INDICATIONS

ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone. Read More

ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function...Read More

Administration

mini-auto-lock-up

Enbrel Mini®

single-dose prefilled cartridge

with

Auto Touch®

reusable autoinjector

50 mg

comfort

One-Handed Injection and Grip Comfort

Patients can inject with one hand, without the need to pinch or stretch their skin, and the ergonomic design creates a comfortable grip.

control

Speed and Sound Control

Patients can choose from one of three injection speeds based on their comfort level and can switch the sound on or off.

confidence

Injection Progress Confidence

Skin sensor means AutoTouch® activates on skin contact. Prompts guide the injection process. Lights, sounds, and status bar help give patients confidence that they completed their ENBREL injection.

First reusable autoinjector in all ENBREL approved indications.* The AutoTouch® autoinjector is reusable for up to 2 years or 130 injections, whichever comes first.

*For biologic use in moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderate to severe polyarticular juvenile idiopathic arthritis, and moderate to severe plaque psoriasis.

PEDIATRIC RESTRICTIONS

Not for use for children with moderate to severe plaque psoriasis (PsO) or juvenile idiopathic arthritis (JIA) who weigh less than 138 lbs

Prescribing Enbrel Mini® with AutoTouch®

Step 1 Write a prescription for Enbrel Mini single-dose prefilled cartridge

Step 1

 

Write a prescription for

Enbrel Mini®

single-dose prefilled cartridge

Verify that Enbrel Mini® with AutoTouch® is selected in your EMR

 Step 2 Give your patient an AutoTouch reusable autoinjector

Step 2

 

Give your patient an

AutoTouch®

reusable autoinjector in the office or use AutoTouch® Direct

Lower mean injection-site pain

All administration options include a phosphate-free ENBREL formulation that resulted in statistically significant lower mean injection-site pain vs the prior formulation.1†

Multicenter, randomized, double-blind crossover study in 111 patients assessed injection site pain associated with a phosphate-free etanercept formulation in adult patients with moderate to severe rheumatoid arthritis (RA) and psoriatic arthritis (PsA). Eligible patients were randomly assigned to start with the prior or phosphate-free formulation of ENBREL 50 mg weekly (QW). Randomization was stratified by disease. Subjects injected the blinded treatment and immediately recorded the associated injection site pain using the visual analog scale (VAS), from “0, No Pain At All” to “100, Worst Pain Imaginable.” Primary endpoint was change in injection site pain score (results showed reduction in mean injection site pain by a score of 4.0 mm P=0.05 between prior and phosphate-free formulations as measured by VAS).

50 mg

SureClick® Autoinjector

  • Designed so patients do not see the needle
  • Medicine is injected automatically
  • Does not need to be mixed or prepared
PEDIATRIC RESTRICTIONS

Not for use for children with moderate to severe plaque PsO or JIA who weigh less than 138 lbs

50 mg25-mg

Prefilled Syringe

  • Medicine is injected manually which allows control of injection speed
  • Does not need to be mixed or prepared
PEDIATRIC RESTRICTIONS

The 25 mg syringe is not for use for children with moderate to severe plaque PsO or JIA who weigh less than 68 lbs

The 50 mg syringe is not for use for children with moderate to severe plaque PsO or JIA who weigh less than 138 lbs

 

Available in

 Enbrel multiple-dose vial

Multiple-Dose Vial

  • Allows for multiple doses
  • For example weight-based dosing in pediatric JIA patients 2 years or older or pediatric moderate to severe plaque PsO patients ages 4-17 who weigh less than 138 lbs

  • Only option available for children with moderate to severe plaque PsO or JIA who weigh less than 68 lbs
  • Medicine is injected manually which allows control of injection speed

How to inject Enbrel using the Vial Adapter Method

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method What is the Vial Adapter Method?
This method uses a vial adapter to help mix the powder with the liquid and withdraw ENBREL. This method should not be used for children using multiple doses from the same vial of ENBREL.

Section One: Gather your injection materials

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Gather your injection materials
Here is what you’ll need to get started.

Gather your injection materials

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Gather your injection materials
  • Wash your hands with soap and warm water
  • Take the ENBREL dose tray out of the refrigerator and place it on a clean, well-lit, flat work surface
  • Leave the dose tray at room temperature for 15 to 30 minutes before using for a more comfortable injection

Check the expiration date

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Check the expiration date
  • If the expiration date has passed, do NOT use the dose tray
  • Contact your pharmacist or call 1-888-4ENBREL (1-888-436-2735)

 Review your injection materials

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Review your injection materials
  • One prefilled diluent syringe with an attached adapter and twist-off cap
  • One plunger
  • One ENBREL vial
  • One vial adapter
  • One 27-gauge ½-inch needle in a hard plastic cover

IMPORTANT: If any of these items are missing or look damaged, call your pharmacist or 1-888-4ENBREL (1-888-436-2735).

 Check the mixing fluid

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Check the mixing fluid
  • With the twist-off cap pointing down, check the amount of liquid in the syringe
  • Be sure there is at least 1 mL of liquid inside

IMPORTANT: Do NOT use the syringe if there is less than 1 mL of liquid. Do NOT use the syringe if the twist-off cap is missing or not tightly attached. Call your pharmacist or 1-888-4ENBREL (1-888-4ENBREL).

Section Two: Prepare the needle, vial, and adapter

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Prepare the needle, vial, and adapter
Learn how to set up your needle, vial, and adapter.

Remove vial cap

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Remove vial cap
  • Remove the pink plastic cap from the vial

IMPORTANT: Do NOT remove the gray stopper or silver metal ring around the top of the vial.

Clean stopper

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Clean stopper
  • Place the vial on your flat work surface or turn your dose tray upside down and place it in the space marked “V”
  • Clean the gray stopper on the vial with an alcohol swab

IMPORTANT: Do NOT touch the gray stopper with your hands.

 Open needle and adapter packages

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Open needle and adapter packages
  • Open the wrappers that hold the needle and vial adapter by peeling apart the tabs 
  • Set them both aside for later

IMPORTANT: Do NOT touch the vial adapter’s twist-on end or the spike inside.

Attach plunger

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Attach plunger
  • Slide the plunger into the flange end of the syringe (see figure 1)
  • Attach the plunger to the gray rubber stopper in the syringe by turning the plunger clockwise until you feel a slight resistance (see figure 2)

 Remove twist-off cap

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Remove twist-off cap
  • Remove the twist-off cap by turning counterclockwise (you may see a drop of liquid when removing the cap–this is normal)
  • Place the cap on your flat work surface

IMPORTANT: Do NOT touch or bump the plunger. Do NOT touch the syringe tip.

 Attach vial adapter to syringe

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Attach vial adapter to syringe
  • Twist the vial adapter onto the syringe, turning clockwise, until you feel slight resistance

IMPORTANT: Do NOT over-tighten.

Attach vial adapter to vial

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Attach vial adapter to vial
  • Hold the vial upright on your flat work surface
  • Hold the sides of the vial adapter and put it over the top of the vial
  • Insert the adapter into the gray stopper on the vial (the spike should puncture the stopper)
  • Be sure the vial adapter fits snugly

IMPORTANT: Do NOT touch or bump the plunger.

 Push plunger down

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Push plunger down
  • Hold the vial upright on your flat work surface 
  • Push the plunger down until all the liquid from the syringe is in the vial (you may see foaming/bubbles in the vial–this is normal)

Dissolve powder

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Dissolve powder
  • Gently swirl the vial in a circular motion to dissolve the powder
  • If you used the dose tray to hold the vial, take the vial out (with the vial adapter and syringe still attached)
  • Wait until all the powder dissolves (usually less than 10 minutes)
  • The solution should be clear and colorless (there may still be foam/bubbles)

IMPORTANT: Do NOT shake. Do NOT inject the solution if it is discolored or contains lumps, flakes, or particles. If all of the powder in the vial is not dissolved or there are still particles after 10 minutes, call 1-888-4ENBREL (1-888-436-2735).

 Section Three: Withdraw the solution

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Withdraw the solution
Learn the steps for filling your syringe with ENBREL.

Withdraw ENBREL from vial

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Withdraw ENBREL from vial
  • Turn the vial upside down
  • Hold the syringe at eye level 
  • Slowly pull the plunger down to the markings on the syringe that match your prescribed dose
  • Be careful not to pull the plunger completely out of the syringe
  • Some white foam may remain in the vial—this is normal

 Check for bubbles

Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Check for bubbles
  • Gently tap the syringe to make any bubbles rise to the top 
  • Slowly push the plunger up to remove the air bubbles
  • If you push some solution back into the vial, slowly pull back on the plunger to fill it back up to your prescribed dose

 Remove vial adapter


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Remove vial adapter
  • Hold the vial adapter with one hand 
  • Turn the syringe counterclockwise with your other hand
  • Place the vial with the vial adapter on your flat work surface

IMPORTANT: Do NOT touch or bump the plunger.

 Attach the needle


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Attach the needle
  • Continue to hold the barrel of the syringe
  • Twist the 27-gauge needle onto the tip of the syringe with your free hand until it fits snugly
  • Place the syringe on your flat work surface until you are ready to inject ENBREL

IMPORTANT: Do NOT remove the needle cover from the syringe yet.

 Section Four: Inject ENBREL


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Inject ENBREL
Walk through each step to inject ENBREL.

Choose your injection site


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Choose your injection site

There are three recommended injection sites for ENBREL:

  1. 1. The front of the middle thighs
  2. 2. The outer area of the upper arms
  3. 3. The stomach (except for the two-inch area right around the navel)

 Rotate injection sites


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Rotate injection sites
  • Alternate your injection sites each time you inject ENBREL
  • Avoid areas with scars or stretch marks

IMPORTANT: Do NOT inject into areas where the skin is tender, bruised, red, or hard. If you have psoriasis, do NOT inject into any raised, thick, red, or scaly skin patches or lesions.

Prepare your injection site


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Prepare your injection site
  • Wipe your injection site with a new alcohol swab

IMPORTANT: Do NOT touch this area again before giving the injection.

Remove needle cover


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Remove needle cover
  • When you are ready to inject, 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 (There may be a drop of liquid at the end of the needle. This is normal.)

IMPORTANT: Do NOT twist or bend the needle cover while you are removing it. Do NOT try to put the needle cover back onto the syringe. Do NOT touch the needle or allow it to touch any surface. Do NOT touch or bump the plunger.

Pinch injection site


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Pinch injection site
  • 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
  • Push the needle into the skin with a quick, dart-like motion

 Push plunger down


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Push plunger down
  • When the needle is completely in the skin, let go of the skin 
  • With your free hand, hold the syringe near its base to stabilize it 
  • Slowly push the plunger to inject all of the ENBREL solution at a steady rate

 Pull needle out


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Pull needle out
  • When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle
  • If there is a little bleeding, you can press a cotton ball over the injection site for 10 seconds, or cover the injection site with a bandage

IMPORTANT: Do NOT rub the injection site. Injection site reactions, such as redness, rash, swelling, itching, or bruising, may occur. These symptoms usually go away within 3 to 5 days. If you experience these reactions and they don’t go away or get worse, call your doctor.

 Repeat steps for additional injections


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Repeat steps for additional injections
  • If your doctor instructed you to take two ENBREL injections on the same day, repeat the steps to give yourself another injection of ENBREL, using a different vial and vial adapter
  • Choose and prepare a new injection site for the second injection

 Section Five: Disposal and Storage


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Disposal and storage
Here’s how to get rid of your materials and store ENBREL.

Getting rid of materials


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Getting rid of materials
  • The syringe, needles, and vial adapters should never be reused
  • Never recap a needle
  • Never throw the needle or syringe in the household trash or recycling
  • Place the used needle and syringe in a hard plastic needle disposal container with a screw-on cap (you can also use a metal container with a plastic lid, such as a coffee can)
  • Always keep the container out of the reach of children

IMPORTANT: Do NOT use glass or clear plastic containers.

How to get rid of needle disposal containers


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method How to get rid of needle disposal containers
  • When the container is full, tape around the cap or lid to make sure the cap or lid does not come off
  • You should always check first with your doctor for instructions on how to properly get rid of a filled disposal container
  • There may be special state and local laws for getting rid of used needles and syringes

IMPORTANT: Do NOT throw the disposal container in the household trash or recycling.

How to get rid of needle disposal containers


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method How to get rid of supplies
  • The ENBREL vial, vial adapter, and used alcohol swabs should be placed in the trash
  • The dose tray and cover may be recycled

Storing ENBREL


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Storing ENBREL

In general, ENBREL should be kept at 36°F to 46°F (2°C to 8°C; the standard temperature range of most refrigerators).

However, if needed, the ENBREL syringe and dose tray can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days.

Important information for storing ENBREL


Do not use this method for children injecting multiple doses from a single vial.

1 of 36
Vial Adapter Method Important information for storing ENBREL
  • ENBREL should be stored in the refrigerator
  • Throw away ENBREL that has been at room temperature for more than 14 days
  • Keep ENBREL in the original box to protect it from light or physical damage
  • Keep ENBREL and all medicines away from children
  • Do NOT put ENBREL back in the fridge after it reaches room temperature
  • Do NOT store ENBREL in extreme heat or cold (for example, in your car)
  • Do NOT freeze ENBREL
  • Do NOT shake ENBREL

In clinical trials, all injection site reactions were described as mild to moderate (erythema, itching, pain, swelling, bleeding, bruising) and generally did not necessitate drug discontinuation. The mean duration of injection site reactions was 3 to 5 days.2

How to inject Enbrel using the Free-Hand Method
1 of 39
Free-Hand Method What is the Free-Hand Method?
This method uses a 25-gauge needle (not included) to help mix the powder with the liquid and withdraw ENBREL. You should get the 25-gauge needle from your doctor.
Section One: Gather your injection materials
1 of 39
Free-Hand Method Gather your injection materials
Here is what you’ll need to get started.
Gather your injection materials
1 of 39
Free-Hand Method Gather your injection materials
  • Wash your hands with soap and warm water
  • Take the ENBREL dose tray out of the refrigerator and place it on a clean, well-lit, flat work surface
  • Leave the dose tray at room temperature for 15 to 30 minutes before using for a more comfortable injection
Check the expiration date
1 of 39
Free-Hand Method Check the expiration date
  • If the expiration date has passed, do NOT use the dose tray
Contact your pharmacist or call 1-888-4ENBREL (1-888-436-2735).
Review your injection materials
1 of 39
Free-Hand Method Review your injection materials
  • One prefilled diluent syringe with an attached adapter and twist-off cap
  • One plunger
  • One ENBREL vial
  • One vial adapter
  • One 27-gauge ½-inch needle in a hard plastic cover 

You will need an additional 25-gauge needle that is not provided in this kit. Your doctor can provide you with this needle.

IMPORTANT: If any of these items are missing or look damaged, call your pharmacist or 1-888-4ENBREL (1-888-436-2735).
 Check the mixing fluid
1 of 39
Free-Hand Method Check the mixing fluid
  • With the twist-off cap pointing down, check the amount of liquid in the syringe
  • Be sure there is at least 1 mL of liquid inside
IMPORTANT: Do NOT use the syringe if there is less than 1 mL of liquid. Do NOT use the syringe if the twist-off cap is missing or not tightly attached. Call your pharmacist or 1-888-4ENBREL (1-888-436-2735).
 Section Two: Prepare the needle and vial
1 of 39
Free-Hand Method Prepare the needle and vial
Learn how to set up your needle and vial.
 Remove vial cap
1 of 39
Free-Hand Method Remove vial cap
  • Remove the pink plastic cap from the vial 

IMPORTANT: Do NOT remove the gray stopper or silver metal ring around the top of the vial.

 Clean stopper
1 of 39
Free-Hand Method Clean stopper
  • Place the vial on your flat work surface or turn your dose tray upside down and place it in the space marked “V”
  • Clean the gray stopper on the vial with an alcohol swab
IMPORTANT: Do NOT touch the gray stopper with your hands.
 Prepare 25-gauge needle
1 of 39
Free-Hand Method Prepare 25-gauge needle

The 25-gauge needle will be used to mix the liquid with the powder and to withdraw ENBREL from the vial.

  • Open the wrapper that holds the 25-gauge needle (available from your doctor) by peeling apart the tabs
  • Set the needle aside for later use
 Attach plunger
1 of 39
Free-Hand Method Attach plunger
  • Slide the plunger into the flange end of the syringe (see figure 1)
  • Attach the plunger to the gray rubber stopper in the syringe by turning the plunger clockwise until you feel a slight resistance (see figure 2)
 Remove twist-off cap
1 of 39
Free-Hand Method Remove twist-off cap
  • Remove the twist-off cap by turning counterclockwise (you may see a drop of liquid when removing the cap–this is normal)
  • Place the cap on your flat work surface

IMPORTANT: Do NOT touch or bump the plunger. Do NOT touch the syringe tip.

 Attach needle to syringe
1 of 39
Free-Hand Method Attach needle to syringe
  • Hold the barrel of the syringe
  • Twist the 25-gauge needle onto the tip of the syringe until it fits snugly
  • Place the syringe on your flat work surface
 Prepare 27-gauge needle
1 of 39
Free-Hand Method Prepare 27-gauge needle

The 27-gauge needle is for injecting ENBREL.

  • Open the wrapper that contains the 27-gauge needle (included in your kit) by peeling apart the tabs
  • Set the needle aside for later use
 Remove needle cover
1 of 39
Free-Hand Method Remove needle cover
  • 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 (see figure 1)
  • Place the needle cover (open side up) in the round space marked “N” in the ENBREL dose tray (see figure 2)
IMPORTANT: Do NOT twist or bend the needle cover while you are removing it. Do NOT try to put the needle cover back on the syringe. Do NOT touch the needle or allow it to touch any surface. Do NOT touch or bump the plunger.
 Section Three: Withdraw the solution
1 of 39
Free-Hand Method Withdraw the solution
Learn the steps for filling your syringe with ENBREL.
Insert needle into vial
1 of 39
Free-Hand Method Insert needle into vial
  • Place the vial on your flat work surface
  • Hold the syringe with the needle facing up
  • Gently pull back on the plunger to pull a small amount of air into the syringe
  • Insert the 25-gauge needle straight through the center ring of the gray stopper. You should feel a slight resistance and then a “pop” as the needle goes through the center of the stopper
  • Look for the needle tip inside the stopper window
IMPORTANT: If the needle is not correctly lined up with the center of the stopper, you will feel constant resistance as it goes through the stopper and you will not hear a “pop.”
 Push plunger down
1 of 39
Free-Hand Method Push plunger down
  • Push the plunger down VERY SLOWLY until all the liquid from the syringe is in the vial (if you add the liquid too fast, it will cause foaming/bubbles)
 Dissolve powder
1 of 39
Free-Hand Method Dissolve powder
  • Gently swirl the vial in a circular motion to dissolve the powder
  • Wait until all the powder dissolves (usually less than 10 minutes)
  • The solution should be clear and colorless (there may still be foam/bubbles)
IMPORTANT: Do NOT shake. Do NOT inject the solution if it is discolored or contains lumps, flakes, or particles. If all the powder in the ENBREL vial is not dissolved or if there are particles present after 10 minutes, call 1-888-4ENBREL (1-888-436-2735).
 Withdraw ENBREL from vial
1 of 39
Free-Hand Method Withdraw ENBREL from vial
  • With the 25-gauge needle in the vial, turn the vial upside down
  • Hold the syringe at eye level
  • Slowly pull the plunger down to the markings on the syringe that match your prescribed dose
  • Be sure to keep the tip of the needle in the solution
  • Some white foam may remain in the vial—this is normal
Check for bubbles
1 of 39
Free-Hand Method Check for bubbles
  • With the 25-gauge needle still inside the vial, gently tap the syringe to make any bubbles rise to the top
  • Slowly push the plunger up to remove the air bubbles
  • If you push some solution back into the vial, slowly pull back on the plunger to fill it back up to your prescribed dose
 Remove syringe and needle from vial
1 of 39
Free-Hand Method Remove syringe and needle from vial
  • Remove syringe and 25-gauge needle from the vial
  • Keep the needle attached to the syringe
  • Insert the 25-gauge needle straight down into the needle cover in the ENBREL dose tray
  • Listen for a “snap” when the needle is secure in the needle cover
  • Untwist the 25-gauge needle from the syringe and put it in your needle disposal container
Attach 27-gauge needle to syringe
1 of 39
Free-Hand Method Attach 27-gauge needle to syringe
  • Twist the 27-gauge needle onto the syringe until it fits snugly
  • Place the syringe on your flat work surface until you are ready to inject ENBREL
IMPORTANT:  Do NOT remove the needle cover from the syringe yet.
Section Four: Inject ENBREL
1 of 39
Free-Hand Method Inject ENBREL
Walk through each step to inject ENBREL.
 Choose your injection site
1 of 39
Free-Hand Method Choose your injection site

There area three recommended injection sites for ENBREL:

  1. 1. The front of the middle thighs
  2. 2. The outer area of the upper arms
  3. 3. The stomach (except for the two-inch area right around the navel)
 Rotate injection sites
1 of 39
Free-Hand Method Rotate injection sites
  • Alternate your injection sites each time you inject ENBREL
  • Avoid areas with scars or stretch marks
IMPORTANT: Do NOT inject into areas where the skin is tender, bruised, red, or hard. If you have psoriasis, do NOT inject into any raised, thick, red, or scaly skin patches or lesions.
 Prepare your injection site
1 of 39
Free-Hand Method Prepare your injection site
  • Wipe your injection site with a new alcohol swab
IMPORTANT: Do NOT touch this area again before giving the injection.
 Remove needle cover
1 of 39
Free-Hand Method Remove needle cover
  • When you are ready to inject, pick up the syringe from your flat work surface
  • Hold the barrel of the syringe with one hand, and pull the 27-gauge needle cover straight off (There may be a drop of liquid at the end of the needle. This is normal.)
IMPORTANT: Do NOT twist or bend the needle cover while you are removing it. Do NOT try to put the needle cover back onto the syringe. Do NOT touch the needle or allow it to touch any surface. Do NOT touch or bump the plunger.
Pinch injection site
1 of 39
Free-Hand Method Pinch injection site
  • 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
  • Push the needle into the skin with a quick, dart-like motion
Push plunger down
1 of 39
Free-Hand Method Push plunger down
  • When the needle is completely in the skin, let go of the skin
  • With your free hand, hold the syringe near its base to stabilize it
  • Slowly push the plunger to inject all of the ENBREL solution at a steady rate
 Pull needle out
1 of 39
Free-Hand Method Pull needle out
  • When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle
  • If there is a little bleeding, you can press a cotton ball over the injection site for 10 seconds, or cover the injection site with a bandage.

IMPORTANT: Do NOT rub the injection site. Injection site reactions such as redness, rash, swelling, itching, or bruising may occur. These symptoms usually go away within 3 to 5 days. If you experience these reactions and they don’t go away or get worse, call your doctor.

Repeat steps for additional injections
1 of 39
Free-Hand Method Repeat steps for additional injections
  • For some children, one vial can be used for more than one dose
  • For each additional dose, you will need two new needles (one 25-gauge needle and one 27-gauge needle). Never reuse a syringe or needle
  • If your doctor instructed you to take two ENBREL injections on the same day, repeat the steps to give yourself another injection of ENBREL
  • Choose and prepare a new injection site for the second injection
IMPORTANT: If there is enough solution in the vial for another dose, write the date you mixed the powder and liquid in the area marked “Mixing Date” on the sticker and attach it to the vial.
Store any remaining solution
1 of 39
Free-Hand Method Store any remaining solution
  • If there is enough solution left in the ENBREL vial for another dose, write the date you mixed the powder and the liquid in the area marked “Mixing Date” on the sticker supplied with these instructions and attach the sticker to the ENBREL vial
  • Refrigerate the ENBREL vial (in the dose tray) after use. Otherwise, throw away the ENBREL vial and any remaining solution
  • Throw away the refrigerated ENBREL solution if more than 14 days have passed since it was mixed
  • Remember: NEVER REUSE A NEEDLE OR SYRINGE
  • You will need to get a new 27-guage needle from you doctor for each additional injection taken from a previously mixed vial
Section Five: Disposal and storage
1 of 39
Free-Hand Method Disposal and storage
Here’s how to get rid of your materials and store ENBREL.
Getting rid of materials
1 of 39
Free-Hand Method Getting rid of materials
  • The syringe and needles should never be reused
  • Never recap a needle
  • Never throw the needle or syringe in the household trash or recycling
  • Place the used needle and syringe in a hard plastic needle disposal container with a screw-on cap (you can also use a metal container with a plastic lid, such as a coffee can)
  • Always keep the container out of the reach of children

IMPORTANT: Do NOT use glass or clear plastic containers.

 How to get rid of needle disposal containers
1 of 39
Free-Hand Method How to get rid of needle disposal containers
  • When the container is full, tape around the cap or lid to make sure the cap or lid does not come off
  • You should always check first with your doctor for instructions on how to properly get rid of a filled disposal container
  • There may be special state and local laws for getting rid of used needles and syringes

 IMPORTANT: Do NOT throw the disposal container in the household trash or recycling.

 How to get rid of needle disposal containers
1 of 39
Free-Hand Method How to get rid of supplies
  • The ENBREL vial and used alcohol swabs should be placed in the trash
  • The dose tray and cover may be recycled
 Storing ENBREL
1 of 39
Free-Hand Method Storing ENBREL
In general, ENBREL should be kept at 36°F to 46°F (2°C to 8°C; the standard temperature range of most refrigerators). However, if needed, the ENBREL syringe and dose tray can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days.
Important information for storing ENBREL
1 of 39
Free-Hand Method Important information for storing ENBREL
  • ENBREL should be stored in the refrigerator
  • Throw away ENBREL that has been at room temperature for more than 14 days
  • Keep ENBREL in the original box to protect it from light or physical damage
  • Keep ENBREL and all medicines away from children
  • Do NOT put ENBREL back in the fridge after it reaches room temperature
  • Do NOT store ENBREL in extreme heat or cold (for example, in your car)
  • Do NOT freeze ENBREL
  • Do NOT shake ENBREL

Dosing

Moderate to Severe Rheumatoid Arthritis

plus-img minus-img

For adult patients, the recommended dose of ENBREL is 50 mg weekly2*:

* MTX, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDS) or analgesics may be continued during treatment with ENBREL.

Psoriatic Arthritis

plus-img minus-img

For adult patients, the recommended dose of ENBREL is 50 mg weekly2*:

* MTX, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDS) or analgesics may be continued during treatment with ENBREL.

Moderate to Severe Plaque Psoriasis

plus-img minus-img

For adult patients, step-down dosing is recommended2:

  • Starting Dose: ENBREL 50 mg twice weekly for 3 months*
  • Maintenance Dose: ENBREL 50 mg once weekly after 3 months
  • Starting doses of ENBREL 25 mg or 50 mg per week were also shown to be efficacious

For pediatric patients ages 4-17, the recommended dosing is weight-based2†:

  • 138 lbs or more: 50 mg once weekly
  • Less than 138 lbs: 0.8 mg/kg once weekly

* MTX, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDS) or analgesics may be continued during treatment with ENBREL.

Higher doses of ENBREL have not been studied in pediatric patients.

Ankylosing Spondylitis

plus-img minus-img

For adult patients, the recommended dose of ENBREL is 50 mg weekly2*:

* MTX, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDS) or analgesics may be continued during treatment with ENBREL.

Moderate to Severe Polyarticular Juvenile Idiopathic Arthritis

plus-img minus-img

For JIA patients ages 2 and older, the recommended dosing is weight-based2*:

  • 138 lbs or more: 50 mg once weekly
  • Less than 138 lbs: 0.8 mg/kg once weekly

* Higher doses of ENBREL have not been studied in pediatric patients.

Glucocorticoids, NSAIDS, or analgesics may be continued during treatment with ENBREL.

Storage Guidelines for ENBREL

Enbrel Mini® Cartridge with AutoTouch® Autoinjector

plus-img minus-img
Temperature
  • Store Enbrel Mini®, the prefilled cartridge which contains ENBREL, in the refrigerator between 36°F to 46°F (2°C to 8°C)
  • If needed, Enbrel Mini® cartridge may be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days
    • Discard Enbrel Mini® cartridge that has been stored at room temperature for more than 14 days
  • Enbrel Mini® cartridge should not be returned to the refrigerator after it has reached room temperature
  • Do not store Enbrel Mini® cartridge in extreme heat or cold. Do not freeze
  • Do not store AutoTouch® reusable autoinjector in the refrigerator
Exposure to Light
  • Store Enbrel Mini® cartridge in the original carton to protect from light or damage
Shaking
  • Do not shake ENBREL

SureClick® Autoinjector

plus-img minus-img
Temperature
  • Store SureClick® autoinjector in the refrigerator at 36°F to 46°F (2°C to 8°C)
  • If needed, SureClick® autoinjector may be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days
    • Discard SureClick® autoinjector that has been stored at room temperature for more than 14 days
  • SureClick® autoinjector should not be returned to the refrigerator after it has reached room temperature
  • Do not store the SureClick® autoinjector injector in extreme heat or cold. Do not freeze
Exposure to Light
  • Store SureClick® autoinjector in the original carton to protect from light or physical damage
Shaking
  • Do not shake ENBREL

Prefilled Syringe

plus-img minus-img
Temperature
  • Store ENBREL prefilled syringe in the refrigerator between 36°F to 46°F (2°C to 8°C)
  • If needed, ENBREL prefilled syringe may be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days
    • Discard ENBREL prefilled syringe that has been stored at room temperature for more than 14 days
  • ENBREL prefilled syringe should not be returned to the refrigerator after it has reached room temperature
  • Do not store the ENBREL prefilled syringe in extreme heat or cold. Do not freeze
Exposure to Light
  • Store ENBREL prefilled syringe in the original carton to protect from light or physical damage
Shaking
  • Do not shake ENBREL

Multiple-Dose Vial

plus-img minus-img
Temperature
  • Store ENBREL multi-dose vial in the refrigerator between 36°F to 46°F (2°C to 8°C)
  • If needed, the dose tray for the ENBREL multi-dose vial may be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days
    • Discard ENBREL multi-dose vial that has been stored at room temperature for more than 14 days
  • Mixed ENBREL powder 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
  • ENBREL multi-dose vial should not be returned to the refrigerator after it has reached room temperature
  • Do not store the ENBREL multi-dose vial in extreme heat or cold. Do not freeze
Exposure to Light
  • Store ENBREL multi-dose vial in the original carton to protect from light or physical damage
Shaking
  • Do not shake ENBREL

Prescription Enbrel® (etanercept) is administered by injection.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

SERIOUS INFECTIONS

Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of their underlying disease. ENBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components. ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before ENBREL use and periodically during therapy. Treatment for latent infection should be initiated prior to ENBREL use, 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness, and 3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with ENBREL should be carefully considered prior to initiating therapy in patients 1) with chronic or recurrent infection, 2) who have been exposed to TB, 3) who have resided or traveled in areas of endemic TB or endemic mycoses, or 4) with underlying conditions that may predispose them to infections such as advanced or poorly controlled diabetes. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ENBREL, including the possible development of TB in patients who tested negative for latent TB prior to initiating therapy.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including ENBREL.

In adult clinical trials of all TNF blockers, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA patients. The role of TNF blocker therapy in the development of malignancies is unknown.

Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in RA and other indications. The risk of leukemia may be higher in patients with RA (approximately 2-fold) than the general population.

Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patients at increased risk for skin cancer.

Pediatric Patients

In patients who initiated therapy at ≤18 years of age, approximately half of the reported malignancies were lymphomas (Hodgkin’s and non-Hodgkin’s lymphoma). Other cases included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.

NEUROLOGIC REACTIONS

Treatment with TNF-blocking agents, including ENBREL, has been associated with rare (<0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability, and with peripheral nervous system demyelinating disorders. Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with ENBREL therapy. Prescribers should exercise caution in considering the use of ENBREL in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.

CONGESTIVE HEART FAILURE

Cases of worsening congestive heart failure (CHF) and, rarely, new-onset cases have been reported in patients taking ENBREL. Caution should be used when using ENBREL in patients with CHF. These patients should be carefully monitored.

HEMATOLOGIC REACTIONS

Rare cases of pancytopenia, including aplastic anemia, some fatal, have been reported. The causal relationship to ENBREL therapy remains unclear. Exercise caution when considering ENBREL in patients who have a previous history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection. Consider discontinuing ENBREL if significant hematologic abnormalities are confirmed.

HEPATITIS B REACTIVATION

Reactivation of hepatitis B has been reported in patients who were previously infected with hepatitis B virus (HBV) and received concomitant TNF-blocking agents, including ENBREL. Most reports occurred in patients also taking immunosuppressive agents, which may contribute to hepatitis B reactivation. Exercise caution when considering ENBREL in these patients.

ALLERGIC REACTIONS

Allergic reactions associated with administration of ENBREL during clinical trials have been reported in <2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of ENBREL should be discontinued immediately and appropriate therapy initiated.

IMMUNIZATIONS

Live vaccines should not be administered to patients on ENBREL. Pediatric patients, if possible, should be brought up to date with all immunizations prior to initiating ENBREL. In patients with exposure to varicella virus, temporarily discontinue ENBREL and consider prophylactic treatment with Varicella Zoster Immune Globulin.

AUTOIMMUNITY

Autoantibodies may develop with ENBREL, and rarely lupus-like syndrome or autoimmune hepatitis may occur. These may resolve upon withdrawal of ENBREL. Stop ENBREL if lupus-like syndrome or autoimmune hepatitis develops.

WEGENER’S GRANULOMATOSIS PATIENTS

The use of ENBREL in patients with Wegener’s granulomatosis receiving immunosuppressive agents (eg, cyclophosphamide) is not recommended.

MODERATE TO SEVERE ALCOHOLIC HEPATITIS

Based on a study of patients treated for alcoholic hepatitis, exercise caution when using ENBREL in patients with moderate to severe alcoholic hepatitis.

ADVERSE REACTIONS

The most commonly reported adverse reactions in RA clinical trials were injection site reaction and infection. In clinical trials of all other adult indications, adverse reactions were similar to those reported in RA clinical trials.

In general, the adverse reactions in pediatric patients were similar in frequency and type as those seen in adult patients. The types of infections reported in pediatric patients were generally mild and consistent with those commonly seen in the general pediatric population.

DRUG INTERACTIONS

The use of ENBREL in patients receiving concurrent cyclophosphamide therapy is not recommended. The risk of serious infection may increase with concomitant use of abatacept therapy. Concurrent therapy with ENBREL and anakinra is not recommended. Hypoglycemia has been reported following initiation of ENBREL therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.

Please see Prescribing Information and Medication Guide.

INDICATIONS

ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). ENBREL can be initiated in combination with methotrexate (MTX) or used alone.

ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). ENBREL can be used with or without MTX.

ENBREL is indicated for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).

ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older.

IMPORTANT SAFETY INFORMATION AND INDICATIONS: SERIOUS INFECTIONS

Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of their underlying disease. ENBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components. ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before ENBREL use and periodically during therapy.