Etanercept Injection: MedlinePlus Drug Information

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Other drug names:	A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Etanercept Injection

(et a ner' set)

Contents of this page:
Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow? What should I do if I forget a dose?	What side effects can this medication cause? What storage conditions are needed for this medicine? In case of emergency/overdose What other information should I know? Brand names

IMPORTANT WARNING: Return to top

[UPDATED 08/31/2009] Supplemental Q&As added

[Posted 08/04/2009] FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia. FDA is also requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy.

TNF blockers are approved for the treatment of one or more of a number of immune system diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis.

[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, dyspnea, 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/Safety/MedWatch, http://www.fda.gov/Drugs and http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements.

IMPORTANT WARNING: Return to top

Etanercept injection may decrease your ability to fight infection and increase the risk that you will get a serious or life-threatening infection including sepsis (infection that affects the entire body). Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores) and chronic infections that do not go away. Also tell your doctor if you have diabetes or any condition that affects your immune system or if you are taking medications that slow the activity of the immune system such as abatacept (Orencia), anakinra (Kineret), azathioprine (Imuran) cancer chemotherapy medications, cyclophosphamide (Cytoxan), cyclosporine (Neoral, Sandimmune), oral corticosteroids, 6-mercaptopurine (Purinethol), methotrexate (Rheumatrex), sirolimus (Rapamune), sulfasalazine (Azulfidine), and tacrolimus (Prograf). If you experience any of the following symptoms during or shortly after your treatment with etanercept, call your doctor immediately: sore throat; cough; fever; extreme tiredness; flu-like symptoms; warm, red, or painful skin; or other signs of infection.

Using etanercept injection increases the risk that you will develop tuberculosis (TB; a serious lung infection), especially if you are already infected with tuberculosis but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. Your doctor will perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medication to treat this infection before you start using etanercept. Your doctor will monitor you for signs of TB during your treatment even if you did not have an inactive infection before you began to use etanercept.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with etanercept injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using etanercept injection.

Why is this medication prescribed? Return to top

Etanercept is used to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including:

rheumatoid arthritis (condition in which the body attacks its own joints, causing pain, swelling, and loss of function) alone or in combination with methotrexate (Rheumatrex®, Trexall®)
psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin)
juvenile idiopathic arthritis (JIA; swelling of the lining of the joints that begins in children younger than 16 years of age)
ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage),
chronic plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body)

Etanercept is in a class of medications called tumor-necrosis factor (TNF) inhibitors. It works by blocking the activity of TNF, a substance in the body that causes inflammation

How should this medicine be used? Return to top

Etanercept injection comes as a solution (liquid) in a prefilled syringe, an automatic injection device, and as a powder to be mixed with a provided liquid. Etanercept is injected subcutaneously (under the skin). It is usually injected once or twice a week. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use etanercept exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

If you are using etanercept injection to treat chronic plaque psoriasis, your doctor may start you on a high dose of medication and decrease your dose after 3 months when your condition is controlled.

You will receive your first dose of etanercept injection in a doctor's office. After that, you can inject the medication yourself at home or have a friend or relative perform the injections. Ask your doctor or pharmacist to show you or the person who will be performing the injections how to inject etanercept. Read the written instructions that come with etanercept before you inject the medication.

You can inject etanercept in the front of your thighs, the outer part of your upper arms, or your stomach, except your navel and the area 2 inches (5 centimeters) around it. To reduce the chances of soreness or redness, use a different site for each injection. Do not inject into an area where the skin is tender, bruised, red, hard, or where there are scars or stretch marks. If you have psoriasis, do not inject into skin that is red, thick, raised, or scaly.

Always look at etanercept solution before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless. The liquid may contain small white particles, but should not contain large or colored particles. Do not use a syringe or dosing pen if it is expired or if the liquid is cloudy or contains large or colored particles.

Vials of etanercept injection may contain enough medication for more than one dose. You may store a vial of etanercept injection for up to 14 days after you mix it if there is enough medication remaining for a complete dose. However, you should not combine the contents of two or more vials of etanercept injection to make a complete dose. You also should not mix any other medications with etanercept injection.

Do not reuse needles, syringes, or automatic injection devices. Dispose of used needles, syringes, and devices in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Etanercept injection will help to control your condition but will not cure it. Continue to use etanercept injection even if you feel well. Do not stop using etanercept without talking to your doctor.

Other uses for this medicine Return to top

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

What special precautions should I follow? Return to top

Before using etanercept injection,

tell your doctor and pharmacist if you are allergic to etanercept or any other medications. If you will be using the pre-filled syringe or automatic injection device, tell your doctor if you are allergic to latex. Do not allow anyone who is allergic to latex to perform the injection for you or handle the device or the syringes.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had seizures; a disease that affects your nervous system, such as multiple sclerosis (MS; loss of coordination, weakness, and numbness due to nerve damage); transverse myelitis (inflammation of the spinal cord that may cause abnormal sensations, loss of sensation, or loss of ability to move the lower body); optic neuritis (inflammation of the nerve that sends messages from the eye to the brain); blood abnormalities; hepatitis B; or heart failure.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using etanercept, call your doctor.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are using etanercept.
do not have any vaccinations during your treatment with etanercept without talking to your doctor. If your child will be treated with etanercept injection, talk to his or her doctor about vaccinations that should be given before the start of treatment. If possible, your child should be given all vaccinations needed for children of his or her age before beginning treatment.
if you are exposed to chickenpox while using etanercept, call your doctor immediately.

What special dietary instructions should I follow? Return to top

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose? Return to top

Call your doctor to find out when you should inject the missed dose. Do not inject a double dose to make up for a missed one.

What side effects can this medication cause? Return to top

Etanercept may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

redness, itching, pain, or swelling at the site of injection
headache
nausea
vomiting
heartburn
stomach pain
weakness
cough

Some side effects can be serious. If you experience any of the following side effects or those mentioned in the IMPORTANT WARNING SECTION, call your doctor immediately:

seizures
bruising
bleeding
pale skin
blistering skin
rash
hives
itching
swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
difficulty breathing or swallowing
rash on the face and arms that worsens in the sun
numbness or tingling
vision problems
weakness in the arms or legs
dizziness

Some adults who took etanercept during clinical trials and some children 18 years of age or younger who took etanercept and similar medications developed lymphoma (cancer that begins in the cells of the immune system) and other types of cancer. There is not enough information to tell whether adults or children who use etanercept are more likely to develop cancer than people who do not use the medication. Talk to your doctor about the risks of using etanercept injection.

Etanercept injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine? Return to top

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store etanercept injection in the refrigerator but do not freeze. Keep the vials, prefilled syringes, or injection devices in their original cartons to protect them from light. If you have mixed a vial of etanercept powder with the provided liquid, you may store the solution in the refrigerator for up to 14 days. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose Return to top

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know? Return to top

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to etanercept.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using etanercept.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names Return to top

Enbrel®

Last Revised - 09/01/2009

American Society of Health-System Pharmacists, Inc. Disclaimer

AHFS^® Consumer Medication Information. © Copyright, 2009. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.