patiromer (Rx)

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%)

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 Administration)

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

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.

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

Oral suspension preparation

Prepare each dose immediately prior to administration following the steps below

• 1: Measure 1/3 cup of water and pour half of water into a glass
• 2: Empty the entire contents of the packet(s) into the glass or cup and stir
• 3: Add the remaining half of water and stir the mixture thoroughly
• 4: The powder will not dissolve and the mixture will look cloudy; add more water to the mixture as needed for desired consistency
• 5: 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

Prepare oral suspension (see above) and drink immediately after preparation

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

Do not take patiromer in its dry form

Patiromer may decrease absorption other oral medications

• Administer patiromer at least 3 hr before or 3 hr after other oral medications

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)