Healthcare is constantly evolving to adapt to the changing needs of patients. In our increasingly digital world, it is important for patients to have access to technology that may help them track respiratory conditions like asthma.
According to the Centers for Disease Control and Prevention (CDC), more than 25 million Americans are living with asthma.¹ Research reveals that a large percentage of people with asthma regularly experience limits to daily activities; however, they only report mild to moderate symptoms.² Objective data on inhaler usage will allow patients and caregivers to view and share the data with healthcare providers (HCPs), if desired, and to have informed discussions around their disease and treatment management.
Recognizing this unmet need, Teva Pharmaceuticals has developed a family of rescue and maintenance digital, breath-actuated inhalers for asthma patients that may help them track their inhaler use and encourage open communication with HCPs. The Digihaler® family of inhalers includes built-in sensors that track how often the inhaler is used and measure inspiratory flow rates during every inhalation. Inhaler use is recorded as an event when the cap is opened or a patient inhales.
This data is then sent directly to the Digihaler® app via Bluetooth® Wireless Technology, giving patients the ability to share their data, if they choose, with their HCPs to help facilitate dialogue around the assessment and treatment of their condition.
The cloud platform securely receives, and stores transferred data from the patient’s or caregiver’s phone. This allows patients or caregivers to efficiently manage and retrieve their inhaler usage data and reports from multiple devices.
The Digihaler® app sends various notifications to patients, including reminders to take their maintenance medication as prescribed, once scheduled. The Digihaler® app also provides patients with instructions on how to use their inhalers.
In addition to the technology integrated within the inhaler, the Digihaler® device also utilizes breath-actuated dry-powder delivery to eliminate the need for hand- and breath coordination during inhalations.
“Teva is proud to provide digital technologies to asthma patients in the United States,” said Keven Gessner, Vice President of Respiratory Marketing at Teva Pharmaceuticals. “The data collection capabilities of our Digihaler® family of inhalers provide patients, and their healthcare providers, an opportunity to gain an understanding of their inhaler usage.”
The Digihaler® family of inhalers currently includes ProAir® Digihaler® (albuterol sulfate) Inhalation Powder, which is the first and only digital rescue inhaler with built-in sensors indicated for the treatment or prevention of bronchospasm in people four years or older who have reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB) in patients aged four years and older. In addition, the portfolio includes two maintenance inhalers that also contain built-in sensors. AirDuo® Digihaler® (fluticasone propionate and salmeterol) Inhalation Powder 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 and ArmonAir® Digihaler® (fluticasone propionate) Inhalation Powder is a prescription medicine for the long-term treatment of asthma in patients 12 years and older. All three products have been approved by the U.S. Food & Drug Administration (FDA) and are now available by prescription to patients.
To learn more, visit www.Digihaler.com.
APPROVED USES FOR PROAIR® DIGIHALER®
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 patients to take their medicine.
IMPORTANT SAFETY INFORMATION FOR PROAIR® DIGIHALER®
- 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
- 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
- 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
- sore throat
- runny nose
- These are not all of the possible side effects of ProAir Digihaler. For more information, ask your healthcare provider or pharmacist
- You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088
Please read the full Prescribing Information for ProAir Digihaler.
APPROVED USES AND IMPORTANT SAFETY INFORMATION FOR AIRDUO® DIGIHALER® AND ARMONAIR® DIGIHALER®
- AIRDUO® DIGIHALER®(fluticasone propionate and salmeterol) inhalation powder 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.
- ARMONAIR® DIGIHALER®(fluticasone propionate) inhalation powder is a prescription medicine for the long-term treatment of asthma in patients 12 years and older.
- AIRDUO DIGIHALER and ARMONAIR DIGIHALER are not used to relieve sudden breathing problems from asthma and won’t replace a rescue inhaler.
AIRDUO DIGIHALER and ARMONAIR DIGIHALER each contain a built-in electronic module that records and stores information about inhaler events. AIRDUO DIGIHALER and ARMONAIR DIGIHALER may be used with, and transmit information to, a mobile App. AIRDUO DIGIHALER and ARMONAIR DIGIHALER do not need to be connected to the app in order for you to take your medicine.
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 or ARMONAIR DIGIHALER to treat sudden breathing problems from asthma. Always have a rescue inhaler with you to treat sudden symptoms.
- Do not use AIRDUO DIGIHALER or ARMONAIR 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 use AIRDUO DIGIHALER or ARMONAIR DIGIHALER more often than prescribed.
- 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 yourhealth conditions.
- Do not stop using ARMONAIR DIGIHALER, even if you are feeling better, unless your healthcare provider tells you to. If you miss a dose of ARMONAIR DIGIHALER, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
- AIRDUO DIGIHALER and ARMONAIR 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 or ARMONAIR 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 ICS (such as AIRDUO DIGIHALER or ARMONAIR 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 tired
- lack of energy
- nausea and vomiting
- low blood pressure
- For AIRDUO DIGIHALER, there may be 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 or ARMONAIR DIGIHALER and call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
- swelling of your face, mouth, and tongue
- breathing problems
AIRDUO DIGIHALER can also cause additional serious side effects, including:
- Effects on the heart
- increased blood pressure
- a fast or irregular heartbeat
- chest pain
- Effects on the nervous system
AIRDUO DIGIHALER and ARMONAIR DIGIHALER can cause:
- 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 or ARMONAIR DIGIHALER.
- For AIRDUO DIGIHALER, changes may occur in laboratory blood values (sugar, potassium, certain types of white blood cells)
- For ARMONAIR DIGIHALER increased wheezing (bronchospasm) may occur. Increased wheezing can happen right away after using ARMONAIR DIGIHALER. If this occurs, stop using ARMONAIR DIGIHALER and call your healthcare provider. Always have a rescue inhaler with you to treat sudden wheezing.
- Common side effects of AIRDUO DIGIHALER and ARMONAIR DIGIHALER include:
- thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
- Additionally, AIRDUO DIGIHALER has common side effects of:
- back pain
- infection of nose and throat (nasopharyngitis)
- ARMONAIR DIGIHALER has common side effects of:
- upper respiratory tract infection
- infection or inflammation of nose and throat (nasopharyngitis)
These are not all the possible side effects of AIRDUO DIGIHALER and ARMONAIR DIGIHALER. Call your healthcare provider for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
¹ National Center for Health Statistics. Centers for Disease Control. Asthma. 2014. http://www.cdc.gov/nchs/fastats/asthma.htm. Accessed on October 9, 2020.
² Allergy & Asthma Network: Observations of patient experience in the nation asthma survey. https://allergyasthmanetwork.org/research/research-projects/. Accessed January 31, 2020.