The label for Invokamet XR (canagliflozin and metformin hydrochloride extended-release) will include a new boxed warning regarding lactic acidosis, effective 2025-12-01. This significant label revision from the FDA specifically concerns the metformin hydrochloride component of the combination drug. The warning highlights postmarketing cases of metformin-associated lactic acidosis, which have resulted in serious outcomes including death, hypothermia, hypotension, and resistant bradyarrhythmia. The warning explicitly states: "WARNING: LACTIC ACIDOSIS WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradya".
Background
Invokamet XR is a combination medication that includes canagliflozin and metformin hydrochloride extended-release. The label revision specifically pertains to the metformin hydrochloride component of this drug.
What this means
The addition of a boxed warning to the Invokamet XR label, specifically for its metformin hydrochloride component, underscores the critical importance for healthcare professionals to be aware of the risk of lactic acidosis. This serious adverse event, as highlighted by postmarketing cases, can lead to severe complications including death, hypothermia, hypotension, and resistant bradyarrhythmia. The warning advises clinicians to refer to the full prescribing information for complete details. This update reinforces the need for careful patient selection, monitoring for signs and symptoms of lactic acidosis, and prompt management if suspected. Clinicians should consider this risk when prescribing or monitoring patients on medications containing metformin hydrochloride, particularly in patients with predisposing factors for lactic acidosis.
Source
This information is based on a label revision from the FDA, effective 2025-12-01. The details of the boxed warning are available on dailymed.nlm.nih.gov.