The Veltassa^® (patiromer) Challenge

Veltassa^® 1 g powder for oral suspension / Veltassa^® 8.4 g powder for oral suspension / Veltassa^® 16.8 g powder for oral suspension / Veltassa^® 25.2 g powder for oral suspension

For full prescribing information refer to the Summary of Product Characteristics (SmPC).

Presentation and active ingredient: Patiromer (as patiromer sorbitex calcium) powder for oral suspension available in sachets containing either 1 g, 8.4 g, 16.8 g or 25.2 g.

List of excipients: Xanthan gum

Indication: Treatment of hyperkalaemia in adults and adolescents aged 12 to 17 years.

Dosage and administration: Veltassa^® is administered once daily. The recommended starting dose in adults is 8.4 g patiromer once daily. The daily dose may be increased or decreased by 8.4 g as needed to achieve the desired serum potassium range, up to a maximum of 25.2 g daily. In adolescents aged 12 to 17 years, the recommended starting dose is 4 g once daily. The dose may be titrated based on serum potassium levels, up to a maximum of 25.2 g daily. For doses above 7 g, switching to 8.4 g sachets is recommended. The daily dose may be adjusted at intervals of one week or longer. Serum potassium should be monitored when clinically indicated. The duration of treatment should be individualized by the treating physician based on the need of serum potassium management. If potassium levels fall below the desired range, the dose should be reduced or discontinued. The onset of action of Veltassa^® occurs 4 - 7 hours after administration. Veltassa^® should not replace emergency treatment for life threatening hyperkalaemia. If a dose is missed, the missed dose should be taken as soon as possible on the same day. The missed dose should not be taken with the next dose. For oral use, Veltassa^® should be mixed with water or permitted liquids/soft foods and stirred to a suspension of uniform consistency. The suspension should be consumed within 1 hour of preparation. It should not be heated or taken in its dry form. Veltassa^® can be taken with or without meals. Administration of Veltassa^® should be separated by 3 hours from other oral medicinal products. Use in children under 12 years is not established. Data in adolescents are limited to 6 months; caution is advised for treatment beyond 6 months. Limited data are available in patients on dialysis or with eGFR <15 mL/min/1.73 m².

Contraindications: Veltassa^® is contraindicated in patients with a hypersensitivity to Patiromer or any of its excipients including xanthan gum.

Special warnings and precautions: Reductions in serum magnesium have been observed during treatment. Serum magnesium should be monitored for at least one month after initiation and as clinically indicated thereafter. Magnesium supplementation should be considered in patients who develop low serum magnesium. Gastrointestinal ischaemia, necrosis and/or intestinal perforation have been reported with other potassium binders. Veltassa^® has not been studied in patients with a history of bowel obstruction, major gastrointestinal surgery, or severe gastrointestinal disorders. The benefits and risks should be carefully evaluated in such patients before and during treatment. Monitor serum potassium according to standard clinical practice, especially following changes in medications that affect potassium levels (e.g., RAAS inhibitors or diuretics), or when Veltassa^® is titrated or discontinued. Discontinuation of Veltassa^® may lead to recurrent hyperkalaemia, particularly if RAAS inhibitor therapy is continued. Potassium increases may occur within 2 days after the last dose. Veltassa^® contains calcium as part of the counterion complex. The benefits and risks should be assessed in patients at risk of hypercalcaemia; serum calcium should be monitored at treatment initiation and as clinically indicated. Each 8.4 g dose contains approximately 4 g of sorbitol; patients with hereditary fructose intolerance should not take this product. 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. Veltassa^® should not be used as an emergency treatment for life-threatening hyperkalaemia because of its delayed onset of action. There are limited clinical trial data in adults with an exposure of one year and longer. Clinical trials in paediatric patients have not included exposure longer than 6 months. Therefore, treatment beyond 6 months should be done with caution in adolescents aged 12 to 17 years. There are no data from the use of Veltassa^® 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 Veltassa^® during pregnancy. Systemic exposure of the breast-feeding woman to Veltassa^® is negligible. No effects on the breastfed newborn/infant are anticipated. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Veltassa^® 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 Veltassa^® on fertility in humans. Animal studies showed no effects on reproductive function or fertility. Veltassa^® has no or negligible influence on the ability to drive and use machines. Overdosage: Since excessive doses of Veltassa^® may result in hypokalaemia, serum potassium levels should be monitored.

Undesirable effects: Common (≥1/100 to <1/10): hypomagnesaemia, constipation, diarrhoea, abdominal pain, nausea, flatulence. Uncommon (≥1/1,000 to <1/100): vomiting. Frequency not known: hypersensitivity. Please consult the SmPC for further information on undesirable effects.

Interactions: Patiromer has the potential to bind some orally co-administered medicinal products, which could decrease their gastrointestinal absorption. As a precautionary measure, administration of patiromer should be separated by at least 3 hours from other oral medicinal products. In vivo studies showed no effect on the bioavailability (AUC) of amlodipine, cinacalcet, clopidogrel, furosemide, lithium, metoprolol, trimethoprim, verapamil and warfarin; no separation is needed for these. Reduced bioavailability was observed with ciprofloxacin, levothyroxine and metformin when co-administered; no interaction was seen when administered 3 hours apart. Interaction studies have only been performed in adults.

Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphataemia.
ATC code: V03AE09
Date of Authorisation: 19.07.2017 Latest update of the SmPC: 16.01.2024
MA Holder: Vifor France, 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France
Veltassa^® is a registered trademark.
Date of preparation: April 2025
AbPI job number: HQ-PAT-2500024

All health care professionals must report Adverse Events and special situations associated with CSL Vifor products, within 24 hours of receipt of the information when they become aware or are informed about it, to Global Drug Safety at safety@viforpharma.com. Medicinal product subject to restricted medical prescription. Full prescribing information is available on request. Please read the full SmPC prior to administration and please refer to the latest version available. Please contact our company for detailed information.