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A TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS, IN ADDITION TO DIET AND EXERCISE

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5

IMPORTANT FACTS ABOUT FARXIGA

1

 

ADD-ON TO DIET AND EXERCISE

When your adult patient’s diet or exercise plan isn’t enough, FARXIGA is indicated as an adjunct to improve glycemic control in adult patients with type 2 diabetes mellitus.

 

2

 

NOT INDICATED FOR TYPE 1 DIABETES OR DKA

NOT INDICATED FOR TYPE 1 DIABETES OR DIABETIC KETOACIDOSIS (DKA)

DIABETIC KETOACIDOSIS (DKA)

FARXIGA is not recommended to treat patients with type 1 diabetes or for the treatment of DKA.

 

3

 

RENAL ASSESSMENT RECOMMENDED

Assessment of renal function is recommended prior to initiation of FARXIGA therapy and periodically thereafter. FARXIGA is not recommended in patients with an eGFR persistently between 30 and <60 mL/min/1.73 m2. FARXIGA is contraindicated in patients with an eGFR <30 mL/min/1.73 m2

 

4

 

NOT APPROPRIATE FOR EVERY PATIENT

FARXIGA is contraindicated in patients with a history of a serious hypersensitivity to FARXIGA and patients with severe renal impairment, end-stage renal disease, or patients on dialysis.

 

5

 

IT’S IMPORTANT TO MONITOR VOLUME STATUS

Your patient’s volume status should be assessed and corrected before starting FARXIGA. After initiating therapy, monitor for signs and symptoms of hypotension.

 

  1. ADD-ON TO DIET AND EXERCISE—When your adult patient’s diet or exercise plan isn’t enough, FARXIGA is indicated as an adjunct to improve glycemic control in adult patients with type 2 diabetes mellitus.
  2. NOT INDICATED FOR TYPE 1 DIABETES OR DIABETIC KETOACIDOSIS (DKA)—FARXIGA is not recommended to treat patients with type 1 diabetes or for the treatment of DKA.
  3. RENAL ASSESSMENT RECOMMENDEDAssessment of renal function is recommended prior to initiation of FARXIGA therapy and periodically thereafter. FARXIGA is not recommended in patients with an eGFR persistently between 30 and <60 mL/min/1.73 m2. FARXIGA is contraindicated in patients with an eGFR <30 mL/min/1.73 m2
  4. NOT APPROPRIATE FOR EVERY PATIENT—FARXIGA is contraindicated in patients with a history of a serious hypersensitivity to FARXIGA and patients with severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis.
  5. IT’S IMPORTANT TO MONITOR VOLUME STATUS—Your patient’s volume status should be assessed and corrected before starting FARXIGA. After initiating therapy, monitor for signs and symptoms of hypotension.

 

Pooled Safety Analysis

ADVERSE REACTIONS IN 12 PLACEBO-CONTROLLED STUDIES

REPORTED IN ≥2% OF PATIENTS TREATED WITH FARXIGA1,a,b

  FARXIGA 5 mg FARXIGA 10 mg Placebo
Female genital mycotic infectionsc 8.4% 6.9% 1.5%
Nasopharyngitis 6.6% 6.3% 6.2%
Urinary tract infectionsd 5.7% 4.3% 3.7%
Back pain 3.1% 4.2% 3.2%
Increased urinatione 2.9% 3.8% 1.7%
Male genital mycotic infectionsf 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%
  (N=1145) (N=1193) (N=1393)

aAdverse events were evaluated with FARXIGA 5 mg and 10 mg in 12 placebo-controlled studies ranging from 12 to 24 weeks.

bFARXIGA was studied as monotherapy in 4 studies, and in 8 studies as add-on to background antidiabetic therapy or as combination with metformin.

cGenital 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).

dUrinary 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.

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

fGenital 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).

Volume depletion1

  • Volume depletion includes reports of dehydration, hypovolemia, orthostatic hypotension, or hypotension.
  • 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 infections1

  • Genital mycotic infections (GMIs) 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 pool.
  • 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.

 

Rates of Hypoglycemia

INCIDENCE OF MAJORg AND MINORh HYPOGLYCEMIA

IN PLACEBO-CONTROLLED STUDIES1

Monotherapyg (24 weeks)
  Major [n (%)] Minor [n (%)]
FARXIGA 5 mg(N=64) 0 0
FARXIGA 10 mg (N=70) 0 0
Placebo/Active Control(N=75) 0 0
Add-on to metforming (24 weeks)
  Major [n (%)] Minor [n (%)]
FARXIGA 5 mg(N=137) 0 2 (1.5%)
FARXIGA 10 mg (N=135) 0 1 (0.7%)
Placebo/Active Control(N=137) 0 0
Active control add-on to metformin vs glipizide (52 weeks)
  Major [n (%)] Minor [n (%)]
FARXIGA 5 mg -
-
-
FARXIGA 10 mg (N=406) 0
7 (1.7%)
Placebo/Active Control(N=408) 3 (0.7%)
147 (36.0%)
Add-on to glimepirideg (24 weeks)
  Major [n (%)] Minor [n (%)]
FARXIGA 5 mg (N=145)
0
8 (5.5%)
FARXIGA 10 mg (N=151) 0
9 (6.0%)
Placebo/Active Control(N=146) 0
3 (2.1%)
Add-on to pioglitazoneg (24 weeks)
  Major [n (%)] Minor [n (%)]
FARXIGA 5 mg (N=141)
0
3 (2.1%)
FARXIGA 10 mg (N=140) 0
0
Placebo/Active Control(N=139) 0
0
Add-on to DPP-4 inhibitor (24 weeks)
  Major [n (%)] Minor [n (%)]
FARXIGA 5 mg -
-
-
FARXIGA 10 mg (N=225) 1 (0.4%)
4 (1.8%)
Placebo/Active Control(N=226) 0
3 (1.3%)
Add-on to insulin with or without other OADs (24 weeks)
  Major [n (%)] Minor [n (%)]
FARXIGA 5 mg (N=212)
1 (0.5%)
92 (43.4%)
FARXIGA 10 mg (N=196) 1 (0.5%)
79 (40.3%)
Placebo/Active Control(N=197) 1 (0.5%)
67 (34.0%)
 

FARXIGA 5 mg

FARXIGA 10 mg

Placebo/Active Control

Monotherapyg (24 weeks)

Major [n (%)]

Minor [n (%)]

N=64

0

0

N=70

0

0

N=75

0

0

Add-on to metforming (24 weeks)

Major [n (%)]

Minor [n (%)]

N=137

0

2 (1.5%)

N=135

0

1 (0.7%)

N=137

0

0

Active control add-on to metformin vs glipizide (52 weeks)

Major [n (%)]

Minor [n (%)]

-

-

-

N=406

0

7 (1.7%)

N=408

3 (0.7%)

147 (36.0%)

Add-on to glimepirideg (24 weeks)

Major [n (%)]

Minor [n (%)]

N=145

0

8 (5.5%)

N=151

0

9 (6.0%)

N=146

0

3 (2.1%)

Add-on to pioglitazoneg (24 weeks)

Major [n (%)]

Minor [n (%)]

N=141

0

3 (2.1%)

N=140

0

0

N=139

0

0

Add-on to DPP-4 inhibitor (24 weeks)

Major [n (%)]

Minor [n (%)]

-

-

-

N=225

1 (0.4%)

4 (1.8%)

N=226

0

3 (1.3%)

Add-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%)

OAD=oral antidiabetic therapy.

gMajor 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.

hMinor 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.

Hypersensitivity reactions1

  • Hypersensitivity reactions (eg, angioedema, urticaria, hypersensitivity) were reported with FARXIGA treatment.
  • 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.

Hypoglycemia: FARXIGA can increase the risk of hypoglycemia when coadministered with insulin and insulin secretagogues. Consider lowering the dose of these agents when coadministered with FARXIGA.