FLUCORTAC (acétate de fludrocortisone)

Key points

Approval of reimbursement for:

• replacement therapy in mineralocorticoid deficiency, in combination with a glucocorticoid in primary adrenocortical insufficiency (Addison's disease), and congenital hyperplasia of the suprarenals with salt loss, in all age groups.
• short-term treatment of severe neurogenic orthostatic hypotension requiring pharmacological treatment in all age groups. Fludrocortisone acetate oral solution is only indicated if general and physical measures are not sufficient. The duration of treatment should be as short as possible.

Disapproval of reimbursement in the treatment of severe non-neurogenic orthostatic hypotension.

Therapeutic improvement?

No improvement in the management strategy for primary adrenocortical insufficiency (Addison's disease) and congenital hyperplasia of the suprarenals with salt loss compared to FLUCORTAC (fludrocortisone) 50 µg, scored tablet.

No progress in the management strategy for the treatment of neurogenic orthostatic hypotension compared to the midodrine-based proprietary medicinal products already listed.

Role in therapeutic strategy?

• Primary adrenocortical insufficiency (Addison's disease) and congenital hyperplasia of the suprarenals with salt loss

Treatment of suspected adrenocortical insufficiency should be started without waiting for the results of hormone assays. Management includes replacement therapy, treatment of the cause, if appropriate, therapeutic education of the patient and close monitoring.

It is based on the combined administration of the deficient hormones:

• hydrocortisone to correct glucocorticoid deficiency;
• fludrocortisone to correct mineralocorticoid deficiency when established (classic form with salt-loss).

Role of the medicinal product

Fludrocortisone is an essential replacement therapy. Fludrocortisone, in combination with a glucocorticoid, is a first-line treatment for primary adrenocortical insufficiency in the event of mineralocorticoid deficiency (Addison's disease) and congenital hyperplasia of the suprarenals with salt loss in all age groups.

Fludrocortisone is an aldosterone analogue. It must be systematically combined with hydrocortisone for the treatment of adrenocortical insufficiency, as its glucocorticoid activity is too weak for it to be used as a monotherapy at the usual dosages. In primary adrenocortical insufficiency, fludrocortisone is the essential replacement therapy.

FLUCORTAC (fludrocortisone) 100 mcg/mL, oral solution, is an additional therapeutic option for replacement therapy in mineralocorticoid deficiency, primary adrenocortical insufficiency (Addison's disease) and congenital hyperplasia of the suprarenals with salt loss.

The Committee underlines the practical value of this new formulation of FLUCORTAC (fludrocortisone) oral solution for use in newborns and young children, and in patients with swallowing disorders.

•  Orthostatic hypotension

According to the recommendations, as soon as the diagnosis is made, dietary and hygiene measures must be proposed: eradication of aggravating factors (antihypertensive treatment, anaemia, dehydration), education of the patient by teaching him/her to get up progressively, to avoid overly abundant and rich meals, to avoid excessively hot environments (leading to peripheral vasodilatation), and to increase his/her daily salt intake (if possible). If symptoms persist, non-medicinal measures such as compression stockings or tights are suggested. If the hypotension is drug-induced, adjusting the dosage, or avoiding or discontinuing the treatment are recommended.

In the event of failure, midodrine and fludrocortisone are the two pharmacological treatments that can be considered. It should be noted that according to the ESC recommendations, there is better evidence of the efficacy of midodrine for the treatment of orthostatic hypotension than fludrocortisone. In addition, the French national diagnosis and treatment protocol (PNDS) (Familial Amyloid Neuropathy – April 2017), recommends the use of fludrocortisone after the failure of midodrine.

To date, there are no specific recommendations for the management of severe orthostatic hypotension.

Role of the medicinal product

Despite the low level of evidence presented by efficacy data, FLUCORTAC (fludrocortisone) oral solution is amongst the recommended first-line treatments for the short-term management of severe neurogenic orthostatic hypotension requiring pharmacological treatment in all age groups. Fludrocortisone acetate oral solution is only indicated if general and physical measures are not sufficient.

The Committee underlines the practical benefit of this new formulation of FLUCORTAC (fludrocortisone) oral solution for use in patients with swallowing disorders and in paediatrics.