Erelzi

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.

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

Common side effects of Erelzi include the following:

• upper respiratory tract infections (sinus infections)
• injection site reactions (itching, redness, swelling, or pain)
• headache

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.

 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 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 

• 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.