Etanercept Injection

Etanercept injection is available as several different products that are considered to be biologic medications (medications made from living organisms). These biosimilar products are highly similar to etanercept injection and work the same way as etanercept injection in the body. Therefore, the term etanercept injection products will be used to represent these medications in this discussion.

Using etanercept injection products may decrease your ability to fight infection and increase the risk that you will get a serious infection, including severe viral, bacterial, or fungal infections that spread throughout the body. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you 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 or have ever had diabetes, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or any other condition that affects your immune system. You should also tell your doctor if you live or have ever lived in areas such as the Ohio and Mississippi river valleys where severe fungal infections are more common. Ask your doctor if you do not know if these infections are common in your area. Also tell your doctor if you are taking medications that decrease the activity of the immune system.

Your doctor will monitor you for signs of infection during and shortly after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: weakness; sweating; difficulty breathing; sore throat; cough; coughing up bloody mucus; fever; weight loss; extreme tiredness; diarrhea; stomach pain; flu-like symptoms; warm, red, or painful skin; or other signs of infection.

You may be infected with tuberculosis (TB, a type of lung infection) or hepatitis B (a type of liver disease) but do not have any symptoms of the disease. In this case, etanercept injection products may increase the risk that your infection will become more serious and you will develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection and may order blood tests to see if you have an inactive hepatitis B infection. If necessary, your doctor will give you medicine to treat this infection before you begin using etanercept injection. 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. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, weight loss, loss of muscle tone, or fever. Also call your doctor immediately if you have any of these symptoms of hepatitis B or if you develop any of these symptoms during or after your treatment: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea or vomiting, muscle aches, dark urine, clay-colored bowel movements, fever, chills, stomach pain, or rash.

Some children and teenagers who received etanercept injection products and similar medications developed severe or life-threatening cancers including lymphoma (cancer that begins in the cells that fight infection). If your child develops any of these symptoms during his treatment, call his doctor immediately: unexplained weight loss; swollen glands in the neck, underarms, or groin; or easy bruising or bleeding. Talk to your child’s doctor about the risks of giving etanercept injection products to your child.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with etanercept injection products 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/DrugSafety/ucm085729.htm) 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?

Etanercept injection products are used alone or with other medications 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) in adults,
• psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin) in adults,
• juvenile idiopathic arthritis (JIA; a condition that affects children in which the body attacks its own joints, causing pain, swelling, loss of function, and delays in growth and development) in children 2 years of age and older,
• 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) in adults and children 4 years of age and older whose psoriasis is too severe to be treated by topical medications alone.

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

🔔 How should this medicine be used?

Etanercept injection products come as a solution (liquid) in single-dose, prefilled syringes, dosing pens, cartridges, and automatic injection devices; Etanercept injection products also come as a powder in a multi-dose vial (contains enough medication for more than one dose) to be mixed with a provided liquid. Etanercept is injected subcutaneously (under the skin). It is usually injected once a week. When etanercept injection products are used to treat chronic plaque psoriasis, it may be injected twice a week during the first 3 months of treatment and then once a week after the first 3 months. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use etanercept injection products exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You will receive your first dose of etanercept injection products 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 injection products. Carefully read the written instructions for use that come with etanercept injection products before you inject the medication. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.

Multi-dose vials of etanercept injection products should be placed in the refrigerator as soon as possible, but no later than 4 hours after you mix it. You may store the vial of etanercept injection product 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 products to make a complete dose. You also should not mix any other medications with etanercept injection products.

If your medication comes in a single-dose prefilled syringe, dosing pen, cartridge, automatic injection device, or vial, use each syringe, dosing pen, cartridge, vial, or device only once and inject all the solution in the syringe, vial or device. Even if there is still some solution left in the syringe, vial, or device, do not use it again. 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.

If you are using an etanercept injection product that has been refrigerated, place it on a flat surface and allow it warm to room temperature for 15-30 minutes before you are ready to inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method.

Do not shake a syringe, dosing pen, cartridge, automatic injection device, or vial that contains etanercept. Be careful not to drop the device onto a hard surface because this may damage the dosing pen, cartridge, device, syringe, or needle.

Always look at etanercept solution before injecting it. Check that the expiration date has not passed. Check with the written instructions for use to find out what your etanercept injection product solution should look like. Do not use a syringe, dosing pen, cartridge, autoinjector, or vial if it is cracked or broken, if it is expired, or if the liquid does not look like it is described in the written instructions for use.

The best place to inject etanercept injection is the front of your middle thighs. You can also inject the medication in your lower stomach below your navel, except the area 2 inches (5 centimeters) around your navel. If someone else is giving you the injection, that person can also inject the medication into your upper arms. Choose 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.

Etanercept injection may help 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.