ISONE

CONDITIONS OR DISEASES:

· COLLAGENOSES-CONNECTIVE TISSUE DISEASES

o Progressive flares of systemic diseases, notably: disseminated lupus erythematosus, vasculitis, polymyositis, visceral sarcoidosis.

· DERMATOLOGICAL

o severe autoimmune bullous dermatoses, in particular pemphigus and bullous pemphigoid;

o severe forms of infantile hemangiomas;

o certain forms of lichen planus;

o certain acute urticarias;

o severe forms of neutrophilic dermatoses.

· DIGESTIVE

o progressive flares of ulcerative colitis and Crohn's disease;

o active autoimmune chronic hepatitis (with or without cirrhosis);

o severe acute alcoholic hepatitis, histologically proven.

· ENDOCRINE

o severe subacute De Quervain thyroiditis;

o certain hypercalcemias.

· HEMATOLOGICAL

o severe immunological thrombocytopenic purpuras;

o autoimmune hemolytic anemias;

o in association with various chemotherapies in the treatment of malignant lymphoid hematopathies;

o acquired or congenital chronic erythroblastopenias.

· INFECTIOUS

o tuberculous pericarditis and severe forms of tuberculosis involving life prognosis;

o Pneumocystis carinii pneumonia with severe hypoxia.

· NEOPLASTIC

o anti-emetic treatment during antineoplastic chemotherapies;

o edematous and inflammatory flare associated with antineoplastic treatments (radiotherapy and chemotherapy).

· NEPHROLOGICAL

o nephrotic syndrome with minimal glomerular lesions;

o primary focal segmental glomerulosclerosis nephrotic syndrome;

o stage III and IV of lupus nephropathy;

o intrarenal granulomatous sarcoidosis;

o vasculitis with renal involvement;

o primary extracapillary glomerulonephritis.

· NEUROLOGICAL

o myasthenia gravis;

o cerebral edema of tumoral cause;

o chronic, idiopathic, inflammatory polyradiculoneuritis;

o infantile spasm (West syndrome) / Lennox-Gastaut syndrome;

o multiple sclerosis in flare, following intravenous corticosteroid therapy.

· OPHTHALMOLOGICAL

o severe anterior and posterior uveitis;

o edematous exophthalmos;

o certain optic neuropathies, following intravenous corticosteroid therapy (in this indication, oral route as first intention is not recommended).

· ENT

o certain serous otitis;

o nasosinusoidal polyposis;

o certain acute or chronic sinusitis;

o seasonal allergic rhinitis in short course;

o acute stridulous laryngitis (subglottic laryngitis) in children.

· RESPIRATORY

o persistent asthma, preferably in short course in case of failure of high-dose inhaled treatment;

o asthma exacerbations, in particular severe acute asthma;

o chronic obstructive pulmonary disease during evaluation of the reversibility of the obstructive syndrome;

o progressive sarcoidosis;

o diffuse interstitial pulmonary fibrosis.

· RHEUMATOLOGICAL

o rheumatoid polyarthritis and certain polyarthritides;

o polymyalgia rheumatica and Horton's disease;

o acute rheumatic fever;

o severe and refractory cervicobrachial neuralgia.

· ORGAN AND ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION

o prophylaxis or treatment of graft rejection;

o prophylaxis or treatment of graft-versus-host disease.

Not applicable.

The frequency of adverse effects is defined using the following convention: very frequent (≥1/10); frequent (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000); undetermined (cannot be estimated on the basis of available data).

They are especially to be feared at large doses or during prolonged treatment over several months.

*After administration of high doses

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/