Etanercept, Enbrel/Biosimilars (Brenzys/Erelzi)
Description: Antirheumatic, Disease-Modifying; Selective T-Cell Costimulation Blocker
“Alert: Black Box Warning
Serious infections
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
Malignancies
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumour necrosis factor (TNF) blockers, including etanercept.”
CSA NA – FDA Approved – REMS (N) – Can Ship
How Does It Work
Etanercept, Enbrel/Biosimilars (Brenzys/Erelzi) is a recombinant DNA-derived protein composed of tumour necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. Etanercept binds tumour 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.
Indications For Use
Ankylosing spondylitis, plaque psoriasis, juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis
Precautions
Before starting Etanercept, Enbrel/Biosimilars (Brenzys/Erelzi) make sure your physician is aware of any allergies or medications you currently take, you may be at an increased risk of developing another autoimmune disorder, heart failure, cancer, and tuberculosis.
Usual Dosing
Inject 25mg to 50mg subcutaneously once to twice weekly depending on the indication.
Pharmacist Tips On Using
How to Take: Follow instructions provided by physician/pharmacy label, inject subcutaneously the thigh (preferred), abdomen (avoiding the 2-inch area around the navel), or outer areas of the 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 the 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.
Side Effects
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 Etanercept, Enbrel only common ones
Frequently Asked Questions
- What do I do if side effects are intolerable?
If side effects are causing a lot of distress speak to your physician as soon as possible to discuss options. - Why would I be given a medication that increases my risk of infections?
This medication is used for autoimmune conditions which are essential when your immune system attacks your body inappropriately as if it were a foreign body like bacteria or viruses. In order to treat this, the immune function that is damaging your body must be subdued, however, this increases the risk of other infections occurring. While on immunosuppressant medications it is important to take all infections more seriously and get them checked out by your physician to ensure that your body is fighting it effectively. - What is a biosimilar drug?
A biosimilar is a biological product that is very similar to a reference biologic and for which there are no clinically meaningful differences in terms of safety, purity, and potency. These molecules are so large, complex, and difficult to make that slight variation in lab technique from one manufacturer to another results in minor molecular differences thereby preventing them from being considered generic. They are not completely interchangeable and therefore more supporting evidence must be provided by the manufacturer in order to be approved by the FDA/Health Canada. - Why are biosimilars more affordable than their brand counterparts?
Biosimilars are considerably more affordable than their brand name counterparts because of the lower cost in manufacturing and entering the marketplace because of minimal investment in research and development.