fluticasone furoate / vilanterol

• Risk factors: Using albuterol more often | Using too much Breo Ellipta (fluticasone furoate / vilanterol)*

Don't use Breo Ellipta (fluticasone furoate / vilanterol) during an asthma attack or COPD flare-up because it won’t give quick relief. Instead, use a rescue inhaler like albuterol if you're having trouble breathing.

If you notice you’re using your rescue inhaler more often than usual, tell your pulmonologist since this might mean your condition is getting worse. Never take more doses of Breo Ellipta (fluticasone furoate / vilanterol) than prescribed since this won’t help your breathing and can raise your risk for serious side effects like heart problems, tremors, and dizziness.

• Risk factors: Using too much Breo Ellipta (fluticasone furoate / vilanterol) | Using together with other LABAs

Using Breo Ellipta (fluticasone furoate / vilanterol) more often, at a higher dose than prescribed, or with other LABAs can raise your risk of overdose. Taking too much can lead to serious side effects like heart problems, and in rare cases, even death. Get medical help right away if you have symptoms like chest pain, a fast or irregular heartbeat, tremor, headache, or nervousness.

• Risk factor: Not rinsing and spitting after using Breo Ellipta (fluticasone furoate / vilanterol)

Breo Ellipta (fluticasone furoate / vilanterol) contains fluticasone furoate, a steroid that can sometimes cause a mouth and throat infection called oral thrush. To help prevent thrush, rinse your mouth with water and spit it out after each dose.

If you do get thrush, your pulmonologist might prescribe an antifungal medication and ask you to pause Breo Ellipta (fluticasone furoate / vilanterol). Let them know if you notice symptoms of thrush, such as white patches in your mouth, cotton-like feeling in your mouth, pain while eating or swallowing, or loss of taste.

• Risk factors: COPD

Studies show that people with COPD who use Breo Ellipta (fluticasone furoate / vilanterol) can have a higher risk of getting pneumonia. In some cases, pneumonia has led to hospitalization or even death. Symptoms of pneumonia can look a lot like a COPD flare-up, so it’s important to watch for warning signs such as fever, chills, cough with mucus, chest pain, or shortness of breath.

• Risk factors: Active, chronic (long-term), or recurrent infection | Medical conditions that weaken the immune system | Taking other medications that can weaken the immune system

Breo Ellipta (fluticasone furoate / vilanterol) can make it harder for your body to fight infections. Infections like tuberculosis, chickenpox, and measles can be more serious if you're using this medication. Don't use Breo Ellipta (fluticasone furoate / vilanterol) if you have an active or ongoing infection without talking with your prescriber first. Let them know right away if you have signs of an infection, such as a fever, body aches, tiredness, vomiting, pain, chills, or nausea.

• Risk factors: High doses of Breo Ellipta (fluticasone furoate / vilanterol) | Taking medications that interact with Breo Ellipta (fluticasone furoate / vilanterol) | Stressful events (e.g., surgery)

Breo Ellipta (fluticasone furoate / vilanterol) can be absorbed into your bloodstream. At the recommended dose, it usually doesn’t affect your adrenal glands, which make important stress hormones. But if you take more than prescribed or also take certain medicines that interact with Breo Ellipta (fluticasone furoate / vilanterol), you might experience adrenal insufficiency, a condition where your body doesn't make enough of its own steroid hormones.

Let your prescriber know if you feel very tired, weak, or sick to your stomach, especially after surgery or during times of stress as these could be signs of low steroid levels.

Breo Ellipta (fluticasone furoate / vilanterol) can sometimes cause paradoxical bronchospasm, which means your airways tighten instead of relax. This is rare but can be life threatening. If you notice more wheezing, shortness of breath, or coughing after using Breo Ellipta (fluticasone furoate / vilanterol), stop using it and use a rescue inhaler (like albuterol) right away. Contact your prescriber since you might need to switch to a different treatment.

• Risk factors: Allergy to milk proteins (lactose)

Serious allergic reactions to Breo Ellipta (fluticasone furoate / vilanterol) are possible. These reactions can include hives, swelling of the face or throat, rash, or trouble breathing. Stop using this inhaler right away if you have any of these reactions and get medical help. Because Breo Ellipta (fluticasone furoate / vilanterol) contains lactose, people with a severe milk protein allergy shouldn't use this medication.

• Risk factors: History of heart problems | Using more Breo Ellipta (fluticasone furoate / vilanterol) than recommended

Breo Ellipta (fluticasone furoate / vilanterol) can sometimes affect your heart. It might raise your heart rate or blood pressure and can cause irregular heart rhythms. Your risk is higher if you take more than prescribed or if you already have heart problems like high blood pressure or irregular heartbeats. If you notice heart-related problems, your prescriber might have you stop using this medication.

• Risk factors: Using Breo Ellipta (fluticasone furoate / vilanterol) long term | Older adult | Unable to move for a long period of time | Family history of osteoporosis | Poor diet | Postmenopausal | Smoking | Using medications that can cause bone loss

If you take Breo Ellipta (fluticasone furoate / vilanterol) for a long time, you might be at risk for bone loss. It's not certain if this will lead to broken bones, but your risk is higher if you're an older adult, postmenopausal, have a poor diet, smoke, or take certain medications. Your prescriber might check your bone density regularly to help protect your bone health. If you've had broken bones or a history of osteoporosis, talk to your prescriber before starting this medication.

Children who use inhaled steroids like Breo Ellipta (fluticasone furoate / vilanterol) might grow more slowly. To help lower this risk, your child's pulmonologist will prescribe the lowest dose needed to control their asthma. Your child's care team will also check their growth regularly while they use this inhaler. If you're concerned about how Breo Ellipta (fluticasone furoate / vilanterol) might affect your child's growth, talk with your child’s pulmonologist to see if it’s the best option.

• Risk factors: Long-term use of Breo Ellipta (fluticasone furoate / vilanterol) | History of eye problems like glaucoma or cataracts

Using Breo Ellipta (fluticasone furoate / vilanterol) for a long time can raise eye pressure, worsen glaucoma, or lead to cataracts. Talk to your prescriber right away if you experience blurry vision, eye discomfort, or other changes in your vision. You might need an eye exam to check for these problems.

Breo Ellipta (fluticasone furoate / vilanterol) can raise blood sugar levels. Let your prescriber know if you're feeling more thirsty or hungry than usual, confused, or urinating more often. These can be signs of high blood sugar.

Medications like Breo Ellipta (fluticasone furoate / vilanterol) can sometimes cause low potassium levels, which can affect your heart rhythm. This drop in potassium is usually short term and doesn’t require treatment. Let your care team know if you have muscle pain or weakness, muscle cramps, or abnormal heartbeat as these can be signs of low potassium.