Details for: SIMLANDI

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Simlandi. Talk about any health conditions or problems you may have, including if:

• you are taking anakinra or abatacept (other biologic drugs);
• a surgery is planned for you in the near future;
• you suffer from congestive heart failure (see Do not use Simlandi if);
• you suffer from any form of cytopenia (a condition where you do not have enough blood cells);
• you have lasting fever, bruising, bleeding or paleness;
• you develop lupus-like symptoms (such as rash, fever, fatigue, headache, painful joints)
• you have a history of tuberculosis;
• you have a history of fungal infections;
• you have a history of hepatitis B (an infection of the liver)
• you have a history of cancer such as leukemia (a cancer of the blood);
• you have a history of lymphoma (a cancer affecting the white blood cells)

Other warnings you should know about:

If you/your child received Simlandi 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 Simlandi received during pregnancy. It is important that you tell your/her baby's doctors and other healthcare professionals about your/her Simlandi use during pregnancy so they can decide when your/her baby should receive any vaccine.

BEFORE you/your child use Simlandi, 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 Simlandi. 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 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 your/your child’s body. If you/your child take Simlandi, 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 browncoloured 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 Simlandi.
• you/your child experience any numbness or tingling or have ever had a disease that affects your/your child’s nervous system like multiple sclerosis or Guillain-Barrésyndrome.
• 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 Simlandi.
• 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 Simlandi. 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 Simlandi.
• you are taking other medicines for your Crohn’s disease or other conditions. You can take other medicines provided your doctor has prescribed them or has told you it is acceptable that you take them while you are taking Simlandi. It is important that you tell the doctor about any other medicines you are taking for other conditions before you start taking Simlandi.
• you/your child are taking any over-the-counter drugs, herbal medicines and vitamin and mineral supplements.
• you/your child are pregnant or could become pregnant.
• you/your child are breast-feeding or plan to breast-feed.

If you are not sure or have any questions about any of this information, ask your/your child’s doctor.