adequate contraception for at least 5 months after the last dose.International label, same product · European Medicines Agency (EMA)
• Adalimumab is excreted in breast milk at very low concentrations (0.1-1% of maternal serum levels) and is poorly absorbed orally; it can be used during breastfeeding.International label, same product · European Medicines Agency (EMA)

• Adalimumab: Binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell-surface TNF receptors; also modulates TNF-induced biological responses such as adhesion-molecule levels (US label).