CELESTENE

AFFECTIONS OR DISEASES:

I-COLLAGENOSES - CONNECTIVE TISSUE DISEASES

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

II-DERMATOLOGICAL

a-severe autoimmune bullous dermatoses, in particular pemphigus and bullous pemphigoid

b-severe forms of infantile angiomas

c-certain forms of lichen planus

d-certain acute urticarias

e-severe forms of neutrophilic dermatoses

III- DIGESTIVE

a-progressive flares of ulcerative colitis and Crohn's disease

b-active autoimmune chronic hepatitis (with or without cirrhosis)

c-severe acute alcoholic hepatitis, histologically proven

IV-ENDOCRINE

a-severe De Quervain subacute thyroiditis

b-certain hypercalcemias

V- HEMATOLOGICAL

a-severe immunological thrombocytopenic purpuras

b-autoimmune hemolytic anemias

c-in association with various chemotherapies in the treatment of malignant lymphoid hematopathies

d-acquired or congenital chronic erythroblastopenias

VI-INFECTIOUS

a-tuberculous pericarditis and severe forms of tuberculosis involving life prognosis

b-Pneumocystis carinii pneumonia with severe hypoxia

VII-NEOPLASTIC

a-anti-emetic treatment during antineoplastic chemotherapies

b-edematous and inflammatory flare associated with antineoplastic treatments (radiotherapy and chemotherapy)

VIII-NEPHROLOGICAL

a-nephrotic syndrome with minimal glomerular lesions

b-nephrotic syndrome of primary focal segmental glomerulosclerosis

c-stage III and IV of lupus nephropathy

d-intrarrenal granulomatous sarcoidosis

e-vasculitis with renal involvement

f-primary extra-capillary glomerulonephritis

IX-NEUROLOGICAL

a-myasthenia gravis

b-cerebral edema of tumor cause

c-chronic, idiopathic, inflammatory polyradiculoneuritis

d-infantile spasm (West syndrome) / Lennox-Gastaut syndrome

e-multiple sclerosis in flare, following intravenous corticosteroid therapy

X-OPHTHALMOLOGICAL

a-severe anterior and posterior uveitis

b-edematous exophthalmos

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

XI- ENT

a-certain serous otitis media

b-nasosinusoidal polyposis

c-certain acute or chronic sinusitis

d-seasonal allergic rhinitis in short course

e-acute stridulous laryngitis (subglottic laryngitis) in children

XII- RESPIRATORY

a-persistent asthma preferably in short course in case of failure of high-dose inhaled treatment

b-asthma exacerbations, in particular severe acute asthma

c-chronic obstructive pulmonary disease during evaluation of the reversibility of the obstructive syndrome

d-progressive sarcoidosis

e-diffuse interstitial pulmonary fibrosis

XIII- RHEUMATOLOGICAL

a-rheumatoid arthritis and certain polyarthritides

b-polymyalgia rheumatica and Horton's disease

c-acute rheumatic fever

d-severe and refractory cervicobrachial neuralgia

XIV- ORGAN TRANSPLANTATION AND ALLOGENIC HEMATOPOIETIC STEM CELL TRANSPLANTATION

a-prophylaxis or treatment of graft rejection

b-prophylaxis or treatment of graft-versus-host reaction

Not applicable.

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

· hydro-electrolytic disorders: hypokaliemia, metabolic alkalosis, water-sodium retention, arterial hypertension, congestive heart failure ;

· endocrine and metabolic disorders: iatrogenic Cushing's syndrome, inertia of ACTH secretion, sometimes permanent adrenocortical atrophy, decreased glucose tolerance, revelation of latent diabetes, growth arrest in children, menstrual irregularities ;

· musculoskeletal disorders: muscle atrophy preceded by muscle weakness (increased protein catabolism), osteoporosis, pathological fractures in particular vertebral compression, aseptic osteonecrosis of the femoral heads ;

· digestive disorders: hiccups, gastroduodenal ulcers, small bowel ulceration, perforations and digestive hemorrhage, acute pancreatitises have been reported, especially in children ;

· skin disorders: acne, purpura, ecchymosis, hypertrichosis, delayed healing and angioedema ;

· neuropsychiatric disorders:

o frequently: euphoria, insomnia, excitement ;

o rarely: manic-like episodes, confusion or confuso-oneiric states, convulsions (general or intrathecal route) ;

o depressive state upon discontinuation of treatment ;

· ocular disorders: certain forms of glaucoma and cataract; blurred vision (see also section 4.4).

Reporting of suspected adverse effects

Reporting of suspected adverse effects after medicinal product authorization is important. It allows continuous monitoring of the benefit/risk ratio 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: www.signalement-sante.gouv.fr .