Veltassa Labeling Change
December 1, 2016 - Veltassa® (patiromer) is a potassium-trapping drug used to reduce hyperkalemia (high blood levels of potassium), primarily for patients with chronic kidney disease or heart failure. Veltassa, manufactured by Relypsa, was approved by the U.S. FDA in October 2015. Its labeling included a boxed warning about its possible interactions with other oral drugs and directions to separate taking it and other drugs by at least six hours. After further testing, FDA is now allowing Relypsa to delete the boxed warning, to move interaction information to other parts of the label and to change the interval between taking Veltassa and other drugs to three hours. Recommended dosing is one packet (containing 8.4 Gm, 16.8 Gm or 25.2 Gm of Veltassa) dissolved in at least one-third cup of water. Patients drink the Veltassa mixture along with food, but it should not be heated or mixed into hot liquids.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.