• SYMBICORT for asthma patients ≥12 years of age uncontrolled on an ICS

THE SPEED THEY WANT

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms.

See Asthma Safety Profile in asthma patients 12 years and older.

SYMBICORT for asthma patients ≥12 years of age uncontrolled on an ICS

BETTER BREATHING—FAST1-3

The majority of patients’ FEV1 improvement occurred at 15 minutes in ASTHMA1-3

In patients ≥12 years of age with asthma taking SYMBICORT 160/4.5* (n=124) in Study 1, 79% of 2-hour postdose FEV1 improvement occurred at 15 minutes on day of randomization, 89% at week 2, and 90% at end of treatment1-3

Sustained improvement in lung function was demonstrated in asthma patients ≥12 years of age in a 12-week efficacy and safety study1,2

*Administered as 2 inhalations twice daily.

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms

The most common adverse reactions ≥3% reported in asthma clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis.

STUDY DESIGN & COMPARATOR ARMS

Study 1: A 12-week, double-blind, placebo-controlled study comparing SYMBICORT 160/4.5 mcg, budesonide 160 mcg, formoterol 4.5 mcg, the free combination of budesonide 160 mcg plus formoterol 4.5 mcg in separate inhalers, and placebo, each administered as 2 inhalations twice daily. A total of 596 patients (124 randomized to receive SYMBICORT) ≥12 years of age were evaluated. The study included a 2-week run-in period with budesonide 80 mcg, 2 inhalations twice daily. Most patients had moderate to severe asthma and were using moderate to high doses of inhaled corticosteroids (ICSs) prior to study entry. This study was designed to assess 2 primary endpoints. The first was predose FEV1 averaged over 12 weeks, and the second was 12-hour average postdose FEV1 at Week 2. Secondary efficacy variables included daytime and nighttime asthma symptom scores and daily rescue medication use (both recorded by patients in the electronic diary).

COMPARATOR ARMS

Mean change in 2-hour postdose FEV1 (mL/%) over 12 weeks:

Day of randomization

SYMBICORT 160/4.5 mcg: 420 mL/20.0%

Budesonide 160 mcg: 100 mL/4.4%

Formoterol 4.5 mcg: 420 mL/19.9%

Budesonide 160 mcg + formoterol 4.5 mcg: 410 mL/19.4%

Placebo: 90 mL/4.4%

2 weeks

SYMBICORT 160/4.5 mcg: 380 mL/18.6%

Budesonide 160 mcg: 120 mL/5.6%

Formoterol 4.5 mcg: 270 mL/12.8%

Budesonide 160 mcg + formoterol 4.5 mcg: 370 mL/18.0%

Placebo: 10 mL/1.2%

End of treatment

SYMBICORT 160/4.5 mcg: 420 mL/20.2%

Budesonide 160 mcg: 140 mL/6.5%

Formoterol 4.5 mcg: 260 mL/12.3%

Budesonide 160 mcg + formoterol 4.5 mcg: 410 mL/19.5%

Placebo: -10 mL/0.4%

THE CONTROL THEY NEED

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms.

See Asthma Safety Profile.

SYMBICORT for asthma patients ≥12 years of age uncontrolled on an ICS

ALL-DAY SYMPTOM CONTROL

Dosed morning and evening for all-day symptom control4

Mean reduction in asthma symptom scores from
baseline over 12 weeks when dosed twice daily4

Mean reduction in asthma symptom scores from baseline over 12 weeks

Daytime asthma symptom scores were recorded daily in the evening, and nighttime symptom scores for the previous night were recorded upon arising each morning.

  • 2x the reduction vs ICS: Absolute mean reduction in daytime symptom scores was 0.34 for SYMBICORT vs 0.17 for budesonide. Absolute mean reduction in nighttime symptom scores was 0.26 for SYMBICORT vs 0.11 for budesonide4
  • The primary comparison for these secondary endpoints was SYMBICORT vs placebo (P<.001)4

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms

*Administered as 2 inhalations twice daily.

Baseline is defined as the mean of all values obtained during the run-in period.

P values shown within the graphic were based on treatment comparison of absolute mean change from baseline for SYMBICORT vs budesonide.

§Mean percent reductions in daytime and nighttime symptom scores for budesonide were 15% and 12%, respectively.

STUDY DESIGN & COMPARATOR ARMS

Study 1: A 12-week, double-blind, placebo-controlled study comparing SYMBICORT 160/4.5 mcg, budesonide 160 mcg, formoterol 4.5 mcg, the free combination of budesonide 160 mcg plus formoterol 4.5 mcg in separate inhalers, and placebo, each administered as 2 inhalations twice daily. A total of 596 patients (124 randomized to receive SYMBICORT) ≥12 years of age were evaluated. The study included a 2-week run-in period with budesonide 80 mcg, 2 inhalations twice daily. Most patients had moderate to severe asthma and were using moderate to high doses of inhaled corticosteroids (ICSs) prior to study entry. This study was designed to assess 2 primary endpoints. The first was predose FEV1 averaged over 12 weeks, and the second was 12-hour average postdose FEV1 at Week 2. Secondary efficacy variables included daytime and nighttime asthma symptom scores and daily rescue medication use (both recorded by patients in the electronic diary).

COMPARATOR ARMS

Mean change in asthma symptom score over 12 weeks (%):

Daytime asthma symptom score*

SYMBICORT 160/4.5 mcg: -33% (n=121)

Budesonide 160 mcg: -15% (n=109)

Formoterol 4.5 mcg: -9% (n=119)

Budesonide 160 mcg + formoterol 4.5 mcg: -31% (n=112)

Placebo: 6% (n=123)

Nighttime asthma symptom score*

SYMBICORT 160/4.5 mcg: -28% (n=121)

Budesonide 160 mcg: -12% (n=109)

Formoterol 4.5 mcg: -10% (n=118)

Budesonide 160 mcg + formoterol 4.5 mcg: -31% (n=113)

Placebo: 11% (n=124)

Symptom scoring

Daytime asthma symptom scores were recorded daily in the evening, and nighttime symptom scores for the previous night were recorded upon arising each morning.

Symptom scores were rated on a scale of 0 to 3:

0 = None; no symptoms of asthma

1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated

2 = Moderate symptoms; asthma symptoms with some discomfort, causing some interference with daily activities or sleep

3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep

*Administered as 2 inhalations twice daily.

SYMBICORT for asthma patients ≥12 years of age uncontrolled on an ICS

SUSTAINED EFFECT OVER 12 WEEKS1,2

Change in 2-hour postdose FEV1 over the 12 week study of asthma patients

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms

Study 1: A 12-week efficacy and safety study of patients with moderate to severe asthma

  • SYMBICORT 160/4.5 significantly improved predose FEV1 (P<.05 vs budesonide, formoterol, and placebo) averaged over the course of the study, and also improved 12-hour average postdose FEV1 (P<.001 vs budesonide, formoterol, and placebo at week 2), coprimary endpoints1; 2-hour postdose FEV1 over 12 weeks was a secondary endpoint2

*Administered as 2 inhalations twice daily.

||Week 12, last observation carried forward.

Baseline is defined as the predose FEV1 value on day of randomization.

#Unadjusted P values based on treatment comparison of absolute mean change from baseline for SYMBICORT vs budesonide and placebo.

STUDY DESIGN & COMPARATOR ARMS

Study 1: A 12-week, double-blind, placebo-controlled study comparing SYMBICORT 160/4.5 mcg, budesonide 160 mcg, formoterol 4.5 mcg, the free combination of budesonide 160 mcg plus formoterol 4.5 mcg in separate inhalers, and placebo, each administered as 2 inhalations twice daily. A total of 596 patients (124 randomized to receive SYMBICORT) ≥12 years of age were evaluated. The study included a 2-week run-in period with budesonide 80 mcg, 2 inhalations twice daily. Most patients had moderate to severe asthma and were using moderate to high doses of inhaled corticosteroids (ICSs) prior to study entry. This study was designed to assess 2 primary endpoints. The first was predose FEV1 averaged over 12 weeks, and the second was 12-hour average postdose FEV1 at Week 2. Secondary efficacy variables included daytime and nighttime asthma symptom scores and daily rescue medication use (both recorded by patients in the electronic diary).

COMPARATOR ARMS

Mean change from baseline in 2-hour postdose FEV1 (mL/%) over 12 weeks:

Day of randomization

SYMBICORT 160/4.5 mcg: 420 mL/20.0%

Budesonide 160 mcg: 100 mL/4.4%

Formoterol 4.5 mcg: 420 mL/19.9%

Budesonide 160 mcg + formoterol 4.5 mcg: 410 mL/19.4%

Placebo: 90 mL/4.4%

2 weeks

SYMBICORT 160/4.5 mcg: 380 mL/18.6%

Budesonide 160 mcg: 120 mL/5.6%

Formoterol 4.5 mcg: 270 mL/12.8%

Budesonide 160 mcg + formoterol 4.5 mcg: 370 mL/18.0%

Placebo: 10 mL/1.2%

End of treatment

SYMBICORT 160/4.5 mcg: 420 mL/20.2%

Budesonide 160 mcg: 140 mL/6.5%

Formoterol 4.5 mcg: 260 mL/12.3%

Budesonide 160 mcg + formoterol 4.5 mcg: 410 mL/19.5%

Placebo: -10 mL/0.4%

*Administered as 2 inhalations twice daily.

SYMBICORT for asthma patients ≥12 years of age uncontrolled on an ICS

Reduced rescue medication use by more than 50%5

Change from baseline in albuterol use over 12 weeks

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms

Study 1: A 12-week efficacy and safety study of patients with moderate to severe asthma

  • The primary comparison for this secondary endpoint was SYMBICORT vs placebo (P<.001)5**

*Administered as 2 inhalations twice daily.

Baseline is defined as the mean of all values obtained during the run-in period.

**P values based on treatment comparison of absolute mean change from baseline for SYMBICORT vs budesonide and placebo.

††Treatment Average (Trt Avg) is defined as the mean of all values obtained during the double-blind treatment period in puffs/day.

STUDY DESIGN & COMPARATOR ARMS

Study 1: A 12-week, double-blind, placebo-controlled study comparing SYMBICORT 160/4.5 mcg, budesonide 160 mcg, formoterol 4.5 mcg, the free combination of budesonide 160 mcg plus formoterol 4.5 mcg in separate inhalers, and placebo, each administered as 2 inhalations twice daily. A total of 596 patients (124 randomized to receive SYMBICORT) ≥12 years of age were evaluated. The study included a 2-week run-in period with budesonide 80 mcg, 2 inhalations twice daily. Most patients had moderate to severe asthma and were using moderate to high doses of inhaled corticosteroids (ICSs) prior to study entry. This study was designed to assess 2 primary endpoints. The first was predose FEV1 averaged over 12 weeks, and the second was 12-hour average postdose FEV1 at Week 2. Secondary efficacy variables included daytime and nighttime asthma symptom scores and daily rescue medication use (both recorded by patients in the electronic diary).

COMPARATOR ARMS

Mean change from baseline in albuterol use over 12 weeks*

SYMBICORT 160/4.5 mcg: -57% (n=121)

Budesonide 160 mcg: -19% (n=109)

Formoterol 4.5 mcg: -22% (n=119)

Budesonide 160 mcg + formoterol 4.5 mcg: -67% (n=113)

Placebo: 29% (n=124)

*Administered as 2 inhalations twice daily.

SYMBICORT for asthma patients ≥12 years of age uncontrolled on an ICS

Significantly reduced nighttime awakenings1,3,6,7

Reduction in percentage of nights with awakenings from asthma over 12 weeks.

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms

Studies 1 and 2: 12-week efficacy and safety studies of patients with moderate to severe asthma (Study 1) and mild to moderate asthma (Study 2)

  • Percentage of awakening-free nights was a secondary efficacy endpoint in these studies1,6,7
  • SYMBICORT 80/4.5 mcg significantly improved predose FEV1 (P≤.027 vs budesonide, formoterol, and placebo) averaged over the course of the study, and also improved 12-hour average postdose FEV1 (P<.001 vs budesonide, formoterol, and placebo at week 2) (Study 2 coprimary endpoints)6
  • SYMBICORT 160/4.5 mcg significantly improved predose FEV1 (P<.05 vs budesonide, formoterol, and placebo) averaged over the course of the study, and also improved 12-hour average postdose FEV1 (P<.001 vs budesonide, formoterol, and placebo at week 2) (Study 1 coprimary endpoints)

*Administered as 2 inhalations twice daily.

Baseline is defined as the mean of all values obtained during the run-in period.

‡‡P values based on treatment comparison of absolute mean change from baseline for SYMBICORT vs placebo.

STUDY DESIGNS

Study 1: A 12-week, double-blind, placebo-controlled study comparing SYMBICORT 160/4.5 mcg, budesonide 160 mcg, formoterol 4.5 mcg, the free combination of budesonide 160 mcg plus formoterol 4.5 mcg in separate inhalers, and placebo, each administered as 2 inhalations twice daily. A total of 596 patients (124 randomized to receive SYMBICORT) ≥12 years of age were evaluated. The study included a 2-week run-in period with budesonide 80 mcg, 2 inhalations twice daily. Most patients had moderate to severe asthma and were using moderate to high doses of inhaled corticosteroids (ICSs) prior to study entry. This study was designed to assess 2 primary endpoints. The first was predose FEV1 averaged over 12 weeks, and the second was 12-hour average postdose FEV1 at Week 2. Secondary efficacy variables included daytime and nighttime asthma symptom scores and daily rescue medication use (both recorded by patients in the electronic diary).

Study 2: A 12-week, randomized, multicenter, double-blind, double-dummy, placebo-controlled study comparing SYMBICORT 80/4.5 mcg, budesonide 80 mcg, formoterol 4.5 mcg, each administered as 2 inhalations twice daily. A total of 480 patients (123 randomized to receive SYMBICORT) ≥12 years of age were evaluated. The study included a 2-week run-in period with placebo and rescue albuterol therapy. Most patients had mild to moderate persistent asthma and were using low to moderate doses of ICS either alone or as part of combination therapy prior to study entry. This study was designed to assess 2 primary endpoints. The first was predose FEV1 averaged over 12 weeks, and the second was 12-hour average postdose FEV1 at Week 2. Secondary efficacy variables included daytime and nighttime asthma symptom scores and daily rescue medication use (both recorded by patients in the electronic diary).

SAFETY PROFILE FOR SYMBICORT IN ASTHMA

SYMBICORT for asthma patients ≥12 years of age uncontrolled on an ICS

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms.

Adverse reactions in asthma clinical studies in patients aged 12 years and older3§§||||

Adverse reactions occurring at an incidence of ≥3% and more commonly than placebo in the SYMBICORT group

SYMBICORT 80/4.5SYMBICORT 160/4.5

Adverse reactions in asthma clinical studies in patients 12 years and older taking SYMBICORT 80/4.5 mcg Adverse reactions in asthma clinical studies in patients 12 years and older taking SYMBICORT 80/4.5 mcg
Adverse reactions in asthma clinical studies in patients 12 years and older taking SYMBICORT 160/4.5 mcg Adverse reactions in asthma clinical studies in patients 12 years and older taking SYMBICORT 160/4.5 mcg

§§All treatments were administered as 2 inhalations twice daily.

||||The incidence of adverse reactions in this table is based upon pooled data from three 12-week, double-blind, placebo-controlled US asthma clinical trials in patients aged 12 years and older.

IMPORTANT SAFETY INFORMATION

  • Use of long-acting beta2-adrenergic agonists (LABA) as monotherapy (without inhaled corticosteroids [ICS]) for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA. When LABA are used in fixed dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to ICS alone
  • SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms
  • SYMBICORT should not be initiated in patients during rapidly deteriorating episodes of asthma or COPD
  • Patients who are receiving SYMBICORT should not use additional formoterol or other LABA for any reason
  • Localized infections of the mouth and pharynx with Candida albicans has occurred in patients treated with SYMBICORT. Patients should rinse the mouth after inhalation of SYMBICORT
  • Lower respiratory tract infections, including pneumonia, have been reported following the administration of ICS
  • Due to possible immunosuppression, potential worsening of infections could occur. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients
  • It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. Particular care is needed for patients who are transferred from systemically active corticosteroids to ICS. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available ICS
  • Caution should be exercised when considering administration of SYMBICORT in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors
  • As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT
  • Immediate hypersensitivity reactions may occur, as demonstrated by cases of urticaria, angioedema, rash, and bronchospasm
  • Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. SYMBICORT should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
  • Long-term use of ICS may result in a decrease in bone mineral density (BMD). Since patients with COPD often have multiple risk factors for reduced BMD, assessment of BMD is recommended prior to initiating SYMBICORT and periodically thereafter
  • ICS may result in a reduction in growth velocity when administered to pediatric patients
  • Glaucoma, increased intraocular pressure, and cataracts have been reported following the administration of ICS, including budesonide, a component of SYMBICORT. Close monitoring is warranted in patients with a change in vision or history of increased intraocular pressure, glaucoma, or cataracts
  • In rare cases, patients on ICS may present with systemic eosinophilic conditions
  • SYMBICORT should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines
  • Beta-adrenergic agonist medications may produce hypokalemia and hyperglycemia in some patients
  • The most common adverse reactions ≥3% reported in asthma clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, pharyngitis, rhinitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis
  • The most common adverse reactions ≥3% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection
  • SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents
  • Beta-blockers may not only block the pulmonary effect of beta-agonists, such as formoterol, but may produce severe bronchospasm in patients with asthma
  • ECG changes and/or hypokalemia associated with nonpotassium-sparing diuretics may worsen with concomitant beta-agonists. Use caution with the coadministration of SYMBICORT

INDICATIONS

  • SYMBICORT is indicated for the treatment of asthma in patients 6 years and older not adequately controlled on a long-term asthma-control medication such as an ICS or whose disease warrants initiation of treatment with both an ICS and LABA (also see DOSAGE AND ADMINISTRATION).
  • SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and to reduce COPD exacerbations.
  • SYMBICORT is NOT indicated for the relief of acute bronchospasm.

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