Patiromer

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.

For adults, the recommended starting dose of Veltassa is 8.4 grams administered orally once daily. For adults, adjust dose by 8.4 grams daily as needed at one-week intervals to obtain desired serum potassium target range. For pediatric patients 12 to 17 years of age, the recommended starting dose of Veltassa is 4 grams administered orally once daily. For pediatric patients 12 to 17 years of age, adjust dose by 4 grams daily as needed at one-week intervals to obtain desired serum potassium target range. The maximum recommended dosage in adults and pediatric patients older than 12 years is 25.2 grams once daily.

2.1General 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.

2.2Recommended 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.

2.3Preparation 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.

Worsening of Gastrointestinal Motility. Hypomagnesemia.

5.1Worsening 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.

5.2Hypomagnesemia 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.

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.

8.1Pregnancy Risk Summary Veltassa

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

The following adverse reaction is discussed in greater detail elsewhere in the label: Hypomagnesemia Most common adverse reactions (incidence ≥ 2%) are constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. To report SUSPECTED ADVERSE REACTIONS, contact Vifor Pharma, Inc. at 1-844-VELTASSA (1-844-835-8277) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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.