ormation about ENBREL®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ENBREL® that was written for healthcare professionals. For more information call 1-888-4ENBREL (1-888-436-2735).
What are the ingredients in ENBREL®?
Single-use Prefilled Syringe and the Single-use Prefilled SureClick Autoinjector:
Active Ingredient: etanercept
Inactive Ingredients: sucrose, sodium chloride, L-arginine hydrochloride and sodium phosphate
Multiple-use Vial:
Active Ingredient: etanercept
Inactive Ingredients: mannitol, sucrose, tromethamine.
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Manufactured by:
Immunex Corporation
Thousand Oaks, CA 91320-1799
Marketed by Amgen Inc. and Wyeth Pharmaceuticals
© 1998 – 2009 Immunex Corporation. All rights reserved.
1XXXXXX – v2.5
Issue Date: xx/xxxx
Printed in the U.S.A.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Patient Instructions for Use
ENBREL® (en-brel)
(etanercept)
Single-use Prefilled Syringe
How do I prepare and give an injection with ENBREL® Single-use Prefilled Syringe?
There are 2 types of ENBREL® single-use prefilled syringes:
The 50 mg single-use prefilled syringe that contains one 50 mg dose of ENBREL®.
The 25 mg single-use prefilled syringe that contains one 25 mg dose of ENBREL®.
Your doctor will tell you which one to use.
A 50 mg dose can be given as one injection using a 50 mg single-use prefilled syringe or as two injections using 25 mg single-use prefilled syringes. Your doctor will tell you whether the two injections with 25 mg single-use prefilled syringes should be given on the same day once a week or on two different days (3 or 4 days apart) in the same week.
Children must weigh at least 138 pounds to use the ENBREL® 50 mg single-use prefilled syringe. Children who weigh less than 138 pounds should use a different form of ENBREL®. The ENBREL® 25 mg single-use prefilled syringe should not be used in pediatric patients weighing less than 68 pounds.
IMPORTANT: The needle cover on the single-use prefilled syringe contains latex. Tell your doctor if you are allergic to latex.
STEP 1: Setting Up for an Injection
Select a clean, well-lit, flat work surface, such as a table.
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° to 8°C [36° to 46°F]). If you have any questions about storage, contact your doctor, nurse, or pharmacist for further instructions.
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.
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 room temperature. Do not warm ENBREL® in any other way (for example, do not warm it in a microwave or in hot water).
Hold the prefilled syringe with the covered needle pointing down. If bubbles are seen in the syringe, very gently tap the prefilled syringe to allow any bubbles to rise to the top of the syringe. Tu |
