In response to data published by the FDA and the American Society of Hospital Pharmacists regarding shortages of a drug used to prevent rejection after organ transplantation, alternative options for the continuation of treatment have been provided.
According to a statement from the Transplant Pharmacy and Pediatric Communities of Practice (COPs), the shortages — which apply to certain generic versions of tacrolimus — may not be resolved until April 2020.
Alternative options suggested include switching to a different generic tacrolimus formulation that is not on shortage or changing the current formulation to a branded tacrolimus formulation (eg, Prograf, Astagraf XL [both Astellas Pharma U.S. Inc.] or Envarsus XR [Veloxis Pharmaceuticals]). Dose adjustments may be required.
Evarus XR tablets are not currently FDA approved for use in pediatric populations, but Astagraf XL capsules are, according to the statement.
“Given the importance of maintaining adequate therapy to prevent transplant rejection, transplant patients and caregivers are encouraged to discuss these options with their care teams before being affected by the shortage to minimize the chances of treatment interruption while ensuring safe and effective prevention of organ rejection,” the Transplant Pharmacy and Pediatric COPs wrote.
For more information on the tacrolimus drug shortages, please visit: www.accessdata.fda.gov/scripts/drugshortages/default.cfm or www.ashp.org/Drug-Shortages.