Jayempi

RSS

azathioprine

Authorised
This medicine is authorised for use in the European Union.

Overview

Jayempi is an immunosuppressant medicine (a medicine that reduces the activity of the immune system) that is used, on its own or with other medicines, to:

  • prevent the body from rejecting a transplanted kidney, liver, heart, lung or pancreas;
  • treat relapsing multiple sclerosis, a disease of the brain and spinal cord in which inflammation attacks the protective covering (sheath) around nerves and damages the nerves themselves;
  • treat generalised myasthenia gravis (a disease that affects nerves and causes muscle weakness).
  • treat the following autoimmune diseases (caused by the body's own defence system attacking normal tissue) in patients for whom corticosteroid medicines are not suitable:
    • severe rheumatoid arthritis or chronic polyarthritis (long-term damage and inflammation of multiple joints) which cannot be controlled by other medicines;
    • chronic inflammatory bowel diseases (diseases of the gut such as Crohn’s disease and ulcerative colitis);
    • autoimmune hepatitis, a liver disease;
    • systemic lupus erythematosus (a condition causing swollen joints, tiredness and rashes);
    • dermatomyositis (worsening muscle inflammation and weakness together with skin rash);
    • polyarteritis nodosa (inflammation of blood vessels);
    • pemphigus vulgaris and bullous pemphigoid (diseases causing blistering of the skin and mucous membranes, moist body surfaces such as the lining of the mouth);
    • Behçet’s disease (a disease in which the immune system attacks its own blood vessels causing recurrent inflammation, especially of the eyes and the mouth and genital mucous membranes);
    • refractory autoimmune haemolytic anaemia (a disease in which the red blood cells are destroyed);
    • refractory idiopathic thrombocytopenic purpura (bleeding under the skin due to damage to the platelets and reduction of their numbers);

Jayempi is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but is given in a different way. The reference medicine for Jayempi is Imurek and is available as tablets, while Jayempi is available as a liquid to be taken by mouth.

Jayempi contains the active substance azathioprine.

This EPAR was last updated on 23/06/2021

Authorisation details

Product details
Name
Jayempi
Agency product number
EMEA/H/C/005055
Active substance
azathioprine
International non-proprietary name (INN) or common name
azathioprine
Therapeutic area (MeSH)
Graft Rejection
Anatomical therapeutic chemical (ATC) code
L04AX01
Publication details
Marketing-authorisation holder
Nova Laboratories Ireland Limited
Date of issue of marketing authorisation valid throughout the European Union
21/06/2021
Contact address

3rd Floor, Ulysses House
Foley Street
Dublin 1, D01 W2T2
Ireland

Product information

21/06/2021 Jayempi - EMEA/H/C/005055 -

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. Azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression).

Jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response.

Jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:

  • severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – DMARDs)
  • auto-immune hepatitis
  •  systemic lupus erythematosus
  • dermatomyositis
  • polyarteritis nodosa
  • pemphigus vulgaris and bullous pemphigoid
  • Behçet’s disease
  • refractory auto-immune haemolytic anaemia, caused by warm IgG antibodies
  • chronic refractory idiopathic thrombocytopenic purpura

Jayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (IBD) (Crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice.

It is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3

Jayempi is indicated for the treatment of generalised myasthenia gravis. Depending on the severity of the disease, Jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Assessment history

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