Etanercept - Enbrel 25mg safety information

Enbrel (etanercept) is a medicine that affects immune system. It is used for moderate to severe rheumatoid arthritis, arthritis with no known cause affecting several joints, in children aged 4 to 17 years (polyarticular juvenile idiopathic arthritis), form of arthritis that occurs predominantly in young men and affects the joints of the spine (ankylosing spondylitis), form of arthritis called psoriatic arthritis that can occur in people with the skin condition psoriasis and for moderate to severe plaque psoriasis.

Enbrel safety information

Allergic reactions: In rare cases, some people who are using this medicine may develop an allergic reaction. Signs of an allergic reaction include: swollen face or throat, a severe rash, difficulty breathing or hives. If these signs occur, contact your doctor. Before you start injections tell your doctor if you have an allergy to rubber or latex, because the needle cover on the prefilled syringe contains dry natural rubber.

Blood disorders: Rarely, people taking Enbrel have become deficient in certain types of blood cells. If you notice blood in the stools, easy bruising, blood or material that looks like coffee grounds in the vomit, black tarry stools or if you look pale or feel faint, immediately contact medical attention.

Cancer: Very rarely, people taking Enbrel develop lymphoma (type of blood cancer). In general, people with psoriasis or rheumatoid arthritis who take medications that suppress the immune system over long periods of time may also have a higher risk of developing lymphoma, even if they don't take Enbrel. Symptoms of lymphoma include fatigue, weight loss, fever, swollen glands, night sweats, and itching.

Heart failure: Enbrel - etanercept may worsen congestive heart failure. Talk to your doctor about the risks and benefits of using this medication, if you have heart failure. Symptoms to watch out for include swelling of the feet and ankles and shortness of breath. If you notice these symptoms, contact your doctor immediately.

Hepatitis B: People infected with hepatitis B virus (an infection that can damage the liver) may have a relapse of their condition while taking etanercept. Your doctor may test you if you are at risk for hepatitis B before starting treatment with etanercept and will follow your condition closely while you are taking Enbrel. If symptoms of a liver problems appear, such as loss of appetite, abdominal pain, yellow eyes or skin, fatigue, or dark urine, contact your doctor immediately.

Infections: Enbrel can lower the ability of your immune system to fight infections. Serious infections can happen in patients taking Enbrel. These include infections caused by viruses and tuberculosis (TB), fungi, or bacteria that have spread throughout the body. You should have test for tuberculosis before taking Enbrel. Doctor should monitor you closely while you are on Enbrel.

Nervous system: Enbrel may cause or worsen nervous system disorders. If you experience weakness in your arms or legs, numbness or tingling, vision changes or dizziness while taking Enbrel, contact your doctor immediately.

Vaccines: Live vaccines like yellow fever, BCG, cholera, typhoid, varicella, should not be given when you are taking Enbrel - etanercept. Before receiving their first dose of etanercept, children with JIA - Juvenile idiopathic arthritis, should complete the recommended vaccination schedule.

Pregnancy and breast-feeding: There have been no studies on the use of etanercept by pregnant women. Enbrel should not be used during pregnancy unless the benefits outweigh the risks. If woman become pregnant while taking Enbrel, she must contact doctor immediately. It is not known if etanercept passes into breast milk. If you are a breast-feeding mother and you are taking this medication, it may affect your baby. Talk to your doctor about breast-feeding and taking Enbrel.

Children: The safety and effectiveness of using Enbrel has not been established for children younger than 4 years old. It can be used to treat children aged 4 to 17 years who have moderate to severe juvenile idiopathic arthritis (JIA).