Veltassa Drug Information
Generic name: PATIROMER
Potassium Binder [EPC]
Uses of Veltassa
Veltassa is indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older. Limitation of Use: Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action . Veltassa is a potassium binder indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older. Limitation of Use Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
Dosage & Administration of Veltassa
General Information Administer Veltassa at least 3 hours before or 3 hours
after other oral medications except those shown to not have a clinically important interaction. Do not heat Veltassa (e.g., microwave) or add to heated foods or liquids. Do not take Veltassa in its dry form.
Recommended Dosing and Titration
The recommended starting dose of Veltassa varies with age and is shown below. Multiple packets may be used to achieve the prescribed dose. Monitor serum potassium and adjust the dose of Veltassa based on the serum potassium level and the desired target range.
The dose may be increased or decreased, as necessary, to reach the desired serum potassium concentration, up to a maximum dose of 25.2 grams once daily in adults and pediatric patients aged 12 years and older. Adults: The recommended starting dose of Veltassa is 8.4 grams patiromer orally once daily. The dose can be up-titrated based on serum potassium level at 1-week or longer intervals, in increments of 8.4 grams.
Pediatric Patients Ages 12 years and older: The recommended starting dose of Veltassa is 4 grams patiromer orally once daily. The dose can be titrated based on serum potassium level at 1-week or longer intervals, in increments of 4 grams.
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.
Side Effects of Veltassa
Clinical Trials Experience Adult Patients
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Veltassa cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. In the safety and efficacy clinical trials, 666 adult patients received at least one dose of Veltassa, including 219 exposed for at least 6 months and 149 exposed for at least one year. Table 1 provides a summary of the most common adverse reactions (occurring in ≥ 2% of patients) in adult patients treated with Veltassa in these clinical trials.
Most adverse reactions were mild to moderate. Constipation generally resolved during the course of treatment. Table 1: Adverse Reactions Reported in ≥ 2% of Patients Adverse Reactions Adult Patients treated with Veltassa (N=666) Note: Diarrhea is an aggregate term for Diarrhea and frequent bowel movements.
Abdominal discomfort is an aggregate term for Abdominal discomfort, abdominal pain, abdominal pain upper, and abdominal pain lower. Constipation 7.2% Hypomagnesemia 5.3% Diarrhea 4.8% Nausea 2.3% Abdominal discomfort 2.0% Flatulence 2.0% The most commonly reported adverse reactions leading to discontinuation of Veltassa were gastrointestinal adverse reactions (2.7%), including vomiting (0.8%), diarrhea (0.6%), constipation (0.5%) and flatulence (0.5%). Mild to moderate hypersensitivity reactions were reported in 0.3% of adult patients treated with Veltassa in clinical trials. Reactions have included edema of the lips.
Laboratory Abnormalities Approximately 4.7% of adult patients in clinical trials developed hypokalemia with a serum potassium value < 3.5 mEq/L. Approximately 9% of adult patients in clinical trials developed hypomagnesemia with a serum magnesium value < 1.4 mg/dL. Pediatric Patients In a single-arm, open-label pediatric study, 14 patients 12 to 17 years of age received at least one dose of Veltassa, including 12 patients exposed for at least 25 weeks. The safety profile was generally similar to that observed in adult patients.
Warnings & Cautions for Veltassa
Worsening of Gastrointestinal Motility
Avoid use of Veltassa in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Veltassa may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in the clinical studies.
Hypomagnesemia Veltassa binds to magnesium in the colon, which can lead to
hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3% of adult patients treated with Veltassa. Monitor serum magnesium.
Consider magnesium supplementation in patients who develop low serum magnesium levels on Veltassa.
Drug Interactions with Veltassa
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 . 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
No Observed Clinically Important Interaction of Veltassa with Other Drugs
The binding of the following drugs to patiromer was evaluated 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
Pregnancy Safety for Veltassa
Pregnancy Risk Summary Veltassa is not absorbed systemically following oral administration and maternal use is not expected to result in fetal risk.
Pediatric Use of Veltassa
Pediatric Use The safety and effectiveness of Veltassa for lowering serum potassium levels have been established in pediatric patients ages 12 years and older. Use of Veltassa for this indication is supported by evidence from an adequate and well-controlled study in adults, with additional pharmacodynamic and safety data in pediatric patients aged 12 years and older. Safety and efficacy have not been established in pediatric patients below the age of 12 years.
Although the pediatric study included 9 patients 6 to less than 12 years of age, the dosing regimen that was evaluated in these patients did not appear to be effective in reducing serum potassium levels in this age group after 2 weeks. The starting dose of Veltassa in this age group was 2 g/day and the median dose at Day 14 was 6 g/day. In this age group the mean change in serum potassium from Baseline to Day 14 was -0.1 mEq/L (95% CI -0.7, 0.4). Because the available data are not sufficient to determine a safe and effective dosing regimen in patients 6 to less than 12 years of age, labeling recommendations cannot be provided for this age group.
Contraindications for Veltassa
Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components. Known hypersensitivity to Veltassa or any of its components.
Overdosage Information for Veltassa
Doses of Veltassa in excess of 50.4 grams per day have not been tested. Excessive doses of Veltassa may result in hypokalemia. Restore serum potassium if hypokalemia occurs.
Clinical Studies of Veltassa
Two-Part, Randomized Withdrawal Study
The efficacy of Veltassa was demonstrated in a two-part, single-blind randomized withdrawal study that evaluated Veltassa in hyperkalemic patients with CKD on stable doses of at least one renin-angiotensin-aldosterone system inhibitor (i.e., angiotensin-converting enzyme inhibitor, angiotensin II receptor blocker, or aldosterone antagonist). In Part A, 243 patients were treated with Veltassa for 4 weeks. Patients with a baseline serum potassium of 5.1 mEq/L to < 5.5 mEq/L received a starting Veltassa dose of 8.4 grams patiromer per day (as a divided dose) and patients with a baseline serum potassium of 5.5 mEq/L to < 6.5 mEq/L received a starting Veltassa dose of 16.8 grams patiromer per day (as a divided dose). The dose of Veltassa was titrated, as needed, based on the serum potassium level, assessed starting on Day 3 and then at weekly visits (Weeks 1, 2 and 3) to the end of the 4-week treatment period, with the aim of maintaining serum potassium in the target range (3.8 mEq/L to < 5.1 mEq/L). The mean age of patients was 64 years, 58% of patients were men, and 98% were white. Approximately 97% of patients had hypertension, 57% had type 2 diabetes, and 42% had heart failure.
Results for the Part A primary endpoint, the change in serum potassium from Baseline to Week 4, are summarized in Table 4. Mean serum potassium over time for the intent-to-treat population is displayed in Figure 3. For the Part A secondary endpoint, 76% (95% CI: 70%, 81%) of patients had a serum potassium in the target range of 3.8 mEq/L to < 5.1 mEq/L at Week 4. The mean daily doses of Veltassa were 13 grams and 21 grams in patients with serum potassium of 5.1 to < 5.5 mEq/L and 5.5 to < 6.5 mEq/L, respectively. Table 4: Veltassa Treatment Phase (Part A): Primary Endpoint Baseline, mean (SD) Week 4 Change from Baseline, Mean ± SE (95% CI) p -value Baseline Potassium 5.1 to <5.5 mEq/L (n=90) Serum Potassium (mEq/L) 5.31 -0.65 ± 0.05 (-0.74, -0.55) Baseline Potassium 5.5 to <6.5 mEq/L (n=147) 5.74 -1.23 ± 0.04 (-1.31, -1.16) Overall Population (n=237) 5.58 -1.01 ± 0.03 (-1.07, -0.95) < 0.001 Figure 3: Estimated Mean (95% CI) of Central Serum Potassium (mEq/L) Over Time In Part B, 107 patients with a Part A baseline serum potassium of 5.5 mEq/L to < 6.5 mEq/L and whose serum potassium was in the target range (3.8 mEq/L to < 5.1 mEq/L) at Part A Week 4 and still receiving RAAS inhibitor medication were randomized to continue Veltassa or to receive placebo to evaluate the effect of withdrawing Veltassa on serum potassium. In patients randomized to Veltassa, the mean daily dose was 21 grams at the start of Part B and during Part B. The Part B primary endpoint was the change in serum potassium from Part B baseline to the earliest visit at which the patient's serum potassium was first outside of the range of 3.8 to < 5.5 mEq/L, or to Part B Week 4 if the patient's serum potassium remained in the range.
In Part B, serum potassium rose by 0.72 mEq/L in patients who were switched to placebo, versus no change in patients who remained on Veltassa. Results are summarized in Table 5. Table 5: Randomized, Placebo-Controlled Withdrawal Phase (Part B): Primary Endpoint Placebo (n=52) Veltassa (n=55) Difference Estimate (95% CI) p -value Estimated Median Change in Serum Potassium from Baseline (mEq/L) 0.72 0.00 0.72 < 0.001 More placebo patients (91%; 95% CI: 83%, 99%) developed a serum potassium ≥ 5.1 mEq/L at any time during Part B than Veltassa patients (43%; 95% CI: 30%, 56%), p < 0.001. More placebo patients (60%; 95% CI: 47%, 74%) developed a serum potassium ≥ 5.5 mEq/L at any time during Part B than Veltassa patients (15%; 95% CI: 6%, 24%), p < 0.001. Figure 3
One-Year Study
The effect of treatment with Veltassa for up to 52 weeks was evaluated in an open-label study of 304 hyperkalemic patients with CKD and type 2 diabetes mellitus on RAAS inhibitor therapy. Figure 4 shows that the treatment effect on serum potassium was maintained during continued therapy. In patients with a baseline serum potassium of > 5.0 to 5.5 mEq/L who received an initial dose of 8.4 grams patiromer per day (as a divided dose), the mean daily dose was 14 grams; in those with a baseline serum potassium of > 5.5 to < 6.0 mEq/L who received an initial dose of 16.8 grams patiromer per day (as a divided dose), the mean daily dose was 20 grams during the entire study.
Figure 4: Mean (95% CI) Serum Potassium over Time Figure 4
Pediatric Study
The potassium-lowering effect of Veltassa was evaluated in an open-label, single-arm study in pediatric patients 12 to 17 years of age with CKD and hyperkalemia. The study included an initial 14-day dose finding phase, followed by an up to 24-week long-term (LT) treatment phase and a 2-week follow-up period. Veltassa was given once daily as a powder for oral suspension.
The dose of Veltassa was titrated, as needed, based on the serum potassium level, assessed starting on Day 3 and then at Day 7 and Day 14, with the aim of maintaining serum potassium in the target range (3.8 mEq/L to < 5.0 mEq/L). All 14 patients 12 to 17 years of age completed the dose finding phase. The mean age was 14.5 years, 79% were male, and all were white. The average weight at baseline was 51 kg and 57% of patients had a baseline eGFR <30 mL/min/1.73 m 2. Approximately 57% were on RAAS inhibitor therapy at baseline.
The mean (SD) baseline serum potassium was 5.5 mEq/L (0.3 mEq/L). The mean change in serum potassium from baseline to Day 14 was -0.5 mEq/L (95% CI -0.8, -0.2). The proportion of patients 12 to 17 years of age with a serum potassium within the normal range was 50% at Day 14. The median dose at Day 14 was 4.2 g/day.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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