Veltassa

Antidotes, Adsorbents
Mineral Binding Agents

Administer with or without food.
Administer at least 3 hours before or 3 hours after other oral medications.
Do not administer in its dry form.
Do not heat (e.g., microwave) or add to heated food or liquids.

Prepare each dose immediately prior to administration.
Measure one-third cup of water, other beverage, or soft food (e.g., apple sauce, yogurt, pudding). Pour half of the water, other beverage, or soft food into a glass.
Empty the entire contents of the packet(s) into the glass and stir thoroughly.
Add the remaining half of the water, other beverage, or soft food to the glass.
Stir thoroughly; the powder will not dissolve, and the mixture will look cloudy. Add more water, other beverage, or soft food to the mixture as needed for desired consistency.
Administer the mixture immediately. If some powder remains in the glass after taking, add more water, other beverage, or soft food; stir and administer immediately. Repeat as needed to ensure the entire dose is administered.

hypomagnesemia / Delayed / 5.3-9.0
constipation / Delayed / 7.2-7.2
hypokalemia / Delayed / 4.7-4.7
edema / Delayed / Incidence not known

diarrhea / Early / 4.8-4.8
nausea / Early / 2.3-2.3
abdominal pain / Early / 2.0-2.0
flatulence / Early / 2.0-2.0

Veltassa

Rx

Oral potassium binder
Used for treatment of hyperkalemia
Dose separation from other oral drugs necessary

8.4 g PO once daily. Monitor serum potassium, and adjust dose by 8.4 g daily as needed at 1 week or longer intervals to obtain the desired serum potassium target range, up to a maximum dose of 25.2 g once daily. Patiromer should not be used as emergency treatment for life-threatening hyperkalemia due to its delayed onset of action.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Alogliptin; Metformin: (Moderate) Separate the administration of patiromer and metformin by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of metformin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Bisoprolol: (Moderate) Separate the administration of patiromer and bisoprolol by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of bisoprolol and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Bisoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Separate the administration of patiromer and bisoprolol by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of bisoprolol and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Canagliflozin; Metformin: (Moderate) Separate the administration of patiromer and metformin by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of metformin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Carvedilol: (Moderate) Separate the administration of patiromer and carvedilol by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of carvedilol and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Ciprofloxacin: (Moderate) Separate the administration of patiromer and oral ciprofloxacin by at least 3 hours if concomitant use is necessary. Simultaneous oral coadministration may reduce gastrointestinal absorption of ciprofloxacin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Dapagliflozin; Metformin: (Moderate) Separate the administration of patiromer and metformin by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of metformin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Dextromethorphan; Quinidine: (Moderate) Separate the administration of patiromer and quinidine by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of quinidine and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Empagliflozin; Linagliptin; Metformin: (Moderate) Separate the administration of patiromer and metformin by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of metformin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Empagliflozin; Metformin: (Moderate) Separate the administration of patiromer and metformin by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of metformin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Ertugliflozin; Metformin: (Moderate) Separate the administration of patiromer and metformin by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of metformin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Glipizide; Metformin: (Moderate) Separate the administration of patiromer and metformin by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of metformin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Glyburide; Metformin: (Moderate) Separate the administration of patiromer and metformin by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of metformin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Levothyroxine: (Moderate) Separate the administration of patiromer and oral levothyroxine by at least 3 hours if concomitant use is necessary. Simultaneous oral coadministration may reduce gastrointestinal absorption of levothyroxine and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Levothyroxine; Liothyronine (Porcine): (Moderate) Separate the administration of patiromer and oral levothyroxine by at least 3 hours if concomitant use is necessary. Simultaneous oral coadministration may reduce gastrointestinal absorption of levothyroxine and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Levothyroxine; Liothyronine (Synthetic): (Moderate) Separate the administration of patiromer and oral levothyroxine by at least 3 hours if concomitant use is necessary. Simultaneous oral coadministration may reduce gastrointestinal absorption of levothyroxine and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Linagliptin; Metformin: (Moderate) Separate the administration of patiromer and metformin by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of metformin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Metformin: (Moderate) Separate the administration of patiromer and metformin by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of metformin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Metformin; Repaglinide: (Moderate) Separate the administration of patiromer and metformin by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of metformin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Metformin; Rosiglitazone: (Moderate) Separate the administration of patiromer and metformin by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of metformin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Metformin; Saxagliptin: (Moderate) Separate the administration of patiromer and metformin by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of metformin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Metformin; Sitagliptin: (Moderate) Separate the administration of patiromer and metformin by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of metformin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Mycophenolate: (Moderate) Separate the administration of patiromer and oral mycophenolate by at least 3 hours if concomitant use is necessary. Simultaneous oral coadministration may reduce gastrointestinal absorption of mycophenolate and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Nebivolol: (Moderate) Separate the administration of patiromer and nebivolol by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of nebivolol and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Nebivolol; Valsartan: (Moderate) Separate the administration of patiromer and nebivolol by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of nebivolol and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Pioglitazone; Metformin: (Moderate) Separate the administration of patiromer and metformin by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of metformin and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Quinidine: (Moderate) Separate the administration of patiromer and quinidine by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of quinidine and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Telmisartan: (Moderate) Separate the administration of patiromer and telmisartan by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of telmisartan and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Telmisartan; Amlodipine: (Moderate) Separate the administration of patiromer and telmisartan by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of telmisartan and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Telmisartan; Hydrochlorothiazide, HCTZ: (Moderate) Separate the administration of patiromer and telmisartan by at least 3 hours if concomitant use is necessary. Simultaneous coadministration may reduce gastrointestinal absorption of telmisartan and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.
Thiamine, Vitamin B1: (Moderate) Separate the administration of patiromer and oral thiamine by at least 3 hours if concomitant use is necessary. Simultaneous oral coadministration may reduce gastrointestinal absorption of thiamine and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk.

Veltassa Oral Pwd F/Recon: 8.4g, 16.8g, 25.2g

25.2 g/day PO.

25.2 g/day PO.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Patiromer is a cation exchange polymer that contains a calcium-sorbitol counterion. Fecal potassium excretion is increased through binding of potassium in the gastrointestinal lumen, with its principle site of action being the colon. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium concentrations.

Patiromer is administered orally. Results from animal pharmacokinetic studies show patiromer is not systemically absorbed and is excreted in the feces. Radiographic analysis in animals demonstrated that patiromer stays in the gastrointestinal tract, with no detectable level of radioactivity in any other tissues or organs.
 
Among 25 patients with hyperkalemia and chronic kidney disease given a controlled potassium diet for 3 days followed by 16.8 g patiromer daily (in divided doses) while continuing the controlled diet for 2 days, a statistically significant reduction in serum potassium (-0.2 mEq/L) was observed 7 hours after the first patiromer dose. Serum potassium concentrations continued to decrease during the 2-day treatment period (-0.8 mEq/L at 48 hours after the first dose). Potassium concentrations remained stable for 24 hours after the last patiromer dose and then increased during the 4-day observation period following patiromer discontinuation.
 
Affected cytochrome P450 isoenzymes and transporters: none

Patiromer is not absorbed systemically following oral administration. Maternal use during pregnancy is not expected to result in fetal risk.

According to the manufacturer, patiromer is not absorbed systemically by the mother; breastfeeding is not expected to result in risk to the infant. Consider the benefits of breast-feeding, the risk of infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, health care providers are encouraged to report the adverse effect to the FDA.