• SYMBICORT for asthma patients 6 to <12 years of age uncontrolled on an ICS

  • Majority of patients’ FEV1* improvement occurred at 15 minutes1,2

*1-hour postdose FEV1.

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

  • Significant improvement in FEV1 at 12 weeks2,3 

BETTER BREATHING—FAST1-3

The majority of patients’ FEV1 improvement occurred at 15 minutes 1,2

In pediatric patients taking SYMBICORT 80/4.5 (n=90) in CHASE 3, 74% of 1-hour postdose FEV1 improvement occurred at 15 minutes on day of randomization and 86% at Week 122

Significant improvement in lung function was demonstrated in a 12-week efficacy and safety study of pediatric patients with asthma 6 to <12 years of age1,3

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 CHASE 3 in pediatric patients with asthma treated with SYMBICORT 80/4.5 included upper respiratory tract infection, pharyngitis, headache, and rhinitis.

THE CONTROL THEY NEED

Significant improvement in FEV1 at 12 weeks1,2

Change from baseline in 1-hour postdose FEV1 over 12 weeks3

Data from an efficacy and safety study of pediatric asthma patients 6 to <12 years of age

  • SYMBICORT 80/4.5 significantly improved 1-hour postdose FEV1 vs budesonide at Week 12 (primary endpoint)1,2

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 predose FEV1 value on day of randomization (Week 0).1

STUDY DESIGN: CHASE 3

CHASE 3: A 12-week, randomized, double-blind, multicenter study of 184 pediatric patients 6 to less than 12 years of age with a documented clinical diagnosis of asthma and on daily medium-dose range ICS or fixed combination of ICS and LABA therapy compared SYMBICORT pMDI 80/4.5 mcg (n=92) with budesonide pMDI 80 mcg (n=92), each administered as 2 inhalations twice daily. The study included a 2- to 4-week run-in period with a low-dose ICS followed by a 12-week treatment period. This study was designed to assess change from baseline to Week 12 in 1-hour postdose FEV1 (primary endpoint). Secondary efficacy variables included predose and 1-hour postdose PEF, predose and 15-minute postdose FEV1, nighttime awakenings, rescue albuterol use, and Pediatric Asthma Quality of Life Questionnaire scores.

SYMBICORT 80/4.5 FOR PEDIATRIC ASTHMA PATIENTS 6 to <12 YEARS

DOSING AND ADMINISTRATION

FOR PEDIATRIC PATIENTS 6 TO LESS THAN 12 YEARS OF AGE3
80/4.5 mcg 2 inhalations BID||

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

  • 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. Beta-adrenergic agonist medications may produce hypokalemia and hyperglycemia in some patients. As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT. Use with caution in patients with diabetes mellitus
  • Do not use any additional long-acting beta2-agonists with SYMBICORT for any reason
  • Do not use SYMBICORT for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids
  • For patients 6 to less than 12 years of age the dosage is 2 inhalations of SYMBICORT 80/4.5 twice daily. Do not use more than twice daily or use a higher number of inhalations (more than two inhalations twice daily) of the prescribed strength of SYMBICORT as this will result in a daily dose of formoterol in excess of the dose determined to be safe

THE ONLY ICS/LABA IN A pMDI WITH EFFICACY DATA APPROVED FOR PEDIATRIC PATIENTS AS YOUNG AS 6 YEARS3,4#

    pMDI¶**

  • Lower inspiratory flow requirement than a DPI6††
  • Can be used with or without a spacer7

||Administered in the morning and evening.

Pressurized metered-dose inhaler.

#Improvement in lung function was demonstrated in 12-week efficacy and safety study.3

**The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system.

††Dry powder inhaler

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.

Please see full Prescribing Information , including Patient Information.

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