Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Vifor Fresenius Medical Care Renal Pharma France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
In clinical studies, serum magnesium values <1.4 mg/dL (0.58 mmol/L) occurred in 9% of patients treated with patiromer. Mean decreases in serum magnesium were 0.17 mg/dL (0.070 mmol/L) or less. Serum magnesium should be monitored for at least 1 month after initiating treatment, and magnesium supplementation considered in patients who develop low serum magnesium levels.
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.
When discontinuing patiromer, serum potassium levels may rise, especially if 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 should be monitored 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.
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. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
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.
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.
There is limited experience in patients with serum potassium concentrations greater than 6.5 mmol/L.
Clinical trials with patiromer have not included exposure longer than one year.
Patiromer has the potential to bind some oral co administered medicinal products, which could decrease their gastrointestinal absorption. As patiromer is not absorbed or metabolised by the body, there are limited effects on the function of other medicinal products.
As precautionary measure, and based on the data summarised below, administration of patiromer should therefore be separated by at least 3 hours from other oral medicinal products.
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.
In vitro studies have shown potential interaction of patiromer with quinidine.
Concomitant administration of patiromer did however not affect the bioavailability as measured by the area under the curve (AUC) of amlodipine, cinacalcet, clopidogrel, furosemide, lithium, metoprolol, trimethoprim, verapamil and warfarin.
In vitro studies have shown no potential interaction of patiromer with the following active substances: allopurinol, amoxicillin, apixaban, acetylsalicylic acid, atorvastatin, cephalexin, digoxin, glipizide, lisinopril, phenytoin, riboflavin, rivaroxaban, spironolactone and valsartan.
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 (see section 5.3). As a precautionary measure, it is preferable to avoid the use of patiromer 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.
There are no data on the effect of patiromer on fertility in humans. Animal studies showed no effects on reproductive function or fertility (see section 5.3).
Patiromer has no or negligible influence on the ability to drive and use machines.
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).
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.
Common: Hypomagnesaemia
Common: Diarrhoea, Abdominal pain, Flatulence
Uncommon: Nausea, Vomiting
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Not applicable.
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