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Breo Ellipta

Generic Name: fluticasone and vilanterol (floo TIK a sone and vye LAN ter ol)
Brand Names: Breo Ellipta

What is Breo Ellipta?

Breo Ellipta inhalation powder contains a combination of fluticasone and vilanterol. Fluticasone is a steroid. It prevents the release of substances in the body that cause inflammation. Vilanterol is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Breo Ellipta is a once-daily combination medicine used in adults with asthma or COPD (chronic obstructive pulmonary disease), to improve symptoms and prevent bronchospasm or asthma attacks.

In people with COPD, Breo Ellipta is for long-term treatment. In people with asthma, this medicine is for short-term treatment until symptoms are well-controlled with with other medicines.

Vilanterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risks and benefits of using this medicine.

Important information

You should not use Breo Ellipta if you are allergic to fluticasone, vilanterol, or milk proteins.

Slideshow: Flashback: FDA Drug Approvals 2013

Breo Ellipta is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack.

Vilanterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known.

Before taking this medicine

You should not use Breo Ellipta if you are allergic to fluticasone, vilanterol, or milk proteins.

Breo Ellipta is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack. Use only a fast acting inhalation medicine for an asthma attack. Tell your doctor if it seems like your asthma medications don't work as well.

Fluticasone can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

To make sure Breo Ellipta is safe for you, tell your doctor if you have:

  • a weak immune system;

  • heart disease, high blood pressure;

  • liver disease;

  • glaucoma or cataracts;

  • a thyroid disorder;

  • seizures;

  • diabetes;

  • any type of infection, including tuberculosis or herpes infection of the eyes; or

  • a personal or family history of osteoporosis.

It is not known whether Breo Ellipta will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether fluticasone and vilanterol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use Breo Ellipta?

Use Breo Ellipta inhalation powder exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

The usual dose of Breo Ellipta is 1 inhalation per day. Use the medicine at the same time each day, and not more than once in a 24-hour period.

Tell your doctor if any of your medicines seem to stop working as well in controlling your symptoms.

Breo Ellipta is a powder that comes with a special inhaler device preloaded with blister packs containing measured doses of the medicine. The device opens and loads a blister of fluticasone and vilanterol each time you use the inhaler. The disk device is not to be used with a spacer. Follow the patient instructions provided with the inhaler device.

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using your inhaler. Do not swallow.

If you also use another steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your Breo Ellipta dose or dosing schedule without your doctor's advice.

Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.

While using Breo Ellipta, your vision and your bone mineral density may need to be checked often.

Your doctor will need to check your lung function on a regular basis. Once your asthma is under control, your doctor may want you to stop using Breo Ellipta. Keep all follow-up appointments and do not stop using the medicine unless your doctor tells you to.

Store Breo Ellipta at room temperature away from moisture, heat, and light. Keep the inhaler device in the sealed foil tray until ready to start using it.

Throw the Breo Ellipta inhaler device away 6 weeks after you have taken it out of the foil pouch, or if the dose indicator shows a zero, whichever comes first.

Breo Ellipta dosing information

Usual Adult Dose of Breo Ellipta for Chronic Obstructive Pulmonary Disease - Maintenance:

Fluticasone 100 mcg-vilanterol 25 mcg (1 inhalation) orally once a day
Maximum dose: 1 inhalation in 24 hours

Comments:
-Breo Ellipta is not indicated for the relief of acute bronchospasm.
-Only fluticasone 100 mcg-vilanterol 25 mcg is indicated for the treatment of COPD.
-If shortness of breath occurs in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.

Uses: Long term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema; to reduce exacerbations in patients with COPD

Usual Adult Dose of Breo Ellipta for Chronic Obstructive Pulmonary Disease:

Fluticasone 100 mcg-vilanterol 25 mcg (1 inhalation) orally once a day
Maximum dose: 1 inhalation in 24 hours

Comments:
-Breo Ellipta is not indicated for the relief of acute bronchospasm.
-Only fluticasone 100 mcg-vilanterol 25 mcg is indicated for the treatment of COPD.
-If shortness of breath occurs in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.

Uses: Long term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema; to reduce exacerbations in patients with COPD

Usual Adult Dose of Breo Ellipta for Asthma - Maintenance:

Initial dose: 1 inhalation of fluticasone 100 mcg-vilanterol 25 mcg or fluticasone 200 mcg-vilanterol 25 mcg orally once a day
Maximum dose: 1 inhalation of fluticasone 200 mcg-vilanterol 25 mcg in 24 hours

Comments:
-Breo Ellipta should not be used in asthma patients adequately controlled on low or medium dose inhaled corticosteroids.
-If asthma symptoms arise in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.
-The starting dosage is based on patients' asthma severity: For patients previously treated with low to mid dose corticosteroid, fluticasone 100 mcg-vilanterol 25 mcg should be considered; for patients previously treated with mid to high dose corticosteroid, fluticasone 200 mcg-vilanterol 25 mcg should be considered.

Use: In patients not adequately controlled on a long-term asthma medication, such as an inhaled corticosteroid, or when the severity of the disease clearly warrants initiation of treatment with both an inhaled corticosteroid and a long-acting beta-adrenoceptor agonist.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Breo Ellipta?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid such as fluticasone.

Breo Ellipta side effects

Get emergency medical help if you have signs of an allergic reaction to Breo Ellipta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • wheezing, choking, or other breathing problems after using this medication;

  • chest pain, shortness of breath, tremors, nervousness;

  • feeling very weak or tired, nausea and vomiting, feeling like you might pass out;

  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;

  • fever, chills, cough with yellow or green mucus;

  • sores or white patches in your mouth and throat, pain when swallowing;

  • low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling; or

  • high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss.

Common Breo Ellipta side effects may include:

  • headache; or

  • runny or stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Breo Ellipta?

Many drugs can interact with fluticasone and vilanterol. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Breo Ellipta, especially:

  • antifungal medicine such as ketoconazole;

  • ritonavir or other HIV/AIDS medicine; or

  • heart medication - atenolol, carvedilol, metoprolol, nebivolol, and others.

This list is not complete and many other drugs can interact with fluticasone and vilanterol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about Breo Ellipta.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Breo Ellipta only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2015 Cerner Multum, Inc. Version: 1.02. Revision Date: 2015-05-12, 9:56:23 AM.

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