Sibnayal
Authorised
This medicine is authorised for use in the European Union
potassium citrate / potassium hydrogen carbonate
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Sibnayal is a medicine used to treat patients from the age of one year with distal renal tubular acidosis (dRTA), a disease in which the kidneys do not remove acid through the urine well enough. This results in a build-up of acid in the blood, which leads to a range of symptoms including hearing and growth problems, vomiting, kidney stones and lack of alertness. The disease also causes levels of potassium in the blood to fall, which can lead to muscle weakness and paralysis.
Sibnayal contains the active substances potassium citrate and potassium hydrogen carbonate.
Sibnayal is available as prolonged-release granules to be taken by mouth, and can only be obtained with a prescription. Prolonged release means that the active substance in Sibnayal is released slowly into the body over a few hours after being taken. The starting dose depends on the age and body weight of the patient, and is gradually increased to obtain the optimal dose that provides adequate control of acid and potassium levels in the blood. Sibnayal is taken twice daily, typically twelve hours apart.
For more information about using Sibnayal, see the package leaflet or contact your doctor or pharmacist.
Sibnayal contains a combination of two salts, potassium citrate and potassium hydrogen carbonate. Because the combination is alkaline and contains potassium, it neutralises excess acid in the blood and restores levels of potassium, thus relieving the symptoms of the disease.
One study in 37 patients with dRTA showed that Sibnayal was effective at reducing the level of acid and normalising the level of potassium in the blood.
Patients were first treated with their usual medicines for neutralising excess acid for 5 days, then switched to Sibnayal. The optimal dose of Sibnayal was reached gradually over 30 days, after which patients were given this dose for at least 5 days.
The large majority (90%) of patients had a reduction in blood acid levels during treatment with Sibnayal, and this effect was generally maintained during 24 months of treatment. In addition, blood potassium levels returned to normal in 83% of patients. The corresponding figures during treatment with other medicines were 45% and 82%, respectively.
The most common side effects with Sibnayal (which may affect more than 1 in 10 people) is abdominal (belly) pain. Nausea (feeling sick) at start of treatment, stomach pain and gut pain may affect up to 1 in 10 people. For the full list of side effects of Sibnayal, see the package leaflet.
Sibnayal must not be used in patients with moderately or severely impaired kidney function and in patients with hyperkalaemia (high blood potassium levels). For the full list of restrictions, see the package leaflet.
Sibnayal was shown to be effective at reducing the level of acid and normalising the level of potassium in dRTA patients’ blood. The safety of Sibnayal was considered acceptable, and its side effects manageable and in line with other treatments for this disease. The European Medicines Agency therefore decided that Sibnayal’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sibnayal have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Sibnayal are continuously monitored. Side effects reported with Sibnayal are carefully evaluated and any necessary action taken to protect patients.
Sibnayal received a marketing authorisation valid throughout the EU on 30 April 2021.
Product information
Latest procedure affecting product information:
IB/0009
27/06/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Sibnayal
- Active substance
- Potassium citrate monohydrated
- Potassium hydrogen carbonate
- International non-proprietary name (INN) or common name
- potassium citrate
- potassium hydrogen carbonate
- Therapeutic area (MeSH)
- Acidosis, Renal Tubular
- Anatomical therapeutic chemical (ATC) code
- A12BA30
Pharmacotherapeutic group
Mineral supplementsTherapeutic indication
Sibnayal is indicated for the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older.
News on Sibnayal
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