SIBNAYAL (bicarbonate de potassium/ citrate de potassium)

Key points

Favourable opinion for reimbursement in the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older.

What therapeutic improvement?

 Therapeutic improvement compared to standard alkalising therapy.

Role in the care pathway?

In distal renal tubular acidosis (dRTA), alkalising therapy is required to correct metabolic acidosis. Patients are generally prescribed sodium bicarbonate or sodium citrate. Children require higher doses (4 to 8 mEq/kg/d) than adults (1 to 2 mEq/kg/d).

The products currently available are immediate-release formulations that require repeated daily doses (up to 6 doses per day), sometimes at night, to adequately control metabolic acidosis over a 24-hour period and have a positive impact on growth and renal function. More than 30 different alkalising formulations are available in Europe, and the absence of reimbursement means that the use of pharmacy-compounded preparations is widespread.

In France, three rapid-release medicinal products (excluding pharmacy-compounded preparations) are also available: FONCITRIL 4000 granules in single-dose sachets (containing citric acid monohydrate, anhydrous monopotassium citrate and anhydrous monosodium citrate, i.e. around 22 mEq for one single-dose sachet; medicinal product not reimbursed in the retail sector); ALCAPHOR 250 mL oral solution (containing dipotassium citrate, disodium citrate and trometamol, i.e. 25 mEq per tablespoonful; medicinal product not reimbursed in the retail sector) and UROCIT-K 10 mEq tablets (1,080 mg of potassium citrate/tablet) or 5 mEq tablets (540 mg of potassium citrate/tablet; available as part of a named-patient compassionate use programme (ATU)). In clinical practice, these medicinal products are little used. Potassium replacement (potassium citrate) is also necessary in the event of hypokalaemia.

Role of the medicinal product in the care pathway

SIBNAYAL (potassium citrate/potassium bicarbonate) represents a first-line alternative to alkalising therapy in pharmacy-compounded preparation form, already used in children aged one year and older. In children, in particular, this pharmaceutical product, administered as two doses per day, should make it possible to reduce the number of daily doses compared to alkalising therapy in pharmacy-compounded preparation form, which can require up to 6 doses per day.