Forxiga (dapagliflozin) 5mg should no longer be used for the treatment of Type 1 Diabetes Mellitus.

Summary 

• Effective 29/10/2021 Forxiga (dapagliflozin) 5mg is no longer authorised for the treatment of patients with type 1 diabetes mellitus (T1DM) and should no longer be used in this population. This is based on Astra Zeneca’s decision to remove the T1DM indication for dapagliflozin 5mg.
• Diabetic ketoacidosis (DKA) is a known side effect of dapagliflozin. In T1DM studies with dapagliflozin, DKA was reported with common frequency (occurring in at least 1 per 100 patients). 
• Additional risk minimisation measures for healthcare professionals and patients, implemented to mitigate the risk of DKA with the use of dapagliflozin in T1DM will no longer be available.
• Discontinuation of dapagliflozin in patients with T1DM must be made by or in consultation with a physician specialised in diabetes care and be conducted as soon as clinically practical. 
• After stopping dapagliflozin treatment, frequent blood glucose monitoring is recommended, and the insulin dose should be increased carefully to minimise the risk of hypoglycaemia.