What is etanercept?
Etanercept works by decreasing a certain protein produced by the immune system. The immune
system helps the body fight infections. In people with autoimmune disorders, the immune system
mistakes the body's own cells for invaders and attacks them.
Etanercept is used to treat the symptoms of rheumatoid arthritis, psoriatic arthritis, or ankylosing
spondylitis, and to prevent joint damage caused by these conditions. It is also used to treat plaque
psoriasis in adults and polyarticular juvenile idiopathic arthritis in children who are at least 2 years old.
Etanercept is
not a cure
for any autoimmune disorder and will only treat the
symptoms of your condition.
Etanercept may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking etanercept?
You should not use this medication if you are allergic to etanercept, or if you have a severe
infection such as sepsis (infection of the blood).
Before using etanercept, tell your doctor if you have ever had tuberculosis, if anyone in your
household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.
If you have any of these other conditions, you may need a dose adjustment or special tests to
safely use this medication:
-
a weak immune system;
-
any type of infection including a skin infection or open
sores;
-
diabetes;
-
congestive heart failure;
-
a nerve disorder such as multiple sclerosis, myelitis, or optic
neuritis;
-
epilepsy or other seizure disorder;
-
asthma or other breathing disorder;
-
if you have ever had hepatitis B;
-
if you are allergic to latex rubber;
-
if you have recently been vaccinated with BCG (Bacille
Calmette-Guerin); or
-
if you are scheduled to receive any vaccines.
FDA pregnancy category B. Etanercept is not expected to be harmful
to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether etanercept passes into breast milk or if it could harm a nursing
baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Children using this medication should be current on all childhood immunizations before
starting treatment with etanercept.
Using etanercept may increase your risk of developing certain types of cancer such as
lymphoma (cancer of the lymph nodes). This risk may be greater in children and young adults. Talk to
your doctor about your specific risk.
How should I take etanercept?
Before you start treatment with etanercept, your doctor may perform tests to make sure you do
not have tuberculosis or other infections.
Some infections are more likely to occur in certain areas of the world. Tell your doctor
where you live and where you have recently traveled or plan to travel to during treatment.
Etanercept is given as an injection under the skin. Your doctor, nurse, or other healthcare
provider will give you this injection. You may be shown how to inject your medicine at home. Do not
self-inject this medicine if you do not fully understand how to give the injection and properly dispose of
used needles and syringes.
This medication comes with patient instructions for safe and effective use. Follow these
directions carefully. Ask your doctor or pharmacist if you have any questions.
You may need to mix etanercept with a liquid (diluent) before using it. If you are using the
injections at home, be sure you understand how to properly mix and store the medication.
A single-use prefilled syringe is for one injection only. Throw the used syringe away after one
use, even if there is still medicine left in it. The prefilled
Sureclick
autoinjector is for
use only in people who weigh 138 pounds or more.
Your care provider will show you the places on your body where you can safely inject the
medication. Do not inject into the same place two times in a row. Avoid injecting into skin that is
bruised, tender, red, or hard.
You may have pain, redness, swelling, or warmth where the medicine was injected. Call
your doctor if these symptoms continue for longer than 5 days.
Use each disposable needle only one time. Throw away used needles in a puncture-proof
container (ask your pharmacist where you can get one and how to dispose of it). Keep this container
out of the reach of children and pets.
Etanercept can lower blood cells that help your body fight infections. This can make it easier
for you to bleed from an injury or get sick from being around others who are ill. While you are using
etanercept, your blood may need to be tested on a regular basis. Do not miss any scheduled
appointments.
If you need to have any type of surgery, tell the surgeon ahead of time that you are using
etanercept.
If you have chronic hepatitis B you may develop liver symptoms while using etanercept and
even months after you stop using it. Your doctor may want to check your liver function at regular visits
for up to several months after you stop using etanercept. Do not miss any scheduled appointments.
Autoimmune disorders are often treated with a combination of different drugs. To best treat
your condition, use all of your medications as directed by your doctor. Be sure to read the medication
guide or patient instructions provided with each of your medications. Do not change your doses or
medication schedule without advice from your doctor.
Store this medication in the refrigerator. Do not freeze. Etanercept that has been mixed
with a diluent should be kept in a refrigerator and used within 14 days. Do not use etanercept if the
expiration date on the medicine label has passed.
You may take the prefilled syringe or autoinjector out of the refrigerator and allow it to reach
room temperature before injecting the medication.
Do not shake the prefilled syringe. Vigorous shaking can ruin the medicine. Do not use the
medication if it has changed colors or appears cloudy. Call your doctor for a new prescription.
What happens if I miss a dose of etanercept?
Call your doctor for instructions if you miss your etanercept dose.
Where can I get more information about etanercept?
Your pharmacist has information about etanercept written for health professionals that you may read.
What are the possible side effects of etanercept?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with etanercept.
Stop using etanercept and call your doctor right away if you have signs of infection
such as:
-
fever, sweating, chills, tired feeling;
-
feeling short of breath;
-
cough, sore throat; or
-
flu symptoms, weight loss.
Call your doctor at once if you have any of these other serious side
effects:
-
shortness of breath with swelling, rapid weight gain;
-
chest pain, ongoing cough, coughing up blood;
-
easy bruising or bleeding, pale skin, unusual weakness;
-
signs of skin infection such as itching, swelling, warmth,
redness, or oozing;
-
black, bloody, or tarry stools;
-
changes in mood or personality (in children);
-
numbness, burning, pain, or tingly feeling;
-
joint pain or swelling with fever, swollen glands, muscle
aches, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or
-
patchy skin color, red spots, or a butterfly-shaped skin rash
over your cheeks and nose (worsens in sunlight).
Less serious side effects may include:
-
nausea, vomiting, diarrhea, stomach pain;
-
runny or stuffy nose, cold symptoms; or
-
headache.
This is not a complete list of side effects and others may occur. Call your
doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
What is the most important information I should know about etanercept?
You should not use this medication if you are allergic to etanercept, or if you have a severe
infection such as sepsis (infection of the blood).
Before using etanercept, tell your doctor if you have ever had tuberculosis, if anyone in your
household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.
Children using this medication should be current on all childhood immunizations before
starting treatment with etanercept.
You may have pain, redness, swelling, or warmth where the medicine was injected. Call
your doctor if these symptoms continue for longer than 5 days.
Serious and sometimes fatal infections may occur during treatment with etanercept. Contact
your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, or if
you feel short of breath.
Some infections are more likely to occur in certain areas of the world. Tell your doctor where
you live and where you have recently traveled or plan to travel to during treatment.
Using etanercept may increase your risk of developing certain types of cancer such as
lymphoma (cancer of the lymph nodes). This risk may be greater in children and young adults. Talk to
your doctor about your specific risk.
What should I avoid while taking etanercept?
Do not receive a "live" vaccine while you are being treated with etanercept, and avoid
coming into contact with anyone who has recently received a live vaccine. There is a chance that the
virus could be passed on to you.
Avoid being near people who are sick or have infections. Call your doctor for preventive
treatment if you are exposed to chicken pox.
What other drugs will affect etanercept?
Tell your doctor about all other medications you use, especially:
-
anakinra (Kineret);
-
cyclophosphamide (Cytoxan, Neosar);
-
sulfasalazine (Azulfidine); or
-
drugs that weaken your immune system (such as cancer
medicine or steroids).
This list is not complete and there may be other drugs that can interact with
etanercept. Tell your doctor about all your prescription and over-the-counter medications, vitamins,
minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication
without telling your doctor.
What happens if I have an overdose of etanercept?