Breo Ellipta Risks, Warnings, and Complications

INCREASED RISK OF HOSPITALIZATIONS AND DEATH FROM ASTHMA-RELATED EVENTS: Breo Ellipta contains vilanterol, which is a long-acting beta-2 adrenergic agonist (LABA). Data from clinical studies has shown that LABA monotherapy (use of LABAs alone, without inhaled corticosteroids or ICS) is associated with a higher risk of asthma-related hospitalization and asthma-related death in pediatric and adolescent patients. However, large clinical trials have not shown a significant increase in risk with the use of LABA/ICS fixed-dose combination.

NOT FOR ACUTE EPISODES OR RAPIDLY DETERIORATING DISEASE: Breo Ellipta is not recommended for relief of acute bronchospasm (sudden trouble breathing). Your doctor will prescribe a rescue inhaler (short-acting beta-2 agonist) for this purpose. If you have previously been using a rescue inhaler regularly (more than 4 times a day), your doctor will ask you to use the rescue inhaler only when needed after you start using Breo Ellipta.

Signs of worsening disease severity of asthma or COPD include increased breathing problems, increased use of a short-acting beta agonist (rescue inhaler), or decreased effectiveness of the rescue inhaler. Breo Ellipta should not be used more than once daily in such a situation. Tell your doctor if Breo Ellipta does not control your symptoms or if you need to use a rescue inhaler (short-acting beta2-agonist) more frequently.

RISK OF OVERDOSE: Do not use Breo Ellipta more than once in 24 hours or at higher doses than prescribed. Also, do not take other long-acting beta-agonists (LABAs) such as salmeterol, formoterol fumarate, arformoterol tartrate, or indacaterol, while using Breo Ellipta because this can result in an overdose.

ORAL CANDIDIASIS: Breo Ellipta contains an inhaled corticosteroid (ICS), fluticasone furoate. Using this inhaler can increase the risk of fungal infections in the mouth and throat with Candida albicans (this condition is called oral candidiasis). Rinse your mouth with water and spit it out (do not swallow the water) after each dose of Breo Ellipta to lower your risk of oropharyngeal candidiasis. If you develop a fungal infection, you may need to take topical (local) or systemic (oral) antifungal drugs. Some patients need to interrupt Breo Ellipta treatment until the fungal infection clears.

PNEUMONIA: There are reports of lower respiratory tract infections, including pneumonia, in patients treated with inhaled corticosteroids such as fluticasone, which is one the active drugs in Breo Ellipta. Your doctor will monitor you carefully for signs and symptoms of pneumonia which can appear similar to COPD exacerbations (flares). Seek immediate medical care for increased cough, increased sputum, changes in sputum color, fever, shortness of breath, or chest pain.

IMMUNOSUPPRESSION AND INCREASED RISK OF INFECTIONS: Fluticasone and other corticosteroids suppress the immune system. Taking these drugs can increase the risk of infections, including severe infections such as chickenpox and measles which can be fatal. It is unclear if the corticosteroid dose and route of administration (oral vs inhaled) affects this risk.

To lower your risk, ensure you get all the recommended immunizations. Avoid contact with people who are sick with chickenpox or measles. Tell your doctor if you are exposed to someone with chickenpox or measles during Breo Ellipta treatment. Your doctor may recommend prophylaxis (prevention) with varicella zoster immune globulin (VZIG) for chickenpox or pooled intramuscular immunoglobulin (IG) for measles.

In addition, inhaled corticosteroids should be used with caution in people with ocular herpes simplex, active or quiescent tuberculosis, respiratory tract infections, and other fungal, viral, bacterial, or parasitic infections.

TRANSITION FROM SYSTEMIC CORTICOSTEROID THERAPY: The hypothalamic-pituitary-adrenal (HPA) axis controls cortisol (stress hormone) levels in the body. Patients taking systemic corticosteroids (oral steroid medicines) have suppression of the HPA axis. Meaning, the body stops making natural steroid hormones. It can take several months for HPA function to return to normal after stopping systemic corticosteroids. Caution is therefore necessary when transitioning from systemic (oral) corticosteroids to inhaled corticosteroids which provide a lower dose of steroids to the body. Transitioning too quickly can result in HPA axis suppression and adrenal insufficiency, which can be fatal.

Signs and symptoms of adrenal insufficiency include weakness, tiredness, decreased energy, low blood pressure, nausea, and vomiting.

Risk factors for HPA axis suppression and adrenal insufficiency include long-term use of steroids, high doses of oral corticosteroids, and complete withdrawal from oral steroids when starting inhaled corticosteroids. To lower the risk, your doctor will gradually lower the dose of oral steroids when they prescribe Breo Ellipta.

People who have been withdrawn from systemic corticosteroids need to resume large doses of oral steroids immediately during severe exacerbations of COPD, severe asthma attacks, or periods of stress. Such individuals should carry a warning card indicating the need for supplementary systemic corticosteroids for sudden symptoms.

In addition, stopping treatment with systemic corticosteroids can unmask symptoms that were suppressed by steroid medicine, such as rhinitis, conjunctivitis, arthritis, and eczema.

Patients coming off systemic corticosteroids may experience systemic symptoms such as joint pain, muscle pain, low energy, and depression despite improvement in lung function.

HYPERCORTICISM AND ADRENAL SUPPRESSION: The use of Breo Ellipta, which contains an inhaled corticosteroid (fluticasone furoate), has not been found to affect the HPA axis at therapeutic doses, even though the steroid medicine is absorbed into the circulation and can have systemic effects. However, taking more than the recommended dosage or taking certain other medicines that can cause HPA dysfunction can increase the risk.

In addition, some sensitive patients can develop systemic corticosteroid effects after Breo Ellipta use, especially during periods of stress or postoperatively. If such effects occur, healthcare providers may recommend reducing the dose of Breo Ellipta or switching to some other medicine for COPD and asthma symptoms.

DRUG INTERACTIONS: Breo Ellipta can interact with other medications called CYP3A4 inhibitors (for example, certain antifungal drugs, HIV medicines, and antibiotics). This can lead to increased levels of corticosteroids in the body and an increased risk of cardiovascular adverse effects.

PARADOXICAL BRONCHOSPASM: Inhaled treatments, including Breo Ellipta, can lead to potentially life-threatening paradoxical bronchospasm (narrowing of the airways). If you develop sudden trouble breathing after taking Breo Ellipta, use a rescue inhaler immediately. Tell your doctor so they can switch you over to some other medicine for long-term maintenance treatment of COPD or asthma symptoms.

SEVERE HYPERSENSITIVITY REACTIONS: There are reports of hypersensitivity reactions, including a mild allergic reaction (skin rash, hives, itching) and a more severe allergic reaction, such as anaphylaxis (throat closing) or angioedema (swelling) after taking Breo Ellipta. Stop using Breo Ellipta and seek emergency medical care if this happens.

Anaphylactic reactions have also been reported in people with severe milk protein allergy after the use of Breo Ellipta and other powder medications that contain milk proteins like lactose. Tell your doctor if you have a severe milk protein allergy - your provider will not prescribe Breo Ellipta in that case.

CARDIOVASCULAR RISKS: One of the active drugs in Breo Ellipta, vilanterol, is a beta2-agonist and can cause serious cardiovascular effects in some people, including increased pulse rate, increased blood pressure, and cardiac arrhythmias (heart rhythm abnormalities) such as supraventricular tachycardia and extrasystoles. You will need to stop Breo Ellipta treatment if you develop these complications.

Beta agonists can also cause ECG changes (for example, they may depress the ST segment, flatten T wave, and prolong QT interval). High doses of inhaled beta-agonists can be fatal.

Tell your doctor if you have a history of high blood pressure, coronary artery disease, or heart arrhythmias before starting maintenance treatment with Breo Ellipta.

DECREASED BONE MINERAL DENSITY: Long-term use of inhaled corticosteroids such as fluticasone can lead to a decrease in bone mineral density, which can lead to osteoporosis (weak bones) and an increased risk of bone fractures. Other risk factors for decreased bone mineral density include a family history of osteoporosis, older age, postmenopausal status, smoking, prolonged immobilization, poor nutrition, and chronic use of drugs that decrease bone mass (oral steroids, anticonvulsant drugs).

Your doctor may measure bone mineral density (BMD) before prescribing Breo Ellipta and periodically while you are on it. You may need to start treatment for osteoporosis if a significant decrease in BMD occurs.

EYE PROBLEMS: Long-term use of inhaled corticosteroids has been linked to eye problems, including cataracts (cloudy lens in the eye) and glaucoma (increased intraocular pressure). Tell your doctor if you have a history of narrow-angle glaucoma. Seek immediate medical care for eye pain, blurred vision, images with halos, changes in color vision, eye redness, or swelling. You will likely need to see an ophthalmologist (eye doctor) if you develop eye problems.

WORSENING OF OTHER MEDICAL CONDITIONS: Breo Ellipta contains sympathomimetic amines, which can cause worsening of health conditions such as seizure disorders, thyrotoxicosis (dangerously high thyroid hormone levels), ketoacidosis, and diabetes mellitus. Give your doctor a complete medical history before starting treatment with Breo Ellpita.

METABOLIC AND ELECTROLYTE ABNORMALITIES: Beta-adrenergic agonists such as vilanterol, which is one of the ingredients in Breo Ellipta, can cause hypokalemia (low potassium), which can lead to cardiovascular adverse effects. In addition, these drugs can lead to temporary hyperglycemia (increased blood sugar levels) in some people.

EFFECTS ON GROWTH: Inhaled corticosteroids can lead to slowed growth rates in children and adolescents. The doctor will monitor your child’s growth regularly while on this medicine. They will prescribe the lowest dose that controls your child’s symptoms. Breo Ellipta has not been studied in children younger than 5 years.