What Is Erelzi?
How is Erelzi used to treat RA?1
Erelzi (etanercept-szzs) is a tumor necrosis factor inhibitor, also classified as a biologic disease modifying antirheumatic drug (DMARD), and is indicated for use in adults with moderate to severe RA. Erelzi can be used in addition to methotrexate. It is also indicated for other inflammation-related conditions such as Polyarticular Juvenile Idiopathic Arthritis (JIA), Ankylosing Spondylitis, Psoriatic Arthritis, and Plaque Psoriasis. For RA, Erelzi works to reduce signs and symptoms of RA, as well as improve physical function and inhibit the progression of structural damage. Erelzi is a biosimilar for Enbrel (etanercept), and was approved by the FDA in August 2016. A medication is considered a biosimilar when it has no clinically meaningful differences in effectiveness and safety to its reference product, in this case, Enbrel. However, Erelzi is not a generic for Enbrel. There is an increased risk of developing serious infections while on Erelzi, and individuals receiving the medication should report all possible signs of infection to their provider.
What are the ingredients in Erelzi?
Erelzi comes as a single-dose prefilled syringe or as a single-dose prefilled Sensoready Pen. The active ingredient in Erelzi is etanercept-szzs, the tumor necrosis factor inhibitor.
How does Erelzi work?
Erelzi’s active ingredient is a tumor necrosis factor inhibitor (TNF-inhibitor), working specifically to neutralize the tumor necrosis factor protein in the body. Conditions like RA are produced by an abnormal immune response, where the body mistakenly attacks healthy tissue, causing joint pain, stiffness, and swelling. In these instances, the body often produces a significant amount of TNF, which can help drive the inappropriate immune response. A TNF-inhibitor works to neutralize this protein product, to drive down the abnormal immune response happening in the body, thus, reducing inflammatory-related symptoms such as joint pain, swelling, and stiffness.
What are the possible side effects of Erelzi?
Multiple clinical trials evaluated the safety and efficacy of Erelzi across many different conditions. The most common side effects of Erelzi are upper respiratory infections and headache. Injection site reactions are also possible while receiving Erelzi. Alert your doctor immediately if you have any signs of reaction, including:
This is not an exhaustive list of all potential side effects of Erelzi. Talk to your healthcare provider or pharmacist for further information.
Things to note about Erelzi
Several rare but more serious side effects can accompany Erelzi including worsening of previous heart failure, and the development of liver failure, blood problems, or nervous system disorders. Alert your doctor if you experience any of the following.
- Shortness of breath, swelling of ankles or feet, sudden weight gain
- Jaundice, poor appetite, pain on the right side of your stomach, and extreme fatigue
- Fever that does not go away, very pale skin, or bruising or bleeding very easily
- Changes in your vision, numbness or tingling in body, weakness of limbs, or seizures
Erelzi weakens the immune system during treatment, and therefore, could lead to an increased risk of infection, including respiratory, skin, fungal, viral, and bacterial infection which can spread throughout the body. Alert your doctor if you have the following signs of infection, including open sores or cuts, blood in your phlegm, weight changes, muscle aches, warm or red areas on your body, chronic infections, diarrhea or stomach pain, cold sores, flu-like symptoms, cough, or fever.
There is also a risk of developing cancers or malignancies while on Erelzi, especially for children and young adults who are taking Erelzi for conditions other than RA. Follow your provider’s recommendations for regular malignancy and cancer screenings. It is not known how Erelzi affects pregnant or breastfeeding woman. It is important to tell your provider about all other medications, vitamins, and herbal supplements you take before starting Erelzi.
Before staring Erelzi talk to your provider if you:
- Think you have an infection or are being treated for an infection
- Have signs of an infection such as flu-like symptoms, cough, or fever
- Frequently get infections or have infections that keep coming back
- Have any immune system problems, diabetes, heart failure, HIV, liver failure, or a history of cancer
- Have TB or have been in close contact with someone who has TB or Chicken Pox
- Are allergic to rubber or latex, as the internal needle cover of the Sensoready Pen and the needle cap of the syringe contain latex
- Live in an area where there is an increased risk in fungal infections
- Have or have had Hepatitis B
- Are allergic to etanercept or any of the other ingredients in Erelzi
- Have recently received or are scheduled to receive a vaccine
- Are pregnant or are planning to become pregnant. It is not known if Erelzi will affect an unborn baby.
- Are breastfeeding or planning to breastfeed. It is not known if Erelzi can pass through breast milk.
Erelzi is administered subcutaneously. Your doctor will determine the appropriate dosage for you. Your first dose will typically be administered by your provider, and your provider will determine if subsequent doses can be self-administered or administered by your caregiver at home. If injections will happen at home, you or a caregiver will receive training on how to administer the medication. Detailed instructions are included in the prescribing information on how to store, prepare, and administer your medication. If you miss a dose of Erelzi, take the next dose as soon as you remember, then take your next dose at the regularly scheduled time. Do not take more doses of Erelzi than prescribed. A typical dose of Erelzi for RA is 50 mg once a week, with or without accompanying methotrexate.
- Erelzi Prescribing Information. Sandoz Inc. Aug 2016. Available from: http://www.erelzi.com/globalassets/erelzi/erelzipi.pdf