What is adalimumab?
Adalimumab reduces the effects of a substance in the body that can cause inflammation.
Adalimumab is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis,
ankylosing spondylitis, and plaque psoriasis. It is also used to treat Crohn's disease after other drugs
have been tried without successful treatment of symptoms.
Adalimumab may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking adalimumab?
You should not use this medication if you are allergic to adalimumab, or if you are also
being treated with anakinra (Kineret).
Before using adalimumab, 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 certain conditions, you may need a dose adjustment or special tests to safely use
this medication. Before using adalimumab, tell your doctor if you have:
-
an active or recent infection;
-
open sores or skin wounds;
-
hepatitis B;
-
congestive heart failure;
-
lupus;
-
an allergy to latex rubber;
-
a disease that affects the nerves or muscles, such as
multiple sclerosis, myasthenia gravis, Guillain-Barre syndrome;
-
if you have recently been vaccinated with BCG (Bacille
Calmette-Guerin); or
-
if you are scheduled to receive any vaccines.
FDA pregnancy category B. This medication is not expected to be
harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during
treatment.
Your name may need to be listed on a Humira pregnancy registry when you start using this
medication.
It is not known whether adalimumab passes into breast milk.
Do not
use
adalimumab without first talking to your doctor if you are breast-feeding a baby.
Using this medication may increase your risk of certain types of cancer, such as breast, colon,
prostate, or lung cancer, lymphoma (cancer of the lymph nodes), or melanoma (a tumor that usually
affects the skin). This risk may be greater in children and young adults. You may also develop an
autoimmune disorder such as a lupus-like syndrome. Talk with your doctor about your specific risk.
How should I take adalimumab?
Before you start treatment with adalimumab, 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.
Use this medication exactly as it was prescribed for you. Do not use the medication in larger
amounts, or use it for longer than recommended by your doctor. Follow the instructions on your
prescription label.
Adalimumab is given as an injection under the skin of your stomach or thigh. Your doctor,
nurse, or other healthcare provider will give you this injection. You may be given instructions on how to
inject your medicine at home. Do not use this medicine at home if you do not fully understand how to
give the injection and properly dispose of needles and syringes used in giving the medicine.
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.
Adalimumab is usually given every other week, although you may need to use it once a week.
Follow your doctor's instructions.
Use each pre-filled syringe of adalimumab only one time. Throw away any unused portion of
the medication. Do not save it for later use.
Throw away used needles and syringes in a puncture-proof container. If your medicine does
not come with such a container, ask your pharmacist where you can get one. Keep this container out
of the reach of children and pets. Your pharmacist can tell you how to properly dispose of the
container.
Adalimumab can lower the 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. To be sure your
blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any
scheduled visits to your doctor.
It is important to use adalimumab regularly to get the most benefit. Get your prescription refilled
before you run out of medicine completely.
If you need to have any type of surgery, tell the surgeon ahead of time that you are using
adalimumab.
Store adalimumab in the refrigerator but do not allow it to freeze. If you travel with the prefilled
syringe, keep it in a small cooler with an ice pack and protect it from light.
Do not remove the prefilled syringe from the refrigerator or cooler until you are ready to give
yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call
your doctor for a new prescription.
What happens if I miss a dose of adalimumab?
Use the medication as soon as you remember, and then go back to your regular injection
schedule.
Do not
use extra medicine to make up the missed dose.
Where can I get more information about adalimumab?
Your pharmacist has information about adalimumab written for health professionals that you may read.
What are the possible side effects of adalimumab?
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 adalimumab.
Stop using adalimumab 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 of your ankles or feet;
-
confusion, seizure (convulsions);
-
pain or burning when you urinate;
-
chest pain, ongoing cough, coughing up blood;
-
easy bruising or bleeding, pale skin, unusual weakness;
-
numbness or tingly feeling, weakness in your legs;
-
jaundice (yellowing of the skin or eyes);
-
red, purple, or scaly skin rash, hair loss, joint or muscle
pain, mouth sores;
-
joint pain or swelling with fever, swollen glands, muscle
aches, vomiting, 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:
-
headache;
-
stuffy nose, sinus pain;
-
nausea, stomach pain; or
-
pain, redness, itching, swelling, or bleeding where you
injected the medication.
This is not a complete list of side effects and others may occur. Tell your
doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about adalimumab?
Before you start treatment with adalimumab, your doctor may perform tests to make sure you
do not have tuberculosis or other infections.
Treatment with adalimumab may increase your risk of developing certain types of cancer such
as lymphoma (cancer of the lymph nodes) or autoimmune disorders (such as a lupus-like syndrome).
This risk may be greater in children and young adults. Talk with your doctor about your individual risk.
Adalimumab can lower the 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. To be sure your
blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any
scheduled visits to your doctor.
Serious and sometimes fatal infections may occur during treatment with adalimumab.
Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, tired
feeling, or feeling 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.
Do not receive a "live" vaccine while you are being treated with adalimumab.
What should I avoid while taking adalimumab?
Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your
doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while you are being treated with adalimumab.
Avoid injecting adalimumab into skin that is bruised, red, tender, or hard.
What other drugs will affect adalimumab?
There may be other drugs that can interact with adalimumab. Tell your doctor about all the
prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal
products, and drugs prescribed by other doctors. Do not start using a new medication without telling
your doctor.
What happens if I have an overdose of adalimumab?
