Patiromer

FDA label, Vifor Pharma, Inc., oral, effective 2025-01-31. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Potassium Binder

Dosing in kidney impairment

Renal Impairment Of the 666 adult patients treated with Veltassa in clinical studies, 93% had chronic kidney disease (CKD). All 14 pediatric patients ages 12 years and older treated with Veltassa in the clinical study had chronic kidney disease. No special dosing adjustments are needed for patients with renal impairment.

Preparation and administration

Preparation of Veltassa Prepare each dose immediately prior to administration. Measure 1/3 cup of water. Pour half of the water into a glass, then add the packet(s) of Veltassa and stir. Add the remaining half of the water and stir thoroughly. The powder will not dissolve and the mixture will look cloudy. Add more water to the mixture as needed for desired consistency.

Drink the mixture immediately. If powder remains in the glass after drinking, add more water, stir and drink immediately. Repeat as needed to ensure the entire dose is administered. Other beverages or soft foods (e.g., apple sauce, yogurt, pudding) can be used instead of water to prepare the mixture by following the same steps as described above.

A minimum volume of 45 mL (3 tablespoons) can be used to prepare doses up to and including 4 grams 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.

Drug interactions

Check patiromer against a medication list
Label text (5 paragraphs)

Veltassa has the potential to bind some oral co-administered medications, which could decrease their gastrointestinal absorption. Binding of Veltassa to other oral medications not listed in Table 3 below could cause decreased gastrointestinal absorption and loss of efficacy when taken close to the time Veltassa is administered. Administer other oral medications at least 3 hours before or 3 hours after Veltassa [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) ] . Take other orally administered drugs at least 3 hours before or 3 hours after Veltassa except those shown to not have a clinically important interaction. ( 2.1 , 7 )

7.1 Clinically Important Interaction of Veltassa with Other Drugs The in-vitro binding of the following drugs to patiromer was evaluated and potentially clinically significant binding was observed. Some drugs were subsequently tested in-vivo and significant reduction in systemic exposure was observed [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) ] . Binding by Veltassa may reduce the systemic exposure and decrease the clinical efficacy of the co-administered drugs shown in Table 2. The administration of these drugs (and any drugs not listed in Table 3) should be separated by at least 3 hours from Veltassa.

Table 2: Clinically important drug interactions of Veltassa Angiotensin II receptor blockers (ARB) Telmisartan β-adrenoceptor blockers (β-blocker) Bisoprolol, carvedilol, nebivolol Antibiotics Ciprofloxacin Anti-Parathyroid Agents and Thyroid Preparations Levothyroxine Blood Glucose Lowering Drugs Metformin Immunosuppressants Mycophenolate mofetil Others Quinidine, thiamine

7.2 No Observed Clinically Important Interaction of Veltassa with Other Drugs The binding of the following drugs to patiromer was evaluated [see Clinical Pharmacology (12.3) ] and no clinically significant binding was observed. No separation of dosing is required for these drugs.

Table 3: No observed clinically important drug interactions of Veltassa Angiotensin-converting enzyme (ACE) inhibitors Benazepril, captopril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, trandolapril Angiotensin II receptor blockers (ARB) Azilsartan, candesartan, irbesartan, losartan, olmesartan, valsartan β-adrenoceptor blockers (β-blocker) Metoprolol Loop diuretics Furosemide, bumetanide, torasemide Mineralocorticoid receptor antagonists (MRA) Eplerenone, finerenone, spironolactone Neprilysin inhibitors Sacubitril Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Canagliflozin, dapagliflozin, empagliflozin Antibiotics Trimethoprim, amoxicillin, cephalexin Anticoagulants Warfarin, apixaban, rivaroxaban Anti-parathyroid agents and Thyroid preparations Cinacalcet Antithrombotic agents Clopidogrel, acetylsalicylic acid Blood glucose lowering drugs Glipizide Calcium channel blockers Amlodipine, verapamil Immunosuppressants Tacrolimus Others Lithium, allopurinol, atorvastatin, digoxin, phenytoin, riboflavin, sevelamer

Contraindications

Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components [see Adverse Reactions (6.1) ]. Known hypersensitivity to Veltassa or any of its components. ( 4 )

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary Veltassa is not absorbed systemically following oral administration and maternal use is not expected to result in fetal risk.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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