(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 treatment, call his 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.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with adalimumab injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of using adalimumab injection.