Erelzi

Erelzi is a prescription medication used to treat inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Erelzi is also used to treat juvenile idiopathic arthritis.

Erelzi belongs to a group of drugs called tumor necrosis factor-alpha inhibitors. These work by blocking the action of a substance in the body that causes inflammation.

This medication is available as a prefilled syringe and pen and are injected under the skin (subcutaneously), usually once or twice a week. 

Common side effects are upper respiratory tract infections, injection site reactions, and headache.

Erelzi is a prescription medication used to treat:

• moderate to severe active rheumatoid arthritis (can be given with methotrexate)
• ankylosing spondylitis (arthritis of the spine)
• psoriatic arthritis (can be given with methotrexate)
• chronic moderate to severe plaque psoriasis in adults 
• polyarticular juvenile idiopathic arthritis (JIA) in patients aged 2 years or older

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Sandoz Inc.

Serious side effects have been reported with Erelzi. See the “Erelzi Precautions” section.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medicines called biologics that are used to treat the same conditions as Erelzi.

Especially tell your doctor if you take any of the following:

• Kineret (anakinra)
• Orencia (abatacept)
• Cytoxan (cyclophosphamide)
• Anti-diabetic medications

Live vaccines should not be given with Erelzi. Tell your doctor is you are planning on receiving any of the following vaccines:

• chicken pox vaccine (Varicella)
• measles, mumps, rubella vaccine (MMR)
• oral polio vaccine
• yellow fever vaccine
• smallpox vaccine
• shingles vaccine (Zostavax)
• rotavirus vaccine
• BCG vaccine

This is not a complete list of Erelzi drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Erelzi including the following: 

• Infections. Since Erelzi affects your immune system, it can lower the ability for your body to fight infections. Serious infections may include tuberculosis (TB) and infections caused by viruses, fungi or bacteria. You will be tested for TB before you start receiving Erelzi. In addition, your doctor should monitor you for signs and symptoms of TB throughout your treatment even if you tested negative for TB. Tell your doctor right away if you notice any signs or symptoms of an infection such as:
  • flu-like symptoms
  • fever
  • fatigue
• Nervous System Disorders. Tell your doctor if you develop:
  • weakness in your arms or legs
  • numbness or tingling in any part of your body
  • vision changes
  • dizziness
• Increased cancer risk. There have been cases of unusual cancers in children and teenage patients who started using TNF-blocking agents at less than 18 years of age. People with rheumatoid arthritis or psoriasis, especially those with very active disease, may be more likely to get lymphoma.  Speak with your doctor if you have ever had any type of cancer.
• Heart Failure. New or worse heart failure can happen in people who use TNF-blocker medicines like Erelzi. Your doctor will monitor you closely. Call your doctor right away if you notice:
  • shortness of breath
  • swelling of ankles or feet
• Blood problems. While on Erelzi, your body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you develop:
  • a fever 
  • bruise or bleed very easily
  • begin looking pale
• Previous Hepatitis B Infection. Patients previously infected with hepatitis B virus are at higher risk for reactivation during and several months after therapy. If reactivation occurs, your doctor may consider stopping Erelzi and beginning anti-viral therapy.
• Lupus-Like Syndrome. Tell your doctor if you notice any of the following signs and symptoms:
  • rash on your face and arms that gets worse in the sun
  • fatigue
  • joint pain
• Autoimmune Hepatitis. Tell your doctor if you notice any of the following signs and symptoms:
  • stomach discomfort
  • fatigue
  • skin or eyes that look yellow
  • vomiting
• Allergic reactions. Some patients have had allergic reactions to this medication. In some cases, these reactions were severe. These reactions can occur during administration of Erelzi or even shortly afterward administration. Your doctor may need to stop or pause your treatment. Your doctor may also have to give you medicines to treat the allergic reaction. Signs of an allergic reaction include:
  • difficulty breathing
  • severe rash
  • swollen face
• Psoriasis. Some people using etanercept products developed new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that may be filled with pus. Your doctor may decide to stop your treatment with Erelzi. 
• Latex allergy. The needle cap of the prefilled syringe and the internal needle cover within the cap of the Sensoready Pen contain latex. Tell your doctor if you have a latex allergy.

Do not receive or administer Erelzi if you are allergic to Erelzi or to any of this medication’s ingredients. 

Do not receive or administer Erelzi if you have an infection that has spread through your body (sepsis). 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Erelzi, there are no specific foods that you must exclude from your diet when receiving this medication.

 Before starting Erelzi, tell your doctor about all of your medical conditions, including:

• Infections. Tell your doctor if you:
  • have an infection
  • are being treated for an infection
  • think you have an infection
  • have symptoms of an infection such as
    • fever
    • sweats or chills
    • cough or flu-like symptoms
    • shortness of breath
    • blood in your phlegm
    • weight loss
    • muscle aches
    • warm red or painful areas on your skin
    • sores on your body
    • diarrhea or stomach pain
    • burning when you urinate or urinating more often than normal
    • feel very tired
  • have any open cuts on your body.
  • have or have had hepatitis B. 
  • get a lot of infections or have infections that keep coming back.
  • have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
  • have TB, or have been in close contact with someone with TB.
  • were born in, lived in, or traveled to countries where there is a risk for getting TB. Ask your doctor if you are not sure.
  • live, have lived in, or traveled to certain parts of the country (such as the Ohio and Mississippi River valleys, or the Southwest) where there is a greater risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). 

Other important medical information you should tell your doctor BEFORE starting ERELZI, includes if you:

• have or had a nervous system problem such as multiple sclerosis or Guillain-Barré syndrome.
• have or had heart failure.
• are scheduled to have surgery.
• have recently received or are scheduled to receive a vaccine.
• are allergic to rubber or latex.
• have been around someone with varicella zoster (chicken pox).
• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are limited studies that have been done in humans with Erelzi. In animal studies, pregnant animals were given this medication, and revealed no evidence of harm to the babies due to etanercept. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed. 

There are limited studies that have been done in humans while breastfeeding. Some data shows that etanercept is present in low levels in human milk and minimally absorbed by a breastfed infant. There are no data on the effects on the breastfed infant, or the effects on milk production.

Many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if you will stop nursing or stop the medication. 

Receive this medication exactly as prescribed. Do not use Erelzi more often than as directed by your doctor.

• Erelzi is given as an injection under the skin (subcutaneous), usually once or twice a week.
• Erelzi is available as single use prefilled syringes or prefilled pens. 
• If your doctor decides that you or a caregiver can give the injections of Erelzi at home, you or your caregiver should receive training on the right way to prepare and inject Erelzi. Do not try to inject Erelzi until you have been shown the right way by your doctor or nurse.

Your doctor will tell you how often you should use this medication.

Do not miss any doses of Erelzi. If you forget a dose of Erelzi, inject your dose as soon as you remember. Then, take your next dose at your regular(ly) scheduled time.

In the case you are not sure when to inject Erelzi, call your doctor or pharmacist.

Administer Erelzi exactly as prescribed. Your doctor may administer Erelzi at the doctor's office or you may be instructed to take Erelzi at home. 

The recommended dose of Erelzi for each of the indications are:

Rheumatoid Arthritis and Psoriatic Arthritis: 50 mg once weekly with or without methotrexate (MTX) 

Ankylosing Spondylitis: 50 mg once weekly  

Adult Plaque Psoriasis: 50 mg twice weekly for 3 months, followed by 50 mg once weekly

Juvenile Idiopathic Arthritis (patients who weigh >63 kg) : 0.8 mg/kg weekly, with a maximum of 50 mg per week 

If Erelzi is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

If Erelzi is taken at home and you take too much Erelzi, call your doctor or local Poison Control Center right away.

• Store Erelzi in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • If needed, you may store the Erelzi syringe or pen, at room temperature between 68°F to 77°F (20°C to 25°C) for up to 28 days
  • Once the medication has reached room temperature, do not put it back into the refrigerator.
• Throw away Erelzi that has been stored at room temperature after 28 days. 
• Do not use Erelzi if the expiration date on the carton or barrel label of the prefilled syringe or pen has passed
• Do not freeze.
• Do not shake.
• Store Erelzi in the original carton to protect from light or physical damage. 
• Keep Erelzi and all medicines out of the reach of children.

WARNINGS:

SERIOUS INFECTIONS

• Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. 
• Erelzi should be discontinued if a patient develops a serious infection or sepsis during treatment. 
• Perform test for latent TB; if positive, start treatment for TB prior to starting ERELZI. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. 

MALIGNANCIES

• Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including etanercept products.