FDA Approves ArmonAir Digihaler Inhalation Powder

The United States Food and Drug Administration has approved ArmonAir Digihaler Inhalation Powder. The drug (fluticasone propionate) is administered using the Digihaler device. The device and inhalation powder are made by Teva Pharmaceutical Industries Ltd.

The ArmonAir Digihaler contains an inhaled corticosteroid drug and can be used by people with asthma who are at least 12 years old. The ArmonAir Digihaler is used for the maintenance or long-term treatment of asthma. It is not meant for rescue or short-term treatment during an asthma attack.

How does ArmonAir Digihaler work?

The active ingredient in ArmonAir Digihaler Inhalation Powder is fluticasone propionate. This is a drug called a corticosteroid. Corticosteroids reduce the inflammation pathway in our body. They affect many different types of cells that contribute to the inflammatory response. Inflammation caused by these cells and the signaling chemicals they make can lead to airway irritation and symptoms of asthma. By blocking the action of these cells and chemicals, airway inflammation may be reduced.

What is a Digihaler?

The corticosteroid is delivered to the body through a new device called the Digihaler. The Digihaler connects to a mobile application and senses different aspects of its use. For example, the Digihaler can measure inspiratory flow rates and the number of times it is used.

The application can also deliver notifications to the user to remind them when it is time to use the inhaler. All of the data collected on the application can be shared with a person’s doctor (if they choose to do so). This can help provide doctors with more information on specific aspects of a person’s asthma.

This digital capability is unique in the asthma treatment field and may help provide more information over time to create long-term treatment plans. However, the Digihaler can be used without connecting to the mobile app if desired.

What are the side effects of ArmonAir Digihaler?

The most common side effects of ArmonAir Digihaler include:

Things to note about ArmonAir Digihaler

ArmonAir Digihaler is not meant to be used as a rescue or short-term therapy. A rescue inhaler is best suited for these situations. People with severe milk allergies should not use the ArmonAir Digihaler. Your doctor should be informed about all allergies, medications, and supplements you are taking before taking this medication. The use of the inhaler should not be changed or stopped on its own without first talking to a doctor.

Several rare but serious side effects may occur when taking an inhaled corticosteroid like ArmonAir Digihaler. These include experiencing:

  • Weakened immune system and increased risk of infection
  • Reduced function of the adrenal glands on the kidneys leading to tiredness, weakness, low blood pressure, nausea, or vomiting
  • Serious allergic reactions with a rash, hives, swelling of the face and mouth, or breathing problems
  • Osteoporosis (bone thinning or weakness)
  • Eye issues including cataracts and glaucoma
  • Increased wheezing requiring a rescue inhaler
  • Decreased growth in children

As mentioned, these are serious, but rare, side effects. Your doctor will help you weigh the risks and benefits of taking ArmonAir Digihaler before starting.1

Read the prescribing information to learn more about ArmonAir Digihaler.

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