ENBREL SPC PDF

Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Enbrel should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease.

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At Enbrel. You can find information about moderate to severe rheumatoid arthritis RA , moderate to severe plaque psoriasis PsO , psoriatic arthritis PsA , moderate to severe polyarticular juvenile idiopathic arthritis JIA , and ankylosing spondylitis AS. The resources available will help you get started. These infections include tuberculosis TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body.

Some patients have died from these infections. There have been some cases of unusual cancers, some resulting in death, reported in children and teenage patients who started using tumor necrosis factor TNF blockers before 18 years of age. Patients with RA may be more likely to get lymphoma. Before starting ENBREL, tell your healthcare provider if you: Have any existing medical conditions Are taking any medicines, including herbals Think you have, are being treated for, have signs of, or are prone to infection.

You should not start taking ENBREL if you have any kind of infection, unless your healthcare provider says it is okay Have any open cuts or sores Have diabetes, HIV, or a weak immune system Have TB or have been in close contact with someone who has had TB Were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your healthcare provider if you are not sure Live, have lived in, or traveled to certain parts of the country such as, the Ohio and Mississippi River valleys, or the Southwest where there is a greater risk for certain kinds of fungal infections, such as histoplasmosis.

Are allergic to rubber or latex Are pregnant, planning to become pregnant, or breastfeeding Have been around someone with chicken pox What are the possible side effects of ENBREL? ENBREL can cause serious side effects including: New infections or worsening of infections you already have; hepatitis B can become active if you already have had it; nervous system problems, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes; blood problems some fatal ; new or worsening heart failure; new or worsening psoriasis; allergic reactions; autoimmune reactions, including a lupus-like syndrome and autoimmune hepatitis.

Common side effects include: Injection site reactions and upper respiratory infections sinus infections. In general, side effects in children were similar in frequency and type as those seen in adult patients. The types of infections reported were generally mild and similar to those usually seen in children. Tell your healthcare provider about any side effect that bothers you or does not go away. If you have any questions about this information, be sure to discuss them with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www. Moderate to Severe Plaque Psoriasis ENBREL is indicated for chronic moderate to severe plaque psoriasis PsO in children 4 years and older and adults who may benefit from taking injections or pills systemic therapy or phototherapy ultraviolet light.

Psoriatic Arthritis ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. Important Safety Information.

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SPS – Specialist Pharmacy Service - The first stop for professional medicines advice

This medicine is authorised for use in the European Union. It explains how the Committee for Medicinal Products for Human Use CHMP assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Enbrel. Expand section Collapse section What is Enbrel? Enbrel is a medicine that contains the active substance etanercept. It is available as vials containing a powder that is made up into a solution for injection, and as prefilled syringes and pens containing a solution for injection.

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