Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Vifor Fresenius Medical Care Renal Pharma France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France
Veltassa is indicated for the treatment of hyperkalaemia in adults and adolescents aged 12 to 17 years.
The onset of action of Veltassa occurs 4–7 hours after administration. It should not replace emergency treatment for life threatening hyperkalaemia (see section 4.4).
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. Serum potassium should be monitored when clinically indicated (see section 4.4). 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.
Administration of Veltassa should be separated by 3 hours from other oral medicinal products (see section 4.5).
The recommended starting dose is 8.4 g patiromer once daily. The daily dose may be increased 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 recommended starting dose is 4 g patiromer once daily. Adjust the daily dose of patiromer based on the serum potassium level and the desired target range, up to a maximum dose of 25.2 g daily. It is recommended to switch to 8.4 g patiromer sachets if doses above 7 g are needed.
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.
No special dose and administration guidelines are recommended for this population.
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.
Patiromer has been studied only in a limited number of patients with estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m².
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. Therefore, treatment beyond 6 months should be done with caution in adolescents aged 12 to 17 years (see section 4.4).
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:
The suspension should be prepared according to the following steps:
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.
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. It should not be heated (e.g. microwaved) or added to heated foods or liquids. It should not be taken in its dry form.
For doses up to 8.4 g patiromer, the suspension should be prepared as described above in the section relating to the oral administration. For doses above 8.4 g and up to 16.8 g patiromer a total volume of 160 mL should be used and for doses above 16.8 g and up to 25.2 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. The recommended diameter of the tubes is 2.17 mm (6.5 Fr) or larger. After administration the tube should be flushed with water. For instructions on disposal, see section 6.6.
Since excessive doses of patiromer may result in hypokalaemia, serum potassium levels should be monitored. Patiromer is excreted after approximately 24 to 48 hours, based on average gastrointestinal transit time. If it is determined that medical intervention is required, appropriate measures to restore serum potassium may be considered.
Doses in excess of 25.2 g patiromer per day for adolescents aged 12 to 17 years and in excess of 12 g for children 6 to less than 12 years old have not been tested. Since excessive doses of patiromer may result in hypokalaemia, serum potassium levels should be monitored. If it is determined that medical intervention is required, appropriate measures to restore serum potassium may be considered.
3 years.
Store and transport refrigerated (2°C–8°C).
If stored at room temperature (below 25°C), Veltassa should be used within 6 months of being taken out of the refrigerator.
For either storage condition, Veltassa should not be used after the expiry date printed on the sachet.
The mixture should be taken within 1 hour of initial suspension.
1 g of patiromer, as powder in sachets made of five layers: polyethylene, aluminium, polyethylene, polyester and paper.
Pack sizes: box of 60 sachets.
8.4 g of patiromer, as powder in sachets made of five layers: polyethylene, aluminium, polyethylene, polyester and paper.
Pack sizes: boxes of 30, 60 or 90 sachets and multipacks comprising 3 cartons, each containing 30 sachets.
16.8 g of patiromer, as powder in sachets made of five layers: polyethylene, aluminium, polyethylene, polyester and paper.
Pack sizes: boxes of 30, 60 or 90 sachets.
25.2 g of patiromer, as powder in sachets made of five layers: polyethylene, aluminium, polyethylene, polyester and paper.
Pack sizes: boxes of 30, 60 or 90 sachets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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