The US FDA has approved concizumab for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. Clinical evidence In a clinical trial involving 91 adult and 42 adolescent patients with hemophilia A or B, concizumab significantly reduced annualized bleeding rates by 86% compared to the no-prophylaxis group.
Dosage and administration Subcutaneous injection to the abdomen or thigh Dosing regimen: Day 1 – Loading dose of 1 mg/kg Day 2 – Once daily dose of 0.2 mg/kg until the individualization of a maintenance dose Contraindications – Hypersensitivity to concizumab or its components or the inactive ingredients Warnings and precautions Thromboembolic events Hypersensitivity reactions Increased laboratory values of fibrin D dimer and…
