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patiromer (Veltassa)

 

Classes: Potassium Binders

Dosing and uses of Veltassa (patiromer)

 

Adult dosage forms and strengths

oral powder for suspension

  • 8.4g/packet
  • 16.8g/packet
  • 25.2g/packet

 

Hyperkalemia

Indicated for hyperkalemia

Initial: 8.4 g PO qDay

Monitor serum potassium and adjust dose based on the serum potassium level and the desired target range

May increase or decrease dose as necessary; not to exceed 25.2 g qDay

May titrate upward at 1-week or longer intervals, in increments of 8.4 g

Note: Doses exceeding 50.4 g/day have not been tested; excessive doses may result in hypokalemia; restore serum potassium if hypokalemia occurs

 

Dosage modifications

Renal impairment

  • No dosing adjustments are needed
  • Of the 666 patients treated with patiromer in clinical studies, 93% had chronic kidney disease

 

Dosing Considerations

Limitations of use

  • Should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action
  • Administer patiromer at least 6 hr before or 6 hr after other oral medications; patiromer may decrease absorption other oral medications

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

Veltassa (patiromer) adverse (side) effects

1-10%

Constipation (7.2%)

Hypomagnesemia (5.3%)

Diarrhea (4.8%)

Hypokalemia, <3.5 mEq/L (4.7%)

Nausea (2.3%)

Abdominal discomfort (2%)

Flatulence (2%)

 

Warnings

Black box warnings

Binds many other orally administered drugs in the GI tract, which could decrease their absorption and reduce their effectiveness

Separate doses of patiromer and any other orally administered medication at least 6 hr; monitor for clinical response and/or blood levels where possible

If adequate dosing separation is not possible, choose continuing either patiromer or the other oral medication

In clinical trials, patiromer was shown to bind about half of the oral medications that were tested

 

Contraindications

Hypersensitivity to patiromer or its components

 

Cautions

Patiromer binds many orally administered medications, which could decrease their GI absorption and lead to reduced efficacy (see Black box warnings)

Avoid use with severe constipation, bowel obstruction, or impaction, including abnormal postoperative bowel motility disorders; patiromer may be ineffective with these conditions present and may worsen GI conditions

Patients with a history of bowel obstruction or major GI surgery, severe GI disorders, or swallowing disorders were not included in clinical trials

Binds to magnesium in the colon, which can lead to hypomagnesemia; monitor serum magnesium; consider magnesium supplementation if low serum magnesium levels observed

 

Pregnancy

Pregnancy

Not absorbed systemically following oral administration, and maternal use is not expected to result in fetal risk

 

Lactation

Not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Veltassa (patiromer)

Mechanism of action

Binds and removes potassium from the GI tract, particularly the colon

Patiromer is a nonabsorbed, cation exchange polymer that contains a calcium-sorbitol counterion

 

Absorption

Not systemically absorbed

Quantitative whole-body autoradiography analysis in rats demonstrated that radioactivity was limited to the GI tract, with no detectable level of radioactivity in any other tissues or organs

 

Elimination

Excretion: Feces

 

Administration

Oral suspension preparation

Prepare each dose immediately prior to administration following the steps below

  • 1: Add about 1 ounce (30 mL) of water to an empty glass or cup
  • 2: Empty the entire contents of the packet(s) into the glass or cup
  • 3: Stir the mixture thoroughly
  • 4: Add an additional 2 ounces (60 mL) of water to the glass or cup containing the mixture
  • 5: Stir the mixture thoroughly; the powder will not dissolve and the mixture will look cloudy
  • 6: Drink the mixture immediately; if some powder remains in the glass after drinking, add more water, stir and drink immediately; repeat as needed to ensure the entire dose is administered

 

Oral administration

Administer patiromer at least 6 hr before or 6 hr after other oral medications; patiromer may decrease absorption other oral medications

Administer with food

Do not heat patiromer (eg, microwave) or add to heated foods or liquids

Do not take patiromer in its dry form

 

Storage

Stored refrigerated at 2-8°C (36-46°F)

If stored at room temperature (25°C [77°F]), patiromer must be used within 3 months of being taken out of the refrigerator

For either storage condition, do not use after the expiration date printed on the packet

Avoid exposure to excessive heat >40°C (>104°F)