Safety Alerts & Recalls

What does this mean?

Although it has been known for some time that tacrolimus should always be prescribed and dispensed by brand, the recent availability of new branded products and various generic and modified release formulations results in greater risk of unintentionally switching between products. The consequence of this, is that there have been associated reports of toxicity and graft rejection. If you, or someone you know is prescribed tacrolimus, it is important that you always take the same branded product. If you ever receive a different brand of tacrolimus, it is important to contact the appropriate healthcare professional immediately. If you have any questions or concerns about the contents of this alert, then please discuss them with your pharmacist or doctor.

Healthcare Professionals Reminded to Prescribe and Dispense Tacrolimus by Brand Name Only

The Medicines and Healthcare products Regulatory Agency (MHRA) has written to healthcare professionals to remind them that tacrolimus should only be prescribed and dispensed by the brand name – Adoport; Advagraf; Capexion; Envarsus; Modigraf; Prograf; Tacni; Vivadex. This is because inadvertent switching between tacrolimus products has been associated with reports of toxicity and graft rejection. If a patient is required to be switched from one brand to another, then careful supervision and monitoring is required by a specialist physician.

Tacrolimus is an immunosuppressant medication, also known by the brand names Adoport; Advagraf; Capexion; Envarsus; Modigraf; Prograf; Tacni; Vivadex and is prescribed to prevent or treat organ transplant rejection.

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Source: MHRA
Publication Date: 2017-12-08
Last Updated: 2017-12-09

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