Invokamet XR Label Adds Boxed Warning for Metformin-Associated Lactic Acidosis

The U.S. Food and Drug Administration (FDA) has added a boxed warning to the label for Invokamet XR (canagliflozin and metformin hydrochloride extended-release), effective January 31, 2026. This significant label revision specifically highlights the risk of lactic acidosis associated with the metformin hydrochloride component of the combination drug, a serious adverse event identified in postmarketing cases.

Background

Invokamet XR is a combination medication that includes canagliflozin and metformin hydrochloride extended-release. Other formulations containing canagliflozin include Invokana and Invokamet. Metformin hydrochloride is also available as a standalone medication. Drugs related to canagliflozin include dapagliflozin and empagliflozin.

What this means

The addition of a boxed warning to the label of Invokamet XR, specifically for its metformin hydrochloride component, represents a critical update for healthcare providers. This warning addresses the risk of lactic acidosis, a severe metabolic complication. The FDA's action underscores the gravity of this condition, which has been documented in postmarketing cases with serious outcomes. These outcomes include death, hypothermia, hypotension, and resistant bradyarrhythmias.

The warning further highlights that the onset of metformin-associated lactic acidosis is often subtle. This characteristic makes early detection challenging, emphasizing the need for heightened clinical suspicion. Healthcare professionals should be vigilant for non-specific symptoms that might indicate the development of lactic acidosis, especially in patients with predisposing factors. Prompt recognition and management are crucial given the life-threatening nature of the condition and its potential for rapid progression. The inclusion of this boxed warning mandates that prescribers and patients are fully informed about this significant safety concern associated with the metformin hydrochloride component.

Source

This information regarding the label revision for Invokamet XR was obtained from the U.S. Food and Drug Administration (FDA). The update, effective January 31, 2026, is documented on the DailyMed database hosted by dailymed.nlm.nih.gov, under the specific set ID 0ef9de1a-b786-4b6c-a250-3f5ac532b16a.