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(a dal aye' mu mab)Using adalimumab injection may decrease your ability to fight infection and increase the chance that you will develop a serious infection, including severe fungal, bacterial, and viral infection that may spread through the body. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores) or chronic infections that do not go away. Also tell your doctor if you have or have ever had any condition that affects your immune system or if you live or have ever lived in areas such as the Ohio or Mississippi river valleys where severe fungal infections are more common. Ask your doctor if you don't know if these infections are more common in your area. Tell your doctor if you are taking medications that decrease the activity of the immune system such as the following: abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), methotrexate (Otrexup, Rasuvo, Trexall), rituximab (Rituxan), or steroids such as dexamethasone, methylprednisolone (Medrol), prednisone (Rayos), or prednisolone (Prelone). Your doctor will monitor you for signs of infection during and after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: weakness; sweating; sore throat; cough; coughing up bloody mucus; fever; weight loss; extreme tiredness; diarrhea; stomach pain; warm, red, or painful skin; painful, difficult, or frequent urination; or other signs of infection. You may already be infected with tuberculosis (TB; a serious lung infection) or hepatitis B (a virus that affects the liver) but not have any symptoms of the disease. In this case, adalimumab injection may increase the risk that your infection will become more serious and you will develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection and may order a blood test to see if you have an inactive hepatitis B infection. If necessary, your doctor may give you medication to treat this infection before you begin your treatment with adalimumab. Tell your doctor if you have or have ever had TB, if you have lived in or visited a country where TB is common, or if you have been around someone who has or has ever had TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, weight loss, loss of muscle tone,fever, or night sweats. Also call your doctor immediately if you have any of these symptoms of hepatitis B or if you develop any of these symptoms during or after your treatment: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea or vomiting, muscle aches, dark urine, clay-colored bowel movements, fever, chills, stomach pain, or rash. Some children, teenagers, and young adults who received adalimumab injection or similar medications developed severe or life-threatening cancers including lymphoma (cancer that begins in the cells that fight infection). Some teenage and young adult males who took adalimumab or similar medications developed hepatosplenic T-cell lymphoma (HSTCL), a very serious form of cancer that often causes death within a short period of time. Most of the people who developed HSTCL were being treated for Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) or ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) with adalimumab or a similar medication along with another medication called azathioprine (Imuran) or 6-mercaptopurine (Purinethol). Tell your child's doctor if your child has ever had any type of cancer. If your child develops any of these symptoms during his or her treatment, call his or her doctor immediately: stomach pain; fever; unexplained weight loss; swollen glands in the neck, underarms, or groin; or easy bruising or bleeding. Talk to your child's doctor about the risks of giving adalimumab injection to your child. Talk to your doctor about the risks of using adalimumab injection.
- rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function) in adults,
- juvenile idiopathic arthritis (JIA; a condition that affects children in which the body attacks its own joints, causing pain, swelling, loss of function, and delays in growth and development) in children 2 years of age and older,
- Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) that has not improved when treated with other medications in adults and children 6 years of age and older,
- ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) when other medications and treatments did not help or could not be tolerated in adults,
- ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage) in adults,
- psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults,
- hidradenitis suppurativa (a skin disease that causes pimple-like bumps in the armpits, groin, and anal area) in adults and children 12 years of age and older,
- uveitis (swelling and inflammation of different areas of the eye) in adults and children 2 years of age and older,
- chronic plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults.
Before using adalimumab injection,
- tell your doctor and pharmacist if you are allergic to adalimumab injection, any other medications, or any of the ingredients in adalimumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients. If you will be using the prefilled syringe, also tell your doctor if you or the person who will be helping you inject adalimumab injection are allergic to latex or rubber.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: cyclosporine (Gengraf, Neoral, Sandimmune), theophylline (Elixophyllin,Theo 24, Theochron), or warfarin (Coumadin, Jantoven). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- in addition to the conditions mentioned in the IMPORTANT WARNING section, tell your doctor if you have or have ever had numbness or tingling in any part of your body, any disease that affects your nervous system, such as multiple sclerosis (a disease in which the nerves do not function properly causing weakness, numbness, loss of muscle coordination and problems with vision, speech, and bladder control), Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage), or optic neuritis (inflammation of the nerve that sends messages from the eye to the brain); any type of cancer, diabetes, heart failure, or heart disease. If you have psoriasis, tell your doctor if you have been treated with light therapy.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding If you become pregnant while using adalimumab injection, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using adalimumab injection.
- do not have any vaccinations without talking to your doctor. If your child will be receiving adalimumab injection, be sure that your child has received all the shots that are required for children of his or her age before he or she begins treatment with adalimumab injection.
- redness, itching, bruising, pain, or swelling in the place you injected adalimumab injection
- back pain
- numbness or tingling
- problems with vision
- weakness in legs
- chest pain
- shortness of breath
- rash, especially a rash on the cheeks or arms that is sensitive to sunlight
- new joint pain
- swelling of the face, feet, ankles, or lower legs
- difficulty breathing or swallowing
- fever, sore throat, chills, and other signs of infection
- unusual bruising or bleeding
- pale skin
- red, scaly patches or pus-filled bumps on the skin