Patiromer calcium

NOT FOR EMERGENCY USE: onset of action occurs 4 to 7 hours after administration and Veltassa should not replace emergency treatment for life-threatening hyperkalaemia (SPC 4.2/4.4). Multiple sachets may be used to achieve the desired dose. If serum potassium falls below the desired range, reduce the dose or discontinue. Duration of treatment is individualised by the treating physician based on the need for serum potassium management. Missed dose: take as soon as possible on the same day; the missed dose should not be taken with the next dose. PREPARATION: recommended total volume of water is dose dependent - 1 g patiromer 10 mL; 2 g 20 mL; 3 g 30 mL; 4 g 40 mL; more than 4 g 80 mL. Pour the first half of the volume into a glass, add the complete dose and stir; add the second half and stir again thoroughly. More water may be added for desired consistency, but larger volumes might lead to accelerated sedimentation of the powder. If powder remains in the glass after drinking, add more water, stir and take immediately; repeat as needed so that the entire dose is taken. Instead of water the following may be used by the same steps: apple, cranberry, pineapple, orange, grape or pear juice, apricot or peach nectar, yoghurt, milk, thickener (for example cornstarch), apple sauce, vanilla and chocolate pudding; the potassium content of any liquid or soft food used should be counted as part of the patient's dietary potassium intake, and cranberry juice should in general be limited to moderate amounts (for example less than 400 mL per day) because of its potential interaction with other medicinal products. NG/PEG TUBE: for doses up to 8.4 g prepare as for oral use; for doses above 8.4 g and up to 16.8 g use a total volume of 160 mL; for doses above 16.8 g and up to 25.2 g use 240 mL. Compatible with polyurethane, silicone and polyvinyl chloride tubes; recommended tube diameter 2.17 mm (6.5 Fr) or larger; flush the tube with water after administration. SPECIAL POPULATIONS: elderly - no special dose and administration guidelines. Dialysis - limited data; no special guidelines were applied in clinical trials. End-stage renal disease - studied only in a limited number of patients with eGFR below 15 mL/min/1.73 m2. SOURCE: Veltassa (Patiromer) 16.8 g powder for oral suspension, eMC product 10416; sections 4.1, 4.2, 4.3, 4.4, 4.5 and 4.6 are complete in the bundle; section 4.8 is truncated at the source-fetch limit. Veltassa contains sorbitol and calcium as part of the counterion complex (see contraindications and monitoring).

Adolescent data are limited to 6 months exposure, so treatment beyond 6 months should be done with caution (SPC 4.2/4.4). No paediatric patients receiving dialysis have been treated with patiromer. In the paediatric trial experience was limited to patients with maximum serum potassium of 6.2 mmol/L and the safety of patiromer has not been studied in patients under 6 years.