This medication can decrease your immune system's ability to fight infections. Though unlikely, this drug may increase your risk of developing serious (possibly fatal) infections. This risk is higher if you are also taking other drugs to suppress the immune system such as cyclosporine. You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. See Side Effects section for symptoms of infection, and seek immediate medical attention if symptoms occur.

Before starting this drug, you should take a tuberculosis (TB) skin test to check for a type of tuberculosis that may not be causing any symptoms (latent TB). If you are diagnosed with TB, you must first be treated for it before you start adalimumab to prevent a serious TB infection.

Though it is very unlikely to happen, there is a risk (especially in children and teenagers) of developing cancer (such as lymphoma, basal and squamous cell non-melanoma) due to this medication or due to your medical condition. Discuss the risks and benefits of treatment with your doctor. Tell your doctor immediately if you develop symptoms such as unusual lumps/growths, swollen glands, unexplained weight loss.

This medication is used to reduce pain and swelling due to certain types of arthritis (e.g., rheumatoid, psoriatic, and ankylosing spondylitis). This medication is also used to treat psoriasis (plaque-type). It works by blocking a protein (tumor necrosis factor or TNF) found in the body's immune system that causes joint swelling and damage.

Early treatment of rheumatoid arthritis with more aggressive therapy, including this type of medication (TNF blockers), helps to reduce further joint damage and preserve joint function.

This medication is also used to treat a bowel condition called Crohn's disease. It is used in cases that are moderate to severe and/or keep coming back.

Read the Patient Information Leaflet and the Medication Guide provided by your pharmacist before you start using adalimumab and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Use this medication exactly as prescribed. This drug is given under the skin (subcutaneously or SC) every other week, or weekly in some cases, or as directed by your doctor. Learn all preparation and usage instructions in the product package. Do not shake.

Rotate injection sites. New injections should be given at least 1 inch (2.5 centimeter) from an old site. Do not inject into any areas of the skin that are sore, bruised, red or hard.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Learn how to store and discard needles and medical supplies safely. Never reuse syringes or needles. Consult your pharmacist.

Redness, itching, pain, or swelling at the injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/irregular/pounding heartbeat, stomach pain, blood in the stools, mental/mood changes, severe headache, easy bruising or bleeding, dark urine, yellowing eyes and skin, leg pain or swelling, numbness or tingling of the hands or feet, unsteadiness, unexplained muscle weakness, vision changes, extreme fatigue, joint pain, butterfly-shaped rash on the nose and cheeks.

Seek immediate medical attention if any of these rare but very serious side effects occur: seizures, chest pain.

Tell your doctor immediately if you develop signs of infection while using this drug, such as: fever, chills, night sweats, persistent sore throat, trouble breathing, painful or frequent urination, persistent cough, unusual vaginal discharge, white patches in the mouth (oral thrush).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warnings section.

Before using adalimumab, tell your doctor or pharmacist if you are allergic to it; or to natural rubber/latex; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an active infection, TB infection, certain fungal infection (histoplasmosis), heart disease (congestive heart failure), lupus.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recurrent infections, hepatitis B infection, decreased bone marrow function, seizures, certain brain/spinal cord disorders (demyelinating disorders such as multiple sclerosis), history of cancer (e.g., lymphoma), scheduled surgery.

Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine. Consult your doctor about the risks of exposure to chickenpox and other infections.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: abatacept, anakinra, live vaccines, other TNF-blockers (such as etanercept, infliximab).

If you are currently using any of these medications, tell your doctor or pharmacist before starting adalimumab.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: other arthritis drugs (e.g., methotrexate, prednisone, leflunomide, anakinra), drugs that suppress the immune system (e.g., cyclosporine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

Do not share this medication with others.

Laboratory and/or medical tests (e.g., CBC, liver function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If you miss a dose, contact your doctor or pharmacist to establish a new dosing schedule.

Store in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light and moisture. Do not freeze. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

Information last revised August 2009 Copyright(c) 2009 First DataBank, Inc.