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FDA agrees to removal of boxed warning on patiromer label
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Relypsa, a Vifor Pharma company, announced the FDA approved a supplemental New Drug Application updating the label of patiromer.
The label for patiromer (Veltassa, Relypsa) will no longer include a boxed warning suggesting the drug be taken 6 hours before or after ingestion of other oral medications, according to a press release issued by the company.
The new label recommends patiromer be taken at least 3 hours before or after other oral medications, the company stated.
“We are extremely pleased the FDA has approved these changes to patiromer’s label, including removal of the boxed warning,” John A. Orwin, president and CEO of Relypsa, said in the release. “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.”
Patiromer is sometimes administered to patients with HF to reduce their risk for hyperkalemia, which may enable them to take renin-angiotensin-aldosterone system inhibitors that have potential to increase risk for hyperkalemia.
According to the release, researchers tested 28 drugs to determine the potential for interaction with patiromer. Of these drugs, there was no interaction in in vitro drug-drug interaction tests between patiromer and 14 of the drugs.
Twelve of the 14 drugs that showed interaction with patiromer were tested in a phase 1 study in healthy volunteers. According to the release, patiromer did not alter nine of the 12 drugs’ absorption and reduced absorption in three of the drugs. However, no interaction was observed when patiromer and any of the three drugs were taken 3 hours apart, the company stated.
Disclosure: Orwin is an employee of Relypsa.