There is generally no applicable use of etanercept in children aged below 2 years in the indication juvenile idiopathic arthritis. Paediatric plaque psoriasis (age 6 years and above) The recommended dose is 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks. Treatment should be discontinued in patients who show no response after 12 weeks. If re-treatment with etanercept is indicated, the above guidance on treatment duration should be followed. The dose should be 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly. There is generally no applicable use of etanercept in children aged below 6 years in the indication plaque psoriasis.
Method of administration Erelzi is administered by subcutaneous injection (see section 6.6). Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi pre-filled syringe” or “Instructions for use of the Erelzi pre-filled pen”. Detailed instructions on unintentional dosing or scheduling variations, including missed doses, are provided in section 3 of the package leaflet. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Sepsis or risk of sepsis.
Treatment with Erelzi should not be initiated in patients with active infections, including chronic or localised infections. 4.4 Special warnings and precautions for use Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Patients should be evaluated for infections before, during, and after treatment with Erelzi, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
Serious infections, sepsis, tuberculosis, and opportunistic infections, including invasive fungal infections, listeriosis and legionellosis, have been reported with the use of etanercept (see section 4.8). These infections were due to bacteria, mycobacteria, fungi, viruses and parasites (including protozoa). In some cases, particular fungal and other opportunistic infections have not been recognised, resulting in delay of appropriate treatment and sometimes death. In evaluating patients for infections, the patient’s risk for relevant opportunistic infections (e.g., exposure to endemic mycoses) should be considered.
Patients who develop a new infection while undergoing treatment with Erelzi should be monitored closely. Administration of Erelzi should be discontinued if a patient develops a serious infection. The safety and efficacy of etanercept in patients with chronic infections have not been evaluated. Physicians should exercise caution when considering the use of Erelzi in patients with a history of recurring or chronic infections or with underlying conditions that may predispose patients to infections, such as advanced or poorly controlled diabetes. 5