The Food and Drug Administration (FDA) has approved NephroScan™ (kit for the preparation of technetium Tc 99m succimer injection) for use as an aid in the scintigraphic evaluation of renal parenchymal disorders in adults and pediatric patients including term neonates.

NephroScan is a sterile, single-dose kit for the preparation of technetium Tc 99m succimer injection. Technetium Tc 99m succimer binds to the cortical region of kidneys and in conjunction with gamma scintigraphy or single photon emission computed tomography is used to image the renal cortices.

“The approval in the US means that Tc-99m DMSA imaging will be brought back as a useful tool for the evaluation of adult and pediatric patients affected by renal diseases,” said Dr Ted Treves, Professor of Radiology at Harvard Medical School and former Chief Division of Nuclear Medicine at Boston Children’s Hospital. “Efforts are underway for renewed education of referring physicians about its value and the Society of Nuclear Medicine and Molecular Imaging practice guidelines have recently been updated.”

Nephroscan contains 1mg of succimer as a lyophilized powder in a single-dose vial. Upon radiolabeling with technetium Tc 99m, it provides up to 1480 MBq (40 mCi) Technetium Tc 99m Succimer Injection as a solution in approximately 5mL volume at calibration date and time.

Image acquisition should begin 1 hour to 4 hours after intravenous administration of the prepared drug product. In patients with severely reduced glomerular filtration rate, image acquisition should be delayed up to 6 hours to 24 hours.

The most common adverse reactions associated with the use of NephroScan were urticaria, rash, pruritus, erythema, syncope, fever, and nausea. Patients should be advised to hydrate before and after administration and to void frequently after administration.

The use of technetium Tc 99m succimer injection in patients with advanced renal failure may have an effect on image interpretation as the kidneys may not absorb the technetium Tc 99m succimer and thus may distribute to organs or parts of the body other than the kidneys.

References

  1. Theragnostics announces US FDA approval for its radiodiagnostic imaging drug NephroScan™ (kit for the preparation of technetium Tc 99m succimer injection). News release. Theragnostics Inc. Accessed February 23, 2022. https://www.prnewswire.com/news-releases/theragnostics-announces-us-fda-approval-for-its-radiodiagnostic-imaging-drug-nephroscan-kit-for-the-preparation-of-technetium-tc-99m-succimer-injection-301488281.html.
  2. NephroScan. Package insert. Theragnostics Inc.; 2022. Accessed February 23, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214993s000lbl.pdf.