PRESCRIBING ALERT®

Dear Health Care Professional,

At MPR, we strive to bring you important drug information in a concise and timely manner. In keeping with this goal, we are pleased to provide you with this PRESCRIBING ALERT containing detailed information about FARXIGA™ (dapagliflozin) tablets, a product of AstraZeneca Pharmaceuticals.

FARXIGA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.1

By inhibiting SGLT2, FARXIGA, a glucuretic, removes glucose via renal excretion.1,2

Consider FARXIGA for patients who need improvement in A1C and have sufficient renal function.1 FARXIGA should not be initiated in patients with an eGFR of <60 mL/min/1.73 m2.1

INDICATION AND LIMITATION OF USEFARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

IMPORTANT SAFETY INFORMATIONContraindications• History of a serious hypersensitivity reaction to FARXIGA• Severe renal impairment, end stage renal disease, or patients on dialysis

WARNINGS AND PRECAUTIONS• Hypotension: FARXIGA causes intravascular volume contraction. Symptomatic hypotension can occur after

initiating FARXIGA, particularly in patients with impaired renal function (eGFR <60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics. Before initiating FARXIGA in patients with one or more of these characteristics, assess and correct volume status. After initiating therapy, monitor for signs and symptoms of hypotension

• Impairment in Renal Function: FARXIGA increases serum creatinine and decreases eGFR. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Adverse reactions related to renal function can occur after initiating FARXIGA. Before initiating FARXIGA, evaluate renal function and monitor periodically thereafter. Discontinue FARXIGA when eGFR is persistently <60 mL/min/1.73 m2

• Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Insulin and insulin secretagogues are known to cause hypoglycemia. FARXIGA can increase the risk of hypoglycemia when combined with these agents. Consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia when used in combination with FARXIGA

• Genital Mycotic Infections: FARXIGA increases the risk of genital mycotic infections. Patients with a history of genital mycotic infections were more likely to develop genital mycotic infections. Monitor and treat appropriately

• Increases in Low-Density Lipoprotein Cholesterol (LDL-C): Increases in LDL-C occur with FARXIGA. After initiating FARXIGA, monitor LDL-C and treat per standard of care

(Important Safety Information continued on next page)

IMPORTANT SAFETY INFORMATION (continued)• Bladder cancer: Across 22 clinical studies, newly diagnosed cases of bladder cancer were reported in 0.17% of

FARXIGA-treated patients and 0.03% of placebo/comparator-treated patients. After excluding patients in whom exposure to study drug was <1 year at the time of diagnosis of bladder cancer, there were 4 cases with FARXIGA and no cases with placebo/comparator. Bladder cancer risk factors and hematuria (a potential indicator of pre-existing tumors) were balanced between treatment arms at baseline. There were too few cases to determine whether the emergence of these events is related to FARXIGA

There are insufficient data to determine whether FARXIGA has an effect on pre-existing bladder tumors. FARXIGA should not be used in patients with active bladder cancer. Use with caution in patients with a prior history of bladder cancer

• Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with FARXIGA or any other antidiabetic drug

ADVERSE REACTIONS• In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with

FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%)

USE IN SPECIFIC POPULATIONS• Pregnant Women: There are no adequate and well-controlled studies of FARXIGA in pregnant women.

Consider appropriate alternative therapies, especially during the second and third trimesters• Nursing Mothers: It is not known whether FARXIGA is excreted in human milk. Because of the potential for

serious adverse reactions in nursing infants from FARXIGA, discontinue nursing or discontinue FARXIGA• Geriatric Use: A higher proportion of patients ≥65 years treated with FARXIGA had adverse reactions related

to volume depletion and renal impairment or failure compared to patients treated with placebo. No FARXIGA dose change is recommended based on age

Please see the full Prescribing Information.

More information about FARXIGA is available in the current edition of MPR.

Sincerely,

Asha Gupta, PharmD Clinical Communications Specialist MPR Custom Programs

REFERENCES1. FARXIGA [Prescribing Information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2014. 2. Bailey CJ, Day C. SGLT2 inhibitors: glucuretic treatment for type 2 diabetes. Br J Diabetes Vasc Dis. 2010;10(4):193–199.

FARXIGA is a trademark of the AstraZeneca group of companies.2995500 Last Updated 6/14

√ MPR PRESCRIBING ALERT

For adults with type 2 diabetes, in addition to diet and exercise

[√] FARXIGA removes glucose via renal excretion

INDICATION AND LIMITATION OF USEFARXIGA™ (dapagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

IMPORTANT SAFETY INFORMATIONContraindications• History of a serious hypersensitivity reaction to FARXIGA• Severe renal impairment, end stage renal disease, or patients on dialysis

1

Please see additional Important Safety Information throughout and US Full Prescribing Information

(continued on next page)

Company: AstraZeneca Pharmaceuticals LPPharmacologic class: Sodium-glucose cotransporter 2 (SGLT2) inhibitor.Active Ingredient: Dapagliflozin 5 mg, 10 mg; tabletsIndication: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitation of use: Not recommended for type 1 diabetes mellitus or treatment of diabetic ketoacidosis.Adults: Take in the AM. Initially 5 mg once daily; if tolerated and need additional glycemic control, may increase to 10 mg once daily. Renal impairment: If eGFR <60 mL/min/1.73 m2, do no initiate. Discontinue if eGFR falls persistently <60 mL/min/1.73 m2.Children <18 yrs: Not established or indicated.Contraindications: History of serious hypersensitivity reaction to FARXIGA; severe renal impairment, end-stage renal disease, or dialysis.Warnings & Precautions: Before initiating FARXIGA, assess volume status and correct hypovolemia in the elderly, in patients

with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy. Evaluate renal function prior to starting and monitor periodically thereafter. Concomitant insulin or insulin secretagogue: Consider a lower dose of insulin/insulin secretagogue to reduce risk of hypoglycemia. Increased risk of genital mycotic infections; monitor and treat if occurs. Monitor for increases in LDL-C; treat if occur. Active bladder cancer: Do not use. History of bladder cancer: Use with caution.Special Populations: Pregnancy (Cat. C). Nursing mothers: Discontinue. Geriatrics: Increased risk of adverse reactions due to reduced intravascular volume. Renal Impairment: Increased risk of adverse reactions due to reduced intravascular volume and renal function.Adverse Reactions: Most common (>5% incidence): Female genital mycotic infections, nasopharyngitis, and urinary tract infections.How Supplied: Tablets—30, 90, 500/bottle. Hospital unit dose cartons of 100.

FARXIGA™(dapagliflozin) tablets℞

SGLT2 INHIBITION: MECHANISM OF ACTION

aIn patients with type 2 diabetes.

SGLT2 = sodium-glucose cotransporter 2.

Sources: Gerich 20101; FARXIGA [Prescribing Information]2; Bailey 2010.3

• By inhibiting SGLT2, FARXIGA, a glucuretic, removes glucose and associated calories2,3

– SGLT2 plays a primary role in removing glucose from the kidney filtrate and transports it back into the bloodstream2

• FARXIGA is not indicated for weight loss

SGLT2

FARXIGAReduces glucose reabsorption back into the bloodstream

Glucose filtration(≈180 g of glucose is filtered by the kidneys each day)3

Urinary excretion of glucose(≈70 g/day or corresponding to ≈280 cal/day with 10 mg dose at 12 weeks‡)

Proximal tubule

Glucose

SGLT2

FARXIGA

SGLT2

FARXIGAReduces glucose reabsorption back into the bloodstream

Glucose filtration(≈180 g of glucose is filtered by the kidneys each day)1

Urinary excretion of glucose(≈70 g/day or corresponding to ≈280 cal/day with 10-mg dose at 12 weeksa)

Proximal tubule

Glucose

SGLT2

FARXIGA

SGLT2

FARXIGAReduces glucose reabsorption back into the bloodstream

Glucose filtration(≈180 g of glucose is filtered by the kidneys each day)1

Urinary excretion of glucose(≈70 g/day or corresponding to ≈280 cal/day with 10-mg dose at 12 weeksa)

Proximal tubule

Glucose

SGLT2

FARXIGA

(continued on next page)2

Please see additional Important Safety Information throughout and US Full Prescribing Information

For adults with type 2 diabetes, in addition to diet and exercise

[√] FARXIGA™ (dapagliflozin) provided significant A1C reductions

■ The combination treatment of FARXIGA 5 mg plus metformin XR provided a –2.1% reduction in A1C from baseline2,4

■ FARXIGA 5 mg monotherapy provided a –1.2% reduction in A1C from baseline2,4

IMPORTANT SAFETY INFORMATIONWarnings and Precautions• Hypotension: FARXIGA causes intravascular volume contraction. Symptomatic hypotension can occur after initiating

FARXIGA, particularly in patients with impaired renal function (eGFR <60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics. Before initiating FARXIGA in patients with one or more of these characteristics, assess and correct volume status. After initiating therapy, monitor for signs and symptoms of hypotension.

• Impairment in Renal Function: FARXIGA increases serum creatinine and decreases eGFR. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Adverse reactions related to renal function can occur after initiating FARXIGA. Before initiating FARXIGA, evaluate renal function and monitor periodically thereafter. Discontinue FARXIGA when eGFR is persistently <60 mL/min/1.73 m2.

• Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Insulin and insulin secretagogues are known to cause hypoglycemia. FARXIGA can increase the risk of hypoglycemia when combined with these agents. Consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia when used in combination with FARXIGA.

• Genital Mycotic Infections: FARXIGA increases the risk of genital mycotic infections. Patients with a history of genital mycotic infections were more likely to develop genital mycotic infections. Monitor and treat appropriately.

MEAN A1C REDUCTIONS WITH FARXIGA 5 MG + METFORMIN XR OR MONOTHERAPY AT 24 WEEKS (PRIMARY END POINT)b,c

Please see study design “Farxiga™ (dapagliflozin) 5 mg With Metformin XR Initial Combination“ on Page 6. bValues are last observation (prior to rescue for rescued patients) carried forward and represent adjusted mean change from baseline. c The median metformin XR dose was 2000 mg per day. dP<0.0001 vs FARXIGA 5 mg or metformin XR.

BL = baseline.

Sources: FARXIGA [Prescribing Information]2; Henry 2012.4

MPR PRESCRIBING ALERT

d

(continued on next page)3

Please see additional Important Safety Information throughout and US Full Prescribing Information

For adults with type 2 diabetes, in addition to diet and exercise

[√] FARXIGA™ (dapagliflozin) provided significant weight reductions

[√] FARXIGA provided significant blood pressure reductionsh hSeen with certain diabetic medications.

SELECT Important Safety InformationWarnings and Precautions• Hypotension: FARXIGA causes intravascular volume contraction. Symptomatic hypotension can occur after initiating

FARXIGA, particularly in patients with impaired renal function (eGFR <60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics. Before initiating FARXIGA in patients with one or more of these characteristics, assess and correct volume status. After initiating therapy, monitor for signs and symptoms of hypotension.

MEAN WEIGHT REDUCTIONS WITH FARXIGA 5 MG + METFORMIN XR OR MONOTHERAPY AT 24 WEEKS (SECONDARY END POINT)e,f

Please see study design “Farxiga™ (dapagliflozin) 5 mg With Metformin XR Initial Combination“ on Page 6. eValues are last observation (prior to rescue for rescued patients) carried forward and represent adjusted mean change from baseline. fThe median metformin XR dose was 2000 mg per day. gP<0.0001 vs metformin XR.

BL = baseline.

Sources: FARXIGA [Prescribing Information]2; Henry 2012.4

g

• In a 24-week, active-controlled study, there was a –6.0 lb weight reduction from baseline in treatment-naïve patients with FARXIGA 5 mg plus metformin XR as initial combination therapy2,4

• FARXIGA is not indicated for weight loss

MEAN CHANGES FROM BASELINE IN SYSTOLIC BLOOD PRESSURE WITH FARXIGA 5 MG + METFORMIN RELATIVE TO PLACEBO PLUS METFORMIN AT 24 WEEKS (OTHER END POINT)i

Please see study design “Add-on to Metformin“ on Page 6. iValues are last observation (including data after rescue) carried forward. jP<0.05 vs placebo + metformin.

BL = baseline.

Sources: FARXIGA [Prescribing Information]2; Bailey 2010.5

j

j

• For the primary end point, the change from baseline in A1C at 24 weeks was –0.7% (BL=8.2%) with FARXIGA 5 mg + metformin, FARXIGA 10 mg + metformin: –0.8% (BL=7.9%), and –0.3% (BL=8.1%) for patients receiving placebo + metformin2,5

• For the other end point (relative to comparator), there was a –4.5 mmHg and –5.3 mmHg reduction in seated systolic blood pressure with FARXIGA 5 mg + metformin and FARXIGA 10 mg + metformin, respectively2,5

• FARXIGA is not indicated for the treatment of hypertension

MPR PRESCRIBING ALERT

(continued on next page)4

Please see additional Important Safety Information throughout and US Full Prescribing Information

[√] Pooled safety analysis

■ Volume depletion includes reports of dehydration, hypovolemia, orthostatic hypotension, or hypotension2

– In a pool of 12 short-term, placebo-controlled studies, these rates were 0.6% with FARXIGA 5 mg, 0.8% with FARXIGA 10 mg, and 0.4% with placebo

– In a pool of 13 short-term, placebo-controlled studies, these rates were 1.1% with FARXIGA 10 mg vs 0.7% with placebo

■ Genital mycotic infections (GMI) were reported in 5.7% of patients with FARXIGA 5 mg, 4.8% with FARXIGA 10 mg, and 0.9% with placebo, in the 12-study placebo-controlled pool2

– Discontinuation from study due to GMI occurred in 0% of placebo-treated patients and 0.2% of patients treated with FARXIGA 10 mg

– Rates of GMI were higher among patients with a history of GMI than in those without

SELECT Important Safety InformationWarnings and Precautions• Increases in Low-Density Lipoprotein Cholesterol (LDL-C): Increases in LDL-C occur with FARXIGA. After initiating

FARXIGA, monitor LDL-C and treat per standard of care.

ADVERSE REACTIONS IN 12 PLACEBO-CONTROLLED STUDIES REPORTED IN ≥2% OF PATIENTS TREATED WITH FARXIGA™ (dapagliflozin)k,l

Adverse Reaction FARXIGA 5 mg (N=1145)

FARXIGA 10 mg (N=1193)

Placebo (N=1393)

Female genital mycotic infectionsm 8.4% 6.9% 1.5%

Nasopharyngitis 6.6% 6.3% 6.2%

Urinary tract infectionsn 5.7% 4.3% 3.7%

Back pain 3.1% 4.2% 3.2%

Increased urinationo 2.9% 3.8% 1.7%

Male genital mycotic infectionsp 2.8% 2.7% 0.3%

Nausea 2.8% 2.5% 2.4%

Influenza 2.7% 2.3% 2.3%

Dyslipidemia 2.1% 2.5% 1.5%

Constipation 2.2% 1.9% 1.5%

Discomfort with urination 1.6% 2.1% 0.7%

Pain in extremity 2.0% 1.7% 1.4% kAdverse events were evaluated with FARXIGA 5 mg and 10 mg in 12 placebo-controlled studies ranging from 12 to 24 weeks. l FARXIGA was studied as monotherapy in 4 studies, and in 8 studies as add-on to background antidiabetic therapy or as combination with metformin.

m Genital mycotic infections include the following adverse reactions, listed in order of frequency reported for females: vulvovaginal mycotic infection, vaginal infection, vulvovaginal candidiasis, vulvovaginitis, genital infection, genital candidiasis, fungal genital infection, vulvitis, genitourinary tract infection, vulval abscess, and vaginitis bacterial (N for females: FARXIGA 5 mg=581, FARXIGA 10 mg=598, placebo=677).

n Urinary tract infections include the following adverse reactions, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection, and prostatitis.

o Increased urination includes the following adverse reactions, listed in order of frequency reported: pollakiuria, polyuria, and urine output increased.

p Genital mycotic infections include the following adverse reactions, listed in order of frequency reported for males: balanitis, fungal genital infection, balanitis candida, genital candidiasis, genital infection male, penile infection, balanoposthitis, balanoposthitis infective, genital infection, posthitis (N for males: FARXIGA 5 mg=564, FARXIGA 10 mg=595, placebo=716).

Source: FARXIGA [Prescribing Information].2

MPR PRESCRIBING ALERT

(continued on next page)5

Please see Important Safety Information on pages 5 and 6 and US Full Prescribing Information

MPR PRESCRIBING ALERT

[√] Rates of hypoglycemia

■ Hypersensitivity reactions (eg, angioedema, urticaria, hypersensitivity) were reported with FARXIGA treatment2

– Across the clinical program, serious anaphylactic reactions and severe cutaneous adverse reactions and angioedema were reported in 0.2% of comparator-treated patients and 0.3% of FARXIGA-treated patients

[√] FARXIGA provides convenient once-daily dosings ■ The recommended starting dose of FARXIGA is 5 mg once-daily, taken in the morning, with or without food2 ■ The dose can be increased to 10 mg for patients tolerating FARXIGA who require additional glycemic control2 sIn patients with volume depletion, correcting this condition prior to initiation of FARXIGA is recommended.

SELECT Important Safety InformationWarnings and Precautions• Bladder cancer: Across 22 clinical studies, newly diagnosed cases of bladder cancer were reported in 0.17% of FARXIGA-

treated patients and 0.03% of placebo/comparator-treated patients. After excluding patients in whom exposure to study drug was <1 year at the time of diagnosis of bladder cancer, there were 4 cases with FARXIGA and no cases with placebo/comparator. Bladder cancer risk factors and hematuria (a potential indicator of pre-existing tumors) were balanced between treatment arms at baseline. There were too few cases to determine whether the emergence of these events is related to FARXIGA.There are insufficient data to determine whether FARXIGA has an effect on pre-existing bladder tumors. FARXIGA should not be used in patients with active bladder cancer. Use with caution in patients with a prior history of bladder cancer.

INCIDENCE OF MAJORq AND MINORr HYPOGLYCEMIA IN PLACEBO-CONTROLLED STUDIES

FARXIGA 5 mg FARXIGA 10 mg Placebo

Monotherapyq (24 weeks)Major [n (%)]Minor [n (%)]

n=6400

n=7000

n=7500

Add-on to metforminq (24 weeks)Major [n (%)]Minor [n (%)]

n=1370

2 (1.5%)

n=1350

1 (0.7%)

n=13700

A ctive control add-on to metformin vs glipizide (52 weeks)Major [n (%)]Minor [n (%)]

---

n=406

07 (1.7%)

n=408

3 (0.7%)147 (36.0%)

Add-on to glimepirideq (24 weeks)Major [n (%)]Minor [n (%)]

n=1450

8 (5.5%)

n=1510

9 (6.0%)

n=1460

3 (2.1%)

Add-on to pioglitazoneq (24 weeks)Major [n (%)]Minor [n (%)]

n=1410

3 (2.1%)

n=14000

n=13900

Add-on to sitagliptin (24 weeks)Major [n (%)]Minor [n (%)]

---

n=2251 (0.4%)4 (1.8%)

n=2260

3 (1.3%)A dd-on to insulin with or without other

OADs (24 weeks)Major [n (%)]Minor [n (%)]

n=212

1 (0.5%)92 (43.4%)

n=196

1 (0.5%)79 (40.3%)

n=197

1 (0.5%)67 (34.0%)

q Major episodes of hypoglycemia were defined as symptomatic episodes requiring external (third-party) assistance due to severe impairment in consciousness or behavior with a capillary or plasma glucose value <54 mg/dL and prompt recovery after glucose or glucagon administration.

r Minor episodes of hypoglycemia were defined as either a symptomatic episode with a capillary or plasma glucose measurement <63 mg/dL, regardless of need for external assistance or an asymptomatic capillary or plasma glucose measurement <63 mg/dL that does not qualify as a major episode.

OAD = oral antidiabetic.

Source: FARXIGA [Prescribing Information].2

6

FARXIGA is a trademark of the AstraZeneca group of companies.©2014 AstraZeneca. All rights reserved.2995119 Last Updated 7/14

This MPR Prescribing Alert is produced as a basic reminder of important information for healthcare professionals. Readers are advised to consult manufacturers and specialists if questions arise about specific products, treatments, or diseases. The publisher and editors do not assume liability for any errors or omissions. MPR and MPR Prescribing Alert are registered trademarks of Haymarket Media, Inc.

© 2014 Haymarket Media, Inc.

REFERENCES 1. Gerich JE. Role of the kidney in normal glucose homeostasis and in the hyperglycemia of diabetes mellitus: therapeutic implications. Diabet Med. 2010;27(2):136-142. 2. FARXIGA [Prescribing Information]. Princeton, NJ: Bristol-Myers Squibb Company; January 2014. 3. Bailey CJ, Day C. SGLT2 inhibitors: glucuretic treatment for type 2 diabetes. Br J Diabetes Vasc Dis. 2010;10(4):193–199. 4. Henry RR, Murray AV, Marmolejo MH, et al. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomized controlled trial. Int J Clin Pract. 2012;66(5):446-456. 5. Bailey CJ, Gross JL, Pieters A, et al. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375(9733):2223-2233.

Study designsFarxiga™ (dapagliflozin) 5 mg With Metformin XR Initial CombinationA 24-week, phase 3, multicenter, randomized, double-blind, parallel-group clinical study to evaluate the efficacy and safety of FARXIGA in combination with metformin XR in treatment-naïve adults (18-77 years) with type 2 diabetes who had inadequate glycemic control (A1C ≥7.5 and ≤12.0%). A total of 603 adult patients in the 5 mg study were randomized to 1 of 3 treatment groups: FARXIGA 5 mg + metformin XR, FARXIGA 5 mg + placebo, or metformin XR + placebo. The metformin XR dose was up-titrated weekly in 500 mg increments, as tolerated, up to a maximum of 2000 mg daily. Patients had a C-peptide ≥0.33 nmol/L and a body mass index ≤45 kg/m2. The primary end point of the study was change in A1C from baseline at Week 24. Values are last observation carried forward and represent adjusted mean change from baseline. Mean metformin XR dose was 1773.5 mg in the combination group and 1843.6 mg for the metformin XR monotherapy group.2,4

Add-on to MetforminA 24-week, phase 3, randomized double-blind, placebo-controlled, multicenter trial to evaluate the efficacy and safety of FARXIGA in adult patients with type 2 diabetes who have inadequate glycemic control (A1C ≥7.0% and ≤10.0%) with metformin. Patients had a body mass index of ≤45 kg/m2. Patients with systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg were excluded. A total of 546 patients on a metformin dose ≥1500 mg/day were randomized to dapagliflozin 2.5 mg,t FARXIGA 5 mg, FARXIGA 10 mg, or placebo. The primary end point of the study was change in A1C from baseline at Week 24.2,5

tDapagliflozin 2.5 mg is not an FDA-approved dose.

SELECT Important Safety InformationWarnings and Precautions• Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction

with FARXIGA or any other antidiabetic drug.

Adverse Reactions• In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg,

and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).

Use in Specific Populations• Pregnant Women: There are no adequate and well-controlled studies of FARXIGA in pregnant women. Consider appropriate

alternative therapies, especially during the second and third trimesters.• Nursing Mothers: It is not known whether FARXIGA is excreted in human milk. Because of the potential for serious adverse

reactions in nursing infants from FARXIGA, discontinue nursing or discontinue FARXIGA.• Geriatric Use: A higher proportion of patients ≥65 years treated with FARXIGA had adverse reactions related to volume

depletion and renal impairment or failure compared to patients treated with placebo. No FARXIGA dose change is recommended based on age.

Please see US Full Prescribing Information.

MPR PRESCRIBING ALERT