Oral tacrolimus products: reminder to prescribe and dispense by brand name only

Inadvertent switching between tacrolimus products has been associated with reports of toxicity and graft rejection. If you switch a patient to a different brand, ensure they receive careful supervision and therapeutic monitoring by an appropriate specialist.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 24 November 2017

• Therapeutic area: Immunosuppression and transplantation

Reminder of prescribing and dispensing advice

Tacrolimus is an immunosuppressant drug that may be given orally to prevent or treat organ transplant rejection. Tacrolimus has a narrow therapeutic index, and even minor differences in blood levels have the potential to cause graft rejection reactions or toxicity.

In June 2012, following reports of graft rejections and toxicity resulting from switching between products, we issued a Drug Safety Update recommending that all oral tacrolimus products should be prescribed and dispensed by brand name only. We are aware of new oral tacrolimus products on the market or about to be launched. Recommendations from June 2012 remain in place, and also apply to any new tacrolimus products launched since this advice was issued. This includes generic products and prolonged-release formulations.

Further information

Oral tacrolimus products: prescribe and dispense by brand name only, to minimise the risk of inadvertent switching between products, which has been associated with reports of toxicity and graft rejection. Drug Safety Update, June 2012.

BNF. Tacrolimus.

Article citation: Drug Safety Update volume 11, issue 4; November 2017: 3.

Published 24 November 2017