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FDA Approves Safety Updates to Synjardy Label
The label for the type 2 diabetes treatment has been updated to include the risk of ketoacidosis and damage to the kidney.
The FDA has approved safety-related labeling changes for Synjardy (empagliflozin/metformin), which is available to treat patients with type 2 diabetes.
According to a Boehringer Ingelheim spokesperson, updates made to the Synjardy prescribing information (PI) were part of a set of label updates that harmonize the PIs across the empagliflozin family of products and implement updates related to the acute kidney injury.
Boehringer Ingelheim also markets initiate Jardiance (empagliflozin) and Glyxambi (empagliflozin/linagliptin), which are also approved to treat patients with type 2 diabetes.
With the growing number of people who have overlapping cardio-renal-metabolic conditions, this label update offers new information, the spokesperson said.
With the revised eGFR cut-off, providers can now initiate Jardiance and Glyxambi in patients with impaired kidney function and an eGFR >30 mL/min/1.73m2 This expands the number of people for whom Jardiance and Glyxambi may be appropriate to: lower blood sugar for adults with type 2 diabetes (Jardiance and Glyxambi), and reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease (Jardiance).
Label harmonization changes resulted in the following:
• The ‘Hypotension’ Warning and Precaution was renamed ‘Volume Depletion.’
• The acute kidney injury warning is now noted in other sections of the label (including in ‘Volume Depletion’) and not as a separate Warning and Precaution.
• As a result, Warning and Precautions were reordered.
• No new Warning and Precautions were added. Ketoacidosis was an existing Warning and Precaution and is consistent with class labeling.
• Information related to Jardiance and Glyxambi use in patients with renal impairment now states: “not recommended for use in patients with an eGFR less than 30 mL/min/1.73 m2 and contraindicated in patients on dialysis.”
• The previous eGFR cut-off was 45 mL/min/1.73 m2.
• Due to the metformin component, the cut-off for Synjardy remains 45 mL/min/1.73 m2.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
