ArmonAir Digihaler (fluticasone propionate inhalation powder)

ArmonAir Digihaler is a prescription inhaled corticosteroid (ICS) for the long-term treatment of asthma in people aged 12 and older.

• ICS medicines like fluticasone propionate decrease lung inflammation, which can cause breathing problems.
• ArmonAir Digihaler does not relieve sudden breathing problems.
• It is not known if ArmonAir Digihaler is safe and effective in children under 12 years old.
• ArmonAir Digihaler contains a built-in electronic module that records and stores inhaler events. ArmonAir Digihaler may be used with an App using Bluetooth wireless technology.
• ArmonAir Digihaler does not need to be connected to the app to take your medicine. The module does not interfere with medicine delivery.

Do not use ArmonAir Digihaler:

• to relieve sudden breathing problems.
• if you have a severe allergy to milk proteins or any ingredients in ArmonAir Digihaler.

What are the side effects of Armonair Digihaler?

ArmonAir Digihaler can cause serious side effects, including:

• Fungal infection in your mouth and throat (thrush). Rinse your mouth after using ArmonAir Digihaler to reduce thrush risk.
• Weakened immune system and increased chance of infections (immunosuppression).
• Reduced adrenal function (adrenal insufficiency). Symptoms include tiredness, lack of energy, weakness, nausea, low blood pressure.
• Serious allergic reactions. Call your healthcare provider or seek emergency medical help if you experience rash, hives, swelling, or breathing problems.
• Bone thinning or weakness (osteoporosis).
• Slowed growth in children. Check a child’s growth regularly.
• Eye problems including glaucoma and cataracts. Have regular eye exams while using ArmonAir Digihaler.
• Increased wheezing (bronchospasm). Stop using ArmonAir Digihaler and call your healthcare provider if wheezing worsens. Keep a rescue inhaler for sudden wheezing.

Common side effects of ArmonAir Digihaler include:

• infection or inflammation of the nose and throat
• upper respiratory tract infection
• thrush in the mouth or throat
• headache
• cough

These are not all the possible side effects of ArmonAir Digihaler. Call your healthcare provider for medical advice. Report side effects to FDA at 1-800-FDA-1088.

QUESTION

What is the dosage for Armonair Digihaler?

• For detailed instructions on how to set up the App, visit www.ARMONAIRDIGIHALER.com or call Teva at 1-888-603-0788.
• Connection to the App or being near your smartphone is not required for ArmonAir Digihaler to work and for you to get your medicine.
• The module does not interfere with medicine delivery.
• ArmonAir Digihaler is for oral inhalation use only.
• Rinse your mouth after each dose of ArmonAir Digihaler.
• Children should use ArmonAir Digihaler with adult supervision.
• ArmonAir Digihaler comes in 3 different strengths as prescribed by your healthcare provider.
• Use ArmonAir Digihaler as directed, not more often than prescribed.
• Use ArmonAir Digihaler twice a day, about 12 hours apart.
• ArmonAir Digihaler does not need priming. Do not use a spacer or volume holding chamber.
• Do not open the cap on your ArmonAir Digihaler inhaler until you are ready for your dose.
• It may take 1 to 2 weeks or longer for your asthma symptoms to improve. Use ArmonAir Digihaler regularly.
• Do not stop using ArmonAir Digihaler without your healthcare provider’s instructions.
• If you miss a dose, skip it. Do not take 2 doses at the same time.
• ArmonAir Digihaler does not relieve sudden symptoms. Always have a rescue inhaler for sudden symptoms.
• Seek medical care if your breathing problems worsen, or if you need to use your rescue inhaler more often.

What drugs interact with Armonair Digihaler?

Inhibitors Of Cytochrome P450 3A4

Fluticasone propionate is a substrate of CYP3A4. Using strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin) with ArmonAir Digihaler is not recommended due to increased corticosteroid adverse effects.

Ritonavir

A drug interaction trial has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase fluticasone propionate exposure, resulting in reduced serum cortisol concentrations. Reports of clinically significant interactions with fluticasone propionate and ritonavir have included systemic corticosteroid effects.

Ketoconazole

Coadministration of orally inhaled fluticasone propionate and ketoconazole resulted in increased fluticasone propionate exposure and decreased plasma cortisol.

Is Armonair Digihaler safe to use while pregnant or breastfeeding?

No randomized clinical studies of ArmonAir Digihaler have been conducted in pregnant women.

Data on fluticasone propionate in human milk, effects on the breastfed child, and milk production are not available. Consider the benefits of breastfeeding and the mother’s clinical need for ArmonAir Digihaler.

Summary

ArmonAir Digihaler is a prescription inhaled corticosteroid for the long-term treatment of asthma in people aged 12 and older. This device can be used with Bluetooth and a smartphone app to monitor dosage and other data.