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Veltassa

Generic Name: patiromer
Dosage Form: powder for oral suspension

WARNING: BINDING TO OTHER ORAL MEDICATIONS

Veltassa binds to many orally administered medications, which could decrease their absorption and reduce their effectiveness. Administer other oral medications at least 6 hours before or 6 hours after Veltassa. Choose Veltassa or the other oral medication if adequate dosing separation is not possible [see Dosage and Administration (2.1), Warnings and Precautions (5.1) and Drug Interactions (7)].

Indications and Usage for Veltassa

Veltassa is indicated for the treatment of hyperkalemia.

Limitation of Use: Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Pharmacodynamics (12.2)].

Veltassa Dosage and Administration

General Information

Administer Veltassa at least 6 hours before or 6 hours after other oral medications [see Warnings and Precautions (5.1) and Drug Interactions (7)].

Administer Veltassa with food. 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 is 8.4 grams patiromer once daily. 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. The dose can be up-titrated based on serum potassium level at 1-week or longer intervals, in increments of 8.4 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 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.

Dosage Forms and Strengths

Veltassa is an off-white to light-brown powder for oral suspension packaged in single-use packets containing 8.4 grams, 16.8 grams or 25.2 grams patiromer.

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)].

Warnings and Precautions

Binding to Other Orally Administered Medications

Veltassa binds many orally administered medications, which could decrease their gastrointestinal absorption and lead to reduced efficacy. Administer other oral medications at least 6 hours before or 6 hours after Veltassa. Choose Veltassa or the other oral medication if adequate dosing separation is not possible [see Dosage and Administration (2.1) and Drug Interactions (7)].

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 patients treated with Veltassa [see Adverse Reactions (6.1)]. Monitor serum magnesium. Consider magnesium supplementation in patients who develop low serum magnesium levels on Veltassa.

Adverse Reactions

The following adverse reaction is discussed in greater detail elsewhere in the label:

Clinical Trials Experience

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 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 Patients treated with Veltassa
(N=666)
Constipation 7.2%
Hypomagnesemia 5.3%
Diarrhea 4.8%
Nausea 2.3%
Abdominal discomfort 2.0%
Flatulence 2.0%

During the clinical studies, 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 patients treated with Veltassa in clinical trials. Reactions have included edema of the lips.

Laboratory Abnormalities

Approximately 4.7% of patients in clinical trials developed hypokalemia with a serum potassium value < 3.5 mEq/L.

Approximately 9% of patients in clinical trials developed hypomagnesemia with a serum magnesium value < 1.4 mg/dL.

Drug Interactions

No formal drug interaction studies have been conducted in humans.

In in vitro binding studies, Veltassa was shown to bind about half of the oral medications that were tested. Binding of Veltassa to other oral medications could cause decreased gastrointestinal absorption and loss of efficacy when taken close to the time Veltassa is administered. Administer other oral medications at least 6 hours before or 6 hours after Veltassa. Monitor for clinical response and/or blood levels where possible.

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary

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

Lactation

Risk Summary

Veltassa is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant.

Pediatric Use

Safety and efficacy in pediatric patients have not been established.

Geriatric Use

Of the 666 patients treated with Veltassa in clinical studies, 59.8% were age 65 and over, and 19.8% were age 75 and over. No overall differences in effectiveness were observed between these patients and younger patients. Patients age 65 and older reported more gastrointestinal adverse reactions than younger patients.

Renal Impairment

Of the 666 patients treated with Veltassa in clinical studies, 93% had chronic kidney disease (CKD). No special dosing adjustments are needed for patients with renal impairment.

Overdosage

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.

Veltassa Description

Veltassa is a powder for suspension in water for oral administration. The active ingredient is patiromer sorbitex calcium which consists of the active moiety, patiromer, a non-absorbed potassium-binding polymer, and a calcium-sorbitol counterion. Each gram of patiromer is equivalent to a nominal amount of 2 grams of patiromer sorbitex calcium.

The chemical name for patiromer sorbitex calcium is cross-linked polymer of calcium 2-fluoroprop-2-enoate with diethenylbenzene and octa-1,7-diene, combination with D-glucitol.

Patiromer sorbitex calcium is an amorphous, free-flowing powder that is composed of individual spherical beads. Patiromer sorbitex calcium is insoluble in solvents such as water, 0.1 M HCl, n-heptane and methanol. The chemical structure of patiromer sorbitex calcium is presented in Figure 1.

Figure 1: Chemical Structure of Patiromer Sorbitex Calcium

Each packet of Veltassa contains 8.4 grams, 16.8 grams or 25.2 grams of patiromer, the active moiety. The inactive ingredient is xanthan gum.

Veltassa - Clinical Pharmacology

Mechanism of Action

Veltassa is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol counterion.

Veltassa increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium levels.

Pharmacodynamics

In a Phase 1 study in healthy adult subjects (6 to 8 subjects per group), Veltassa (0 grams to 50.4 grams per day) administered three times a day for 8 days caused a dose-dependent increase in fecal potassium excretion. A corresponding dose-dependent decrease in urinary potassium excretion with no change in serum potassium were also observed. Compared to placebo, Veltassa doses of 25.2 and 50.4 grams per day significantly decreased mean daily urinary potassium excretion.

In a Phase 1, open-label, multiple-dose crossover study in 12 healthy subjects, 25.2 grams of patiromer per day was administered orally as a once daily, twice daily or thrice daily regimen for 6 days in a randomly assigned order. A significant increase in mean daily fecal potassium excretion and concomitant decrease in mean daily urinary potassium excretion were observed during the treatment periods for all three dosing regimens. The mean increase in fecal potassium excretion ranged from 1283 to 1550 mg/day, and the mean decrease in urinary potassium excretion ranged from 1438 to 1534 mg/day across the three dosing regimens. No significant differences were observed among the dosing regimens with respect to mean daily fecal potassium and urinary potassium excretion. This was true for the overall comparison among the three dosing regimens, as well as for the pairwise comparisons.

In an open-label, uncontrolled study, 25 patients with hyperkalemia (mean baseline serum potassium of 5.9 mEq/L) and chronic kidney disease were given a controlled potassium diet for 3 days, followed by 16.8 grams patiromer daily (as divided doses) for 2 days while the controlled diet was continued. A statistically significant reduction in serum potassium (-0.2 mEq/L) was observed at 7 hours after the first dose. Serum potassium levels continued to decline during the 48-hour treatment period (-0.8 mEq/L at 48 hours after the first dose). Potassium levels remained stable for 24 hours after the last dose, then rose during the 4-day observation period following discontinuation of Veltassa.

Pharmacokinetics

In radiolabeled ADME studies in rats and dogs, patiromer was not systemically absorbed and was excreted in the feces. Quantitative whole-body autoradiography analysis in rats demonstrated that radioactivity was limited to the gastrointestinal tract, with no detectable level of radioactivity in any other tissues or organs.

Drug Interactions

Veltassa binds many other orally administered medications in the gastrointestinal tract, which could lead to a decrease in absorption of other medications.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Patiromer was not genotoxic in the reverse mutation test (Ames assay), chromosome aberration or rat micronucleus assays.

Carcinogenicity studies have not been performed.

Patiromer did not impair the fertility in male or female rats at doses up to 10-fold the maximum recommended human dose (MRHD).

Clinical Studies

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 Caucasian. 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 2. Mean serum potassium over time for the intent-to-treat population is displayed in Figure 2. For the Part A secondary endpoint, 76% (95% confidence interval [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 2: Veltassa Treatment Phase (Part A): Primary Endpoint
Baseline Potassium Overall Population (n=237)
5.1 to < 5.5 mEq/L
(n=90)
5.5 to < 6.5 mEq/L
(n=147)
Serum Potassium (mEq/L)
Baseline, mean (SD) 5.31 (0.57) 5.74 (0.40) 5.58 (0.51)
Week 4 Change from Baseline, Mean ± SE
(95% CI)
-0.65 ± 0.05

(-0.74, -0.55)
-1.23 ± 0.04

(-1.31, -1.16)
-1.01 ± 0.03

(-1.07, -0.95)
p-value < 0.001

Figure 2: 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 3.

Table 3: 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
(0.46, 0.99)
< 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.

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 3 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 3: Mean (95% CI) Serum Potassium over Time

How Supplied/Storage and Handling

How Supplied

Veltassa is supplied as a powder for oral suspension formulated with xanthan gum. Veltassa is packaged in single-use packets containing 8.4 grams, 16.8 grams or 25.2 grams patiromer as follows:

Veltassa (grams) Single Use Packet Carton of 4 Packets Carton of 30 Packets
8.4 NDC 53436-084-01 NDC 53436-084-04 NDC 53436-084-30
16.8 NDC 53436-168-01 - NDC 53436-168-30
25.2 NDC 53436-252-01 - NDC 53436-252-30

Stability and Storage

Veltassa should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F).

If stored at room temperature (25°C ± 2°C [77°F ± 4°F]), Veltassa must be used within 3 months of being taken out of the refrigerator. For either storage condition, do not use Veltassa after the expiration date printed on the packet.

Avoid exposure to excessive heat above 40°C (104°F).

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Drug Interactions

Advise patients who are taking other oral medication to separate the dosing of Veltassa by at least 6 hours (before or after) [see Drug Interactions (7)].

Dosing Recommendations

Inform patients to take Veltassa as directed with food and adhere to their prescribed diets. Instruct patients to prepare each dose separately using the preparation instructions provided in the FDA-approved patient labeling (Medication Guide).

Inform patients that Veltassa should not be heated (e.g., microwaved) or added to heated foods or liquids and should not be taken in its dry form.

Manufactured for:

Relypsa, Inc.
Redwood City, CA 94063

Version 02; May 2016

  This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: May 2016
MEDICATION GUIDE
Veltassa™ (vel-TAS-sa)
(patiromer) for oral suspension
Read this Medication Guide before you start taking Veltassa and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about Veltassa?

  • Veltassa may affect other medicines taken by mouth if they are taken too close together. This can cause you to have too little of other medicines in your body, which may affect the way your other medicines work. Take Veltassa at least 6 hours before or at least 6 hours after any other medicine taken by mouth.
  • Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
What is Veltassa?
Veltassa is a prescription medicine used to treat high levels of potassium in your blood (hyperkalemia).
  • It is not known if Veltassa is safe and effective in children.
Who should not take Veltassa?
Do not take Veltassa if you are allergic to patiromer sorbitex calcium or any of the ingredients in Veltassa. See the end of this leaflet for a complete list of ingredients in Veltassa.
What should I tell my doctor before taking Veltassa?
Before you take Veltassa, tell your doctor about all of your medical conditions, including if you:
  • have problems having a bowel movement, including if you have severe constipation, a blockage (obstruction) in your bowel, or dry hard stool that will not pass out of your rectum (impaction)
  • have problems with your bowels after bowel surgery
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. See "What is the most important information I should know about Veltassa?"
How should I take Veltassa?
  • Veltassa is given to lower the amount of potassium in your blood. Your doctor will check the potassium levels in your blood during treatment with Veltassa.
  • Take Veltassa exactly as your doctor tells you to take it. Your doctor may change your dose if needed.
  • To mix a dose of Veltassa:
    • Measure 1/3 cup of water. Pour half of the water into a glass.
    • Carefully pour all of the contents of the packet of Veltassa into the glass with the water. You may need more than 1 packet for your prescribed dose.
    • Stir the mixture well.
    • Pour the remaining water into the glass containing the mixture.
    • Stir the mixture well. The powder will not dissolve and the mixture will look cloudy. If the mixture is too thick, you can add more water.
    • Drink the mixture right away.
    • If any powder is left in the glass after drinking, add more water, stir the mixture, and drink the mixture right away. Repeat as needed to make sure you take your entire dose of Veltassa.
  • Take Veltassa 1 time a day with food.
  • Mix Veltassa with water only. Do not take Veltassa that has not been mixed with water.
  • Do not heat, microwave, or add Veltassa to heated foods or liquids.
  • Prepare each dose of Veltassa separately.
  • Follow the diet that your doctor has prescribed for you.
What are the possible side effects of Veltassa?
Veltassa may cause serious side effects, including:
  • See "What is the most important information I should know about Veltassa?"
  • Low levels of magnesium in your blood (hypomagnesemia). Low levels of magnesium in the blood can happen when taking Veltassa. Your doctor will check the magnesium levels in your blood during treatment with Veltassa. Your doctor may prescribe a magnesium supplement if you have low levels of magnesium in your blood.
The most common side effects of Veltassa include: constipation, diarrhea, nausea, stomach-area (abdominal) discomfort, and gas.
Tell your doctor if you have any side effect that bothers you or does not go away.
These are not all of the possible side effects of Veltassa. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Veltassa?
  • Store Veltassa in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • If Veltassa cannot be stored in the refrigerator, it may be stored at room temperature, between 73°F to 81°F (23°C to 27°C) for up to 3 months.
  • Use Veltassa that has been stored at room temperature within 3 months of being taken out of the refrigerator.
  • Do not use Veltassa after the expiration date (EXP) printed on the packet.
  • Avoid exposure to heat above 104°F (40°C).
General information about the safe and effective use of Veltassa
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take Veltassa for a condition for which it was not prescribed. Do not give Veltassa to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about Veltassa that is written for health professionals.
What are the ingredients in Veltassa?
Active ingredient: patiromer sorbitex calcium
Inactive ingredients: xanthan gum
Manufactured for: Relypsa, Inc. Redwood City, CA 94063
For more information go to www.Veltassa.com or call 1-844-835-8277.

PRINCIPAL DISPLAY PANEL - 8.4 g Packet Carton

30 packets
NDC 53436-084-30

Veltassa
(patiromer)

For Oral Suspension

www.Veltassa.com

Each packet contains 8.4 grams of patiromer.
ATTENTION: Dispense with enclosed Medication Guide.
Dispense as 1 box; 30-day supply.

Rx only
8.4 g

PRINCIPAL DISPLAY PANEL - 16.8 g Packet Carton

30 packets
NDC 53436-168-30

Veltassa
(patiromer)

For Oral Suspension

www.Veltassa.com

Each packet contains 16.8 grams of patiromer.
ATTENTION: Dispense with enclosed Medication Guide.
Dispense as 1 box; 30-day supply.

Rx only
16.8 g

PRINCIPAL DISPLAY PANEL - 25.2 g Packet Carton

30 packets
NDC 53436-252-30

Veltassa
(patiromer)

For Oral Suspension

www.Veltassa.com

Each packet contains 25.2 grams of patiromer.
ATTENTION: Dispense with enclosed Medication Guide.
Dispense as 1 box; 30-day supply.

Rx only
25.2 g

Veltassa 
patiromer powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53436-084
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
patiromer (patiromer) patiromer 8.4 g
Inactive Ingredients
Ingredient Name Strength
xanthan gum 0.12 g
Product Characteristics
Color WHITE (off-white to light-brown) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:53436-084-04 4 PACKET in 1 CARTON
1 NDC:53436-084-01 1 POWDER, FOR SUSPENSION in 1 PACKET
2 NDC:53436-084-30 30 PACKET in 1 CARTON
2 NDC:53436-084-01 1 POWDER, FOR SUSPENSION in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205739 10/23/2015
Veltassa 
patiromer powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53436-168
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
patiromer (patiromer) patiromer 16.8 g
Inactive Ingredients
Ingredient Name Strength
xanthan gum 0.24 g
Product Characteristics
Color WHITE (off-white to light-brown) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:53436-168-30 30 PACKET in 1 CARTON
1 NDC:53436-168-01 1 POWDER, FOR SUSPENSION in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205739 10/23/2015
Veltassa 
patiromer powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53436-252
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
patiromer (patiromer) patiromer 25.2 g
Inactive Ingredients
Ingredient Name Strength
xanthan gum 0.36 g
Product Characteristics
Color WHITE (off-white to light-brown) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:53436-252-30 30 PACKET in 1 CARTON
1 NDC:53436-252-01 1 POWDER, FOR SUSPENSION in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205739 10/23/2015
Labeler - Relypsa, Inc. (808446087)
Revised: 06/2016
 
Relypsa, Inc.
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