Monday, 18 January 2016 00:00

Drug Safety Communication – Drug Interaction Study Requirement

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The Agency has been notified of the important safety information for Kayexalate powder. Kayexalate (Sodium Polystyrene Sulfonate) is used in the treatment of high blood potassium levels (hyperkalemia). It can be administered either orally or rectally. It elicits its pharmacological effect by binding to potassium injection the large intestine leading to its elimination from the system.

Kayexalate is labelled to decrease the absorption of lithium and thyroxine; however in-depth drug-drug interaction studies of the drug are yet to be conducted.

Upon review of other drugs which lower blood potassium levels; Veltassa (Patiromer) was discovered to bind to about half of the medicines it was co-administered with during the investigation. This poses risk for patients who are on the drug and also have other medications for other ailments at the same time. Hence, labels of Veltassa clearly warn that patients on the medication should avoid other orally administered medications within six hours of taking Veltassa.

Kayexalate could in a similar fashion bind to some co-administered drugs. In view of this, detailed studies should be conducted on Kayexalate to assess its interaction with other orally administered drugs. If the studies conducted confirm significant interactions, all manufacturers of Sodium Polystyrene Sulfonate would have to update their labels to warn patients by including these possible drug-drug interactions.

Healthcare Provider/Patient’s Action

  • Healthcare Providers should consider separating Kayexalate dosing from other orally administered medications by at least six hours to reduce potential risks.
  • Healthcare Providers should also monitor blood levels or clinical response to the other medications appropriately.
  • Patients should not discontinue their blood potassium lowering drugs without consulting their healthcare provider.
  • Report all serious adverse events or side effects related to the use of this drug to NAFDAC PRASCOR (20543 – Toll free from all network) or via individual case safety report forms or e-mail : This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC… Safeguarding the health of the Nation!

Read 11086 times Last modified on Wednesday, 18 May 2016 14:22

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