The #approval of AirDuo Digihaler is based on the review of the supplemental new drug application (sNDA) submitted by Teva to the #FDA. AirDuo Digihaler combines a breath-actuated, multi-dose dry powder inhaler with fluticasone propionate, an inhaled corticosteroid (ICS) medicine that may help to decrease inflammation in the lungs, which can lead to breathing problems, and salmeterol, a long acting beta2 adrenergic agonist (LABA), which helps the muscles around the airways in the lungs stay relaxed in order to prevent symptoms. AirDuo Digihaler contains salmeterol. LABA medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. AirDuo Digihaler contains an ICS and a LABA. When an ICS and a LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
AirDuo Digihaler was approved in a low, medium and high dose: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily. As a fixed dose combination asthma therapy containing an ICS and a LABA, AirDuo Digihaler contains the same active ingredients as Advair Diskus, which is also approved in low, medium and high doses: 100/50 mcg, 250/50 mcg and 500/50 mcg.
AIRDUO® DIGIHALER™ APPROVED USES
AirDuo Digihaler is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in people 12 years of age and older. AirDuo Digihaler is not used to relieve sudden breathing problems from asthma and won’t replace a rescue inhaler.
AirDuo Digihaler contains a built-in electronic module that records and stores information about inhaler events. AirDuo Digihaler may be used with, and transmits information to, a mobile App.
AirDuo Digihaler does not need to be connected to the app in order for you to take your medicine.
AIRDUO® DIGIHALER™ IMPORTANT SAFETY INFORMATION
AirDuo Digihaler contains salmeterol. Long-acting beta2-agonist (LABA) medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. AirDuo Digihaler contains an inhaled corticosteroid (ICS) and a LABA. When an ICS and a LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
Do not use AirDuo Digihaler to treat sudden breathing problems from asthma. Always have a rescue inhaler with you to treat sudden symptoms.
Do not use AirDuo Digihaler if you have a severe allergy to milk proteins or if you are allergic to any of the ingredients in the product. Ask your healthcare provider if you are not sure.
Do not take AirDuo Digihaler with other medicines that contain a LABA for any reason.
Tell your healthcare provider about all the medicines you take and about all of your health conditions.
AirDuo Digihaler can cause serious side effects, including:
Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using AirDuo Digihaler to help reduce your chance of getting thrush.
Weakened immune system and increased chance of getting infections (immunosuppression).You should avoid exposure to chickenpox and measles, and, if exposed, tell your healthcare provider right away. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye (ocular herpes simplex) may occur.
Reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as AirDuo Digihaler). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:feeling tiredlack of energyweaknessnausea and vomitinglow blood pressure
Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using AirDuo Digihaler and call your healthcare provider right away.
Serious allergic reactions. Stop using AirDuo Digihaler and call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:rashhivesswelling of your face, mouth, and tonguebreathing problems
Effects on heartincreased blood pressurea fast or irregular heartbeatchest pain
Effects on nervous system tremornervousness
Bone thinning or weakness (osteoporosis)Slowed growth in children. A child’s growth should be checked often.
Eye problems including glaucoma and cataracts. You should have regular eye exams while using AirDuo Digihaler. Changes in laboratory blood values (sugar, potassium, certain types of white blood cells)
Common side effects of AirDuo Digihaler include:
Infection of nose and throat (nasopharyngitis)
thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
These are not all the possible side effects of AirDuo Digihaler.