Safety Information
Important safety information for ABRILADA
This page contains important safety information that you need to be aware of before and during treatment with ABRILADA (adalimumab). For complete safety information, please consult the Patient Medication Information leaflet contained in your product package.
Before using ABRILADA, talk to the doctor or pharmacist if you/your child:
View conditions
- have or have had any kind of infection including an infection that is in only one place in the body (such as an open cut or sore), or an infection that is in the whole body (such as the flu). Having an infection could put you/your child at risk for serious side effects from ABRILADA. If you are unsure, ask your/your child’s doctor.
- 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.
- have ever had tuberculosis, or 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. The doctor will need to examine you/your child for tuberculosis and perform a skin test.
- resided or travelled 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 the body. If you/your child take ABRILADA, 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.
- 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-coloured urine, vomiting, and abdominal pain. If you/your child experience any of these signs and symptoms, contact the doctor immediately. These symptoms may occur several months after starting therapy with ABRILADA.
- experience any numbness or tingling or have ever had a disease that affects the nervous system like multiple sclerosis or Guillain-Barré syndrome.
- have or have had heart failure.
- are scheduled to have major surgery or dental procedures.
- 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 ABRILADA.
- are taking other medicines for Crohn’s disease, ulcerative colitis, 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 to take them while taking ABRILADA. It is important that you tell the doctor about any other medicines you/your child are taking for other conditions before starting ABRILADA.
- are taking any over-the-counter drugs, herbal medicines and vitamin and mineral supplements.
- are pregnant or could become pregnant.
- are breast-feeding or plan to breast-feed.
Warnings and precautions
Before starting, during, and after treatment with ABRILADA, 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, ABRILADA 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 ABRILADA, 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 adalimumab. Most patients had also been treated with other medications for Crohn’s disease and the majority w-ere in adolescent and young adult males. The link between HSTCL and adalimumab 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 ABRILADA havedeveloped 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 who 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 ABRILADA 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 ABRILADA, 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 ABRILADA or other TNF-blockers. Signs that you/your child could be experiencing a problem affecting your/your child’s 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 ABRILADA 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 ABRILADA 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 ABRILADA received during pregnancy. It is important that you tell your/her baby’s doctors and other healthcare professionals about your/her ABRILADA use during pregnancy so they can decide when your/her baby should receive any vaccine.
Side effects and what to do about them
Like all medicines, ABRILADA can cause side effects. Most side effects are mild to moderate. However, some may be serious and require treatment. Talk to your/your child’s doctor if you experience any side effects.
Immediately:
- 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) or low platelets
As soon as possible:
- 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
Serious side effects, how often they happen, and what to do about them
Very common side effects
Injection site reaction. Talk to your doctor/pharmacist in all cases.
Common side effects
- Cough and cold symptoms, including sore throat. Talk to your doctor / pharmacist in all cases.
- Headache. Talk to your doctor / pharmacist only if severe.
- Rash. Talk to your doctor / pharmacist in all cases.
- Nausea. Talk to your doctor / pharmacist in all cases.
- Pneumonia. Talk to your doctor / pharmacist in all cases and stop taking ABRILADA.
- Fever. Talk to your doctor / pharmacist in all cases.
- Abdominal pain. Talk to your doctor / pharmacist only if severe.
Uncommon side effects
- If any of the following side effects appear, talk to your doctor / pharmacist in all cases and stop taking ABRILADA.
- Tuberculosis
- Other serious infections
- Nerve disorder
- Appendicitis
- Blood clots: abdominal pain, chest pain, leg or arm pain with redness and swelling
- Bladder infection (painful urination)
- Hepatitis (jaundice [yellow skin, dark urine], abdominal pain, tiredness)
This is not a complete list of side effects. For any unexpected effects while taking ABRILADA, contact your/your child’s doctor or pharmacist.
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