Tacrolimus

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An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

• * Drug overdose

A 36-year-old man developed hypoglycaemia during immunosuppressant drug therapy with tacrolimus. Additionally, he accidently received tacrolimus in overdose, which was not associated with the development of adverse reactions.

The man, who had undergone 4/6 mismatch simultaneous pancreas-kidney transplant, had been receiving immunosuppressant drug therapy with tacrolimus [dosage and route not stated] along with antithymocyte globulin [thymoglobulin] induction, mycophenolate and prednisolone. He had no albuminuria and normal pancreatic function. He did not require insulin. Seven and half months following the uneventful transplantation, he was admitted to hospital due to COVID-19 [aetiology not stated]. He had mild tachypnoea, for which he received oxygen. During the hospitalisation, he developed acute renal dysfunction and metabolic acidosis, which resolved in 4−9 days. These two events were attributed to the effects of COVID-19 disease. The hospital stay was prolonged for four days due to an accidental overdose of tacrolimus (four times the usual dose), but no related adverse reactions were noted. Later, on day 53, a new onset albuminuria [aetiology not stated] and short term weight gain due to social isolation were noted. He also had asymptomatic transient hypoglycaemia. He had serum insulin in the range of 28−31 mU/L, C-peptide 0.83−0.99 mmol/L and negative insulin antibodies, which were considered secondary to transient increase in beta cell dysfunction in the setting of insulin resistance. It was considered that the treatment with tacrolimus contributed in the beta cell dysfunction, which led to asymptomatic transient hypoglycaemia. The albuminuria also resolved. Subsequently, he was discharged home with no concerns.