Patiromer
Generic Name: patiromer
Brand Names:
Veltassa
11 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.
Overview
11 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.
Uses
1 INDICATIONS AND USAGE 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 [see Clinical Pharmacology (12.2) ] . Veltassa is a potassium binder indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older. ( 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 )
Dosage
2 DOSAGE AND ADMINISTRATION For adults, the recommended starting dose of Veltassa is 8.4 grams administered orally once daily. ( 2.2 ) For adults, adjust dose by 8.4 grams daily as needed at one-week intervals to obtain desired serum potassium target range. ( 2.2 ) For pediatric patients 12 to 17 years of age, the recommended starting dose of Veltassa is 4 grams administered orally once daily. ( 2.2 ) 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. ( 2.2 ) The maximum recommended dosage in adults and pediatric patients older than 12 years is 25.2 grams once daily.
Side Effects
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 Vifor Pharma, Inc. 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 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.
Interactions
7 DRUG INTERACTIONS 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.
Warnings
5 WARNINGS AND PRECAUTIONS Worsening of Gastrointestinal Motility. ( 5.1 ) Hypomagnesemia. ( 5.2 ) 5.1 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. 5.2 Hypomagnesemia Veltassa binds to magnesium in the colon, which can lead to hypomagnesemia. 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 )
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.
Storage
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).
Frequently Asked Questions
What is Patiromer used for?▼
1 INDICATIONS AND USAGE 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 [see Clinical Pharmacology (12.2) ] . Veltassa is a potassium binder indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older. ( 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 )
What are the side effects of Patiromer?▼
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 Vifor Pharma, Inc. 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 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.
Can I take Patiromer during 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.
What are the important warnings for Patiromer?▼
5 WARNINGS AND PRECAUTIONS Worsening of Gastrointestinal Motility. ( 5.1 ) Hypomagnesemia. ( 5.2 ) 5.1 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. 5.2 Hypomagnesemia Veltassa binds to magnesium in the colon, which can lead to hypomagnesemia. 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.