Posology : מינונים

4.2     Posology and method of administration

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).

Posology

Adults
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.
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).

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 Veltassa in patients on dialysis. No special dose and administration guidelines were applied to these patients in clinical studies.

Patients with end-stage renal disease (ESRD)
Patiromer has been studied only in a limited number of patients with estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m².

Paediatric population
Veltassa is not indicated for treatment in children aged under 18 years old.

Method of administration
Oral use.
Veltassa should be mixed with water and stirred to a suspension of uniform consistency, according to the following steps:

The complete dose should be poured into a glass containing approximately 40 ml of water, then stirred. Another approximately 40 ml of water should be added, and the suspension stirred again thoroughly. The powder will not dissolve. More water may be added to the mixture as needed for desired consistency.

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.

Veltassa 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.