Nordimet

Nordimet received a marketing authorisation valid throughout the EU on 18 August 2016.

Nordimet is available in pre-filled injection pens or syringes and it can only be obtained with a prescription. It should be prescribed only by doctors with expertise in the use of methotrexate and a full understanding of the risks of methotrexate treatment.

Nordimet should be injected under the skin once a week on the same day each week. The dose injected each week depends on which condition it is being used for and how well the treatment is working and, for children, on the child’s height and weight. In most cases, methotrexate medicines are used for long-term treatment.

A doctor may decide that patients can inject Nordimet themselves after receiving adequate training, but the first self-injection should be supervised by a doctor or a nurse.

For more information about using Nordimet, see the package leaflet or contact your doctor or pharmacist.

The way methotrexate, the active substance in Nordimet, works in patients with arthritis, psoriasis and Crohn’s disease is not completely understood, but the benefits of methotrexate are thought to be due to its ability to reduce inflammation and suppress an overactive immune system.

The company provided data from the published literature on methotrexate. No additional studies were needed as Nordimet is a hybrid medicine that is given by injection and contains the same active substance as the reference medicine, Lantarel FS. Because Nordimet has the same composition as the reference medicine its benefits are taken as being the same as those of Lantarel FS.

For the full list of side effects and restrictions of Nordimet, see the package leaflet.

The most common side effects with Nordimet (which may affect more than 1 in 10 people) include effects on the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing changes in how well the liver works. The most serious side effects include reduced production of blood cells, damage to the lungs, liver, kidneys and nerves, thromboembolism (problems caused by clots in blood vessels), severe allergic reactions and Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).

Nordimet must not be used in patients who abuse alcohol or those with severe liver or kidney problems, blood disorders, weakened immune system (the body’s natural defences), severe or long-term infections such as tuberculosis and HIV infection, mouth ulcers, inflammation of the lining of the mouth, and ulcers in the digestive system. It must not be used if the patient is pregnant, breastfeeding or is receiving live vaccines.

The European Medicines Agency concluded that Nordimet was comparable to its reference medicine. The Agency therefore decided that Nordimet’s benefits are greater than its risks and it can be authorised for use in the EU.

The company that markets Nordimet will send out follow-up questionnaires for dosing errors that result in overdose.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nordimet have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Nordimet are continuously monitored. Side effects reported with Nordimet are carefully evaluated and any necessary action taken to protect patients.