Data from FDA - Curated by Marshall Pearce - Last updated 01 September 2017

Indication(s)

1 INDICATIONS AND USAGE 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 Clinical Pharmacology (12.2)]. Veltassa is a potassium binder indicated for the treatment of hyperkalemia. (1) Limitation of Use Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action. (1)

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Hypogonadism

Hypogonadism

Epidemiology, pathophysiology, diagnosis/treatment guidelines, recent publication summaries and more.

+ 1 more

Fabry Disease

Fabry Disease

Explore the pathophysiology and treatment options for Fabry disease, a deficiency of the lysosomal enzyme alpha-galactosidase A

Transplantation

Transplantation

See information on best practice in solid organ transplantation, and expert discussions on related hot topics.

Load more

Related Content

Advisory information

contraindications
4 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)
Adverse reactions
6 ADVERSE REACTIONS The following adverse reaction is discussed in greater detail elsewhere in the label: Hypomagnesemia [see Warnings and Precautions (5.2)] Most common adverse reactions (incidence ≥ 2%) are constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Relypsa at 1-844-VELTASSA (1-844-835-8277) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION The recommended starting dose of Veltassa is 8.4 grams administered orally once daily with food. (2.2) Adjust dose by 8.4 grams daily as needed at one week intervals to obtain desired serum potassium target range. (2.2) 2.1 General Information Administer Veltassa at least 3 hours before or 3 hours after other oral medications [see Drug Interactions (7) and Clinical Pharmacology (12.3)]. 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. 2.2 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. 2.3 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.
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Veltassa is not absorbed systemically following oral administration and maternal use is not expected to result in fetal risk. 8.2 Lactation Risk Summary Veltassa is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant. 8.4 Pediatric Use Safety and efficacy in pediatric patients have not been established. 8.5 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. 8.6 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.

Interactions

7 DRUG INTERACTIONS In clinical studies, Veltassa decreased systemic exposure of some coadministered oral medications [see Pharmacokinetics (12.3)]. 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 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. (2.1, 7)

More information

Category Value
Authorisation number NDA205739
Agency product number 1FQ2RY5YHH
Orphan designation No
Product NDC 53436-252,53436-084,53436-168
Date Last Revised 18-08-2017
Type HUMAN PRESCRIPTION DRUG
Storage and handling 16.2 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).
Marketing authorisation holder Relypsa, Inc.