Patiromer Other names: Patiromer sorbitex calcium

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

In vitro studies have shown potential interaction of patiromer with bisoprolol, carvedilol, mycophenolate mofetil, nebivolol, quinidine, and telmisartan.

Concomitant administration of patiromer showed reduced bioavailability of ciprofloxacin, levothyroxine and metformin. However, there was no interaction when patiromer and these medicinal products were taken 3 hours apart.

Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in the clinical trials. 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 adult and paediatric patients with current or history of severe gastrointestinal disorders, before and during the treatment.

There is limited experience in patients with serum potassium concentrations greater than 6.5 mmol/L. In the paediatric population, experience is limited to patients with maximum serum potassium concentrations of 6.2 mmol/L. Patiromer should not be used as an emergency treatment for life-threatening hyperkalaemia because of its delayed onset of action.

There is limited data on the use of patiromer in patients on dialysis. No special dose and administration guidelines were applied to these patients in clinical trials. No paediatric patients receiving dialysis have been treated with patiromer.

There are no data from the use of patiromer in pregnant women.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

As a precautionary measure, it is preferable to avoid the use of patiromer during pregnancy.

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast feeding woman to patiromer is negligible. A decision must be made whether to discontinue breast feeding or to discontinue/abstain from patiromer therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There are no data on the effect of patiromer on fertility in humans. Animal studies showed no effects on reproductive function or fertility.

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

Summary of the safety profile

The majority of the adverse reactions (ARs) reported from trials in adult patients were hypomagnesaemia (1.8%) and gastrointestinal disorders, with the most frequently reported ARs being constipation (3.7%), diarrhoea (3%), abdominal pain (1.4%), nausea (1.3%) and flatulence (1%). Gastrointestinal disorder reactions were generally mild to moderate in nature, did not appear to be dose related, generally resolved spontaneously or with treatment, and none were reported as serious. Hypomagnesaemia was mild to moderate, with 0.3% of patients developing a serum magnesium level <1 mg/dL (0.4 mmol/L).

Tabulated list of adverse reactions

Adverse reactions reported in clinical trials are listed below by system organ class (SOC) and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

^* Adverse reactions reported also in the paediatric clinical trials
¹ ARs reported in the post-marketing setting.
² Hypersensitivity reactions included rash, urticaria, swelling in the oral cavity and lips and were mild to moderate severity.
³ Constipation is an aggregate term combining the preferred terms constipation and faeces hard.
⁴ Diarrhoea is an aggregate term for diarrhoea and frequent bowel movements.
⁵ Abdominal pain is an aggregate term combining the preferred terms of abdominal discomfort, abdominal pain, abdominal pain upper and abdominal pain lower.

Paediatric population

The safety of patiromer for the treatment of hyperkalaemia has been studied in a single trial of 23 paediatric patients aged 6 to 17 years of age. The adverse reaction profile observed in paediatric patients was broadly consistent with the safety profile in adults. The safety of patiromer has not been studied in patients less than 6 years of age.

Adverse reactions were reported for 4 subjects overall; 3 in age group 12 to <18 years and 1 in age group 6 to <12 years. In 2 of these subjects, the adverse reactions belonged to the SOC gastrointestinal disorders, i.e., diarrhoea, constipation, frequent bowel movements, and flatulence. The remaining adverse drug reactions were blood calcium increased and hypokalaemia. These were all non-serious adverse reactions and mild to moderate in severity.