FORXIGA® (dapagliflozin)

FORXIGA® (dapagliflozin) is a highly selective SGLT2 inhibitor for type 2 diabetes mellitus, with 4-year safety and efficacy data, that removes glucose and its associated calories via the kidney.1

FORXIGA®’s (dapagliflozin) safety profile is defined by our RCTs and more than 5 years of clinical use1

You and your patient

What do you and your patient need to know?

The benefits of FORXIGA® (dapagliflozin) are down to the MoA1

FORXIGA® (dapagliflozin) selectively inhibits SGLT2, reducing glucose reabsorption – this leads to glucose excretion in the urine19. The excretion of the calories which accompany glucose contribute to weight loss.1

Because of this, there is an increased risk of some adverse events1

Whilst T2D is associated with an increased risk of UTIs and GIs*, due to the renal-dependent nature of the MoA, incidence is higher among patients taking FORXIGA® (dapagliflozin) vs placebo.1,20

Most UTIs and GIs were mild to moderate, rarely led to discontinuation and were treatable with a single course of treatment.1,19

How FORXIGA<sup>® </sup>facilitates the reabsorption of glucose back into the circulation
How FORXIGA<sup>® </sup>facilitates the reabsorption of glucose back into the circulation

Rates of UTIs and GIs

Incidence of UTIs and GIs
Incidence of UTIs and GIs

 

For more detailed information, consult the SPC
*Genital infection include the preferred terms, listed in order of frequency reported: vulvovaginal mycotic infection, vaginal infection, balanitis, genital infection fungal, vulvovaginal candidiasis, vulvovaginitis, balanitis candida, genital candidiasis, genital infection, genital infection male, penile infection, vulvitis, vaginitis bacterial and vulval abscess. 
Urinary tract infection includes the following preferred terms, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection and prostatitis.1

 

The benefits of FORXIGA® (dapagliflozin) are down to the MoA1

Taking FORXIGA® (dapagliflozin) means there is an increased amount of fluid, along with glucose, removed from the body through the kidneys.1
 
Because of this, there is an increased risk of some adverse events1

This could cause a lowering of blood pressure which may be more pronounced in a patient with a very high blood glucose level. However, in patients who are already at risk of low blood pressure (e.g. those already taking antihypertensive medications), this further lowering of blood pressure could lead to symptoms of hypotension i.e. dizziness and light-headedness.1

Although this is uncommon, it’s important to discuss with patients how FORXIGA® (dapagliflozin) might interact with concomitant medicines, and whether any special monitoring is needed.1

Dapagliflozin is not recommended for use in patients receiving loop diuretics or who are volume depleted, e.g. due to acute illness caution should be exercised in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or elderly patients. For patients receiving dapagliflozin, in case of intercurrent conditions that may lead to volume depletion, careful monitoring of volume status and electrolytes is recommended.

For detailed information consult the SmPC

*The incidence of volume depletion was analysed in a pre-specified pooled analysis of 13 placebo-controlled studies. 2360 subjects were treated with FORXIGA®(dapagliflozin) 10 mg and 2295 were treated with placebo. Reactions related to volume depletion (including, reports of dehydration, hypovolaemia or hypotension) were reported in 1.1% and 0.7% of subjects who received FORXIGA® (dapagliflozin) 10 mg and placebo,respectively; serious reactions occurred in <0.2% of subjects balanced between FORXIGA®  (dapagliflozin) 10 mg and placebo.1

You and your practice

What would you like to know?

 Renal function and FORXIGA® (dapagliflozin)*       

  • The MoA of all SGLT2is means their glucose-lowering effect is dependent on renal function1, 22, 23
  • Data from 12 placebo-controlled randomised studies showed that patients treated with FORXIGA® (dapagliflozin) did not experience a decline in renal function over 102 weeks.1

With FORXIGA® (dapagliflozin), mean eGFR decreased at Week 1 then returned to or above baseline by Week 24 and was maintained to Week 10224

 

Effect of FORXIGA® on mean eGFR across 102 weeks
Effect of FORXIGA® on mean eGFR across 102 weeks

Adapted from Ptaszynska A et al. 2012

 *FORXIGA® (dapagliflozin) is not recommended for use in patients with moderate to severe renal impairment (patients with creatinine clearance (CrCl) <60 ml/min or an eGFR <60 ml/min/1.73m2)1
 


Formore detailed information, consult the SPC
MoA, mode of action; SGLT2i, sodium-glucose co-transporter-2 inhibitor; eGFR, estimated glomerular filtration rate.

No increased risk of CV events with FORXIGA® (dapagliflozin) in RCTs 1,25

In a meta-analysis of 21 studies, of 9339 patients with varying degrees of CV risk and duration of T2D, FORXIGA® (dapagliflozin) demonstrated: 1,25*

  • No increased risk of major adverse cardiovascular events (MACE), HR 0.77 (95% CI 0.54-1.10)1,25
  • No increased risk of CV death (HR=0.79, 95% CI, 0.36 to 1.69)25
  • A consistent CV safety profile in patients with established CVD 1,25

Adapted from Sonesson et al 2016

FORXIGA® (dapagliflozin)is not indicated to reduce the risk of cardiovascular events1

For more detailed information, consult the SPC.

MACE: Cardiovascular death, mycardial infraction, ischaemic or haemorrhagic stroke

CV, cardiovascular; HR, hazard ratio; CI: confidence interval

An insulin-independent MoA28

  • Normally, most filtered glucose is reabsorbed at the proximal tubule by SGLT2 (90%) and  then re-enters the blood29
  • FORXIGA®(dapagliflozin) selectively inhibits SGLT2, reducing glucose reabsorption. This leads to glucose excretion in the urine 1

Renal function and SGLT2

  • The MoA of all SGLT2s means their glucose-lowering effect is dependent on renal function1,22-24
  • Patients treated with FORXIGA® (dapagliflozin) maintained renal function over 102 weeks24

 

How FORXIGA® facilitates the reabsorption of glucose back into the circulation
How FORXIGA® facilitates the reabsorption of glucose back into the circulation

No SGLT2 inhibitor can be initiated in patients with an eGFR <60 mL/min/1.73m 1,22-24