ArmonAir Digihaler (fluticasone propionate inhalation powder)

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

• ICS medicines such as fluticasone propionate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
• ArmonAir Digihaler is not used to relieve sudden breathing problems.
• It is not known if ArmonAir Digihaler is safe and effective in children younger than 12 years of age.
• ArmonAir Digihaler contains a built-in electronic module that records and stores information about inhaler events. ArmonAir Digihaler may be used with, and transmits information to, an App through Bluetooth wireless technology.
• ArmonAir Digihaler does not need to be connected to the app in order for you to take your medicine. The electronic module does not control or interfere with delivery of the medicine through the inhaler.

Do not use ArmonAir Digihaler:

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

ArmonAir Digihaler can cause serious side effects, including:

• Fungal infection in your mouth and throat (thrush). Rinse your mouth with water without swallowing after using ArmonAir Digihaler to help reduce your chance of getting thrush.
• Weakened immune system and increased chance of getting infections (immunosuppression).
• Reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as ArmonAir Digihaler). 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
• weakness
• nausea and vomiting
• low blood pressure
• Serious allergic reactions. Call your healthcare provider or get emergency medical help if you get any of the following signs or symptoms of a serious allergic reaction:
• rash
• hives
• swelling of your face, mouth, and tongue
• breathing problems
• 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 ArmonAir Digihaler.
• Increased wheezing (bronchospasm). 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 ArmonAir Digihaler include:

• infection or inflammation of nose and throat (nasopharyngitis)
• upper respiratory tract infection
• thrush in your mouth or throat
• headache
• cough

These are not all the possible side effects with ArmonAir Digihaler. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• For detailed instructions on how to set up the App go to www.ARMONAIRDIGIHALER.com or call Teva at 1-888-603-0788.
• Connection to the App, having your Bluetooth turned on, or being near your smartphone is not required for your ArmonAir Digihaler to work and for you to get your medicine.
• The electronic module does not control or interfere with delivery of the medicine through the inhaler.
• ArmonAir Digihaler is for oral inhalation use only.
• Rinse your mouth with water without swallowing after each dose of ArmonAir Digihaler.
• Children should use ArmonAir Digihaler with an adult’s help, as instructed by the child’s healthcare provider.
• ArmonAir Digihaler comes in 3 different strengths. Your healthcare provider prescribed the strength that is right for you.
• Use ArmonAir Digihaler exactly as your healthcare provider tells you to use it. Do not use ArmonAir Digihaler more often than prescribed.
• Use ArmonAir Digihaler 2 times a day (about 12 hours apart) at the same time every day.
• ArmonAir Digihaler does not need priming. Do not use a spacer or volume holding chamber with ArmonAir Digihaler.
• Do not open the cap on your ArmonAir Digihaler inhaler until you are ready for your dose because this will waste your medicine or may damage your inhaler.
• It may take 1 to 2 weeks or longer after you start ArmonAir Digihaler for your asthma symptoms to get better. You must use ArmonAir Digihaler regularly.
• 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.
• ArmonAir Digihaler does not relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
• Call your healthcare provider or get medical care right away if:
  • your breathing problems get worse.
  • you need to use your rescue inhaler more often than usual.
  • your rescue inhaler does not work as well to relieve your symptoms.
  • you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.
  • you use 1 whole canister of your rescue inhaler in 8 weeks.
  • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.

Inhibitors Of Cytochrome P450 3A4

Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with ArmonAir Digihaler is not recommended because increased systemic corticosteroid adverse effects may occur.

Ritonavir

A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations. During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression.

Ketoconazole

Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.

There are no randomized clinical studies of ArmonAir Digihaler in pregnant women.

There are no available data on the presence of fluticasone propionate in human milk, the effects on the breastfed child, or the effects on milk production. Other corticosteroids have been detected in human milk. However, fluticasone propionate concentrations in plasma after inhaled therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ArmonAir Digihaler and any potential adverse effects on the breastfed child from ArmonAir Digihaler or from the underlying maternal condition.