Brand Name

Enbrel

Generic Name
Etanercept
View Brand Information
FDA approval date: June 07, 2019
Classification: Tumor Necrosis Factor Blocker
Form: Solution

What is Enbrel (Etanercept)?

Enbrel is a tumor necrosis factor blocker indicated for the treatment of: Rheumatoid Arthritis .

Approved To Treat

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Brand Information

ENBREL (etanercept)
1DOSAGE FORMS AND STRENGTHS
  • Injection: 25 mg/0.5 mL and 50 mg/mL clear, colorless solution in a single-dose prefilled syringe
  • Injection: 50 mg/mL clear, colorless solution in a single-dose prefilled SureClick autoinjector
  • Injection: 25 mg/0.5 mL clear, colorless solution in a single-dose vial
  • For Injection: 25 mg lyophilized powder in a multiple-dose vial for reconstitution
  • Injection: 50 mg/mL clear, colorless solution in Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector only
2CONTRAINDICATIONS
Enbrel is contraindicated in patients with sepsis.
3ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
  • Serious Infections
  • Neurologic Reactions
  • Malignancies
  • Patients with Heart Failure
  • Hematologic Reactions
  • Hepatitis B Reactivation
  • Allergic Reactions
  • Autoimmunity
  • Immunosuppression
3.1Clinical Trials Experience
Across clinical studies and postmarketing experience, the most serious adverse reactions with Enbrel were infections, neurologic events, CHF, and hematologic events
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not predict the rates observed in clinical practice.
3.2Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to etanercept in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
3.3Postmarketing Experience
Adverse reactions have been reported during post approval use of Enbrel in adults and pediatric patients. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Enbrel exposure.
Adverse reactions are listed by body system below:
Opportunistic infections, including atypical mycobacterial infection, herpes zoster, aspergillosis and
Rare (< 0.1%) cases of IBD have been reported in JIA patients receiving Enbrel, which is not effective for the treatment of IBD.
4DRUG INTERACTIONS
Specific drug interaction studies have not been conducted with Enbrel.
4.1Vaccines
Most PsA patients receiving Enbrel were able to mount effective B-cell immune responses to pneumococcal polysaccharide vaccine, but titers in aggregate were moderately lower and fewer patients had 2-fold rises in titers compared to patients not receiving Enbrel. The clinical significance of this is unknown. Patients receiving Enbrel may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving Enbrel.
Patients with a significant exposure to varicella virus should temporarily discontinue Enbrel therapy and be considered for prophylactic treatment with varicella zoster immune globulin
4.2Immune-Modulating Biologic Products
In a study in which patients with active RA were treated for up to 24 weeks with concurrent Enbrel and anakinra therapy, a 7% rate of serious infections was observed, which was higher than that observed with Enbrel alone (0%)
In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events, including infections, and did not demonstrate increased clinical benefit
4.3Cyclophosphamide
The use of Enbrel in patients receiving concurrent cyclophosphamide therapy is not recommended
4.4Sulfasalazine
Patients in a clinical study who were on established therapy with sulfasalazine, to which Enbrel was added, were noted to develop a mild decrease in mean neutrophil counts in comparison to groups treated with either Enbrel or sulfasalazine alone. The clinical significance of this observation is unknown.
5OVERDOSAGE
No dose-limiting toxicities have been observed during clinical trials of Enbrel. Single IV doses up to 60 mg/m
6DESCRIPTION
Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the C
Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.
Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3.
Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.
7REFERENCES
  1. National Cancer Institute. Surveillance, Epidemiology, and End Results Database (SEER) Program. SEER Incidence Crude Rates, 13 Registries, 1992-2002.
  2. Bröms G, Granath F, Ekbom A, et al. Low Risk of Birth Defects for Infants Whose Mothers Are Treated With Anti-Tumor Necrosis Factor Agents During Pregnancy.
8HOW SUPPLIED/STORAGE AND HANDLING
Enbrel (etanercept) injection is supplied as a clear and colorless sterile, preservative-free solution for subcutaneous administration in single-dose prefilled syringes, an Enbrel single-dose prefilled SureClick autoinjector with a 27-gauge, ½-inch needle, or a single-dose vial. The prefilled syringe and SureClick autoinjector are not made with natural rubber latex.
Each Enbrel
The AutoTouch reusable autoinjector contains no drug and must use an Enbrel Mini single-dose prefilled cartridge. In addition, the AutoTouch Connect
9PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling
Patients or their caregivers should be provided the Enbrel "Medication Guide" and provided an opportunity to read it and ask questions prior to initiation of therapy. The healthcare provider should ask the patient questions to determine any risk factors for treatment. Patients developing signs and symptoms of infection should seek medical evaluation immediately.
10INSTRUCTIONS FOR USE ENBREL®[en-brel] (etanercept) injection, for subcutaneous use mg/mL single-dose prefilled SureClick®autoinjector
This Instructions for Use contains information on how to inject ENBREL with a SureClick autoinjector.
If your healthcare provider decides that you or a caregiver may be able to give your injections of ENBREL at home, you should receive training on the right way to prepare and inject ENBREL. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse.
The medicine in the ENBREL autoinjector is for injection under the skin (subcutaneous injection). See the ENBREL
Important Information You Need to Know Before Injecting ENBREL
  • It is important that you do not try to give the injection until you have fully read and understood this Instructions for Use.
  • Check the autoinjector label and prescription to make sure you have the correct medicine and dose.
  • Do not use the autoinjector if the carton is damaged or the seal is broken.
  • Do not use the autoinjector after the expiration date on the label.
  • Do not shake the autoinjector.
  • Do not remove the white cap from the autoinjector until you are ready to inject.
  • Do not use the autoinjector if it has been frozen.
  • Do not use the autoinjector if it has been dropped on a hard surface. Part of the autoinjector may be broken even if you cannot see the break. Use a new autoinjector, and call 1-888-4ENBREL (1-888-436-2735).
  • Children must weigh at least 138 pounds to use the ENBREL SureClick autoinjector. Children who weigh less than 138 pounds should use a different form of ENBREL.
  • The autoinjector is not made with natural rubber latex.
Frequently asked questions:
For additional information and answers to frequently asked questions, visit www.enbrel.com.
Where to get help:
If you want more information or help using ENBREL:
  • Contact your healthcare provider,
  • Visit
  • Call 1-888-4ENBREL (1-888-436-2735).
Storing and Preparing to Inject ENBREL
  • Refrigerate the autoinjector carton until you are ready to use it.
  • Keep the autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Keep the autoinjector in the original carton to protect it from light or physical damage.
  • Do not freeze the autoinjector.
  • Do not store the autoinjector in extreme heat or cold. For example, avoid storing in your vehicle's glove box or trunk.
  • Wait 30 minutes for the autoinjector to reach room temperature.
  • Remove the autoinjector and put any unused autoinjectors back into the refrigerator.
  • Let the autoinjector warm up naturally.
  • Do not heat the autoinjector with hot water, a microwave, or direct sunlight.
  • Do not shake the autoinjector at any time.
  • Using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection.
  • You may keep ENBREL at room temperature for up to 30 days, if needed.
  • For example, when you are traveling, you may keep ENBREL at room temperature.
  • Keep it at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not put it back in the refrigerator.
  • Record the date you removed it from the refrigerator and use it within
  • Inspect the medicine. It should be clear and colorless to slightly yellow.
  • It is okay to see air bubbles or small white particles in the medicine.
  • Do not use the autoinjector if the medicine is cloudy, discolored, or contains large lumps, flakes or colored particles.
  • Check the expiration date (Exp.) and inspect the autoinjector for damage.
  • Do not use the autoinjector if the expiration date has passed.
  • Do not use the autoinjector if:
  • the white cap is missing or loose in carton,
  • it has cracks or broken parts, or
  • it has been dropped on a hard surface.
Getting Ready to Inject ENBREL
  • Gather and place the following items for your injection on a clean, flat, and well-lit surface:
  • ENBREL autoinjector (room temperature),
  • Sharps disposal container [see
  • Alcohol wipe,
  • Adhesive bandage, and
  • Cotton balls or gauze pads.
  • Select 1 of these injection sites.
  • Select the thigh or stomach (except for 2 inches around the belly button).
  • Someone else can inject in your thigh, stomach, or back of the upper arm.
  • Change injection site each time, shifting the area of the injection to avoid skin irritation
  • Wash your hands thoroughly with soap and water.
  • Clean the injection site with an alcohol wipe.
  • Let the skin dry on its own.
  • Do not touch this area again before injecting.
Injecting ENBREL
  • Grasp the autoinjector so you can see the window. Pull the white cap straight off. You may need to pull hard.
  • Do not twist, bend, or wiggle the white cap to pull it off.
  • Never put the white cap back on. It may damage the needle.
  • Do not put your finger inside the dark green safety guard.
  • It is normal to see a drop of medicine come out of the needle or dark green safety guard.
  • Stretch or pinch the skin to create a firm surface at the injection site until the injection is finished. Place the dark green safety guard straight against the skin.
  • Make sure you can see the window.
  • Make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle).
  • Firmly push the autoinjector down until the dark green safety guard stops moving. Hold the autoinjector down, do not lift.
  • The dark green safety guard pushes in and unlocks the purple start button.
  • Keep pushing the autoinjector down and press the purple start button to start the injection.
  • You may hear or feel a click.
  • The window starts to turn yellow.
  • It is okay to let go of the purple start button.
  • Keep pushing the autoinjector down. Wait for the window to turn fully yellow.
  • The injection may take up to
  • You may hear or feel a click.
  • After the window turns fully yellow, lift the autoinjector away from the skin.
  • The dark green safety guard locks around the needle.
Completing the Injection and Disposal
  • Confirm a full dose of medicine was injected.
  • Do not touch the dark green safety guard.
  • A small drop of liquid on the injection site is okay.
  • Check the injection site.
  • Do not rub the injection site.
  • If there is blood, press a cotton ball or gauze pad on your injection site.
  • Apply an adhesive bandage if necessary.
  • Place the used autoinjector and white cap in an FDA-cleared sharps disposal.
    Important: Do not throw away the autoinjector in your household trash.
  • Do not reuse the autoinjector.
  • Do not touch the dark green safety guard.
Additional information about your sharps disposal container
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
Disposing of sharps disposal containers:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
There may be state or local laws about how you should throw away used needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at:
http://www.fda.gov/safesharpsdisposal
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
Do not recycle your used sharps disposal container.
Keep the autoinjector and sharps disposal container out of the sight and reach of children.
For more information or help call 1-888-4ENBREL (1-888-436-2735).
ENBREL (etanercept)
AMGEN
Manufactured by:
Immunex Corporation
Thousand Oaks, CA 91320-1799
U.S. License Number 1132
©1998–2016, 2019-2025 Immunex Corporation. All rights reserved.
1XXXXXX
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
11Instructions for Use Enbrel®(en-brel) (etanercept) injection, for subcutaneous use Single-dose Prefilled Syringe
How do I prepare and give an injection with Enbrel Single-dose Prefilled Syringe?
There are 2 types of Enbrel single-dose prefilled syringes:
  • The 50 mg/mL single-dose prefilled syringe that contains one 50 mg dose of Enbrel.
  • The 25 mg/0.5 mL single-dose prefilled syringe that contains one 25 mg dose of Enbrel.
Your healthcare provider will tell you which one to use.
A 50 mg dose can be given as one injection using a 50 mg/mL single-dose prefilled syringe or as two injections using 25 mg/0.5 mL single-dose prefilled syringes. Your healthcare provider will tell you whether the two injections with 25 mg/0.5 mL single-dose 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/mL single-dose prefilled syringe. Children who weigh less than 138 pounds should use a different form of Enbrel. The Enbrel 25 mg/0.5 mL single-dose prefilled syringe should not be used in pediatric patients weighing less than 68 pounds.
Important: The Enbrel prefilled syringe is not made with natural rubber latex.
Storage of your Enbrel prefilled syringe
  • Store the Enbrel prefilled syringe in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Store the Enbrel prefilled syringe in the original carton to protect from light or physical damage.
  • If needed, you may store your Enbrel prefilled syringe at room temperature between 68°F to 77°F (20°C to 25°C) for up to 30 days.
  • Throw away any Enbrel prefilled syringe that has been stored at room temperature after 30 days.
  • Do not store the Enbrel prefilled syringe in extreme heat or cold. For example, avoid storing Enbrel prefilled syringe in your vehicle's glove box or trunk.
  • Do not freeze.
  • Do not shake.
  • Keep the Enbrel prefilled syringe and all medicines out of the reach of children.
If you have any questions about storage, contact your healthcare provider or call 1-888-4ENBREL (1-888-436-2735) for further instructions.
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. Carefully lift the prefilled syringe straight up out of the box.
  3. Check the expiration date on the prefilled syringe. If the expiration date has passed,
  4. Do not use the prefilled syringe if the needle cover is missing or not securely attached. Call 1-888-4ENBREL (1-888-436-2735).
  5. For a more comfortable injection, leave the prefilled syringe at room temperature for about 15 to 30 minutes before injecting.
  6. 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. Turn the syringe so that the purple horizontal lines on the barrel are directly facing you. Check to see if the amount of liquid in the syringe falls between the purple lines. The top of the liquid may be curved. If the syringe does not have the right amount of liquid,
  7. Assemble the additional supplies you will need for your injection. These include an alcohol swab, a cotton ball or gauze, and a sharps disposal container (see
  8. Wash your hands with soap and warm water.
  9. Make sure the solution in the prefilled syringe is clear and colorless. You may notice small white particles in the solution. These particles are formed from Enbrel and this is acceptable. However,
Step 2: Choosing and Preparing an Injection Site
  1. Recommended injection sites for Enbrel using a prefilled syringe include:
  2. Rotate the site for each injection.
  3. If you have psoriasis, you should not inject directly into any raised, thick, red, or scaly skin patches or lesions.
  4. To prepare the area of skin where Enbrel is to be injected, wipe the injection site with an alcohol swab.
Step 3: Injecting Enbrel Using a Prefilled Syringe
Do not remove the needle cover from the prefilled syringe until you are ready to inject.
  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, only when you are ready to inject.
  2. Holding the syringe with the needle pointing up, check the syringe for air bubbles. If there are bubbles,
  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. With a quick and "dart-like" motion, insert the needle at a 45-degree angle into the skin.
  5. When the needle is completely inserted into the skin, let go of the skin that you are holding. With your free hand, hold the syringe near its base to stabilize it. Then push the plunger to inject all of the Enbrel solution at a slow, steady rate.
  6. 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.
Step 4: Disposing of Supplies
The syringe should
  • Put the used prefilled syringes in a FDA-cleared sharps disposal container right away after use.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used syringes and needles. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
  • Do not reuse the syringe.
  • Do not recycle the syringe or sharps disposal container or throw them into household trash.
Important: Always keep the sharps disposal container out of the reach of children.
A healthcare provider familiar with Enbrel should answer all questions. Call 1-888-4ENBREL (1-888-436-2735) or visit www.enbrel.com for more information about Enbrel.
This Instructions for Use have been approved by the U.S. Food and Drug Administration.
AMGEN
Manufactured by:
Immunex Corporation
Thousand Oaks, CA 91320-1799
U.S. License Number 1132
© 1998 – 2016, 2019-2020, 2022-2024 Immunex Corporation. All rights reserved.
1XXXXXX – v13
ImageThis printed material is recyclable.
12Instructions for Use Enbrel®(en-brel) (etanercept) for injection, for subcutaneous use Multiple-dose Vial
How do I prepare and give an injection with Enbrel multiple-dose vial?
A multiple-dose vial contains 25 mg of Enbrel.
Storage of Enbrel multiple-dose vial
  • Store Enbrel multiple-dose vial in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Store Enbrel multiple-dose vial in the original carton to protect from light or physical damage.
  • If needed, you may store your Enbrel multiple-dose vial and diluent syringe (dose tray) at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days.
  • Throw away Enbrel multiple-dose vial that has been stored at room temperature after 14 days.
  • Mixed (reconstituted) Enbrel multiple-dose vial should be used right away or kept in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 14 days.
  • Do not store Enbrel multiple-dose vial in extreme heat or cold. For example, avoid storing Enbrel multiple-dose vial in your vehicle’s glove box or trunk.
  • Do notfreeze.
  • Do not shake.
  • Keep Enbrelmultiple-dose vial and all medicines out of the reach of children.
If you have any questions about storage, contact your healthcare provider or call 1-888-4ENBREL (1-888-436-2735) for further instructions.
Step 1: Setting Up for an Injection
  1. Select a clean, well-lit, flat work surface, such as a table.
  2. Take the Enbrel dose tray out of the refrigerator and place it on your flat work surface.
  3. Check the expiration date on the dose tray. If the expiration date has passed,
  4. For a more comfortable injection, leave the dose tray at room temperature for about 15 to 30 minutes before injecting.
  5. Wash your hands with soap and warm water.
  6. Peel the paper seal off the dose tray and remove all items.
  7. Inspect the volume of diluent in the syringe with the twist-off cap pointing down. Use the unit markings on the side of the syringe to make sure there is at least 1 mL of liquid in the syringe. If the level of liquid is below the 1 mL mark,
  8. Do not use the syringe if the twist-off cap is missing or not securely attached. Call 1-888-4ENBREL (1-888-436-2735).
  9. Two alcohol swabs should be available for the preparation and injection of Enbrel. Alcohol swabs can be found at your local drug store.
Step 2: Preparing the Enbrel Solution
There are two methods for preparing the Enbrel solution. For some children, one vial of Enbrel solution can be used for more than one dose. The free-hand method should be used for children on Enbrel who are using one vial of Enbrel solution for more than one dose.
  • The Vial Adapter Method
Adults and larger children on Enbrel may use the vial adapter device to assist with mixing the powder with the liquid and withdrawing Enbrel, and then use a 27-gauge needle to inject the dose.
  • The Free-Hand Method
In the free-hand method, a 25-gauge needle is used to assist with mixing the powder with the liquid and withdrawing Enbrel, and a 27-gauge needle is used to inject the dose. Obtain 25-gauge needles from your healthcare provider. Instructions for using the free-hand method are in Step 2B. 
The instructions for preparing additional doses from the same vial of Enbrel solution are in Step 3. For each additional dose, you will need two new needles (one 25-gauge needle to withdraw the solution and one 27-gauge needle for injection) and one new empty syringe (1 mL).
If you are using the vial of Enbrel for more than one dose, you should write the date you mixed the powder and liquid in the area marked “Mixing Date:” on the sticker supplied with these instructions, and attach the sticker to the Enbrel vial.
After you have withdrawn the dose of Enbrel that you need, store the Enbrel vial (in the dose tray) in the refrigerator at 36º to 46ºF (2º to 8ºC) as soon as possible, but always within 4 hours of mixing the solution.
The Enbrel solution must be used within 14 days of the mixing date. You should discard the Enbrel vial and any remaining solution if it is not used within 14 days.
STEP 2A: Vial Adapter Method
  1. Remove the pink plastic cap from the Enbrel vial.
  2. Place the Enbrel vial on your flat work surface or turn your dose tray upside down and place your Enbrel vial in the round space marked “V”. Use one alcohol swab to clean the gray stopper on the Enbrel vial.
  3. Open the wrapper that contains the 27-gauge needle by peeling apart the tabs and set the needle aside for later use.
  4. Open the wrapper that contains the vial adapter by peeling apart the tabs and set the vial adapter aside for later use.
  5. Slide the plunger into the flange end of the syringe.
  6. Attach the plunger to the gray rubber stopper in the syringe by turning the plunger clockwise until you feel a slight resistance.
  7. Remove the twist-off cap from the prefilled diluent syringe by turning counter-clockwise.
  8. Once the twist-off cap is removed, pick up the vial adapter with your free-hand. Twist the vial adapter onto the syringe, turning clockwise until you feel a slight resistance.
  9. Hold the Enbrel vial upright on your flat work surface. Grasp the sides of the vial adapter and place it over the top of the Enbrel vial.
  10. Hold the Enbrel vial upright on your flat work surface and push the plunger down until all the liquid from the syringe is in the Enbrel vial. You may see foaming (bubbles) in the vial. This is normal.
  11. Gently swirl the Enbrel vial in a circular motion to dissolve the powder. If you used the dose tray to hold your Enbrel vial, take the vial (with the vial adapter and syringe still attached) out of the dose tray, and gently swirl the vial in a circular motion to dissolve the powder.
  12. Turn the Enbrel vial upside down. Hold the syringe at eye level and slowly pull the plunger down to the unit markings on the side of the syringe that correspond with your/your child’s dose. For adult patients, remove the entire volume (1 mL), unless otherwise instructed by your healthcare provider. Be careful not to pull the plunger completely out of the syringe. Some white foam may remain in the Enbrel vial. This is normal.
  13. Check for air bubbles in the syringe. Gently tap the syringe to make any air bubbles rise to the top of the syringe. Slowly push the plunger up to remove the air bubbles. If you push solution back into the vial, slowly pull back on the plunger to again draw the correct amount of solution back into the syringe.
  14. Remove the syringe from the vial adapter, by holding the vial adapter with one hand and turning the syringe counter-clockwise with your other hand.
  15. Continue to hold the barrel of the syringe. With your free-hand, twist the 27-gauge needle onto the tip of the syringe until it fits snugly.
Go to Step 4: Choosing and Preparing an Injection Site.
Step 2B: Free-Hand Method
If you are preparing a dose from an Enbrel vial that was previously used, go to Step 3: Preparing Additional Doses from a Single Enbrel Vial.
  1. Remove the pink plastic cap from the Enbrel vial.
  2. Place the Enbrel vial on your flat work surface. Use one alcohol swab to clean the gray stopper on the Enbrel vial.
  3. Open the wrapper that contains the 25-gauge needle by peeling apart the tabs and set the needle aside for later use. The 25-gauge needle will be used to mix the liquid with the powder and for withdrawing Enbrel from the vial.
  4. Slide the plunger into the flange end of the syringe.
  5. Attach the plunger to the gray rubber stopper in the syringe by turning the plunger clockwise until you feel a slight resistance.
  6. Remove the twist-off cap from the prefilled diluent syringe by turning counter-clockwise.
  7. Continue to hold the barrel of the syringe. With your free-hand, twist the 25-gauge needle onto the tip of the syringe until it fits snugly. Place the syringe on your flat work surface.
  8. Open the wrapper that contains the 27-gauge needle by peeling apart the tabs and set the needle aside for later use.  The 27-gauge needle will be used to inject the dose.
  9. Pick up the syringe from your flat work surface. Hold the barrel of the syringe with one hand, and pull the needle cover straight off. To avoid damaging the needle,
  10. Place the needle cover (open side up) in the round space marked “N” in the Enbrel dose tray.
  11. Place the Enbrel vial on your flat work surface. Hold the syringe with the needle facing up, and gently pull back on the plunger to pull a small amount of air into the syringe. Then, insert the needle straight down through the
  12. Push the plunger down very slowly until all liquid from the syringe is in the Enbrel vial. Adding the liquid too fast will cause foaming (bubbles).
  13. Leave the syringe in place. Gently swirl the Enbrel vial in a circular motion to dissolve the powder.
  14. With the needle in the Enbrel vial, turn the vial upside down. Hold the syringe at eye level and slowly pull the plunger down to the unit markings on the side of the syringe that correspond with the correct dose. Make sure to keep the tip of the needle in the solution. Some white foam may remain in the Enbrel vial. This is normal.
  15. With the needle still inserted in the Enbrel vial, check for air bubbles in the syringe. Gently tap the syringe to make any air bubbles rise to the top of the syringe. Slowly push the plunger up to remove the air bubbles. If you push solution back into the vial, slowly pull back on the plunger to draw the correct amount of solution back into the syringe.
  16. Remove the syringe and needle from the Enbrel vial. Keep the needle attached to the syringe and insert the 25-gauge needle straight down into the needle cover in the Enbrel dose tray.
  17. Twist the 27-gauge needle onto the syringe until it fits snugly.
  18. If there is enough solution left in the Enbrel vial for another dose, write the date you mixed the powder and liquid in the area marked “Mixing Date:” on the sticker supplied with these instructions, and attach the sticker to the Enbrel vial. Refrigerate the reconstituted (mixed) Enbrel vial (in the dose tray) after mixing. Prepare additional doses from the Enbrel vial as described in Step 3. Otherwise, throw away (discard) the Enbrel vial and any remaining solution.
Go to Step 4: Choosing and Preparing an Injection Site.
Step 3: Preparing Additional Doses from a Single Enbrel Vial
  1. Select a clean, well-lit, flat work surface, such as a table.
  2. Do not reuse the needles and syringes supplied with Enbrel dose tray. You will need new needles and syringes for each additional dose. Your healthcare provider will tell you what type of syringes (1 mL) and needles (25-gauge and 27-gauge) to use. Place the sterile syringe with a 25-gauge needle (for withdrawing Enbrel), a 27-gauge needle (for injecting Enbrel) and two alcohol swabs on your flat work surface.
  3. Take the vial of Enbrel solution that is stored in the dose tray out of the refrigerator and place it on your flat work surface.
  4. Check the mixing date you wrote on the sticker on the Enbrel vial.
  5. Wash your hands with soap and warm water.
  6. Use one alcohol swab to clean the gray stopper on the Enbrel vial.
  7. If the syringe and the 25-gauge needle are not pre-assembled, assemble them as instructed by your healthcare provider.
  8. Open the wrapper that contains the 27-gauge needle by peeling apart the tabs and set the needle aside for later use. The 27-gauge needle will be used to inject the dose of Enbrel.
  9. Hold the syringe and pull the needle cover straight off. To avoid damaging the needle,
  10. Place the Enbrel vial on your flat work surface. Hold the syringe with the needle facing up, and gently pull back the plunger to pull a small amount of air into the syringe. Then, insert the 25-gauge needle straight down through the
  11. Keep the needle in the Enbrel vial and turn the vial upside down. Hold the syringe at eye level, and slowly pull the plunger down to the unit markings on the syringe that correspond to your child’s dose. As the amount of solution in the Enbrel vial drops, you may need to pull the needle back just enough to keep the tip of the needle in the solution.
  12. With the needle still inserted in the Enbrel vial, check for air bubbles in the syringe. Gently tap the syringe to make any air bubbles rise to the top of the syringe. Slowly push the plunger up to remove the air bubbles. If you push solution back into the Enbrel vial, slowly pull back on the plunger to again draw the correct amount of solution back into the syringe.
  13. Remove the syringe and needle from the Enbrel vial. Keep the needle attached to the syringe and insert the 25-gauge needle straight down into the needle cover in the Enbrel dose tray. You should hear a “snap” when the needle is secure in the needle cover. Once the needle is secure in the needle cover, remove the 25-gauge needle from the syringe and dispose of the needle in a sharps disposal container (see
  14. Attach the 27-gauge needle onto the tip of the syringe until it fits snugly.
Step 4: Choosing and Preparing an Injection Site
  1. The 3 recommended injection sites for Enbrel include:
  2. Rotate the site for each injection.
  3. If you have psoriasis, you should not inject directly into any raised, thick, red, or scaly skin patches or lesions.
  4. To prepare the area of skin where Enbrel is to be injected, wipe the injection site with a new alcohol swab.
Step 5: Injecting the Enbrel Solution
Do not remove the needle cover from the syringe until you are ready to inject.
  1. Pick up the syringe from your flat work surface. Hold the barrel of the syringe with one hand and pull the needle cover straight off. To avoid damaging the needle,
  2. With one hand, gently pinch the cleaned area of skin and hold it firmly. With the other hand, hold the syringe (like a pencil) at a 45-degree angle to the skin.
  3. With a quick and "dart-like" motion, insert the needle at a 45-degree angle into the skin.
  4. When the needle is completely inserted into the skin, let go of the skin that you are holding. With your free-hand, hold the syringe near its base to stabilize it. Then push the plunger to inject all of the Enbrel solution at a slow, steady rate.
  5. When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted.
  6. 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.
  7. If your healthcare provider has instructed you to take two Enbrel injections on the same day, repeat the steps to prepare and give an injection of Enbrel. Choose and prepare a new injection site for the second injection.
  8. For the Free-Hand Method: If there is enough solution left in the Enbrel vial for another dose, refrigerate the reconstituted (mixed) Enbrel vial (in the dose tray) after use. Otherwise, discard the Enbrel vial and any remaining solution.
Step 6: Disposing of Supplies
The syringe, needles, and vial adapter should
  • Put the used syringes, needles, and vials in a FDA-cleared sharps disposal container right away after use.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used syringes and needles. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal
  • Do not reuse the syringe or vial.
  • Do not recycle the syringe, vial, or sharps disposal container or throw them into household trash.
Important: Always keep the sharps disposal container out of the reach of children.
A healthcare provider familiar with Enbrel should answer all questions. Call 1-888-4ENBREL (1-888-436-2735) or visit www.enbrel.com for more information about Enbrel.
This Instructions for Use have been approved by the U.S. Food and Drug Administration.
AMGEN
Manufactured by:
Immunex Corporation
Thousand Oaks, CA 91320-1799
U.S. License Number 1132
© 1998 – 2016, 2019 Immunex Corporation. All rights reserved.
1XXXXXX – v9
Revised: 10/2019
Image This printed material is recyclable.
13Instructions for Use Enbrel®(en-brel) (etanercept) injection, for subcutaneous use single-dose vial
Read this Instructions for Use before you start taking Enbrel and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition and treatment.
Step 1: Set up
Image
1a. Strength and dose
The strength of the Enbrel single-dose vial is different than the Enbrel multiple-dose vial.
Each single-dose vial contains 25 mg (0.5 mL).
Review your prescription carefully for dose and dosing schedule. Only inject Enbrel after you or your caregiver has received training by your healthcare provider. Your healthcare provider will tell you how often you should use Enbrel.
Keep Enbrel out of the reach of children.
Image
1b. Store Enbrel single-dose vials
Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C). You may also store the Enbrel single-dose vials at room temperature between 68°F to 77°F (20°C to 25°C) for up to 30 days. Throw away Enbrel that has been stored at room temperature after 30 days.
Do not shake.
Do not freeze or store in extreme heat or cold.
Store Enbrel in the original carton to protect from light or damage.
1c. Remove correct number of vials
Remove the correct number of Enbrel single-dose vials from the original carton.
Check your prescription to determine if your dose will require 1 or 2 single-dose vials.
Your dose is determined in milliliters (mL).
Your child's dose of Enbrel depends on his or her weight. Your child's healthcare provider will tell you which form of Enbrel to use and how much to give your child.
1d. Inspect the single-dose vial(s)
Leave the single-dose vial(s) at room temperature, with the green cap(s) on, for at least 30 minutes.
Enbrel is clear and colorless. There may be small white particles in the solution. Check the expiration date.
Keep out of direct sunlight.
Do not use Enbrel if:
  • the expiration date has passed
  • the green cap is not attached
  • it has lumps, is discolored, or is cloudy.
If there are any issues with your Enbrel single-dose vials, please call 1-888-4ENBREL (1-888-436-2735).
Image
1e. Gather all materials and wash hands
Wash your hands with soap and water.
Place the following items on a clean well-lit, flat surface:
  • 1 mL syringe
  • Long needle: for withdrawal
  • Short needle: for injection
  • Alcohol wipes
  • Cotton balls
  • Bandage
  • Sharps disposal container
Image
1f. Pop off the green vial cap then wipe the gray stopper
Use an alcohol wipe to clean the gray stopper.
If you require a second single-dose vial, clean the gray stopper of the second single-dose vial with a new alcohol wipe.
Image
1g. Attach the long needle to the syringe
Twist the long needle onto the syringe.
Step 2: Prepare dose
Image
2a. Pull plunger back, insert needle, and push air into single-dose vial
Pull the needle cap straight off and away from your body. Save the needle cap for later.
Pull the syringe plunger back to 0.5 mL.
Hold the single-dose vial on a flat surface with 1 hand. Insert the long needle through the gray rubber stopper above the medicine in the single-dose vial.
Slowly push 0.5 mL of air into the single-dose vial.
Image
2b. Tilt the single-dose vial to withdraw
Slowly pull back the plunger to fill the syringe
Remove needle from the single-dose vial.
The air in the syringe will be removed later.
Image
2c. Gently tap the syringe with fingers to release bubbles
Gently tap the syringe with your fingers to release air pockets and bubbles until they rise to the top of the syringe.
Image
2d. Push out large air pockets and bubbles
After you have gently tapped the large air pockets and bubbles to the top of the syringe, push the plunger up to remove the air out of the syringe.
Small amounts of tiny air bubbles are ok.
If you need 1 single-dose vial, push the plunger to your
If you need more than 1 single-dose vial to get your
Using 1 hand, slide the needle into the cap and scoop upwards to cap the needle, without using your other hand.
Then use your other hand to secure the cap and snap into place.
Step 3: Inject and throw away
Image
3a. Replace the long needle with the short needle
Twist the long needle off of the syringe.
Throw away the long needle in the sharps disposal container.
Twist the short needle onto the syringe.
Do not remove the needle cover until you are ready to inject.
Image
3b. Choose and clean the injection site
  • thigh or stomach (avoid 2 inches around the navel)
  • back of upper arm (only if someone else is giving the injection)
Choose a different site each time you give yourself an injection. Avoid injecting into tender, raised, red or scaly skin.
Clean the injection site with an alcohol wipe and let dry.
Image
3c. Pinch and inject Enbrel
Gently pinch skin. With a quick firm action, insert the needle into your skin at a 45-degree angle.
When the needle is completely inserted into the skin, slowly push the plunger all the way down.
When the syringe is empty, remove the needle and syringe from your skin. Do not recap the needle.
Do not rub the injection site. If you see drops of blood at the injection site, you can press a cotton ball over the injection site until bleeding has stopped. Apply an adhesive bandage, if needed.
Image
3d. Throw away the used single-dose vials, needles and syringe
Single-dose vials do not contain preservatives and are for
Additional disposal information
Do not throw away the vials, needles, and syringe in your household trash.
If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic
  • can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out
  • upright and stable during use
  • leak-resistant
  • properly labeled to warn of hazardous waste inside the container
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to throw away your sharps disposal container. There may be state or local laws about how you should throw away used vials, needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
  • Do not throw away your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
  • Do not reuse the vials, syringe, or needles.
  • Do not recycle the vials, syringe, needles, or sharps disposal container or throw them into household trash.
Important: Always keep the sharps disposal container out of the reach of children.
If you experience any difficulty using your Enbrel single-dose vials, please call 1-888-4ENBREL (1-888-436-2735).
If you have any questions about your Enbrel dosing, please call your healthcare provider.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
AMGEN
Manufactured by:
Immunex Corporation
Thousand Oaks, CA 91320-1799
U.S. License Number 1132
© 1998-2020, 2022, 2024 Immunex Corporation. All rights reserved.
[part number]
Revised: 10/2024 v3
ImageThis printed material is recyclable.
Front Panel
14PRINCIPAL DISPLAY PANEL - 25 mg/0.5 mL Syringe Carton
Contains 4 Single-Dose Prefilled Syringes
NDC 58406-010-04
Enbrel
25
Not made with
25 mg/0.5 mL
Attention: Not for use in pediatric patients under 31 kg (68 pounds).
Each single-dose prefilled syringe contains 0.5 mL of a clear and
Specific activity: approximately 1.7 x 10
Manufactured by Immunex Corporation, Thousand Oaks, CA 91320
©2013, 2017, 2022-2023 Immunex Corporation
This carton is recyclable.
PRINCIPAL DISPLAY PANEL - 25 mg/0.5 mL Syringe Carton
15PRINCIPAL DISPLAY PANEL - 50 mg/mL Syringe Carton
Contains 4 Single-Dose Prefilled Syringes
NDC 58406-021-04
Enbrel
50
Not made with
50 mg/mL
Attention: Not for use in pediatric patients under 63 kg (138 pounds).
Each single-dose prefilled syringe contains 1 mL of a clear and
Specific activity: approximately 1.7 x 10
Manufactured by Immunex Corporation, Thousand Oaks, CA 91320
©2013, 2017, 2022-2023 Immunex Corporation
This carton is recyclable.
PRINCIPAL DISPLAY PANEL - 50 mg/mL Syringe Carton
16PRINCIPAL DISPLAY PANEL - 50 mg/mL Autoinjector Carton - 032-04
4 x Single-Dose Prefilled Autoinjectors
NDC 58406-032-04
Enbrel
50
50 mg/mL
Attention: Not for use in pediatric patients under 63 kg
For Subcutaneous Use Only
Sterile Solution - No Preservative
ATTENTION: Enclosed Medication Guide is required for each patient.
CAUTION, See package insert for full
Keep out of the sight and
Do not re-use
Refrigerate
AMGEN
PRINCIPAL DISPLAY PANEL - 50 mg/mL Autoinjector Carton - 032-04
17PRINCIPAL DISPLAY PANEL - 50 mg/mL Autoinjector Carton - 032-96
1 x Single-Dose Prefilled Autoinjector
NDC 58406-032-96
50
Enbrel
50 mg/mL
Attention: Not for use in pediatric patients under 63 kg
For Subcutaneous Use Only
Sterile Solution - No Preservative
ATTENTION: Enclosed Medication Guide is required for each patient.
CAUTION, See package insert for full
Keep out of the sight and
Do not re-use
Refrigerate
Not for Sale
AMGEN
PRINCIPAL DISPLAY PANEL - 50 mg/mL Autoinjector Carton - 032-96
18PRINCIPAL DISPLAY PANEL - 50 mg/mL Cartridge Carton
Contains 4 Single-dose prefilled cartridges
NDC 58406-044-04
Enbrel
50
Not made with
Enbrel Mini
Attention: Not for use in pediatric patient under 138 lbs.
Carton contents (4 prefilled cartridges, 1 package insert with attached
ATTENTION: Enclosed Medication Guide is required for each patient.
Do not Reuse
CAUTION, See package insert
Rx Only
AMGEN
↓ OPEN HERE ↓
PRINCIPAL DISPLAY PANEL - 50 mg/mL Cartridge Carton
19PRINCIPAL DISPLAY PANEL - 50 mg/mL Single-dose Prefilled Cartridge Autoinjector Label
NDC 58406-480-01
AMGEN
Bluetooth
AutoTouch Connect™
For use with Enbrel Mini
Contains 1 AutoTouch Connect™ reusable autoinjector
Store in a dry place at room temperature: 50°F to 104°F (10°C to 40°C)
Do Not Use if Package is Damaged
Rx Only
PRINCIPAL DISPLAY PANEL - 50 mg/mL Single-dose Prefilled Cartridge Autoinjector Label
20PRINCIPAL DISPLAY PANEL - 25 mg/0.5 mL Vial Carton
4 Single-Dose Vials, each vial is 25 mg/0.5mL
AMGEN
Enbrel
25
25 mg/0.5 mL
For Subcutaneous Use Only.
U.S. License No. 1132
Rx Only
PRINCIPAL DISPLAY PANEL - 25 mg/0.5 mL Vial Carton