Veltassa

Drug overview for VELTASSA (patiromer calcium sorbitex):

Generic name: PATIROMER CALCIUM SORBITEX (pa-TIR-oh-mer)
Drug class: Potassium-Removing Resins
Therapeutic class: Electrolyte Balance-Nutritional Products

Patiromer sorbitex calcium, which consists of patiromer, a nonabsorbed cation-exchange polymer, and a calcium-sorbitol counterion, is used for the removal of excess potassium.

No enhanced Uses information available for this drug.

DRUG IMAGES

VELTASSA 8.4 GM POWDER PACKET
VELTASSA 16.8 GM POWDER PACKET
VELTASSA 25.2 GM POWDER PACKET

The following indications for VELTASSA (patiromer calcium sorbitex) have been approved by the FDA:

Indications:
Hyperkalemia

Professional Synonyms:
Hyperpotassemia

The following dosing information is available for VELTASSA (patiromer calcium sorbitex):

Dosing
Administration
VELTASSA
Generic

Dosage of patiromer sorbitex calcium is expressed in terms of patiromer.

Patiromer is administered orally as an oral suspension without regard to food. Patiromer should be administered at least 3 hours before or 3 hours after other oral drugs, unless the drug has not been shown to have a clinically important interaction. Patiromer powder should be mixed with water immediately prior to administration to form an oral suspension.

The entire contents of the packet(s) containing patiromer should be emptied into a glass or cup containing 40 mL of water. The mixture should be stirred and then an additional 40 mL of water should be added to the suspension. The suspension should again be stirred thoroughly and more water may be added to achieve the desired consistency.

The suspension should be administered immediately after preparation. If powder remains in the glass after initial administration, more water should be added and the mixture should be stirred and then administered immediately; this should be repeated, as needed, until the entire dose is administered. The mixture can also be prepared by using other liquids or soft foods (e.g., apple sauce, yogurt, pudding) instead of water.

A minimum volume of 45 mL (3 tablespoons) can be used to prepare doses up to and including 4 g of patiromer. 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. Patiromer should not be heated (e.g., in a microwave) or added to heated foods or liquids.

Dosing information for VELTASSA
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
VELTASSA 8.4 GM POWDER PACKET	Maintenance	Adults take 1 packet (8.4 gram) by oral route once daily add to 30 mL water and mix; add additional 60 mL water, stir and drink immediately
VELTASSA 16.8 GM POWDER PACKET	Maintenance	Adults take 1 packet (16.8 gram) by oral route once daily add to 30 mL water and mix; add additional 60 mL water, stir and drink immediately

No generic dosing information available.

The following drug interaction information is available for VELTASSA (patiromer calcium sorbitex):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 1 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Potassium Supplements/Potassium Binders SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Patiromer, sodium polystyrene sulfonate and sodium zirconium cyclosilicate bind to potassium.(1-3) CLINICAL EFFECTS: Concurrent use of potassium supplements and patiromer, sodium polystyrene sulfonate or sodium zirconium cyclosilicate may decrease the effectiveness of both agents. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients should normally not receive potassium supplements and patiromer, sodium polystyrene sulfonate or sodium zirconium cyclosilicate concurrently.(1-3) Patiromer, sodium polystyrene sulfonate or sodium zirconium cyclosilicate are indicated for management of hyperkalemia. Consider discontinuing or holding potassium supplements in patients who develop hyperkalemia requiring treatment. DISCUSSION: Patiromer, sodium polystyrene sulfonate and sodium zirconium cyclosilicate are indicated for hyperkalemia. Consider discontinuing or holding potassium supplements in patients receiving sodium polystyrene sulfonate or sodium zirconium cyclosilicate.	DEXTROSE 5%-ELECTROLYTE #48, EFFER-K, K-PHOS NO.2, K-PHOS ORIGINAL, KCL-D5W-0.2% NACL, KCL-D5W-0.225% NACL, KCL-D5W-0.45% NACL, KCL-D5W-0.9% NACL, KLOR-CON, KLOR-CON 10, KLOR-CON 8, KLOR-CON M10, KLOR-CON M15, KLOR-CON M20, KLOR-CON-EF, POKONZA, POTASSIUM ACETATE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE IN D5LR, POTASSIUM CHLORIDE-0.45% NACL, POTASSIUM CHLORIDE-0.9% NACL, POTASSIUM CHLORIDE-DEXTROSE 5%, POTASSIUM CHLORIDE-WATER, POTASSIUM CL-LIDOCAINE-NS, POTASSIUM PHOSPHATE, POTASSIUM PHOSPHATE-0.9% NACL, POTASSIUM PHOSPHATES

Drug Interaction

Drug Names

Potassium Supplements/Potassium Binders

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Patiromer, sodium polystyrene sulfonate and sodium zirconium cyclosilicate bind to potassium.(1-3)

CLINICAL EFFECTS: Concurrent use of potassium supplements and patiromer, sodium polystyrene sulfonate or sodium zirconium cyclosilicate may decrease the effectiveness of both agents.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Patients should normally not receive potassium supplements and patiromer, sodium polystyrene sulfonate or sodium zirconium cyclosilicate concurrently.(1-3) Patiromer, sodium polystyrene sulfonate or sodium zirconium cyclosilicate are indicated for management of hyperkalemia. Consider discontinuing or holding potassium supplements in patients who develop hyperkalemia requiring treatment.

DISCUSSION: Patiromer, sodium polystyrene sulfonate and sodium zirconium cyclosilicate are indicated for hyperkalemia. Consider discontinuing or holding potassium supplements in patients receiving sodium polystyrene sulfonate or sodium zirconium cyclosilicate.

DEXTROSE 5%-ELECTROLYTE #48, EFFER-K, K-PHOS NO.2, K-PHOS ORIGINAL, KCL-D5W-0.2% NACL, KCL-D5W-0.225% NACL, KCL-D5W-0.45% NACL, KCL-D5W-0.9% NACL, KLOR-CON, KLOR-CON 10, KLOR-CON 8, KLOR-CON M10, KLOR-CON M15, KLOR-CON M20, KLOR-CON-EF, POKONZA, POTASSIUM ACETATE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE IN D5LR, POTASSIUM CHLORIDE-0.45% NACL, POTASSIUM CHLORIDE-0.9% NACL, POTASSIUM CHLORIDE-DEXTROSE 5%, POTASSIUM CHLORIDE-WATER, POTASSIUM CL-LIDOCAINE-NS, POTASSIUM PHOSPHATE, POTASSIUM PHOSPHATE-0.9% NACL, POTASSIUM PHOSPHATES

There are 8 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Patiromer/Ciprofloxacin SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Patiromer may bind to ciprofloxacin.(1) CLINICAL EFFECTS: Concurrent use may result in decreased gastrointestinal absorption and loss of efficacy of ciprofloxacin.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of patiromer recommends that you administer patiromer at least 3 hours before or 3 hours after ciprofloxacin.(1) DISCUSSION: A study in healthy volunteers showed that patiromer decreased the systemic exposure of coadministered ciprofloxacin. No interaction was seen when these drugs were taken 3 hours apart.(1)	CIPRO, CIPROFLOXACIN, CIPROFLOXACIN HCL
Patiromer/Thyroid Preparations SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Patiromer may bind to thyroid preparations.(1) CLINICAL EFFECTS: Concurrent use may result in decreased gastrointestinal absorption and loss of efficacy of the thyroid preparation.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of patiromer recommends that you administer patiromer at least 3 hours before or 3 hours after levothyroxine.(1) DISCUSSION: A study in healthy volunteers showed that patiromer decreased the systemic exposure of coadministered levothyroxine. No interaction was seen when these drugs were taken 3 hours apart.(1)	ADTHYZA, ARMOUR THYROID, CYTOMEL, ERMEZA, EUTHYROX, LEVO-T, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM DILUTION, LEVOXYL, LIOTHYRONINE SODIUM, NIVA THYROID, NP THYROID, PCCA T3 SODIUM DILUTION, PCCA T4 SODIUM DILUTION, RENTHYROID, SYNTHROID, THYQUIDITY, THYROID, TIROSINT, TIROSINT-SOL, UNITHROID
Patiromer/Metformin SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Patiromer may bind to metformin.(1) CLINICAL EFFECTS: Concurrent use may result in decreased gastrointestinal absorption and loss of efficacy of metformin.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of patiromer recommends that you administer patiromer at least 3 hours before or 3 hours after metformin.(1) DISCUSSION: A study in healthy volunteers showed that patiromer decreased the systemic exposure of coadministered metformin. No interaction was seen when these drugs were taken 3 hours apart.(1)	ACTOPLUS MET, ALOGLIPTIN-METFORMIN, DAPAGLIFLOZIN-METFORMIN ER, GLIPIZIDE-METFORMIN, GLYBURIDE-METFORMIN HCL, INVOKAMET, INVOKAMET XR, JANUMET, JANUMET XR, JENTADUETO, JENTADUETO XR, KAZANO, METFORMIN ER GASTRIC, METFORMIN ER OSMOTIC, METFORMIN HCL, METFORMIN HCL ER, PIOGLITAZONE-METFORMIN, RIOMET, SAXAGLIPTIN-METFORMIN ER, SEGLUROMET, SITAGLIPTIN-METFORMIN, SITAGLIPTIN-METFORMIN ER, SYNJARDY, SYNJARDY XR, TRIJARDY XR, XIGDUO XR, ZITUVIMET, ZITUVIMET XR
Patiromer/Telmisartan SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Patiromer may bind to telmisartan.(1) CLINICAL EFFECTS: Concurrent use may result in decreased gastrointestinal absorption and loss of efficacy of telmisartan.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of patiromer recommends administering patiromer at least 3 hours before or 3 hours after telmisartan.(1) DISCUSSION: An in vitro binding study found potentially clinically significant binding of telmisartan by patiromer. It is recommended to take these drugs 3 hours apart.(1)	MICARDIS, MICARDIS HCT, TELMISARTAN, TELMISARTAN-AMLODIPINE, TELMISARTAN-HYDROCHLOROTHIAZID
Patiromer/Bisoprolol; Carvedilol; Nebivolol SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Patiromer may bind to bisoprolol, carvedilol, and nebivolol.(1) CLINICAL EFFECTS: Concurrent use may result in decreased gastrointestinal absorption and loss of efficacy of bisoprolol, carvedilol, and nebivolol.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of patiromer recommends administering patiromer at least 3 hours before or 3 hours after bisoprolol, carvedilol, or nebivolol.(1) DISCUSSION: An in vitro binding study found potentially clinically significant binding of bisoprolol, carvedilol, and nebivolol by patiromer. It is recommended to take these drugs 3 hours apart.(1)	BISOPROLOL FUMARATE, BISOPROLOL-HYDROCHLOROTHIAZIDE, BYSTOLIC, CARVEDILOL, CARVEDILOL ER, COREG, COREG CR, NEBIVOLOL HCL
Patiromer/Mycophenolate SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Patiromer may bind to mycophenolate.(1) CLINICAL EFFECTS: Concurrent use may result in decreased gastrointestinal absorption and loss of efficacy of mycophenolate.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of patiromer recommends administering patiromer at least 3 hours before or 3 hours after mycophenolate.(1) DISCUSSION: An in vitro binding study found potentially clinically significant binding of mycophenolate by patiromer. It is recommended to take these drugs 3 hours apart.(1)	CELLCEPT, MYCOPHENOLATE MOFETIL, MYCOPHENOLIC ACID, MYFORTIC, MYHIBBIN
Patiromer/Quinidine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Patiromer may bind to quinidine.(1) CLINICAL EFFECTS: Concurrent use may result in decreased gastrointestinal absorption and loss of efficacy of quinidine.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of patiromer recommends administering patiromer at least 3 hours before or 3 hours after quinidine.(1) DISCUSSION: An in vitro binding study found potentially clinically significant binding of quinidine by patiromer. It is recommended to take these drugs 3 hours apart.(1)	NUEDEXTA, QUINIDINE GLUCONATE, QUINIDINE SULFATE
Patiromer/Thiamine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Patiromer may bind to thiamine.(1) CLINICAL EFFECTS: Concurrent use may result in decreased gastrointestinal absorption and loss of efficacy of thiamine.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of patiromer recommends administering patiromer at least 3 hours before or 3 hours after thiamine.(1) DISCUSSION: An in vitro binding study found potentially clinically significant binding of thiamine by patiromer. It is recommended to take these drugs 3 hours apart.(1)	THIAMINE HCL

The following contraindication information is available for VELTASSA (patiromer calcium sorbitex):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

*Known hypersensitivity to the drug or to any ingredient in the formulation.

There are 1 contraindications. Absolute contraindication.

Contraindication List
Gastrointestinal obstruction

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Gastrointestinal hypomotility

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Hypomagnesemia

The following adverse reaction information is available for VELTASSA (patiromer calcium sorbitex):

Overview
Severe
Less Severe

Adverse reaction overview.

The most common adverse effects reported with patiromer in clinical studies (incidence >=2%) were constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort, and flatulence.

There are 2 severe adverse reactions.

More Frequent	Less Frequent
Hypomagnesemia	None.

Rare/Very Rare
Hypersensitivity drug reaction

There are 8 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Constipation Diarrhea Flatulence Nausea	Hypokalemia

Rare/Very Rare
Lip swelling Vomiting

The following precautions are available for VELTASSA (patiromer calcium sorbitex):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of patiromer for the treatment of hyperkalemia have been established in pediatric patients 12 years of age or older. Use of the drug in pediatric patients is supported by an adequate and well-controlled study in adults as well as pharmacodynamic and safety data from a single-arm, open-label study in pediatric patients 12-17 years of age. Safety and efficacy of patiromer have not been established in pediatric patients younger than 12 years of age. Although there were some patients 6 to less than 12 years of age in the open-label pediatric study, the available data are not sufficient to determine a safe and effective dosing regimen for this pediatric age group.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Patiromer is not expected to cause fetal harm when administered to pregnant women because the drug is not absorbed systemically following oral administration.

Breast-feeding is not expected to result in risk to infants of patiromer-treated women because the drug is not absorbed systemically following oral administration.

In clinical studies of patiromer, 60% of patients receiving the drug were 65 years of age or older, while 20% were 75 years of age or older. No overall differences in efficacy were observed between geriatric patients and younger adults. However, adverse GI effects were reported more frequently in those 65 years of age or older compared with younger patients.