How long can Enbrel (etanercept) be left unrefrigerated?

• Enbrel may be left unrefrigerated for up to 14 days, as long as it is protected from light and not exposed to heat.
• Once Enbrel has been taken out of the refrigerator for more than 15 minutes, do not put it back in the refrigerator.
• If Enbrel has not been used within 14 days of being taken out of the refrigerator, discard it.

Enbrel (etanercept) is a subcutaneous (under the skin) injection that is administered either once or twice a week and is approved to treat several inflammatory conditions such as psoriasis and rheumatoid arthritis. It belongs to the class of medicines called TNF inhibitors.

Enbrel should be kept refrigerated at between 36°F to 46°F (2°C to 8°C) until it needs to be administered.

Before administering Enbrel, take it out of the refrigerator and allow it to warm up to room temperature for 30 minutes. This will make the injection feel more comfortable. Do not attempt to warm it up with a microwave or hot water as this will destroy the medicine. Just leave it on the kitchen bench in its original packaging.

Always check the expiry date and do not administer Enbrel that has expired.

Enbrel may be left unrefrigerated for a maximum of 14 days, as long as it is kept at room temperature between 68°F to 77°F (20°C to 25°C) and not exposed to light or a heat source. If Enbrel is not used within 14 days after being taken out of the fridge, throw it away in an approved sharps container.

Do not shake the Enbrel injection.

How is the Enbrel autoinjector administered?

Your doctor or nurse may administer Enbrel autoinjector or they can teach you to do it yourself.

You should only inject Enbrel into your thigh, stomach area (except for a 2 inch [5cm]) area around your belly button, or the outer area of your upper arm (if somebody else is administering it to you).

1. Take your Enbrel autoinjector out of the refrigerator and let it warm up naturally to room temperature for 30 minutes. Do not put it in the microwave or use hot water to heat it. Do not shake the autoinjector or remove the white cap just yet.
2. Wash your hands with soap and water.
3. Check the injection status through the viewing window of your Enbrel autoinjector. The fluid inside should look clear and colorless. There may be some small white particles in the medicine. Do not use if the medicine is cloudy or discolored or contains large particles. Also, check the expiry date located on the side of the autoinjector and do not use if expired.
4. Choose an injection site and wipe it with an alcohol wipe. Let it dry. Do not use a site where the skin is discolored, bruised, broken, covered with a psoriatic lesion, or has a rash.
5. Pull the Enbrel autoinjector cap straight off. Do not leave the cap off for more than five minutes as this can dry out the medicine.
6. Create a firm surface on your injection site by either using your fingers to stretch out the skin or pinch it up. Place the autoinjector on your chosen injection site at a 90° angle (straight up and down).
7. Firmly press and hold down the Enbrel autoinjector. Once you are ready to inject, push down on the purple start button. This will insert the needle and start the injection. You will hear a clicking sound.
8. Hold the autoinjector down firmly until the clicking sound stops and the viewing window turns from clear to yellow when the injection is done. You may hear a second click. If the window doesn’t change color contact your health care provider.
9. Dispose of your autoinjector and cap in an approved sharps bin. Do not put the cap back on the autoinjector.

Each Enbrel autoinjector is administered just one time only.

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What is Enbrel used for?

Enbrel is approved to treat the following conditions:

• Rheumatoid arthritis
• Plaque psoriasis in adults and children who are at least 4 years old
• Psoriatic arthritis
• Ankylosing spondylitis
• Polyarticular juvenile idiopathic arthritis in children who are at least 2 years old.

It is sometimes used in combination with methotrexate when used to treat rheumatoid arthritis and psoriatic arthritis.

How does Enbrel work?

Although the exact cause of many diseases such as psoriasis or rheumatoid arthritis, is not known, experts do know that the immune system plays a role.

Normally our immune system protects us from infection and helps our tissues to repair. In some people, the immune system does not function as it should and produces abnormal levels of immune cells or factors.

One of these factors is called TNF (tumor necrosis factor). TNF is a naturally occurring cytokine (cytokines are small proteins that are involved in interactions and communications between cells). Cytokines and other proteins play an important role in the development of many inflammatory conditions such as psoriasis and rheumatoid arthritis, and the resulting joint destruction. Elevated levels of TNF are found in the tissues and body fluids of people with these conditions.

TNF binds to one of two receptors on cells – these are called p55 TNF receptor or p75 TNF receptor. Enbrel acts as a decoy p75 TNF receptor, which means both TNF-alpha and TNF-beta bind to it instead of the cell surface TNF receptors. This renders TNF inactive. A fragment of human immunoglobulin G1 that is attached to the structure of Enbrel gives it a more profound and long-lasting effect than naturally occurring soluble TNF receptors.