Veltassa
Authorised
This medicine is authorised for use in the European Union
patiromer
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Veltassa is a medicine used for treating adults and adolescents aged 12 years and above with high levels of potassium in the blood (hyperkalaemia). Hyperkalaemia can cause serious heart problems and muscle weakness.
Veltassa contains the active substance patiromer.
Veltassa is available as sachets containing a powder for mixing with water, liquid or soft food and is to be taken by mouth once daily. The recommended starting dose depends on the patient’s age; the dose is adjusted based on the patient’s blood levels of potassium.
The medicine can only be obtained with a prescription. For more information about using Veltassa, see the package leaflet or contact your doctor or pharmacist.
When Veltassa is taken by mouth, the active substance, patiromer, remains in the gut where it attaches tightly to potassium to form a compound that is then passed out in the stool. In this way, patiromer draws potassium from the body into the gut and so reduces the amount of potassium in the blood.
One main study involving adults with chronic kidney disease who had hyperkalaemia found that Veltassa is effective in reducing potassium levels in the blood.
In the first part of the study, 243 patients with hyperkalaemia (with an average potassium level of 5.6 mmol/litre) were treated with Veltassa. After 4 weeks of treatment, their potassium level fell on average by 1.0 mmol/litre.
The second part of the study compared Veltassa with placebo (a dummy treatment) in 107 patients whose potassium level had fallen with Veltassa during the first part of the study. After 4 weeks, the average potassium level did not change in patients who received Veltassa but it went back up by an average of 0.7 mmol/litre in patients who received placebo.
Another study involved 14 adolescents aged 12 years and above with hyperkalaemia (with an average potassium level of 5.5 mmol/litre). After 14 days of treatment with Veltassa, their potassium levels fell on average by 0.5 mmol/litre. This effect persisted, leading to an average reduction by 1.1 mmol/litre after 26 weeks of treatment.
For the full list of side effects and restrictions with Veltassa, see the package leaflet. The most common side effects with Veltassa (which may affect up to 1 in 10 people) include constipation, diarrhoea, abdominal (belly) pain, wind and low levels of magnesium in the blood.
The European Medicines Agency decided that Veltassa’s benefits are greater than its risks and it can be authorised for use in the EU. The Agency considered that there is a need for effective treatment of hyperkalaemia and Veltassa achieves a meaningful lowering of potassium levels. The side effects are relatively moderate but the doctor should take them into account when considering treatment with Veltassa.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Veltassa have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Veltassa are continuously monitored. Suspected side effects reported with Veltassa are carefully evaluated and any necessary action taken to protect patients.
Veltassa received a marketing authorisation valid throughout the EU on 19 July 2017.
Product information
Latest procedure affecting product information:
II/0034/G
06/06/2024
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
- Veltassa
- Active substance
- patiromer sorbitex calcium
- International non-proprietary name (INN) or common name
- patiromer
- Therapeutic area (MeSH)
- Hyperkalemia
- Anatomical therapeutic chemical (ATC) code
- V03AE09
Pharmacotherapeutic group
Drugs for treatment of hyperkalemia and hyperphosphatemiaTherapeutic indication
Veltassa is indicated for the treatment of hyperkalaemia in adults and adolescents aged 12 to 17 years.
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