FDA approves ProAir Digihaler (albuterol sulfate) as the first and only digital inhaler with built-in sensors
drugs.com
Teva Pharmaceutical Industries Ltd. announced recently that the U.S. Food and Drug Administration (FDA) has approved ProAir Digihaler (albuterol sulfate 117 mcg) inhalation powder, the first and only digital inhaler with built-in sensors which connects to a companion mobile application and provides inhaler use information to people with asthma and COPD. ProAir Digihaler is indicated for the treatment or prevention of bronchospasm in patients aged four years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB) in patients aged four years and older.
This approval marks a significant milestone not only for Teva, but for the respiratory community as it allows patients and their caregivers to better understand inhaler usage through digital technology, said Sven Dethlefs, Executive Vice President, Global Marketing Portfolio.
Teva recognizes the importance of integrating technology into patient care, and we are very proud to lead the way with the approval of ProAir Digihaler. The digital technology built into ProAir Digihaler provides patients with data on their inhaler use, which may help them to have a more informed dialogue with their healthcare provider regarding their asthma or COPD management.
ProAir Digihaler contains built-in sensors that detect when the inhaler is used and measure inspiratory flow. This inhaler-use data is then sent to the companion mobile app using Bluetooth Wireless Technology so patients can review their data over time, and if desired, share it with their healthcare professionals.
The approval of ProAir Digihaler is based on the review of a supplemental new drug application (sNDA) submitted by Teva to the FDA. ProAir Digihaler combines a breath-activated, multi-dose dry powder inhaler with albuterol, the most widely used asthma rescue medication, with a built-in electronic module and a companion mobile app.
One of the challenges physicians are faced with in caring for their asthma and COPD patients is knowing if their patients are using their inhaled medication as they should. Thats what makes a product like this so important to doctor-patient discussions, said Tushar Shah, M.D., Global Head of Specialty Clinical Development Medical Affairs at Teva Pharmaceuticals. Offering a tool that enables doctors to see data on their patients inhaler usage will allow them to have more productive conversations about identifying issues and how to manage their illness.
Approved uses
ProAir Digihaler (albuterol sulfate) Inhalation Powder is a prescription medicine used in people 4 years of age and older to:
treat or prevent bronchospasm in people who have reversible obstructive airway disease
prevent exercise-induced bronchospasm
ProAir Digihaler contains a built-in electronic module that detects, records and stores inhaler event information. ProAir Digihaler may be used with, and transmits information to, a mobile app. ProAir Digihaler does not need to be connected to the mobile app in order for you to take your medicine.
Important safety information
Do not use ProAir Digihaler (albuterol sulfate) Inhalation Powder if you are allergic to albuterol sulfate, lactose, milk proteins, or any of the ingredients in ProAir Digihaler. Ask your healthcare provider if you have any questions or are not sure
Before using ProAir Digihaler, tell your healthcare provider about all of your medical conditions, including if you:
have heart problems
have high blood pressure (hypertension)
have convulsions (seizures)
have thyroid problems
have diabetes
have low potassium levels in your blood
are pregnant or planning to become pregnant
are breastfeeding or planning to breastfeed
Tell your healthcare provider about all the medicines you take, especially:
other inhaled medicines or asthma medicines
beta blocker medicines
diuretics
digoxin
monoamine oxidase inhibitors
tricyclic antidepressants
Do not increase your dose or take extra doses of ProAir Digihaler without first talking to your healthcare provider
Get medical help right away if ProAir Digihaler no longer helps your symptoms, your symptoms get worse or you need to use your inhaler more often While you are using ProAir Digihaler, do not use other inhaled rescue medicines and asthma medicines unless your healthcare provider tells you to do so
ProAir Digihaler may cause serious side effects, including:
worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens, stop using ProAir Digihaler and call your healthcare provider or get emergency help right away.
This is more likely to happen with your first use of a new asthma inhalation medicine
heart problems, including faster heart rate and higher blood pressure
possible death in people with asthma who use too much ProAir Digihaler
allergic reactions. Call your healthcare provider right away if you have the following symptoms of an allergic reaction:
itchy skin
swelling beneath your skin or in your throat
rash
worsening trouble breathing
changes in laboratory blood values (sugar, potassium)
The most common side effects of ProAir Digihaler include:
back pain
body aches and pain
upset stomach
sinus headache
urinary tract infection
your heart feels like it is pounding or racing (palpitations)
chest pain
fast heart rate
shakiness
nervousness
headache
dizziness
sore throat
runny nose
These are not all of the possible side effects of ProAir Digihaler.
