American Society of Transplantation issues statement on Tacrolimus shortage

By ASN Staff

According to the statement released by the American Society of Transplantation (AST):

“The Food and Drug Administration (FDA) and the American Society of Hospital Pharmacists (ASHP) recently published data on shortages of tacrolimus, an anti-rejection medicine used to prevent rejection after organ transplantation. At the time this information was published, these shortages apply to some generic versions of tacrolimus, and dates for resolution of the shortages range from July 2019 to April 2020. Generic formulations have been evaluated by the FDA and are equivalent to brand-name (innovator) medicines. If this shortage affects your patients, we recommend discussing alternative options within your teams to devise a management strategy.

Some alternative options to continue tacrolimus treatment if the formulation used by the patient is on shortage include:

- Changing the current formulation on shortage to a different generic tacrolimus formulation that is not on shortage

     - These can be identified by discussing with your pharmacists and consulting the FDA and ASHP websites

- Changing the current formulation on shortage to a branded tacrolimus formulation, which may not be directly interchangeable with twice-daily tacrolimus products. These formulations include:

     - Prograf® twice-daily capsules

     - Astagraf XL® once-daily capsules

     - Envarsus XR® once-daily tablets

     - Prograf® twice-daily granules for oral suspension
 

If you have any patients thinking through anti-rejection medication decisions, use this as a resource.

For more information, please read the full statement from AST.

Category:
Subcategory:
Author:
ASN Staff
Body:

According to the statement released by the American Society of Transplantation (AST):

“The Food and Drug Administration (FDA) and the American Society of Hospital Pharmacists (ASHP) recently published data on shortages of tacrolimus, an anti-rejection medicine used to prevent rejection after organ transplantation. At the time this information was published, these shortages apply to some generic versions of tacrolimus, and dates for resolution of the shortages range from July 2019 to April 2020. Generic formulations have been evaluated by the FDA and are equivalent to brand-name (innovator) medicines. If this shortage affects your patients, we recommend discussing alternative options within your teams to devise a management strategy.

Some alternative options to continue tacrolimus treatment if the formulation used by the patient is on shortage include:

- Changing the current formulation on shortage to a different generic tacrolimus formulation that is not on shortage

     - These can be identified by discussing with your pharmacists and consulting the FDA and ASHP websites

- Changing the current formulation on shortage to a branded tacrolimus formulation, which may not be directly interchangeable with twice-daily tacrolimus products. These formulations include:

     - Prograf® twice-daily capsules

     - Astagraf XL® once-daily capsules

     - Envarsus XR® once-daily tablets

     - Prograf® twice-daily granules for oral suspension
 

If you have any patients thinking through anti-rejection medication decisions, use this as a resource.

For more information, please read the full statement from AST.

Date:
Thursday, August 22, 2019