BREO ELLIPTA

Uses of BREO ELLIPTA

BREO ELLIPTA is approved for people 5 years and older with asthma. BREO is a prescription medicine used long term to prevent and control symptoms of asthma for better breathing and to prevent symptoms such as wheezing.

BREO ELLIPTA contains vilanterol. LABA (long-acting beta₂-adrenergic agonist) medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. BREO ELLIPTA contains an ICS (inhaled corticosteroid) and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

BREO ELLIPTA is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.

Precautions and Warnings

Before using this medication, tell your doctor or pharmacist if you are allergic to fluticasone or vilanterol; or if you have any other allergies. This product may contain inactive ingredients (such as milk proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, bone loss (osteoporosis), depression, diabetes, eye problems (such as cataracts, glaucoma), heart problems (such as angina, irregular heartbeat), any recent infection, liver problems, overactive thyroid (hyperthyroidism), seizures.

Fluticasone/vilanterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using fluticasone/vilanterol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using fluticasone/vilanterol safely.

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Fluticasone/vilanterol can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

This medication may temporarily slow down a child’s growth if used for a long time. However, poorly controlled asthma can also slow down growth. See the doctor regularly so your child’s height can be checked.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breastfeeding.

Side Effects

Common side effects:

• Headache,
• Dry/irritated throat,
• Hoarseness,
• Runny nose,
• Coughing