Arnuity Ellipta (Fluticasone Furoate)

Arnuity Ellipta (fluticasone furoate) is a prescription inhaler used every day to help control asthma. It reduces inflammation and irritation in the airways, which may help prevent asthma symptoms and flare-ups over time. Arnuity Ellipta is not a rescue inhaler and should not be used for sudden breathing problems or an asthma attack. It comes as a dry powder inhaler with a built-in dose counter and is approved for adults and children ages 5 and older.

Directions

Arnuity Ellipta should only be inhaled through the mouth. The usual dosage is 1 inhalation once per day at about the same time each day. Do not use more than 1 dose in 24 hours. Adults and children 12 and older may use the 100 mcg or 200 mcg strength, depending on their asthma severity. Children 5 to 11 years old should use the 50 mcg strength once daily. After each dose, rinse your mouth with water and spit it out to help prevent thrush and hoarseness. Use Arnuity Ellipta every day, even when you feel well, and keep a quick-relief rescue inhaler nearby for sudden breathing problems.

Ingredients

The active ingredient in Arnuity Ellipta is fluticasone furoate. The inactive ingredient is lactose monohydrate.

Cautions

Before using this medication, you may want to consult a healthcare provider about the following:

• Any existing health conditions
• Any allergies
• A list of all medications currently being taken

Arnuity Ellipta is not a rescue inhaler. Do not use it to treat sudden breathing problems. Anyone with rapidly worsening asthma needs immediate medical attention and a fast-acting bronchodilator.

Inhaled corticosteroids can cause oral yeast infections (Candida or thrush) and a hoarse voice. Rinsing the mouth with water (and spitting it out) after each dose may help reduce this risk.

Use with caution if you have an active or latent tuberculosis infection, or untreated fungal, bacterial, viral, or parasitic infections. Inhaled corticosteroids can also make chickenpox or measles more serious, especially in people who haven’t had these infections or been vaccinated.

People switching from an oral corticosteroid such as prednisone need to taper off slowly. Stopping an oral steroid too quickly can cause adrenal insufficiency and unmask allergy or autoimmune symptoms.

Long-term use or higher doses can lead to systemic steroid effects such as hypercorticism (Cushing-like changes) or adrenal suppression. If these occur, the dose should be reduced gradually.

In rare cases, an inhaled medicine can cause paradoxical bronchospasm, which is sudden wheezing or shortness of breath right after using the inhaler. If this happens, stop Arnuity Ellipta and seek medical care.

Long-term use of inhaled corticosteroids can lower bone mineral density and increase the risk of cataracts and glaucoma. Bone density checks and routine eye exams may be needed.

In children, long-term use may slow growth. Growth should be monitored regularly, and the lowest effective dose used.

Fluticasone furoate is broken down by the liver enzyme CYP3A4. Strong CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, or clarithromycin) can raise fluticasone furoate levels in the body and increase the risk of systemic steroid effects.

People with moderate or severe liver problems may have higher systemic exposure to fluticasone furoate and should be monitored for systemic corticosteroid effects.

Contraindications

Avoid taking or using this medication if any of the following apply:

• Status asthmaticus or other acute episodes of asthma that need intensive treatment. Arnuity Ellipta is not a rescue medicine.
• A severe hypersensitivity to milk proteins. Arnuity Ellipta contains lactose monohydrate, which contains milk proteins.
• A known hypersensitivity to fluticasone furoate or any of the other ingredients in Arnuity Ellipta.

Side Effects

Common side effects of Arnuity Ellipta in adults and adolescents 12 years and older include:

• Stuffy or runny nose with sore throat
• Bronchitis
• Upper respiratory tract infection (cold-like symptoms)
• Headache
• Cough or hoarseness
• Throat irritation or oral yeast infection (thrush)

In children 5 to 11 years old, the most common side effects are sore throat (pharyngitis), bronchitis, and viral infection.

Get immediate medical help for any signs of a serious allergic reaction such as swelling of the face, lips, tongue, or throat, trouble breathing, hives, or a severe rash.

Stop Arnuity Ellipta and seek care for sudden worsening of wheezing or shortness of breath right after a dose (paradoxical bronchospasm).

Long-term or higher-dose use of inhaled corticosteroids can lead to less common but more serious problems, including systemic steroid effects (such as Cushing-like changes or adrenal suppression), thinning of the bones, cataracts, glaucoma, slower growth in children, and a higher risk of infections.

References

• Arnuity Ellipta Highlights of Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline LLC; 2023.
• Arnuity Ellipta Drug Label Information. Research Triangle Park, NC: GlaxoSmithKline LLC; 2023.