Veltassa (patiromer calcium sorbitex)

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.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Bile Acid Sequestrants And Ion Exchange Resins/Tiratricol

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

MECHANISM OF ACTION: Bile acid sequestrants and ion exchange resins may decrease the gastrointestinal absorption of tiratricol.(1,2)

CLINICAL EFFECTS: Simultaneous administration of a bile acid sequestrants and ion exchange resins may result in decreased absorption and effectiveness of tiratricol.(1,2)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of tiratricol states concurrent use of bile acid sequestrants and ion exchange resins with tiratricol should be avoided.(1) The UK manufacturer of tiratricol states use of antacids, charcoal, calcium, cationic resins (e.g. cholestyramine), iron, sucralfate, and other gastrointestinal agents may interfere with the gastrointestinal absorption of tiratricol should be taken before or after tiratricol (more than 2 hours before or after if possible). For cholestyramine, tiratricol should be taken 1 hour before or 4 hours after the resin dose. Adjustment of the tiratricol dose may be required to obtain the desired effect.(2)

DISCUSSION: Bile acid sequestrants and ion exchange resins decrease thyroid hormone exposure by binding and delaying or preventing absorption.(1,2)

Potassium Binders/Potassium Supplements

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.

Moderate Interaction: Assess the risk to the patient and take action as needed.

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)

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)

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)

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)

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)

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)

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)

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)

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

• Gastrointestinal obstruction

• Gastrointestinal hypomotility

• Hypomagnesemia

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

More Frequent

• Hypomagnesemia

Rare or Very Rare

• Hypersensitivity drug reaction

More Frequent

• Acute abdominal pain
• Constipation
• Diarrhea
• Flatulence
• Nausea

Less Frequent

• Hypokalemia

Rare or Very Rare

• Lip swelling
• Vomiting

No enhanced messaging available.

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.

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.