Nepexto

Nepexto treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.

Patients treated with Nepexto should be given the Patient Card. Nepexto is available in strengths of 25 and 50 mg. 4 Posology Rheumatoid arthritis 25 mg etanercept administered twice weekly is the recommended dose. 1). Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis The recommended dose is 25 mg etanercept administered twice weekly, or 50 mg administered once weekly.

For all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period.

Plaque psoriasis The recommended dose of etanercept is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or a dose of 50 mg once weekly.

Treatment with Nepexto should continue until remission is achieved, for up to 24 weeks. 1). Treatment should be discontinued in patients who show no response after 12 weeks. If re-treatment with Nepexto is indicated, the same guidance on treatment duration should be followed.

The dose should be 25 mg twice weekly or 50 mg once weekly. Special populations Renal and hepatic impairment No dose adjustment is required. Elderly No dose adjustment is required. Posology and administration are the same as for adults 18-64 years of age.

Paediatric population Nepexto is only available as 25 mg pre-filled syringe, 50 mg pre-filled syringe and 50 mg pre-filled pen. Thus, it is not possible to administer Nepexto to paediatric patients that require less than a full 25 mg or 50 mg dose.

Paediatric patients who require a dose other than a full 25 mg or 50 mg should not receive Nepexto. If an alternate dose is required, other etanercept products offering such an option should be used. The dosage of etanercept is based on body weight for paediatric patients.

Summary of the safety profile The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), headache, allergic reactions, development of autoantibodies, itching, and fever.

Serious adverse reactions have also been reported for etanercept. TNF-antagonists, such as etanercept, affect the immune system and their use may affect the body’s defenses against infection and cancer. Serious infections affect fewer than 1 in 100 patients treated with etanercept.

Reports have included fatal and life-threatening infections and sepsis. Various malignancies have also been reported with use of etanercept, including cancers of the breast, lung, skin and lymph glands (lymphoma). Serious haematological, neurological and autoimmune reactions have also been reported.

These include rare reports of pancytopenia and very rare reports of aplastic anaemia. Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with etanercept use. There have been rare reports of lupus, lupus-related conditions, and vasculitis.

12 Tabulated list of adverse reactions The following list of adverse reactions is based on experience from clinical trials in adults and on post -marketing experience. Within each System Organ Class, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

4) Respiratory, thoracic, and mediastinal disorders Interstitial lung disease (including pneumonitis and pulmonary fibrosis)* Gastrointestinal disorders Inflammatory bowel disease Hepatobiliary disorders Elevated liver enzymes* Autoimmune hepatitis* Skin and subcutaneous tissue disorders Pruritus, rash Angioedema, psoriasis (including new onset or worsening and pustular, primarily palms and soles), urticaria, psoriasiform rash Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions Toxic epidermal necrolysis Musculoskeletal and connective tissue disorders Cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus, lupus-like syndrome 14 System Organ Class Very Common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Very Rare <1/10,000 Not Known (Cannot be Estimated from Available Data) Renal and urinary disorders Glomerulonephritis General disorders and administration site conditions Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)* Pyrexia * see Description of selected adverse reactions, below.

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 Nepexto, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).

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.

, exposure to endemic mycoses) should be considered. Patients who develop a new infection while undergoing treatment with Nepexto should be monitored closely. Administration of Nepexto 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 Nepexto 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.

Tuberculosis Cases of active tuberculosis, including miliary tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with etanercept. Before starting treatment with Nepexto, all patients must be evaluated for both active and inactive (‘latent’) tuberculosis.

This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy. , tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).

1. Sepsis or risk of sepsis. Treatment with Nepexto should not be initiated in patients with active infections, including chronic or localised infections.