"The US Food and Drug Administration (FDA) has approved a supplemental biologics license application for use of etanercept (Enbrel, Amgen) in children aged 4 years and older with chronic moderate-to-severe plaque psoriasis who are candidate"...
SERIOUS INFECTIONS and MALIGNANCIES
Patients treated with Enbrel are at increased risk for developing serious infections that may lead to hospitalization or death [see WARNINGS AND PRECAUTIONS 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, including Legionella and Listeria.
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.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Enbrel.
Enbrel (etanercept), a tumor necrosis factor (TNF) blocker, 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 (etanercept) Injection in the single-dose prefilled syringe and the single-dose prefilled SureClick autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.
Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3.
Table 5. Contents of Enbrel
|Presentation||Active Ingredient Content||Inactive Ingredients Content|
|Enbrel 50 mg prefilled syringe and SureClick autoinjector||0.98 mL of a 50 mg/mL solution of etanercept||25 mM L-arginine hydrochloride
100 mM sodium chloride
25 mM sodium phosphate
|Enbrel 25 mg prefilled syringe||0.51 mL of a 25 mg/0.5 mL solution of etanercept||25 mM L-arginine hydrochloride
100 mM sodium chloride
25 mM sodium phosphate
|Enbrel 25 mg multiple-dose vial||After reconstitution, 25 mg etanercept in 1 mL||40 mg mannitol
10 mg sucrose
1.2 mg tromethamine
What are the possible side effects of etanercept (Enbrel, Enbrel Prefilled Syringe, Enbrel SureClick)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using etanercept and call your doctor right away if you have any of these symptoms of lymphoma:
- fever, night sweats, weight loss, tiredness;
- feeling full after eating only a small amount;
- pain in your upper stomach that may spread to your shoulder;
- easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid...
What are the precautions when taking etanercept (Enbrel)?
Before using etanercept, tell your doctor or pharmacist if you are allergic to it; or to latex or natural dry rubber (found in the prefilled syringes or pen injectors); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: active or recurrent infection (such as hepatitis B, HIV, tuberculosis), blood disorders (such as leukemia, anemia), weakened bone marrow, history of cancer (such as lymphoma), diabetes, heart failure, seizures, nervous system problems (such as multiple sclerosis), a certain liver problem (alcoholic hepatitis), blood vessel disorders (such as...
Last reviewed on RxList: 11/18/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Enbrel Information
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