*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® – simple dosing for your patients1
HFpEF patients - FORXIGA® PBS clinical criteria2
Authority Required (STREAMLINED): 14471
Patient must be symptomatic with NYHA classes Il, Ill or IV prior to initiating treatment with this drug
Patient must have a documented left ventricular ejection fraction (LVEF) of greater than 40%
AND
Patient must have documented evidence of structural changes in the heart on echocardiography that would be expected to cause diastolic dysfunction (eg,: left ventricular hypertrophy)
AND
At least one of
i) diastolic dysfunction with high filling pressure on echocardiography, stress echocardiography or cardiac catheterisation;
OR
ii) hospitalisation for heart failure in the 12 months prior to initiating treatment with this drug
OR
(iii) requirement for intravenous diuretic therapy in the 12 months prior to initiating treatment with this drug
OR
(iv) elevated N-terminal pro brain natriuretic peptide (NT-proBNP) levels in the absence of another cause
AND
Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor
HFrEF patients - FORXIGA® PBS clinical criteria2
Authority required (STREAMLINED): 15047
Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug
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%.
CVRM Hub
Explore resources for the management of cardiovascular, renal and metabolic diseases
HF, heart failure; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction; LVEF, left ventricular ejection fraction; PBS, Pharmaceutical Benefits Scheme; SoC, standard of care.
References: 1. Approved Product Information. 2. The Pharmaceutical Benefits Scheme (PBS). PBS website. https://www.pbs.gov.au. Accessed July 2026.
Need more information?
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.
PLEASE CLICK HERE TO REVIEW FULL PRODUCT INFORMATION BEFORE PRESCRIBING.
FURTHER INFORMATION AVAILABLE ON REQUEST FROM ASTRAZENECA ON 1800 805 342.
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 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. Date of preparation: July 2026, AU-25471
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DELIVER primary composite outcome: CV death or worsening HF1,6‡
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 primary composite outcome: CV death or worsening HF1,5†
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 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 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%.
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.
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.