Humira (Adalimumab)

Before starting, during and after treatment with HUMIRA, you/your child should be checked for active or inactive tuberculosis infection with a tuberculin skin test.

Any medicine can have side effects. Like all medicines that affect your/your child’s immune system, HUMIRA can cause serious side effects. The possible serious side effects include:

Serious Warnings and Precautions

• Allergic reactions: If you/your child develop a severe rash, swollen face or difficulty breathing while taking HUMIRA, call your/your child’s doctor right away.
• Hepatosplenic T-cell lymphoma: Very rare reports of hepatosplenic T-cell lymphoma (HSTCL), a rare serious lymphoma that is often fatal, have been identified in patients treated with HUMIRA. Most patients had also been treated with other medications for Crohn’s disease and the majority were in adolescent and young adult males. The link between HSTCL and HUMIRA is not clear.
• Other cancers: There have been very rare cases of certain kinds of cancer in patients taking HUMIRA or other TNF-blockers. Some patients receiving HUMIRA have developed types of cancer called non-melanoma skin cancer. Tell your/your child’s doctor if you/your child have a bump or open sore that does not heal. People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting a kind of cancer that affects the lymph system, called lymphoma. If you/your child take HUMIRA or other TNF-blockers, your/your child’s risk may increase. There have been cases of lymphoma and other cancers, including unusual types, in children, adolescents and young adults taking TNF-blocking agents, including HUMIRA, which sometimes resulted in death. For children and adults taking TNF-blocker medicines, the chances of developing lymphoma or other cancers may increase.
• Lupus-like symptoms: Some patients have developed lupus-like symptoms that got better after their treatment was stopped. If you/your child have chest pains that do not go away, shortness of breath, joint pain or a rash on your/your child’s cheeks or arms that gets worse in the sun, call your/your child’s doctor right away. Your/your child’s doctor may decide to stop your/your child’s treatment.
• Nervous system diseases: There have been rare cases of disorders that affect the nervous system of people taking HUMIRA or other TNF-blockers. Signs that you/your child could be experiencing a problem affecting your nervous system include: numbness or tingling, problems with your/your child’s vision, weakness in your/your child’s legs, and dizziness.
• Serious infections: There have been rare cases where patients taking HUMIRA or other TNF-blocking agents have developed serious infections. Some of these cases have been life-threatening. Such infections include tuberculosis, infections caused by bacteria or fungi, and bacterial infections that have spread throughout the body (sepsis). Infection causes include tuberculosis, legionellosis (a serious form of bacterial pneumonia), listeriosis (an infection that usually develops after eating food contaminated by bacteria called listeria), and very rare cases of hepatitis B infection relapse.
• Blood problems: In some instances, patients treated with TNF-blocking agents may develop low blood counts, such as anemia (low red blood cells) or low platelets. If you/your child develop symptoms such as persistent fever, bleeding, or bruising, you should contact your/your child’s doctor right away.

If you/your child received HUMIRA while pregnant, your/her baby may be at higher risk for getting an infection for up to approximately five months after the last dose of HUMIRA received during pregnancy. It is important that you tell your/her baby's doctors and other healthcare professionals about your/her HUMIRA use during pregnancy so they can decide when your/her baby should receive any vaccine.

BEFORE you/your child use HUMIRA, talk to the doctor or pharmacist if:

• you/your child have or have had any kind of infection including an infection that is in only one place in your/your child’s body (such as an open cut or sore), or an infection that is in your/your child’s whole body (such as the flu). Having an infection could put you/your child at risk for serious side effects from HUMIRA. If you are unsure, ask your/your child’s doctor.
• you/your child have a history of infections that keep coming back or other conditions that might increase your/your child’s risk of infections, including fungal infections.
• you/your child have ever had tuberculosis, or if you/your child have been in close contact with someone who has had tuberculosis. If you/your child develop any of the symptoms of tuberculosis (a dry cough that doesn't go away, weight loss, fever, night sweats) call your/your child’s doctor right away. Your/your child’s doctor will need to examine you/your child for tuberculosis and perform a skin test.
• you/your child resided or traveled to areas where there is a greater risk for certain kinds of infections such as tuberculosis, histoplasmosis, coccidioidomycosis, blastomycosis, or parasitic infections. These infections are caused by a bacteria or a fungus that can affect the lungs or other parts of your/your child’s body. If you/your child take HUMIRA these may become active or more severe. If you don't know if you/your child have lived in or travelled to an area where these infections are common, ask your/your child’s doctor.
• you/your child have ever had liver injury or hepatitis B virus infection or are at risk of developing this infection. Signs and symptoms include the following: yellowing of the skin or eyes (jaundice), feeling of sickness, tiredness, loss of appetite, joint pain, fever, dark brown-colored urine, vomiting, and abdominal pain. If you/your child experience any of these signs and symptoms, contact your/your child’s doctor immediately. These symptoms may occur several months after starting therapy with HUMIRA.
• you/your child experience any numbness or tingling or have ever had a disease that affects your nervous system like multiple sclerosis or Guillain-Barré syndrome.
• you/your child have or have had heart failure.
• you/your child are scheduled to have major surgery or dental procedures.
• you/your child are scheduled to be vaccinated for anything. It is recommended that pediatric patients, if possible, be brought up to date with all immunizations according to current guidelines before starting HUMIRA.
• you/your child are taking other medicines for your/your child’s rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, psoriasis, or other conditions. You/your child can take other medicines provided your/your child’s doctor has prescribed them, or has told you it is acceptable that you/your child take them while you/your child are taking HUMIRA. It is important that you tell your/your child’s doctor about any other medicines you/your child are taking for other conditions (for example, high blood pressure medicine) before you/your child start taking HUMIRA.
• you/your child is taking other medicines for your/your child’s Crohn’s disease or other conditions. You/your child can take other medicines provided your/your child’s doctor has prescribed them or has told you it is acceptable that you/your child takes them while you/your child is taking HUMIRA. It is important that you tell the doctor about any other medicines you/your child is taking for other conditions before you/your child starts taking HUMIRA.
• you/your child are taking any over-the-counter drugs, herbal medicines and vitamin and mineral supplements.
• you/your child are pregnant, could become pregnant, or are breast-feeding. HUMIRA has not been studied in pregnant women or nursing mothers, so the effects on pregnant women or nursing babies are unknown. HUMIRA may cross the placenta into the serum of infants born to women treated with HUMIRA during pregnancy. Breast-feeding is not recommended for at least five months after the last HUMIRA treatment.
• If you are not sure or have any questions about any of this information, ask your/your child’s doctor.

Like all medicines, HUMIRA can cause side effects. Most side effects are mild to moderate. However, some may be serious and require treatment.

Tell your/your child’s doctor immediately if you/your child experience any of the following:

• severe rash, hives or other signs of allergic reaction
• swollen face, hands, feet
• trouble breathing, swallowing
• sudden weight gain (this is possibly indicative of new or worsening heart failure)
• bruising or bleeding very easily, looking very pale; this could mean a blood problem such as low red blood cells (anemia).

Tell the doctor as soon as possible if you/your child notice any of the following:

• signs of infection such as fever, malaise, wounds, dental problems, burning on urination
• feeling weak or tired
• coughing
• tingling
• numbness
• double vision
• arm or leg weakness
• arm or leg pain, swelling or redness
• bump or open sore that does not heal
• red scaly patches or raised bumps that are filled with pus (this could be new or worsening hidradenitis suppurativa, new or worsening psoriasis or a skin infection)
• alopecia (loss of hair)
• changes in the colour of the skin
• changes in the colour of your/your child’s urine (dark or red)
• worsening of the appearance of a scar
• night sweats
• weight loss
• pain in the abdomen or chest

You/your child should not take HUMIRA with:

• other TNF-blockers such as Enbrel, Remicade, Cimzia, or Simponi
• abatacept (Orencia)
• anakinra (Kineret)

If you have questions, ask your/your child’s doctor.

HUMIRA is administered by injection under the skin (by subcutaneous injection).

Overdose:

If you/your child accidentally inject HUMIRA more frequently than instructed, contact your/your child’s doctor or local poison control centre right away.

Missed Dose:

If you/your child forget to give yourself/your child an injection, you/your child should inject the missed dose of HUMIRA as soon as you/your child remember. Then administer the next dose as you would have on the originally scheduled date.