RISKS + SIDE EFFECTS
Please review this safety information.
Below you can learn about the risks and side effects of BREO ELLIPTA. This, however, is not all the safety information and does not replace your talking to your healthcare professional about your medical condition or treatment. Please see the complete Prescribing Information, including Patient Information, for BREO ELLIPTA for more information, or ask your healthcare provider or pharmacist.
Do not use BREO ELLIPTA:
to treat sudden, severe symptoms of asthma or COPD.
if you have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
if you are allergic to fluticasone furoate, vilanterol, or any of the ingredients in BREO ELLIPTA. See "What are the ingredients in BREO ELLIPTA?" below for a complete list of ingredients.
What should I tell my healthcare provider before using BREO ELLIPTA?
Tell your healthcare provider about all of your medical conditions, including if you:
- have heart problems.
- have high blood pressure.
- have seizures.
- have thyroid problems.
- have diabetes.
- have liver problems.
- have weak bones (osteoporosis).
- have an immune system problem.
- have eye problems such as glaucoma or cataracts.
- are allergic to milk proteins.
- have any type of viral, bacterial, fungal, or parasitic infection.
- are exposed to chickenpox or measles.
- are pregnant or plan to become pregnant. It is not known if BREO ELLIPTA may harm your unborn baby.
- are breastfeeding. It is not known if the medicines in BREO ELLIPTA pass into your breast milk and if they can harm your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BREO ELLIPTA and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take antifungal or anti-HIV medicines.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
What are the possible side effects with BREO ELLIPTA?
BREO ELLIPTA can cause serious side effects, including:
- See “What is the most important information I should know about BREO ELLIPTA?”
- fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using BREO ELLIPTA to help reduce your chance of getting thrush.
- pneumonia. People with COPD have a higher chance of getting pneumonia. BREO ELLIPTA may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:
- increase in mucus (sputum) production
- change in mucus color
- increased cough
- increased breathing problems
- 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 corticosteroid (such as BREO ELLIPTA). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death.
Symptoms of adrenal insufficiency include:
- feeling tired
- lack of energy
- nausea and vomiting
- low blood pressure (hypotension)
- sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop taking BREO ELLIPTA and call your healthcare provider right away.
- serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
- swelling of your face, mouth, and tongue
- breathing problems
- effects on heart
- increased blood pressure
- a fast or irregular heartbeat, awareness of heartbeat
- chest pain
- effects on nervous system
- bone thinning or weakness (osteoporosis)
- eye problems including glaucoma and cataracts. You should have regular eye exams while using BREO ELLIPTA.
- changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia).
Common side effects of BREO ELLIPTA 100/25 for COPD include:
- runny nose and sore throat
- upper respiratory tract infection
- thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
- back pain
- inflammation of the sinuses
- mouth and throat pain
- joint pain
- increased blood pressure
These are not all the possible side effects of BREO ELLIPTA.
Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088.
What are the ingredients in BREO ELLIPTA?
Active ingredients: fluticasone furoate, vilanterol trifenatate
Inactive ingredients: lactose monohydrate (contains milk proteins), magnesium stearate
Once-daily BREO 100/25 is a prescription medicine used long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups. BREO is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.
Find out about BREO for another approved use.