What are the considerations for using Farxiga (dapagliflozin) in patients with a history of pancreatitis or at high risk for developing it for the treatment of type 2 diabetes?

From the Guidelines

Farxiga (dapagliflozin) can be used in patients with a history of pancreatitis or at high risk for developing it when treating type 2 diabetes, as there is no established causal relationship between SGLT2 inhibitors and pancreatitis, according to the most recent guidelines 1. When considering the use of Farxiga in these patients, it's essential to weigh the benefits of its glucose-lowering efficacy against the potential risks. The standard dosing of Farxiga starts at 5 mg once daily, taken in the morning, with possible titration to 10 mg daily if needed and tolerated. Some key points to consider when using Farxiga in patients with a history of pancreatitis or at high risk for developing it include:

• Monitoring for symptoms of pancreatitis, including severe abdominal pain, nausea, and vomiting
• Regular follow-ups, particularly in the first few months of treatment, for patients with a history of pancreatitis
• Maintaining adequate hydration to reduce the risk of volume depletion and associated complications
• Being aware of the contraindications for Farxiga, including severe renal impairment (eGFR less than 30 mL/min/1.73m²), type 1 diabetes, or diabetic ketoacidosis, regardless of pancreatitis history It's also important to note that other diabetes medications, such as GLP-1 receptor agonists and DPP-4 inhibitors, have been associated with rare cases of pancreatitis, but Farxiga works through a different mechanism by increasing glucose excretion through the kidneys 1. Overall, the use of Farxiga in patients with a history of pancreatitis or at high risk for developing it should be individualized, taking into account the patient's specific clinical circumstances and medical history.

From the FDA Drug Label

Type 2 diabetes mellitus and pancreatic disorders (e.g., history of pancreatitis or pancreatic surgery) are also risk factors for ketoacidosis. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes mellitus using SGLT2 inhibitors, including dapagliflozin

The main consideration for using Farxiga (dapagliflozin) in patients with a history of pancreatitis or at high risk for developing it is the increased risk of ketoacidosis. Patients with a history of pancreatitis are at a higher risk for ketoacidosis, and dapagliflozin may exacerbate this condition.

• Key points to consider:
  • Monitor patients for signs and symptoms of ketoacidosis, such as nausea, vomiting, abdominal pain, and shortness of breath.
  • Assess for ketoacidosis regardless of presenting blood glucose levels in patients who present with signs and symptoms consistent with severe metabolic acidosis.
  • Discontinue dapagliflozin if ketoacidosis is suspected, and promptly evaluate and treat ketoacidosis if confirmed.
  • Educate patients on the signs and symptoms of ketoacidosis and instruct them to seek medical attention immediately if they occur 2.

From the Research

Considerations for Using Farxiga in Patients with a History of Pancreatitis

• The use of Farxiga (dapagliflozin) in patients with a history of pancreatitis or at high risk for developing it requires careful consideration of the potential benefits and risks 3.
• While dapagliflozin is effective in reducing blood glucose levels and has cardiovascular benefits, there have been case reports of pancreatitis associated with its use 3, 4.
• A case report of a patient who developed acute pancreatitis after starting dapagliflozin highlights the possible association between SGLT-2 inhibitors and pancreatitis 3.
• However, it is essential to note that the overall risk of pancreatitis with SGLT-2 inhibitors is still being studied, and more research is needed to fully understand this potential association 5.

Risk of Pancreatitis with SGLT-2 Inhibitors

• A review of SGLT-2 inhibitors notes that pancreatitis is not a known side effect of these medications, but there have been case reports of pancreatitis associated with their use 5.
• Another study found that the use of GLP-1 receptor agonists, a different class of diabetes medications, was not associated with an increased risk of pancreatitis in a comorbidity-free subgroup of patients with type 2 diabetes 6.
• The risk of pancreatitis with SGLT-2 inhibitors, including dapagliflozin, should be weighed against the potential benefits of these medications in reducing blood glucose levels and improving cardiovascular outcomes 7, 5.

Monitoring and Patient Education

• Patients with a history of pancreatitis or at high risk for developing it should be closely monitored while taking dapagliflozin, and educated on the symptoms of acute pancreatitis 3.
• Healthcare providers should carefully review the patient's medical history and consider alternative treatment options if necessary 5.
• The benefits and risks of dapagliflozin should be discussed with the patient, and informed decisions made about its use in patients with a history of pancreatitis or at high risk for developing it 7, 3.