ENBREL（etanercept solution）
ENBREL - etanercept solution
ENBREL - etanercept
Immunex Corp
ENBREL®
(etanercept)
For Subcutaneous Injection
WARNINGS
SERIOUS INFECTIONS
Patients treated with ENBREL® are at increased risk for developing serious infections that may lead to hospitalization or death (see WARNINGS and ADVERSE REACTIONS). Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
ENBREL® should be discontinued if a patient develops a serious infection or sepsis.
Reported infections include:
Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before ENBREL® use and during therapy. Treatment for latent infection should be initiated prior to ENBREL® use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
Bacterial, viral and other infections due to opportunistic pathogens.
The risks and benefits of treatment with ENBREL® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ENBREL®, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
MALIGNANCIES
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including ENBREL®.
DESCRIPTION
ENBREL® (etanercept) is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons.
ENBREL® single-use prefilled syringes are available in 25 mg (0.51 mL of a 50 mg/mL solution of etanercept) and 50 mg (0.98 mL of a 50 mg/mL solution of etanercept) dosage strengths.
ENBREL® single-use prefilled SureClick® autoinjectors are available in 50 mg (0.98 mL of a 50 mg/mL solution of etanercept).
The olution of ENBREL® is clear and colorless, sterile, preservative-free, and is formulated at pH 6.3 ± 0.2. Each ENBREL® prefilled syringe and SureClick autoinjector contains a 50 mg/mL solution of etanercept with 1% sucrose, 100 mM sodium chloride, 25mM L-arginine hydrochloride, and 25mM sodium phosphate.
ENBREL® multiple-use vials are available |
