Patiromer is an oral potassium binder indicated for the treatment of hyperkalemia in adults and pediatric patients 12 years and older. Patiromer is not appropriate for rapid correction of life-threatening hyperkalemia because of its delayed onset of action. Patiromer binds many orally administered drugs and could result in decreased gastrointestinal absorption and loss of efficacy of the other drug if administered temporally to patiromer; dose separation is necessary.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Oral Administration
-Administer with or without food.
-Administer at least 3 hours before or 3 hours after other oral medications.
Oral Liquid Formulations
-Do not administer patiromer in its dry form.
-Prepare each dose immediately prior to administration.
-Measure 80 mL of water, other beverage, or soft food (e.g., apple sauce, yogurt, pudding). A minimum volume of 45 mL can be used to prepare doses up to and including 4 g patiromer. Pour half of the water, other beverage, or soft food into a glass. Do not heat (e.g., microwave) or add to heated food or liquids.
-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 (serum magnesium less than 1.4 mg/dL) was reported in 5% to 9% of adult patients receiving patiromer during clinical trials. Monitor serum magnesium concentrations and consider magnesium supplementation in patients who develop hypomagnesemia while receiving patiromer.
Hypokalemia (serum potassium less than 3.5 mEq/L) was reported in approximately 5% of adult patients receiving patiromer during clinical trials.
Constipation (7%), diarrhea (5%), nausea (2%), abdominal pain (2%), and flatulence (2%) were reported in adult patients receiving patiromer during clinical trials. Constipation generally resolved with continued treatment.
Mild to moderate hypersensitivity reactions, including edema of the lips, were reported in 0.3% of adult patients receiving patiromer during clinical trials.
Administer patiromer 3 hours before or 3 hours after other orally administered medications to prevent patiromer from binding to other oral medications, which may result in decreased gastrointestinal absorption and reduced efficacy of the bound drug.
Avoid the use of patiromer in patients with severe constipation, GI obstruction, or fecal impaction, including abnormal post-operative bowel motility disorders. Patiromer may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction, major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were excluded from patiromer clinical studies.
Use patiromer cautiously in patients with a history of hypomagnesemia. Patiromer binds to magnesium in the colon. Hypomagnesemia was reported in patients receiving patiromer in clinical trials. Monitor serum magnesium concentrations, and consider magnesium supplementation in patients who develop hypomagnesemia while receiving patiromer.
Patiromer is not absorbed systemically following oral administration. Maternal use during pregnancy is not expected to result in fetal risk.
Patiromer is not absorbed systemically by the mother; therefore, breast-feeding 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.
Safe and effective use of patiromer in infants and children younger than 12 years with hyperkalemia has not been established. During a clinical trial involving patients 6 to 11 years of age (n = 9), the dosing regimen of patiromer used in these patients (initial dose, 2 g/day; median dose, 6 g/day at day 14) did not appear effective in reducing potassium concentrations after 2 weeks.
For the treatment of hyperkalemia:
Oral dosage:
Adults: 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.
Children and Adolescents 12 to 17 years: 4 g PO once daily. Monitor serum potassium, and adjust dose by 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.
Maximum Dosage Limits:
-Adults
25.2 g/day PO.
-Geriatric
25.2 g/day PO.
-Adolescents
25.2 g/day PO.
-Children
12 years: 25.2 g/day PO.
1 to 11 years: Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
No dosage adjustments are needed.
*non-FDA-approved indication
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; 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.
Vitamin B Complex Supplements: (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.
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 concentration 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
-Route-Specific Pharmacokinetics
Oral Route
Food does not affect the pharmacokinetics of patiromer. In an open-label study (n = 114), the serum potassium at the end of treatment, the change from baseline in serum potassium, and the mean dose of patiromer were similar between patients who took patiromer with food and those who took it without food.
-Special Populations
Geriatric
No difference in effectiveness was observed between younger and older patients receiving patiromer during clinical trials (n = 666; 60% were 65 years and older, 20% were 75 years and older).