ENBREL/BRENZYS/ERELZI (Etanercept) - Ships From USA

What is this medication?

ENBREL/BRENZYS/ERELZI (Etanercept)
Antirheumatic, Disease Modifying; Selective T-Cell Costimulation Blocker

ENBREL and biosimilars BRENZYS, and ERELZI are indicated for reducing signs and symptoms and stopping the progression of structural damage associated with rheumatoid arthritis, active polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

ALERT: WARNING
Patients treated with etanercept are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients treated with etanercept who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. Discontinue etanercept if a patient develops a serious infection or sepsis.  Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including etanercept.

What is a biosimilar biologic drug?

Manufacturers have found cost-efficient ways to recreate the molecules used in the original or “reference” biologic drug.  Biosimilars are highly “similar” to a reference biological drug despite differing in their chemical composition.  

The FDA approval of biosimilar drugs is based on a totality of evidence which is used by regulators in the approval of reference and biological drugs.  The FDA uses the same approach in evaluating biosimilars to confirm that there are no clinically meaningful differences in safety and efficacy between the reference biologic drug and the biosimilar.  The rigorous standard for authorization means that you can have confidence knowing that the quality, safety, and efficacy of a biosimilar is the same as any other biologic drug.

ENBREL is a biologic
BRENZYS is a biosimilar to ENBREL (Etanercept)
ERELZI is a biosimilar to ENBREL (Etanercept)

What are the ingredients in this medication?

ENBREL
Medicinal ingredient:
Etanercept
Non-medicinal ingredients:
L-arginine hydrochloride, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and sucrose. Preservative-free.

BRENZYS
Medicinal ingredient: 
Etanercept
Non-medicinal ingredients: 
Sodium chloride, sodium phosphate and sucrose.

ERELZI
Medicinal ingredient:
Etanercept
Non-medicinal ingredients:
Citric acid, L-lysine hydrochloride, sodium chloride, sodium citrate and sucrose.

How does this medication work? 

ENBREL/BRENZYS/ERELZI (Etanercept) is a recombinant DNA-derived protein composed of tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1.  Etanercept binds tumor necrosis factor (TNF) which is an inflammatory cytokine and subsequently blocks its interaction with cell surface receptors.  The suppression of TNF stops the inflammatory cascade and resulting joint and skin pathology that occurs in immune mediated arthritis and psoriasis.

How should I take this medication? 

SQ: Inject 25mg to 50mg subcutaneously once to twice weekly depending on indication.

How to Take: Follow instructions provided by physician/pharmacy label, inject subcutaneously to the thigh (preferred), abdomen (avoiding the 2-inch area around the navel), or outer areas of upper arm. New injections should be given at least 1 inch from an old site and never into areas where the skin is tender, bruised, red, or hard; any raised thick, red, or scaly skin patches or lesions; or areas with scars or stretch marks. For a more comfortable injection, allow autoinjectors, prefilled syringes, and dose trays to reach room temperature for 15 to 30 minutes (≥30 minutes for autoinjector) prior to injection; do not remove the needle cover while allowing product to reach room temperature. There may be small white particles of protein in the solution; this is not unusual for proteinaceous solutions.

Note: If the health care provider determines that it is appropriate, patients may self-inject after proper training in injection technique.

What should I watch for while using this medication? 

Before starting ENBREL/BRENZYS/ERELZI (Etanercept) make sure your physician is aware of any allergies or medications you currently take.  Etanercept will increase the risk of developing a serious infection that may lead to hospitalization or death. Reported infections have included active tuberculosis, including reactivation of latent tuberculosis. Additionally, invasive fungal infections such as histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis have been associated with using etanercept.  Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria have also been reported.  The risks and benefits of treatment with etanercept should be carefully considered prior to initiating therapy.  Closely monitor for signs and symptoms of infection during and after treatment with etanercept, including the possible development of tuberculosis should be done prior to treatment.  Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including etanercept.

What size needle does this medication use?

ENBREL
Prefilled syringe: 27-gauge, ½ inch needle
Autoinjector: 27-gauge, ½ inch needle

BRENZYS
Prefilled syringe: 27-gauge, ½ inch needle
Autoinjector: 27-gauge, ½ inch needle

ERELZI
Prefilled syringe: 27-gauge, ½ inch needle
Autoinjector: 27-gauge, ½ inch needle

What is the difference between a prefilled syringe and an autoinjector?

Both an autoinjector device and prefilled syringe are comparable with respect to ease of use, tolerability, and efficacy.  However the addition of an autoinjector to deliver a prefilled syringe can enhance patient safety.

What if I miss a dose?

If you miss a dose, take it as soon as you remember. However, if it’s almost time for your next dose, just skip the missed dose and give yourself your next injection at its regular time. You shouldn’t give yourself two injections at once to make up for a missed dose. This can raise your risk for serious side effects.

How should I store this medication?

ENBREL/BRENZYS/ERELZI (Etanercept) should be kept cool, between 36°F and 46°F (2°C and 8°C). However, Etanercept can also be stored at room temperature between 68°F and 77°F (20°C and 25°C) for up to 14 days. Once the medication has reached room temperature, do not put it back in the refrigerator. Throw away any medication that has been stored at room temperature after 14 days.

What are the possible side effects of using this medication?

Local injection site irritation, skin rash, diarrhea, positive ANA titer, antibody formation, infection, upper respiratory tract infections.

Note this is not a complete list of side effects for ENBREL/BRENZYS/ERELZI (Etanercept), only common ones.