What is Veltassa - Patiromer and what is it used for?
Veltassa is a medicine used to treat adults with high levels of potassium in the blood (hyperkalemia). Hyperkalemia can cause severe heart problems and muscle weakness.
Veltassa contains the active ingredient patiromer.
How is Veltassa - Patiromer used?
Veltassa is available in the form of sachets (8.4, 16.8 and 25.2 g) of patiromer 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 a day. The doctor then adjusts the dose at intervals of at least a week, based on the potassium levels in the patient's blood. The maximum dose is 25.2 g once a day. The Veltassa mixture must be taken with food and at least three hours before or after any other medicine that 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 that is subsequently eliminated with feces. In this way patiromer extracts potassium from the body in the intestine and therefore reduces the amount in the blood.
What benefits has Veltassa - Patiromer shown during the studies?
A main study in patients with chronic kidney disease presenting with hyperkalemia found that Veltassa is effective in reducing blood potassium levels.
In the first part of the study, 243 patients with hyperkalemia (with an average 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 dropped through Veltassa treatment during the first part of the study. After four weeks, the average potassium level did not change in patients who had taken Veltassa for four weeks, on the contrary, they rose 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 of 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 that show 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 has 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 hyperkalemia and that Veltassa induces a significant reduction in potassium levels. The side effects are relatively moderate but the doctor must take them into consideration when evaluating a treatment with Veltassa
What measures are being taken to ensure the safe and effective use of Veltassa - Patiromer?
Recommendations and precautions to be followed by healthcare professionals and patients for Veltassa to be used safely and effectively have been included in the summary of product characteristics and the package leaflet.
More information on Veltassa - Patiromer
For the full version of Veltassa EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Veltassa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
