Veltassa - Patiromer
What is Veltassa - Patiromer and what is it used for?
Veltassa is a medicine used to treat adults with high blood potassium levels (hyperkalaemia). Hyperkalaemia can cause severe heart problems and muscle weakness.
Veltassa contains the active substance patiromer.
How is Veltassa - Patiromer used?
Veltassa is available in the form of patiromer sachets (8.4, 16.8 and 25.2 g) containing a powder to be mixed with water or some fruit juices and taken by mouth. The recommended starting dose is 8.4 g once daily. The doctor then adjusts the dose at intervals of at least one week, based on the patient's blood potassium levels. The maximum dose is 25.2 g once a day. The Veltassa mixture should be taken with food and at least three hours before or after any other medicines the patient takes by mouth. For more information, see the package leaflet.
The medicine can only be obtained with a prescription
How does Veltassa - Patiromer work?
When Veltassa is taken by mouth, the active ingredient, patiromer, remains in the intestine where it binds firmly to potassium to form a compound which is subsequently eliminated in the faeces. In this way, patiromer extracts the potassium from the body into the intestine and then it reduces the amount in the blood.
What benefit has Veltassa - Patiromer shown during the studies?
One main study in chronic kidney disease patients with hyperkalaemia found Veltassa to be effective in lowering blood potassium levels.
In the first part of the study, 243 patients with hyperkalaemia (with a mean potassium level of 5.6 mmol / liter) were treated with Veltassa. After four weeks of treatment, their potassium level dropped by an average of 1.0 mmol / liter.
The second part of the study compared Veltassa with placebo (a dummy treatment) in 107 patients whose potassium level had decreased with Veltassa treatment during the first part of the study. After four weeks, the mean potassium level did not change in patients who took Veltassa for four weeks, on the contrary, it rose by an average of 0.7 mmol / liter in patients who took placebo.
What are the risks associated with Veltassa - Patiromer?
The most common side effects with Veltassa (which may affect more than 1 in 100 people) are those affecting the digestive system (constipation, diarrhea, abdominal pain and flatulence) and blood tests showing low levels of magnesium in the blood. For the full list of restrictions and side effects reported with Veltassa, see the package leaflet.
Why has Veltassa - Patiromer been approved?
The European Medicines Agency decided that Veltassa's benefits are greater than its risks and recommended that it be approved for use in the EU. The Agency considered that there is a need for effective treatment of hyperkalaemia and that Veltassa induces a significant reduction in potassium levels. Undesirable effects are relatively moderate but the doctor should take them into consideration when considering treatment with Veltassa.
What measures are being taken to ensure the safe and effective use of Veltassa - Patiromer?
The recommendations and precautions to be observed by healthcare professionals and patients for Veltassa to be used safely and effectively have been set out in the summary of product characteristics and package leaflet.
More information about Veltassa - Patiromer
For the complete version of Veltassa's EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Veltassa therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
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