Label Change Approved for Hyperkalemia Drug
FDA approvea Relypsa, Inc.’s supplemental New Drug Application with label updates of Veltassa.
The FDA has approved Relypsa, Inc.’s supplemental New Drug Application (sNDA) with label updates of Veltassa (patiromer) for oral suspension. Veltassa was approved by the FDA for the treatment of hyperkalemia on October 21, 2015.
Veltassa’s updated label no longer includes a boxed warning regarding drug-drug interactions with other oral medications. The new label now recommends patients to take Veltassa at least 3 hours before or 3 hours after other oral medications, and provides data from the Veltassa drug-drug interaction program.
“These important updates are based on our positive data, which showed there is a low risk for drug-drug interactions with Veltassa when it is separated from other oral medications by at least 3 hours,” John A. Orwin, president and chief executive officer of Relypsa, said in a press release. “We believe the 3-hour dose separation and addition of data from our drug-drug interaction program to the label can provide doctors greater flexibility in choosing Veltassa and adding it to patients’ daily treatment regimen.”
The most common adverse reactions associated with Veltassa include constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort, and flatulence.