Farxiga Regret, Stopping, and Restarting: What Real Users and Clinical Data Actually Show

Side effects seen in the trials

The Farxiga label reports how often selected adverse reactions occurred. In 12 pooled placebo-controlled glycemic trials, female genital mycotic infections occurred in 6.9% of people taking dapagliflozin 10 mg versus 1.5% on placebo, male genital mycotic infections in 2.7% versus 0.3%, increased urination in 3.8% versus 1.7%, and urinary tract infections in 4.3% versus 3.7% [1].

What does the label say happens after the last dose?

Dapagliflozin blocks SGLT2 in the kidney, so more glucose leaves the body in urine [1]. That does not stop with the last tablet. The label states that urinary glucose excretion persists for 3 days after Farxiga is discontinued, and it notes postmarketing reports of ketoacidosis and/or glucosuria lasting greater than 6 days and some up to 2 weeks after SGLT2 inhibitors are stopped [1]. The label also says blood glucose at presentation with ketoacidosis may be below 250 mg/dL, and that patients should discontinue Farxiga and seek medical attention immediately if signs and symptoms of ketoacidosis occur [1].

What does the label say about stopping for surgery?

The Farxiga label says to withhold the drug for at least 3 days, if possible, before surgery or procedures associated with prolonged fasting. It also says to withhold it, if possible, in temporary situations that could predispose to ketoacidosis [1].

What did the large trials test?

In DAPA-HF (4,744 adults with heart failure and ejection fraction 40% or less), worsening heart failure or cardiovascular death occurred in 16.3% on dapagliflozin versus 21.2% on placebo (HR 0.74, 0.65 to 0.85) over a median 18.2 months [2]. In DELIVER (6,263 adults with ejection fraction over 40%), the same outcome occurred in 16.4% versus 19.5% (HR 0.82, 0.73 to 0.92) over a median 2.3 years [3]. In DAPA-CKD (4,304 adults with chronic kidney disease), the composite of sustained eGFR fall of 50% or more, end-stage kidney disease, or kidney or cardiovascular death occurred in 9.2% versus 14.5% (HR 0.61; number needed to treat 19) over a median 2.4 years, and the trial was stopped early for efficacy [4].

Dosing and checks the label describes

The label specifies assessing renal function before initiation and then as clinically indicated, and assessing volume status and correcting volume depletion before initiation [1].

For glycemic control, dapagliflozin is not recommended at an eGFR below 45 mL/min/1.73 m2. For heart failure and kidney disease the dose is 10 mg once daily; treatment is not started below an eGFR of 25, though a patient already taking it may continue 10 mg if eGFR falls below 25 [1]. The label says a lower dose of insulin or an insulin secretagogue such as a sulfonylurea may be required to reduce hypoglycemia risk, and that serum lithium should be monitored more often during initiation and dose changes [1].