Medication Guide ENBREL® (en-brel) (etanercept)
/ all vaccines should be brought up-to-date before starting ENBREL®
/ people taking ENBREL® should not receive live vaccines
/ ask your doctor if you are not sure if you received a live vaccine
are allergic to rubber or latex
/ the needle covers on the single-use prefilled syringes and the
single-use prefilled SureClick® autoinjectors contains dry
natural rubber
Read the Medication Guide that comes with ENBREL® before you start
using it and each time you get a refill. There may be new information.
This Medication Guide does not take the place of talking with your doctor
about your medical condition or treatment. It is important to remain under
your doctor’s care while using ENBREL®.
ENBREL® is a prescription medicine called a Tumor Necrosis Factor (TNF)
blocker that affects your immune system.
What is the most important information I should know
about ENBREL®?
ENBREL may cause serious side effects, including:
1. R isk o f infectio n
ENBREL® can lower the ability of your immune system to fight infections.
Some people have serious infections while taking ENBREL®. These
infections include tuberculosis (TB), and infections caused by viruses,
fungi or bacteria that spread throughout their body. Some people have
died from these infections.
• Your doctor should test you for TB before starting ENBREL®.
• Your doctor should monitor you closely for symptoms of TB during
treatment with ENBREL® even if you tested negative for TB.
• Your doctor should check you for symptoms of any type of infection
before, during, and after your treatment with ENBREL®.
You should not start taking ENBREL® if you have any kind of infection
unless your doctor says it is okay.
2. R isk o f ca nce r
• There have been cases of unusual cancers in children and teenage
patients who started using TNF-blocking agents at less than
18 years of age.
• For children, teenagers, and adults taking TNF-blocker medicines,
including ENBREL, the chances of getting lymphoma or other
cancers may increase.
• People with rheumatoid arthritis or psoriasis, especially those with
very active disease, may be more likely to get lymphoma.
B efore s ta rtin g ENBREL®, be su re to ta lk to y o u r do ctor:
ENBREL® may not be right for you. Before starting ENBREL®, tell your
doctor about all of your medical conditions, including:
In fe ctio n s - te ll y o u r d o c to r if you:
• have an infection. (See “What is the most important information
I should know about ENBREL®?” )
• are being treated for an infection
• think you have an infection
• have symptoms of an infection such as fever, sweats or chills, cough
or flu-like symptoms, shortness of breath, blood in your phlegm, weight
loss, muscle aches, warm, red, or painful areas on your skin, sores
on your body, diarrhea or stomach pain, burning when you urinate
or urinate more often than normal, and feel very tired.
• have any open cuts on your body
• get a lot of infections or have infections that keep coming back
• have diabetes, HIV, or a weak immune system. People with these
conditions have a higher chance for infections.
• have TB, or have been in close contact with someone with TB
• were born in, lived in, or traveled to countries where there is a risk for
getting TB. Ask your doctor if you are not sure.
• live, have lived in, or traveled to certain parts of the country (such as the
Ohio and Mississippi River val eys, or the Southwest) where there is a
greater risk for getting certain kinds of fungal infections (histoplasmosis,
coccidioidomycosis, blastomycosis). These infections may happen or
become more severe if you use ENBREL®. Ask your doctor if you do not
know if you live or have lived in an area where these infections are common.
• have or have had hepatitis B
Also, BEFORE s ta rtin g ENBREL®, te ll yo u r doctor:
• A bout all th e m ed icine s you ta ke including prescription
and nonp re scrip tion m edicines, v ita m in s and herbal
su pplem e nts including:
/ Orencia® (abatacept) or Kineret® (anakinra). You have a higher
chance for serious infections when taking ENBREL® with Orencia®
or Kineret®.
/ Cyclophosphamide (Cytoxan®). You may have a higher chance for
getting certain cancers when taking ENBREL® with cyclophosphamide.
Keep a list of all your medications with you to show your doctor and
pharmacist each time you get a new medicine. Ask your doctor if you are
not sure if your medicine is one listed above.
O ther im p o rta n t m e d ica l in fo rm a tio n you sh ould te ll yo u r
d o cto r BEFORE s ta rtin g ENBREL®, in clu d in g if you:
• have or had a nervous system problem such as multiple sclerosis
• have or had heart failure
• are scheduled to have surgery
• have recently received or are scheduled to receive a vaccine
• have been around someone with varicella zoster (chicken pox)
• are pregnant or plan to become pregnant. It is not known if ENBREL®
will harm your unborn baby.
/ Pregnancy Registry: Amgen has a registry for pregnant women
who take ENBREL®. The purpose of this registry
is to check the health of the pregnant mother and her child.
Talk to your doctor if you are pregnant and contact the registry
at 1-877-311-8972.
• are breast feeding or plan to breast feed. It is not known if ENBREL®
passes into your breast milk. You and your doctor should decide
if you will take ENBREL® or breast feed. You should not do both.
See the section “What are the possible side effects of ENBREL®?”
below for more information.
What is ENBREL®?
ENBREL® is a prescription medicine called a Tumor Necrosis Factor
(TNF) blocker.
ENBREL® is used to treat:
• moderately to severely active rheumatoid arthritis (RA). ENBREL®
can be used alone or with a medicine cal ed methotrexate.
• psoriatic arthritis. ENBREL® can be used alone or with methotrexate.
• ankylosing spondylitis (AS)
• chronic, moderate to severe plaque psoriasis in adults ages
18 years and older
• moderately to severely active polyarticular juvenile idiopathic
arthritis (JIA) in children ages 2 years and older.
You may continue to use other medicines that help treat your condition
while taking ENBREL®, such as non-steroidal anti-inflammatory drugs
(NSAIDs) and prescription steroids, as recommended by your doctor.
ENBREL® can help reduce joint damage, and the signs and symptoms of
the above mentioned diseases. People with these diseases have too much
of a protein called tumor necrosis factor (TNF), which is made by your
immune system. ENBREL® can reduce the effect of TNF in the body and
block the damage that too much TNF can cause, but it can also lower the
ability of your immune system to fight infections. See “What is the most
important information I should know about ENBREL®?” and “What
are the possible side effects of ENBREL®?”
Who should not use ENBREL®?
Do not use ENBREL® if you:
• have an infection that has spread through your body (sepsis)
• have ever had an allergic reaction to ENBREL®. See the end of this
Medication Guide for a complete list of ingredients in ENBREL®.
How should I use ENBREL®?
• ENBREL® is given as an injection under the skin (subcutaneous or SC).
• If your doctor decides that you or a caregiver can give the injections of
ENBREL® at home, you or your caregiver should receive training on the
right way to prepare and inject ENBREL®. Do not try to inject ENBREL®
until you have been shown the right way by your doctor or nurse.
• ENBREL® is available in the forms listed below. Your doctor wil
prescribe the type that is best for you.
° Single-use Prefilled Syringe
° Single-use Prefilled SureClick Autoinjector
° Multiple-use Vial
• See the detailed “Patient Instructions for Use" with this Medication
Guide for instructions about the right way to prepare and give your
ENBREL® injections at home.
• Your doctor will tell you how often you should use ENBREL®. Do not
miss any doses of ENBREL®. If you forget to use ENBREL®, inject your
dose as soon as you remember. Then, take your next dose at your
regular(ly) scheduled time. In case you are not sure when to inject
ENBREL®, call your doctor or pharmacist. Do not use ENBREL®
more often than as directed by your doctor.
• Your child’s dose of ENBREL® depends on his or her weight. Your child’s
doctor will tell you which form of ENBREL® to use and how much to give
your child.
What are the possible side effects of ENBREL®?
ENBREL® can cause se rio u s side e ffe c ts , in cluding :
See “ What is the most im portant inform ation I should know
about ENBREL® ? ”
• Infections. ENBREL® can make you more likely to get infections or
make any infection that you have worse. Call your doctor right away
if you have any symptoms of an infection. See “ Before starting
ENBREL®, be sure to talk to your doctor” for a list of symptoms
of infection.
• Hepatitis B infection in people who carry the virus in their blood. If
you are a carrier of the hepatitis B virus (a virus that affects the liver),
the virus can become active while you use ENBREL®. Your doctor may
do a blood test before you start treatment with ENBREL® and while you
use ENBREL®.
• Nervous system problems. Rarely, people who use TNF blocker
medicines have developed nervous system problems such as multiple
sclerosis, seizures, or inflammation of the nerves of the eyes. Tel your
doctor right away if you get any of these symptoms: numbness or
tingling in any part of your body, vision changes, weakness in your arms
and legs, and dizziness.
• Blood problems. Low blood counts have been seen with other TNF
blocker medicines. Your body may not make enough of the blood cells
that help fight infections or help stop bleeding. Symptoms include fever,
bruising or bleeding very easily, or looking pale.
• Heart failure including new heart failure or worsening of heart failure
you already have. New or worse heart failure can happen in people who
use TNF blocker medicines, like ENBREL®. If you have heart failure your
condition should be watched closely while you take ENBREL®. Call your
doctor right away if you get new or worsening symptoms of heart failure
while taking ENBREL® such as shortness of breath or swelling of your
lower legs or feet.
• Psoriasis. Some people using ENBREL® developed new psoriasis or
worsening of psoriasis they already had. Tell your doctor if you develop
red scaly patches or raised bumps which may be filled with pus . Your
doctor may decide to stop your treatment with ENBREL®.
• Allergic reactions. Allergic reactions can happen to people who use
TNF blocker medicines. Call your doctor right away if you have any
symptoms of an allergic reaction. Symptoms of an allergic reaction
include a severe rash, a swollen face, or trouble breathing.
• Autoimmune reactions, including:
/ Lupus-like syndrome. Symptoms include a rash on your face and
arms that gets worse in the sun. Tell your doctor if you have this
symptom. Symptoms may go away when you stop using ENBREL®.
/ Autoimmune hepatitis. Liver problems can happen in people who
use TNF blocker medicines, including ENBREL®. These problems
can lead to liver failure and death. Call your doctor right away if you
have any of these symptoms: feel very tired, skin or eyes look
yellow, poor appetite or vomiting, pain on the right side of your
stomach (abdomen).
C om m on side e ffe c ts o f ENBREL® include :
• Injection site reactions such as redness, swelling, itching, or pain.
These symptoms usually go away within 3 to 5 days. If you have pain,
redness or swelling around the injection site that doesn’t go away or
gets worse, call your doctor.
• Upper respiratory infections (sinus infections)
• Headache
These are not all the side effects with ENBREL®. Tell your doctor about
any side effect that bothers you or does not go away.
Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
How should I store ENBREL®?
• Store ENBREL® in the refrigerator at 36° to 46°F (2° to 8°C).
• Do not freeze.
• Do not shake.
• Keep ENBREL® in the original carton to protect from light.
• Keep ENBREL® and all medicines out of the reach of children.
General Information about ENBREL®
Medicines are sometimes prescribed for purposes not mentioned in a
Medication Guide. Do not use ENBREL® for a condition for which it was
not prescribed. Do not give ENBREL® to other people, even if they have
the same condition. It may harm them.
This Medication Guide summarizes the most important information about
ENBREL®. If you would like more information, talk with your doctor. You
can ask your doctor or pharmacist for information about ENBREL® that
was written for healthcare professionals. For more information call
1-888-4ENBREL (1-888-436-2735).
What are the ingredients in ENBREL®?
Single-use Prefilled Syringe and the Single-use Prefilled
SureClick Autoinjector:
Active Ingredient: etanercept
Inactive Ingredients: sucrose, sodium chloride, L-arginine hydrochloride
and sodium phosphate
Multiple-use Vial:
Active Ingredient: etanercept
Inactive Ingredients: mannitol, sucrose, tromethamine.
1XXXXXX-v3
Issue Date: 11/2009
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
/1MGGN*
Manufactured by Immun» Corporation
Thousand Oaks, CA 91320
Marketed by
Amgen Inc. and Pfizer Inc.
w v rw .m ib r a l.c o m
©2010 8-ngsnl nc., Thouund Oaks, CA91320and Pfizer Inc. Al rights ressnrcd.
