Veltassa (patiromer) is a medicine that binds itself to potassium in your digestive tract. This helps prevent your body from absorbing too much potassium. Patiromer also helps your body get rid of excess potassium through your stools (bowel movements).
VELTASSA- patiromer powder, for suspension
Relypsa, Inc.
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)].
2 DOSAGE AND ADMINISTRATION
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.
3 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.
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)].
5 WARNINGS AND PRECAUTIONS
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. 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.
6 ADVERSE REACTIONS
The following adverse reaction is discussed in greater detail elsewhere in the label:
Hypomagnesemia [see Warnings and Precautions (5.2)]