Special Warning : אזהרת שימוש

4.4     Special warnings and precautions for use

Low Magnesium


In clinical studies, serum magnesium values <1.4 mg/dL (0.58 mmol/L) occurred in 7.1% of adult patients treated with patiromer with 0.3% of patients developing a serum magnesium level <1.0 mg/dL (0.4 mmol/L). Mean decreases in serum magnesium were 0.137 mg/dL (0.0564 mmol/L) or less.
Serum magnesium should be monitored for at least 1 month after initiating treatment and as clinically indicated during treatment, and magnesium supplementation considered in patients who develop low serum magnesium levels (see section 4.8).
Gastrointestinal Disorders

Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in the clinical studies. Gastrointestinal ischaemia, necrosis and/or intestinal perforation have been reported with other potassium binders. The benefits and risks of administering patiromer should be carefully evaluated in patients with current or history of severe gastrointestinal disorders, before and during treatment.

Discontinuing patiromer

When discontinuing patiromer, serum potassium levels may rise leading to recurrent hyperkalaemia, especially if renin angiotensin aldosterone system (RAAS) inhibitor treatment is continued. Patients should be instructed not to discontinue therapy without consulting their physicians. Increases in serum potassium may occur as early as 2 days after the last patiromer dose.

Serum potassium levels

Serum potassium should be monitored as per standard practice when clinically indicated, including after changes are made to medicinal products that affect the serum potassium concentration (e.g.
RAAS inhibitors or diuretics) and after the patiromer dose is titrated or discontinued.


Limitations of the clinical data
Patients with end-stage renal disease (ESRD)

Patiromer has been studied only in a limited number of patients with estimated glomerular filtration rate (eGFR) <15 ml/min/1.73 m2 and patients receiving dialysis treatment.

Severe hyperkalaemia

There is limited experience in patients with serum potassium concentrations greater than 6.5 mmol/L.
Veltassa should not be used as an emergency treatment for life-threatening hyperkalaemia because of its delayed onset of action (see section 4.2).

Long term exposure

There are limited clinical trial data in adults with an exposure of one year and longer.
Information about sorbitol

Veltassa contains sorbitol as part of the counterion complex. The sorbitol content is approximately 4 g (10.4 kcal) per 8.4 g of patiromer and approximately 0.5 g (1.2 kcal) per 1 g of patiromer.
Patients with hereditary fructose intolerance (HFI) should not take this medicinal product .

Information about calcium

Veltassa contains calcium as part of the counterion complex. Calcium is partially released, some of which may be absorbed (see section 5.1). The benefits and risks of administering this medicinal 

product should be carefully evaluated in patients at risk of hypercalcaemia. Serum calcium should be monitored for at least 1 month after initiating treatment and as clinically indicated during treatment.

Effects on Driving

4.7         Effects on ability to drive and use machines
Patiromer has no or negligible influence on the ability to drive and use machines.