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Etanercept (Hamster) Solution for injection

It is used for the treatment of rheumatoid arthritis in adults and children

Generic Name: etanercept

Brand Names: Enbrel, Enbrel Prefilled Syringe, Enbrel SureClick

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 09/07/2011] ISSUE: FDA notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNF) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning and Warnings and Precautions sections of the labels for all of the TNF blockers have been revised so that they contain consistent information about the risk for serious infections and the associated disease-causing pathogens.

Patients treated with TNF blockers are at increased risk for developing serious infections involving multiple organ systems and sites that may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens.

BACKGROUND: The class of TNF blockers are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis.

RECOMMENDATION: The risks and the benefits of TNF blockers should be considered prior to initiating therapy in patients with chronic or recurrent infection and patients with underlying conditions that may predispose them to infection. See the Drug Safety Communication for a listing of recommendations for healthcare professionals and patients, as well as a data summary. For more information visit the FDA website at: [Web] and [Web].

[Posted 04/14/2011] ISSUE: FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factors (TNF) blockers, as well as with azathioprine, and/or mercaptopurine. TNF blockers include infliximab (Remicade), etancercept (Enbrel), adalimumab (Humira), certolizumab pegol (Cimzia) and golimumab (Simponi).

BACKGROUND: HSTCL is an aggressive (fast-growing) cancer and is usually fatal. The majority of cases reported were in patients being treated for Crohn’s disease or ulcerative colitis, but also included a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis. FDA is now updating the number of reported cases of HSTCL.

Although most reported cases of HSTCL occurred in patients treated with a combination of medicines known to suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine, there have been cases reported in patients receiving azathioprine or mercaptopurine alone.

  • Educate patients and caregivers about the signs and symptoms of malignancies such as HSTCL so that they are aware of and can seek evaluation and treatment of any signs or symptoms. These may include splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, and weight loss.
  • Monitor for the emergence of malignancies when a patient has been treated with TNF blockers, azathioprine, and/or mercaptopurine.
  • Know that people with rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis may be more likely to develop lymphoma than the general U.S. population. Therefore, it may be difficult to measure the added risk of TNF blockers, azathioprine, and/or meracaptopurine.

Read the Drug Safety Communications for other specific recommendations for Healthcare Professionals and Patients and the Data Summary for additional information. For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for etanercept to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

ETANERCEPT (et a NER sept) is used for the treatment of rheumatoid arthritis in adults and children. The medicine is also used to treat psoriatic arthritis, ankylosing spondylitis, and psoriasis.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • blood disorders
  • cancer
  • congestive heart failure
  • diabetes
  • exposure to chickenpox
  • immune system problems
  • infection
  • multiple sclerosis
  • seizure disorder
  • tuberculosis, a positive skin test for tuberculosis or have recently been in close contact with someone who has tuberculosis
  • Wegener's granulomatosis
  • an unusual or allergic reaction to etanercept, latex, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

The medicine is given by injection under the skin. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 4 years of age for selected conditions, precautions do apply.

What if I miss a dose?

If you miss a dose, contact your health care professional to find out when you should take your next dose. Do not take double or extra doses without advice.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • anakinra

This medicine may also interact with the following medications:

  • cyclophosphamide
  • sulfasalazine
  • vaccines

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You will be tested for tuberculosis (TB) before you start this medicine. If your doctor prescribes any medicine for TB, you should start taking the TB medicine before starting this medicine. Make sure to finish the full course of TB medicine.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • changes in vision
  • fever, chills or any other sign of infection
  • numbness or tingling in legs or other parts of the body
  • red, scaly patches or raised bumps on the skin
  • shortness of breath or difficulty breathing
  • swollen lymph nodes in the neck, underarm, or groin areas
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual swelling or fluid retention in the legs
  • unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • dizziness
  • headache
  • nausea
  • redness, itching, or swelling at the injection site
  • vomiting


Last Updated: June 24, 2013
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