Enbrel

[etanercept]

• Heart problems. You should also tell your doctor if you have ever been treated for heart failure. If you have, your doctor may choose not to start you on ENBREL®, ormay want to monitor you more closely.

• Allergic reactions. Some patients have had allergic reactions to ENBREL®. If you develop a severe rash, swollen face or difficulty breathing while taking ENBREL®,call your doctor right away.

• Malignancies. RA patients, particularly those with highly active RA, may be at higher risk for lymphoma (a type of cancer). There have been rare reports of lymphoma in patients taking ENBREL® or other TNF blockers, occurring more often than expected for people in general. The role of ENBREL® in the development of cancer is not known. Before you start taking ENBREL® you should tell your doctor if you have or have had any of the following:

Text Continues Below

---

• Any kind of infection including an infection that is in only one place in your body(such as an open sore), or an infection that is in your whole body (such as the flu). Having an infection could put you at risk for serious side effects from ENBREL®.

• A history of infections that keep coming back or other conditions, like diabetes, that might increase your risk of infections.• Tuberculosis (TB), or if you have been in close contact with someone who has had tuberculosis. If you develop any of the symptoms of tuberculosis (a dry cough that doesn’t go away, weight loss, fever, night sweats) call your doctor. You will need tobe examined for TB and have a skin test.

• Any numbness or tingling or a disease that affects your nervous system like multiplesclerosis.
• Been newly diagnosed or are being treated for congestive heart failure.
• Been scheduled to have major surgery.
• Been scheduled to be vaccinated for anything.
If you are not sure or have any questions about any of this information, ask your doctor.

What are the other more common side effects with ENBREL®?

• Reactions where the injection was given. These reactions are usually mild andincluded redness, rash, swelling, itching, or bruising. These usually go away within 3to 5 days. If you have pain, redness or swelling around the injection site that doesn’t go away or gets worse, call your doctor.

• Upper respiratory infections (sinus infections)

• Headaches

What are other possible side effects with ENBREL®?

• The needle cover on the single-use prefilled syringe contains latex. Tell your doctorif you have any allergies to rubber or latex.

Who should not take ENBREL®?

You should not take ENBREL® if you have ever had an allergic reaction to ENBREL®.

Can I take ENBREL® if I am pregnant or breast-feeding?

ENBREL® has not been studied in pregnant women or nursing mothers, so we don’tknow what the effects are on pregnant women or nursing babies. You should tell your doctor if you are pregnant, become pregnant, or are thinking about becoming pregnant.

Can I take ENBREL® if I am taking other medicines for my RheumatoidArthritis, Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis or other conditions?

Yes, you can take other medicines if your doctor has prescribed them or has told you it is OK to take them while you are taking ENBREL®. It is important that you tell your doctor about any other medicines (for example, high blood pressure medicine) you aretaking for other conditions before you start taking ENBREL®. Taking ENBREL® with Kineret® (anakinra) is not recommended because this may increase your risk of getting a serious infection.

You should also tell your doctor about any over-the-counter drugs, herbal medicines andvitamin and mineral supplements you are taking.

How do I take ENBREL®?

ENBREL® is given by injection under the skin. Make sure you have been shown how to inject ENBREL® before you do it yourself. You can call your doctor or the ENBREL® toll-free information line at 1-888-4ENBREL(1-888-436-2735) if you have any questions about ENBREL® or about giving yourself an injection. Someone you know can also help you with your injection. Remember to take this medicine just as your doctor has told you and do not miss any doses.

Adults

If you have RA, psoriatic arthritis, or AS, the recommended dose of ENBREL® for adults is 50 mg per week given as one injection using a single-use prefilled syringe. If you have psoriasis, the recommended starting dose of ENBREL® for adult patients is a 50 mg dose twice a week (3 or 4 days apart) given for three months. After 3 months, your doctor will tell you to reduce your dose to 50 mg once per week. The 50 mg dose of ENBREL® can be given as one injection using a single-use prefilled syringe.

Children

The recommended dose of ENBREL® for children with juvenile rheumatoid arthritis is based upon the child’s body weight. Your child’s doctor will tell you the correct amount of ENBREL® you child should take. The 50 mg/mL single-use prefilled syringe of ENBREL® is only recommended for children weighing 138 pounds ormore.

What should I do if I miss a dose of ENBREL®?

If you forget to take ENBREL® when you are supposed to, contact your doctor to findout when to take your next dose of ENBREL®.

What do I need to do to prepare and give an injection of ENBREL®?

STEP 1: Setting Up for an Injection

1. Select a clean, well-lit, flat work surface, such as a table.

2. Take the ENBREL® carton containing the prefilled syringes out of the refrigerator and place it on your flat work surface. Remove one prefilled syringe and place it on your work surface. Do not shake the prefilled syringe of ENBREL®. Place the carton containing any remaining prefilled syringes back into the refrigerator (2° to8°C (36° to 46°F)). If you have any questions about storage, contact your doctor,nurse, or pharmacist for further instructions.

3. Check the expiration date on the prefilled syringe. If the expiration date has passed, do not use the prefilled syringe and contact your pharmacist or call 1-888-4ENBREL(1-888-436-2735) for assistance.

4. Wait 15 to 30 minutes to allow the ENBREL® in the prefilled syringe to reach room temperature. DO NOT remove the needle cover while allowing it to reach roomtemperature. Do not warm ENBREL® in any other way (for example, do not warm it in a microwave or in hot water).

5. Assemble the additional supplies you will need for your injection. These include analcohol swab, a cotton ball or gauze, and a puncture-resistant disposal container.

6. Wash your hands with soap and warm water.

7. Make sure the solution in the prefilled syringe is clear and colorless. Do not injectthe solution if it is discolored, contains lumps, flakes, or particles. If the solution in the prefilled syringe is not clear and colorless, or contains particles; contact your pharmacist or call 1-888-4ENBREL (1-888-436-2735) for assistance.

STEP 2: Choosing and Preparing an Injection Site

1. Three recommended injection sites for ENBREL® using a prefilled syringe include:

(1) the front of the middle thighs;
(2) the abdomen, except for the two-inch area right around the navel; and,
(3) the outer area of the upper arms.

2. Rotate the site for each injection. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks.

3. If you have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“psoriasis skin lesions”).

4. To prepare the area of skin where ENBREL® is to be injected, wipe the injection site with an alcohol swab. Do not touch this area again before giving the injection.

STEP 3: Injecting ENBREL® Using a Prefilled Syringe

1. Pick up the prefilled syringe from your flat work surface. Hold the barrel of the prefilled syringe with one hand and pull the needle cover straight off. When you remove the needle cover, there may be a drop of liquid at the end of the needle; this is normal. Do not touch the needle or allow it to touch any surface. Do not touch or bump the plunger. Doing so could cause the liquid to leak out.

2. Holding the syringe with the needle pointing up, check the syringe for air bubbles. If there are bubbles, gently tap the syringe with your finger until the air bubbles rise tothe top of the syringe. Slowly push the plunger up to force the air bubbles out of the syringe.

3. Holding the syringe in one hand like a pencil, use the other hand to gently pinch a fold of skin at the cleaned injection site and hold it firmly.

4. Insert the needle at a slight angle (45 degrees) to the skin. With a quick, “dart like” motion insert the needle into the skin.

5. After the needle is inserted, let go of the skin. Pull the plunger back slightly. If blood comes into the syringe, do not inject ENBREL® because the needle has entered a blood vessel. Withdraw the needle and discard it in a puncture-resistant container. Repeat the steps to prepare for an injection using a new prefilled syringe of ENBREL®. Do not use the same prefilled syringe.

6. If no blood appears in the syringe, slowly push the plunger all the way down to inject ENBREL®.

7. When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted. There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site for 10 seconds. Do not rub the injection site. If needed, you may cover the injection site with a bandage.

STEP 4: Disposing of Supplies

• The syringe should NEVER be reused. NEVER recap a needle.

• Dispose of the used syringe in a puncture-resistant container. Use a hard plastic container with a screw top or hard plastic lid. A SHARPS container made specifically for disposing of used syringes and needles may be used. Puncture resistant containers may also be purchased at your local pharmacy. Do not recycle the container.

• Keep the container out of reach of children. When the container is about two-thirds full, dispose of it as instructed by your healthcare provider. Follow any special state or local laws regarding the proper disposal of needles and syringes.

• Used alcohol swabs should be placed in the trash.

A healthcare provider familiar with ENBREL® should answer all questions. A toll-free
information service is also available: 1-888-4ENBREL (1-888-436-2735).
Manufactured by:
Immunex Corporation,
Thousand Oaks, CA 91320-1799
Marketed by Amgen and Wyeth Pharmaceuticals
©2004 Immunex Corporation. All rights reserved.
Issue Date: 09/27/2004

ENBREL®
(etanercept)
Multiple-use Vial

Page:  << Prev | 1 | 2 | 3 | 4 | 5