Patiromer Other names: Patiromer sorbitex calcium

Concomitant administration of patiromer sorbitex calcium showed reduced bioavailability of ciprofloxacin. However, there was no interaction when patiromer sorbitex calcium and ciprofloxacin were taken 3 hours apart.

Concomitant administration of patiromer sorbitex calcium showed reduced bioavailability of levothyroxine. However, there was no interaction when patiromer sorbitex calcium and levothyroxine were taken 3 hours apart.

Concomitant administration of patiromer sorbitex calcium showed reduced bioavailability of metformin. However, there was no interaction when patiromer sorbitex calcium and metformin were taken 3 hours apart.

In vitro studies have shown potential interaction of patiromer sorbitex calcium with quinidine.

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 calcium during pregnancy.

No effects on the breast fed 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 calcium 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 were gastrointestinal disorders, with the most frequently reported ARs being constipation (6.2%), diarrhoea (3%), abdominal pain (2.9%), flatulence (1.8%) and hypomagnesaemia (5.3%). 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 no patient developing a serum magnesium level <1 mg/dL (0.4 mmol/L).

List of adverse reactions

Adverse reactions are listed below by system organ class 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.

Metabolism and nutrition disorders

Common: Hypomagnesaemia

Gastrointestinal disorders Constipation

Common: Diarrhoea, Abdominal pain, Flatulence

Uncommon: Nausea, Vomiting