Veltassa

/ CTS

The recommended starting dose is 8.4 g patiromer once daily.
The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range. 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. If serum potassium falls below the desired range, the dose should be reduced or discontinued.

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.

Administration o should be separated by 3 hours from other oral medicinal products.

The onset of action of the drug occurs 4-7 hours after administration. It should not replace emergency treatment for life-threatening hyperkalaemia.

Patients on dialysis
There is limited data on the use of the drug in patients on dialysis. No special dose and administration guidelines were applied to these patients in clinical studies.
Elderly population (≥65 years of age)
No special dose and administration guidelines are recommended for this population.
Paediatric population
The safety and efficacy  in children aged under 18 years have not yet been established. No data are available.
Method of administration:
Oral use.
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.
The 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, 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.
The drug can be taken with or without food. It should not be heated (e.g. microwaved) or added to heated foods or liquids. It should not be taken in its dry form.

Treatment of hyperkalaemia in adults.

Hypersensitivity to the active substance or to any of the excipients.

Low Magnesium.
Serum magnesium should be monitored for at least 1 month after initiating treatment and as clinically indicated during treatment, and magnesium supplementation considered in patients who develop low serum magnesium levels.
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 studies. 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 patients with current or history of severe gastrointestinal disorders, before and during treatment. Please refer to the license holder for further details.
Discontinuing patiromer
When discontinuing patiromer, serum potassium levels may rise, especially if 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.
Serum potassium levels
Serum potassium should be monitored when clinically indicated, including after changes are made to medicinal products that affect the serum potassium concentration (e.g. RAAS inhibitors or diuretics) and after the patiromer dose is titrated.
Information about sorbitol
Veltassa contains sorbitol as part of the counterion complex. The sorbitol content is approximately 4 g (10.4 kcal) per 8.4 g of patiromer.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Information about calcium
Veltassa contains calcium as part of the counterion complex. Calcium is partially released some of which may be absorbed. The benefits and risks of administering this medicinal product should be carefully evaluated in patients at risk of hypercalcaemia.
Limitations of the clinical data
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 and patients receiving dialysis treatment.
Data regarding efficacy and safety in end stage renal disease CKD-5 and patients on dialysis is limited.
Severe hyperkalaemia
There is limited experience in patients with serum potassium concentrations greater than 6.5 mmol/L. This medical product should not be used as an emergency treatment for life-threatening hyperkalaemia because of its delayed onset of action
Long term exposure
Clinical trials with patiromer have not included exposure longer than one year.
See prescribing information for full details.

Constipation, diarrhea, abdominal pain, Nausea, flatulence and hypomagnesaemia.
See prescribing information for full details.

Effect of patiromer on other medicinal products:
Patiromer has the potential to bind some oral co-administered medicinal products, which could decrease their gastrointestinal absorption. Increased bioavailability of co-administrated drugs was not observed in the conducted drug-drug interaction studies. As patiromer is not absorbed or metabolised by the body, there are limited effects on the function of other medicinal products.
As precautionary measure, and based on the data summarised below, administration of patiromer should therefore be separated by at least 3 hours from other oral medicinal products.
In vivo studies:
Concomitant administration of patiromer did not affect the bioavailability as measured by the area under the curve (AUC) of amlodipine, cinacalcet, clopidogrel, furosemide, lithium, metoprolol, trimethoprim, verapamil and warfarin. For these medicinal products no separation is needed.
Concomitant administration of patiromer showed reduced bioavailability of ciprofloxacin, levothyroxine and metformin. However, there was no interaction when patiromer and these medicinal products were taken 3 hours apart.
In vitro studies:
In vitro studies have shown no potential interaction of patiromer with the following active substances: allopurinol, amoxicillin, apixaban, acetylsalicylic acid, atorvastatin, azilsartan, benazepril, bumetanide, canagliflozin, candesartan, captopril, cephalexin, dapagliflozin, digoxin, empagliflozin, enalapril, eplerenone, finerenone, fosinopril, glipizide, irbesartan, lisinopril, losartan, olmesartan, perindopril, phenytoin, quinapril, ramipril, riboflavin, rivaroxaban, sacubitril, sevelamer, spironolactone tacrolimus, torasemide, trandolapril, and valsartan.
In vitro studies have shown potential interaction of patiromer with bisoprolol, carvedilol, mycophenolate mofetil, nebivolol, quinidine, and telmisartan.

There are no data from the use of patiromer in pregnant women.
No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to patiromer is negligible.
See prescribing information for full details.

Since excessive doses 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.

Store and transport refrigerated (2°C – 8°C).
Patients may store the drug below 25°C for up to 6 months.
For either storage condition, the drugshould not be used after the expiry date printed on the sachet.
The mixture should be taken within 1 hour of initial suspension.