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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.

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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. Contact your doctor right away if you have signs of infection such as:

• fever, chills, sore throat, flu symptoms, weight loss;

• joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, unusual thoughts or behavior, and/or seizure (convulsions);

• patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight);

• chest pain, ongoing cough, coughing up blood; or

• easy bruising or bleeding, pale skin, unusual weakness.

Call your doctor at once if you have any of these other serious side effects:

• feeling short of breath, even with mild exertion;

• swelling of your ankles or feet;

• red, purple, or scaly skin rash, hair loss, joint or muscle pain, mouth sores;

• confusion, seizure (convulsions);

• pain or burning when you urinate;

• numbness or tingly feeling, weakness in your legs; or

• jaundice (yellowing of the skin or eyes).

Less serious side effects are more likely to occur, such as:

• pain, redness, itching, swelling, or bleeding where you injected the medication;

• headache;

• stuffy nose, sinus pain; or

• nausea, stomach pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I use adalimumab?
Before you start treatment with adalimumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections. 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.

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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 or autoimmune disorders (such as a lupus-like syndrome). 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.

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What happens if I miss a dose?
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.

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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.

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Adalimumab has been assigned to pregnancy category B by the FDA. Animal studies have revealed no teratogenic, embryotoxic or fetotoxic effects. There are no controlled data in human pregnancy. Adalimumab is only recommended for use during pregnancy when benefit outweighs risk.

To monitor outcomes of pregnant women exposed to adalimumab, a pregnancy registry has been established. Physicians are encouraged to register patients by calling 1-877-311-8972.

There are no data on the excretion of adalimumab into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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Who should NOT use this medication?

• Known hypersensitivity to adalimumab or any ingredient in the formulation.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. An overdose of adalimumab is not expected to produce life-threatening symptoms.

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What should I discuss with my healthcare provider before using adalimumab?
Do 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 are allergic to any drugs, or if you have: an active or recent infection; a history of tuberculosis; 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; or if you are scheduled to have major surgery or receive any vaccines.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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