*In adults with proteinuric CKD (with or without T2D),
FORXIGA® reduced the risk of composite of ≥50% sustained decline in eGFR, ESKD, or renal or CV death, vs placebo (P<0.0001), both + SoC.1,2
In adults with HFrEF# and HFpEF** (with or without T2D),
FORXIGA® reduced the risk of composite of CV death or worsening of HF§ vs placebo (P<0.0001 and P<0.001), both + SoC, respectively.1,3,4
Dapagliflozin improves glycaemic control in patients with type 2 diabetes mellitus and provides cardio-renal benefits. The cardio-renal benefits of dapagliflozin are not solely dependent on the blood glucose-lowering effect and not limited to patients with diabetes.1 ESKD defined as the need for maintenance dialysis for at least 28 days, renal transplantation or sustained eGFR <15 mL/min/1.73 m2 for at least 28 days;2 #HFrEF defined as NYHA class II-IV HF and ejection fraction of ≤40;3 **HFpEF defined as NYHA class II-IV HF and ejection fraction of >40%;4 §In DAPA-HF, worsening HF was defined as either an unplanned hospitalisation or an urgent visit resulting in intravenous therapy for HF; in DELIVER worsening HF was defined as either an unplanned hHF or an urgent visit for HF.3,4

CKD, chronic kidney disease; CV, cardiovascular; eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; HF, heart failure; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction; NYHA, New York Heart Association; SoC, standard of care; T2D, type 2 diabetes.

References: 1. FORXIGA® Approved Product Information. 2. Heerspink HJL et al. N Engl J Med. 2020;383(15):1436–1446. 3. McMurray JJV et al. N Engl J Med. 2019;381(21):1995–2008. 4. Solomon SD et al. N Engl J Med. 2022;387(12):1089–1098.

FORXIGA® helps patients feel better1–3

vs placebo (both + SoC) as measured by KCCQ^ in patients with HFrEF* and HFpEF#

*HFrEF defined as NYHA class II-IV HF and ejection fraction of ≤40%;4 #HFpEF defined as NYHA class II-IV and ejection fraction of >40%;5 ^As measured by KCCQ scores (TSS, CSS, PLS, and OSS). The KCCQ is a 23-item, self-administered disease-specific instrument that quantifies symptoms (frequency, severity, and recent change), physical function, quality of life, and social function over the previous 2 weeks. In the KCCQ, the total symptom score (TSS) quantifies the symptom frequency and severity, KCCQ Physical Limitation Score (PLS) evaluates the physical function, KCCQ clinical summary score (CSS) includes the symptoms and physical function domains, and KCCQ overall summary score (OSS) summarises all key domains (TSS, physical function, quality of life, and social function). For each domain, the validity, reproducibility, responsiveness, and interpretability have been independently established. Scores are transformed to a range of 0 to 100, in which higher scores reflect better health status;2,3 In DAPA-HF, FORXIGA® improved mean KCCQ-TSS, -CSS, and -OSS at 8 months (2.8, 2.5, and 2.3 points higher respectively vs placebo; nominal P<0.0001 for all) and in DELIVER, FORXIGA® improved KCCQ-TSS, -PLS, -CSS, and -OSS at 8 months (2.4, 1.9, 2.3, and 2.1 points higher respectively vs placebo; nominal P<0.001 for all).2,3

With FORXIGA®, symptom improvement is more common, 
and deterioration is less common1–3

vs placebo (both + SoC) as measured by KCCQ-TSS in patients with HFrEF* and HFpEF#

Adapted from FORXIGA® Approved product Information and Kosiborod et al, 2023.1,3
*HFrEF defined as NYHA class II-IV HF and ejection fraction of ≤40%;4 #HFpEF defined as NYHA class II-IV and ejection fraction of >40%;5 Taking account of death.1

KCQQ study procedures and clinical outcomes2,3

*HFrEF defined as NYHA class II-IV HF and ejection fraction of ≤40%;4 #HFpEF defined as NYHA class II-IV HF and ejection fraction of >40%.5

CVRM Hub

Explore resources for the management of cardiovascular, renal and metabolic diseases

CI, confidence interval; CSS, clinical summary score; CV, cardiovascular; DAPA-HF, Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure; DELIVER, Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure; HF, heart failure; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction; KCCQ, Kansas City Cardiomyopathy Questionnaire; OSS, overall summary score; PLS, physical limitation score; SoC, standard of care; TSS, total symptom score.

References: 1. FORXIGA® Approved Product Information. 2. Kosiborod MN et al. Circulation. 2020;141:90–99. 3. Kosiborod MN et al. J Am Coll Cardiol. 2023;81(5):460–473. 4. McMurray JJV et al. N Engl J Med. 2019; 381(21):1995–2008. 5. Solomon SD et al. N Engl J Med. 2022;387:1089–1098.

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AstraZeneca and the Forxiga team are committed to supporting you and your patients.
If you would like further information or have a request for resources not currently available, please request a rep visit below.

DELIVER – a study in 6,263 adults with HFpEF
DELIVER – a study in 6,263 adults with HFpEF

DELIVER primary composite outcome: CV death or worsening HF1,6‡

Adapted from Solomon et al. 2022.6
Adapted from Solomon et al. 2022.6
18% RRR (3.1% ARR)  (HR 0.82; 95% CI: 0.73, 0.92; P<0.001)
18% RRR (3.1% ARR)  (HR 0.82; 95% CI: 0.73, 0.92; P<0.001)

Adapted from Solomon et al. 2022.6

Studied in 6,263 patients with HFpEF (SoC included SoC for all comorbidities as per patient’s location).6,8 #HFpEF defined as NYHA class II-IV HF and ejection fraction of >40%;6 ‡In DELIVER worsening HF was defined as either an unplanned hHF or an urgent visit for HF.6 View Study Design.

DAPA-HF - a study in 4,744 adults with HFrEF
DAPA-HF - a study in 4,744 adults with HFrEF

DAPA-HF primary composite outcome: CV death or worsening HF1,5† 

Adapted from McMurray et al. 2019.
Adapted from McMurray et al. 2019.
26% RRR (4.9% ARR)  (HR 0.74; 95% CI: 0.65, 0.85; P<0.0001)
26% RRR (4.9% ARR)  (HR 0.74; 95% CI: 0.65, 0.85; P<0.0001)

Adapted from McMurray et al. 2019.5

Studied in 4,744 patients with HFrEF on guideline-directed therapy. (SoC: including beta-blockers, diuretics, MRA, RAASi, and an implantable device).5 *HFrEF defined as NYHA class II-IV HF and ejection fraction of ≤40%;5 †Worsening HF was defined as either an unplanned hospitalisation or an urgent visit resulting in intravenous therapy for HF.5  View Study Design.

HFpEF spectrum
HFpEF spectrum

HFpEF patients – Product Familiarisation Program (PFP) 

The FORXIGA® HFpEF PFP provides healthcare professionals with an opportunity to gain clinical experience with FORXIGA® to improve patient care, prior to listing on Pharmaceutical Benefits Scheme (PBS). The FORXIGA® PFP runs from August 2023 until December 2023 or when FORXIGA® becomes PBS-listed, whichever comes first, or as advised by AstraZeneca.

1. Register
for the FORXIGA® HFpEF Product Familiarisation Program

2. Enrol
eligible patients into the PFP (subject to criteria) and provide a prescription for FORXIGA®;  AstraZeneca will provide FORXIGA® to eligible patients at no cost for the duration of PFP. Stock will be delivered to a pharmacy  nominated by the patient.

3. Review
your patient and reorder new packs every two months until program ends. 

HFrEF spectrum
HFrEF spectrum

HFrEF patients - FORXIGA® PBS clinical criteria10

Patient must be symptomatic with NYHA classes II, III or IV Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%

AND

The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated

AND

The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor OR an angiotensin II antagonist OR an angiotensin receptor with neprilysin inhibitor combination therapy, unless these are contraindicated according to the TGA approved Product Information or cannot be tolerated

AND

Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor

Please refer to PBS website for full Authority Information. FORXIGA® is not listed on the PBS for LVEF >40%. 

FORXIGA® – simple dosing1

One tablet
Once a day
No titration

FORXIGA®– resources for you and your patients

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Act Today Protect Tomorrow.
Act Today Protect Tomorrow.

Clinical Considerations1

The safety profile of dapagliflozin is consistent across all indications.1

• Renal impairment

There is limited experience with initiating treatment with FORXIGA® in patients with eGFR <25mL/ min/1.73m2. Initiating treatment with FORXIGA® in these patients is not recommended.

• Volume depletion and/or hypotension

FORXIGA® induces osmotic diuresis which may lead to a modest decrease in blood pressure. Caution should be exercised in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk.

• Ketoacidosis in patients with diabetes mellitus

There have been reports of ketoacidosis, including DKA, a serious life-threatening condition requiring urgent hospitalisation in patients taking dapagliflozin and other SGLT2is. Fatal cases of ketoacidosis have been reported in patients taking dapagliflozin. Appropriate precautions need to be taken during treatment with SGLT2i to detect and manage occurrences of DKA.

Please refer to FORXIGA® Approved Product Information for further information on safety including contraindications, special warnings and precautions for use and adverse effects. For information on Adverse Events in DAPA-HF and DELIVER studies, please click this link: 

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FORXIGA Logo

PBS Information: FORXIGA® Authority Required (STREAMLINED): Type 2 Diabetes, Chronic Heart Failure and Chronic Kidney Disease. Refer to PBS Schedule for full Authority Required Information. FORXIGA® is not listed for treatment of Chronic Heart Failure with preserved ejection fraction.

PLEASE CLICK HERE TO REVIEW FULL PRODUCT INFORMATION BEFORE PRESCRIBING. FURTHER INFORMATION AVAILABLE ON REQUEST FROM
ASTRAZENECA ON 1800 805 342 OR WWW.ASTRAZENECA.COM.AU/PI

ACE = angiotensin-converting enzyme; AE = adverse event; ARR = absolute risk reduction; CI = confidence interval; CV = cardiovascular; DAPA-HF = Dapagliflozin And Prevention of Adverse outcomes in Heart Failure; DELIVER = Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure; DKA = diabetic ketoacidosis; eGFR = estimated glomerular filtration rate; EF = ejection fraction; HF = heart failure; HFrEF = heart failure with reduced ejection fraction; HFmrEF = heart failure with mildly reduced ejection fraction; HFpEF = heart failure with preserved ejection fraction; hHF = hospitalisation for heart failure; HR = hazard ratio; KCCQ = Kansas City Cardiomyopathy Questionnaire; LVEF = left ventricular ejection fraction; MRA = mineralocorticoid receptor antagonist; NT-proBNP = N-terminal pro-B-type natriuretic peptide; NYHA = New York Heart Association; PBS = Pharmaceutical Benefits Scheme; PACD = Primary analysis censoring date; PFP = Product Familiarisation Program; RRR = relative risk reduction; SAE = serious adverse events; SGLT2i = sodium–glucose co-transporter-2 inhibitor; SHAPE = Study of Heart Failure in the Australian Primary carE setting; SoC = standard of care; SR = sinus rhythm; T2D = type 2 diabetes; TGA = Therapeutic Goods Administration; UTI = urinary tract infection.

References: 1. FORXIGA® Approved Product Information. 2. Chen L et al. Snapshot of heart failure in Australia, Mary MacKillop Institute for Health Research (ACU), Melbourne, Australia, 2017, pp1-39. 3. Sindone AP et al. Med J Aust. 2022;217(4):212-217. 4. Sindone AP et al. ESC Heart Fail. 2021;8(6):4497-4505. 5. McMurray JJV et al. N Engl J Med. 2019;381(21):1995-2008. 6. Solomon SD et al. N Engl J Med. 2022;387(12):1089-1098. 7. Vaduganathan M et al. JAMA Cardiol. 2022;7(12):1259-1263. 8. Solomon SD et al. Eur J Heart Fail. 2021;23(7):1217–1225. 9. Berg DD et al. JAMA Cardiol. 2021; 6(5):499-507. 10. The Pharmaceutical Benefits Scheme (PBS). https://www.pbs.gov.au Last accessed July 2023. 11. Supplement to: McMurray JJV et al. N Engl J Med. 2019; 381(21):1995-2008. 12. Supplement to: Solomon SD et al. N Engl J Med. 2022;387(12):1089-1098. 13. McMurray JJV et al. Eur J Heart Fail. 2019; 21:665–675. 14. Solomon SD et al. JACC Heart Fail. 2022;10(3):184–197.

FORXIGA® is a registered trademark of the AstraZeneca group of companies. Registered user AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com. AU-17513. September 2023.