VELTASSA

What it is

Veltassa is a powder for oral suspension containing patiromer sorbitex calcium in strengths of 8.4 g, 16.8 g or 25.2 g per sachet. Patiromer sorbitex calcium is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol complex as a counterion and increases faecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract.

Approved indications

— Treatment of hyperkalaemia in adults

Dosing overview

The recommended starting dose of Veltassa is 8.4 g patiromer (as sorbitex calcium) once daily. The daily dose should be adjusted based on the serum potassium level and the desired target range, with the dose increased at 1-week or longer intervals by increments of 8.4 g, or decreased by 8.4 g, as necessary to reach the desired target range, up to a maximum dose of 25.2 g daily. The onset of action of Veltassa occurs 4–7 hours after administration.

Key safety warnings

Reversible causes of hyperkalaemia should be excluded and therapy initiated only if the serum potassium remains elevated and uncontrolled with dietary modification, with treatment needing to be closely supervised or monitored. Veltassa should not replace emergency treatment of hyperkalaemia and could be used in conjunction with other measures to stabilise the myocardium but is not recommended as the sole treatment of patients with hyperkalaemia and ECG changes. In clinical studies, serum magnesium values less than 1.4 mg/dL occurred in 7.1 per cent of patients treated with patiromer sorbitex calcium, with 0.3 per cent of patients developing a serum magnesium level less than 1.0 mg/dL, and mean decreases in serum magnesium occurred early during patiromer sorbitex calcium use with a maximum decrease of 0.137 mg/dL four weeks after initiation. Magnesium supplementation should be considered in patients who develop low serum magnesium levels on patiromer sorbitex calcium. Veltassa contains calcium as part of the counterion complex with calcium partially released and some of which may be absorbed, and the benefits and risks of administering this medicinal product should be carefully evaluated in patients at risk of hypercalcaemia. 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, and patients should be monitored carefully such that the benefits and risks of administering Veltassa can be evaluated before and during treatment. The majority of adverse drug reactions reported from trials were hypomagnesaemia and gastrointestinal disorders, with the most frequently reported adverse events being constipation, diarrhoea, abdominal pain, nausea, flatulence and vomiting, which were generally mild to moderate in nature, did not appear to be dose related, and generally resolved spontaneously or with treatment.

Contraindications

Veltassa is contraindicated in cases of hypersensitivity to patiromer sorbitex calcium or any of its excipients.

PBS listing

Veltassa was recommended by the PBAC in March 2023 for chronic hyperkalaemia in patients with chronic kidney disease stages 3–4. Further pricing and restriction information is not available in the provided sources.

Regulatory history

Veltassa patiromer (as sorbitex calcium) was first listed on the Australian Register of Therapeutic Goods on 12 December 2017 in three strengths: 8.4 g, 16.8 g and 25.2 g powder for oral suspension sachets. The TGA approved the application to register Veltassa for the treatment of hyperkalaemia in adults on 5 December 2017, with the TGA Delegate concluding that Veltassa has an overall positive benefit-risk profile for the proposed indication. The PBAC initially did not recommend Veltassa in November 2022, but subsequently recommended it in March 2023 for chronic hyperkalaemia in patients with chronic kidney disease stages 3–4.