Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS LABA use may result in the following: Serious asthma-related events – hospitalizations, intubations, and death [see Warnings and Precautions (5.1) ] .
Cardiovascular and central nervous system effects [see Warnings and Precautions (5.11) ].
Systemic and local corticosteroid use may result in the following: Candida albicans infection [see Warnings and Precautions (5.4) ] Immunosuppression [see Warnings and Precautions (5.5) ] Hypercorticism and adrenal suppression [see Warnings and Precautions (5.7) ] Growth effects in pediatrics [see Warnings and Precautions (5.13) ] Glaucoma and cataracts [see Warnings and Precautions (5.14) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Most common adverse reactions (reported in ≥3% in any treatment arm and greater than placebo) included: Nasopharyngitis, sinusitis and headache.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Adult and Adolescent Patients Aged 12 Years and Older The safety data described below is based on 3 clinical trials which randomized 1913 patients 12 years of age and older with asthma, including 679 patients exposed to DULERA for 12 to 26 weeks and 271 patients exposed for 1 year.
DULERA was studied in two placebo- and active-controlled trials (n=781 and n=728, respectively) and in a long-term 52-week safety trial (n=404).
In the 12 to 26-week clinical trials, the population was 12 to 84 years of age, 41% male and 59% female, 73% Caucasian, 27% non-Caucasian.
Patients received two inhalations twice daily of DULERA (100 mcg/5 mcg or 200 mcg/5 mcg), mometasone furoate MDI (100 mcg or 200 mcg), formoterol MDI (5 mcg) or placebo.
In the long-term 52-week active-comparator safety trial, the population was 12 years to 75 years of age with asthma, 37% male and 63% female, 47% Caucasian, 53% non-Caucasian and received two inhalations twice daily of DULERA 100 mcg/5 mcg or 200 mcg/5 mcg, or an active comparator.
5 WARNINGS AND PRECAUTIONS LABA monotherapy increases the risk of serious asthma-related events.
( 5.1 ) Deterioration of disease and acute episodes: Do not initiate in acutely deteriorating asthma or to treat acute symptoms.
( 5.2 ) Use with additional long-acting beta 2 -agonist: Do not use in combination because of risk of overdose.
( 5.3 ) Localized infections: Candida albicans infection of the mouth and throat may occur.
Monitor patients periodically for signs of adverse effects on the oral cavity.
Like all medications, Dulera can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: