Humira
Authorised
adalimumab
Medicine
Human
Authorised
Humira is a medicine that acts on the immune system and is used to treat the following conditions:
Humira is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments. For detailed information on the use of Humira in all conditions, including when it can be used in children, see package leaflet or contact your doctor or pharmacist.
Humira contains the active substance adalimumab.
Humira is given as an injection under the skin, usually every 2 weeks. The dose and frequency of injection depends on the condition to be treated and the dose for a child is calculated according to the child’s weight.
Treatment with Humira must be started and supervised by a doctor who has experience in the treatment of the diseases that Humira is used for. Doctors treating uveitis should also take advice from doctors who have experience of using Humira. Patients or their carers can inject Humira once they have been trained.
Humira can only be obtained with a prescription. For more information about using Humira, see the package leaflet or contact your doctor or pharmacist.
The active substance in Humira, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF). This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Humira is used to treat. By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
More than twenty main studies involving over 9,500 patients have looked at the effects of Humira in reducing symptoms of inflammatory conditions. The studies included adult patients for the most part, but included children in studies for Crohn’s disease, ulcerative colitis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, non-infectious anterior uveitis and enthesitis-related arthritis.
Humira, when used as directed, has been shown in clinical trials to be effective at reducing important symptoms of each of the conditions for which it is approved. Below is a brief description of the studies and their results:
The most common side effects with Humira (which may affect more than 1 in 10 people) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Humira and other medicines of its class may also affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using Humira.
Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, nerve damage caused by breakdown of the covering around the nerve fibres, lupus and lupus-like conditions (where the immune system attacks the patient’s own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals). For the full list of side effects of Humira, see the package leaflet.
Humira must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body). For the full list of restrictions with Humira, see the package leaflet.
Humira has been studied extensively and has been shown to be effective at reducing symptoms in patients with inflammatory conditions.
Some rare but serious side effects have been reported, including serious infections. However, these are considered to be manageable and specific recommendations are given to help doctors manage these risks.
The European Medicines Agency therefore decided that Humira’s benefits are greater than its risks and it can be authorised for use in the EU.
Patients treated with Humira must be given a reminder card with information on the safety of the medicine.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Humira have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Humira are continuously monitored. Side effects reported with Humira are carefully evaluated and any necessary action taken to protect patients.
Humira received a marketing authorisation valid throughout the EU on 8 September 2003.
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
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