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Veltassa is a brand name for Patiromer. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Veltassa is indicated for the treatment of hyperkalaemia in adults and adolescents aged 12 to 17 years.
Verbatim from this product's EMA label. Tap a section to expand.
The onset of action of Veltassa occurs 4 – 7 hours after administration. 4). Posology Veltassa is administrated once daily. The recommended starting dose of Veltassa varies with age. Multiple sachets may be used to achieve the desired dose.
The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range. 4). The duration of treatment should be individualized by the treating physician based on the need of serum potassium management.
If serum potassium falls below the desired range, the dose should be reduced or discontinued. 5). 4 g patiromer once daily. 2 g daily. Adolescents aged 12 to 17 years The recommended starting dose is 4 g patiromer once daily. 2 g daily.
4 g patiromer sachets if doses above 7 g are needed. Missed doses 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. Special populations Elderly No special dose and administration guidelines are recommended for this population.
Patients on dialysis 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.
73 m². Paediatric population The safety and efficacy of patiromer in children aged under 12 years have not yet been established. The data in adolescents aged 12 to 17 years are limited to 6 months exposure. 4). Method of administration Oral use.
Veltassa should be mixed with water and stirred to a suspension of uniform consistency. The recommended total volumes for preparation of the suspension are dose dependent: • 1 g patiromer: 10 mL • 2 g patiromer: 20 mL • 3 g patiromer: 30 mL • 4 g patiromer: 40 mL • >4 g patiromer: 80 mL The suspension should be prepared according to the following steps: • The first half of the recommended volume for the required dose should be poured into a glass and the complete dose of patiromer should be added, then stirred.
• The second half of the recommended volume should be added and the suspension stirred again thoroughly. 4 The powder will not dissolve. More water may be added to the mixture as needed for desired consistency. However, larger volumes might lead to an accelerated sedimentation of the powder.
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. 4). 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.
MedDRA system organ class Common Uncommon Frequency not known Immune System Disorders Hypersensitivity(1,2) Metabolism and nutrition disorders Hypomagnesaemia Gastrointestinal disorders Constipation(3)* Diarrhoea(4)* Abdominal pain(5) Nausea Flatulence* Vomiting *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.
4 mmol/L). 0564 mmol/L) or less. 1440 mmol/L). 58 mmol/L) during the paediatric clinical trial. 8). Gastrointestinal disorders 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.
5 Discontinuing patiromer When discontinuing patiromer, serum potassium levels may rise leading to recurrent hyperkalaemia, especially if renin-angiotensin-aldosterone system (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. There is limited information on serum potassium levels in paediatric patients on patiromer discontinuation. g. RAAS inhibitors or diuretics) and after the patiromer dose is titrated or discontinued.
5 mmol/L. 2 mmol/L. 2). Long term exposure 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.
Information about sorbitol Veltassa contains sorbitol as part of the counterion complex. 2 kcal) per 1 g of patiromer. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product. Information about calcium Veltassa contains calcium as part of the counterion complex.
1). The benefits and risks of administering this medicinal product should be carefully evaluated in adult and paediatric patients at risk of hypercalcaemia. Serum calcium should be monitored for at least 1 month after initiating treatment and as clinically indicated during treatment.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The mixture should be taken within 1 hour of initial suspension. If powder remains in the glass after drinking, more water should be added and the suspension stirred and taken immediately. This may be repeated as needed to ensure the entire dose is administered.
According to personal preferences, following liquids or soft foods can be used instead of water to prepare the mixture by following the same steps as described above: apple juice, cranberry juice, pineapple juice, orange juice, grape juice, pear juice, apricot nectar, peach nectar, yoghurt, milk, thickener (for example: cornstarch), apple sauce, vanilla and chocolate pudding.
The potassium content of liquids or soft foods used to prepare the mixture should be considered as part of the dietary recommendations on potassium intake for each individual patient. In general, cranberry juice intake should be limited to moderate amounts (for example less than 400 mL per day) due to its potential interaction with other medicinal products.
This medicine can be taken with or without meals. g. microwaved) or added to heated foods or liquids. It should not be taken in its dry form. 4 g patiromer, the suspension should be prepared as described above in the section relating to the oral administration.
2 g patiromer a total volume of 240 mL. These volumes ensure that the suspension readily flows through the tubes. Compatibility has been shown with tubes made from polyurethane, silicone, and polyvinyl chloride. 5 Fr) or larger. After administration the tube should be flushed with water.
6.
, 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. 8 Reporting of suspected adverse reactions 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.