Etanercept Injection

Conditions Treated

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

Possible Side Effects

What Side Effects Can This Cause?

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
• red, scaly patches or pus-filled bumps on the skin

Receiving etanercept injection may increase the risk of developing leukemia (cancer that begins in the white blood cells) and other types of cancer in adults and children. Talk to your doctor about the risks of receiving 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].

Usage Instructions

How Should This Medication Be Used

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.

What Dietary Instructions Should I Follow

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

Are There Any Special Instructions

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. 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.