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Drug Notebook

Generic Name: etanercept

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Enbrel, Enbrel Prefilled Syringe, Enbrel SureClick
An antirheumatic - It is used for the treatment of rheumatoid arthritis in adults and children
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FDA Alerts

Special Alerts:

[Posted 09/04/2008] FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses. For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the pathogen(s) are identified. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF2, http://www.fda.gov/cder/drug/InfoSheets/HCP/TNF_blockersHCP.htm and http://www.fda.gov/bbs/topics/NEWS/2008/NEW01879.html.

[Posted 06/03/2008] FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF and http://www.fda.gov/cder/drug/early_comm/TNF_blockers.htm.

[Posted 05/01/2008] Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for etanercept (Enbrel). The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with etanercept. Infections have included bacterial sepsis and tuberculosis. The ADVERSE REACTIONS section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with etanercept. Healthcare professionals should screen patients for latent tuberculosis infection before beginning etanercept. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, etanercept should be discontinued. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Enbrel, http://www.fda.gov/medwatch/safety/2008/AmgenDearHCPLetter.pdf and http://www.fda.gov/medwatch/safety/2008/enbrel_pi.pdf.

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etanercept
(et a NER sept)
What is this medicine?What is the price of this medication and similar alternatives?What side effects may I notice from receiving this medicine?How should I use this medicine?What if I miss a dose?What may interact with this medicine?Who should NOT use this medication?What should I watch for while using this medicine?What should I tell my health care provider before I take this medicine?Can I stop taking the medication if I feel better?I am on so many medications; do I have to take them all?Where can I get more information?

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.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Enbrel 25MG Kit AMGEN4/$839.81 or 8/$1630.3

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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

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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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.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

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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.

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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

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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Who should NOT use this medication?

  • Known hypersensitivity to etanercept or any ingredient in the formulation.
  • Sepsis.

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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.

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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

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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