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  • CLASSES

    Antidotes, Adsorbents
    Mineral Binding Agents

    DEA CLASS

    Rx

    DESCRIPTION

    Oral potassium binder
    Used for treatment of hyperkalemia
    Dose separation from other oral drugs necessary

    COMMON BRAND NAMES

    Veltassa

    HOW SUPPLIED

    Veltassa Oral Pwd F/Recon: 8.4g, 16.8g, 25.2g

    DOSAGE & INDICATIONS

    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.

    MAXIMUM DOSAGE

    Adults

    25.2 g/day PO.

    Geriatric

    25.2 g/day PO.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Oral Administration

    Administer with or without food.
    Administer at least 3 hours before or 3 hours after other oral medications.
    Do not administer in its dry form.
    Do not heat (e.g., microwave) or add to heated food or liquids.

    Oral Liquid Formulations

    Prepare each dose immediately prior to administration.
    Measure one-third cup of water, other beverage, or soft food (e.g., apple sauce, yogurt, pudding). Pour half of the water, other beverage, or soft food into a glass.
    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.

    STORAGE

    Veltassa:
    - Avoid excessive heat (above 104 degrees F)
    - Refrigerate (between 36 and 46 degrees F)
    - Upon dispensing, product may be stored refrigerated (36 to 46 degrees F), or at or below 77 degrees F for up to 3 months

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Patiromer is contraindicated in patients with a history of hypersensitivity to patiromer or any of its components.

    Binding to other oral medications

    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.

    Constipation, fecal impaction, GI obstruction

    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.

    Hypomagnesemia

    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.

    Pregnancy

    Patiromer is not absorbed systemically following oral administration. Maternal use during pregnancy is not expected to result in fetal risk.

    Breast-feeding

    According to the manufacturer, patiromer is not absorbed systemically by the mother; breastfeeding 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.

    ADVERSE REACTIONS

    Moderate

    hypomagnesemia / Delayed / 5.3-9.0
    constipation / Delayed / 7.2-7.2
    hypokalemia / Delayed / 4.7-4.7
    edema / Delayed / Incidence not known

    Mild

    diarrhea / Early / 4.8-4.8
    nausea / Early / 2.3-2.3
    abdominal pain / Early / 2.0-2.0
    flatulence / Early / 2.0-2.0

    DRUG INTERACTIONS

    There are no drug interactions associated with Patiromer products.

    PREGNANCY AND LACTATION

    Pregnancy

    Patiromer is not absorbed systemically following oral administration. Maternal use during pregnancy is not expected to result in fetal risk.

    According to the manufacturer, patiromer is not absorbed systemically by the mother; breastfeeding 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.

    MECHANISM OF ACTION

    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.

    PHARMACOKINETICS

    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 level 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