FDA Approves Removal of Boxed Warning for Hyperkalemia Drug
Updated label for patiromer now recommends the drug be taken at least 3 hours before or after other oral medications.
The FDA has approved removal of a boxed warning from the patiromer (Veltassa) drug label related to the timing of drug administration.
The boxed warned stated that the drug, which is indicated for the treatment of hyperkalemia, should be taken at least 6 hours before or after other oral medications. The updated label will now recommend patients take patiromer at least 3 hours before or after other oral medications. Details of this information will be provided in the dosage and administration section (Section 2) of the drug interactions section (Section 7) of the label.
The FDA approval follows the reporting of positive data earlier this year showing there is a low risk for drug-drug interaction when patiromer is separated from other oral medications by at least 3 hours, according to a press release from Relypsa, Inc., which makes the drug.