Breo Ellipta powder

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

Long-acting beta-agonists, such as one of the active ingredients in Breo Ellipta powder (vilanterol), have been rarely associated with an increased risk of asthma-related death. Breo Ellipta powder is not approved to treat asthma; safety and effectiveness in patients with asthma have not been confirmed.


Breo Ellipta powder is used for:

Treating chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It may also be used for other conditions as determined by your doctor.

Breo Ellipta powder is an inhaled corticosteroid and long-acting bronchodilator combination. The corticosteroid works by reducing inflammation in the lungs, and the bronchodilator works by widening the airways in the lungs. This helps you breathe more easily.

Do NOT use Breo Ellipta powder if:

  • you are allergic to any ingredient in Breo Ellipta powder or to milk proteins
  • you are having severe breathing problems (eg, sudden, severe onset or worsening of COPD symptoms [such as chest tightness, cough, shortness of breath, wheezing])
  • you are using another medicine that has a long-acting inhaled bronchodilator (eg, formoterol, salmeterol) in it
  • you are taking cobicistat or protease inhibitors (eg, atazanavir, boceprevir, indinavir, ritonavir)

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Breo Ellipta powder:

Some medical conditions may interact with Breo Ellipta powder. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of diabetes, eye problems (eg, cataracts, glaucoma, increased pressure in the eye), heart problems (eg, fast or irregular heartbeat, heart blood vessel problems), high blood pressure, nervous system problems, liver problems, low blood potassium levels, high blood acid levels (eg, ketoacidosis), seizures, thyroid problems, or an adrenal gland tumor
  • if you are having a COPD flare-up, have recently been to an emergency room for asthma, have a history of frequent hospitalizations for asthma, or have ever had a life-threatening asthma attack
  • if you have a fungal, bacterial, or parasitic infection; a viral infection (eg, measles, chickenpox, shingles); herpes virus infection of the eye; tuberculosis (TB); a history of a positive TB skin test; an immune system problem or if you are taking a medicine to suppress the immune system (eg, tacrolimus); or if you have had a recent vaccination
  • if you have weak bones (osteoporosis) or have risk factors of osteoporosis (eg, a family history of osteoporosis, tobacco use, long-term alcohol use, long-term use of corticosteroids or certain seizure medicines, limited physical exercise, poor nutrition)
  • if you have had an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping
  • if you are taking an oral corticosteroid (eg, prednisone) or an inhaled corticosteroid (eg, fluticasone)
  • if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or tricyclic antidepressant (eg, amitriptyline), or if you have taken either of these medicines within the last 14 days

Some MEDICINES MAY INTERACT with Breo Ellipta powder. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Diuretics (eg, hydrochlorothiazide, furosemide) or other long-acting inhaled bronchodilators (eg, salmeterol, formoterol) because the risk of low blood potassium or irregular heartbeat may be increased
  • Beta-blockers (eg, propranolol) because they may decrease Breo Ellipta powder's effectiveness
  • Azole antifungals (eg, itraconazole, ketoconazole), conivaptan, macrolide antibiotics (eg, clarithromycin), MAOIs (eg, phenelzine), nefazodone, protease inhibitors (eg, boceprevir, ritonavir), telithromycin, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Breo Ellipta powder's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Breo Ellipta powder may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Breo Ellipta powder:

Use Breo Ellipta powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Breo Ellipta powder comes with an extra patient information sheet called a Medication Guide. It also comes with detailed instructions for use. Read them carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about Breo Ellipta powder.
  • To prepare a dose of Breo Ellipta powder, remove the inhaler from the foil pouch. Open the cover of the inhaler until you hear a click. The counter will count down by 1 number. Your inhaler is now ready to use.
  • Do not open the cover of the inhaler until you are ready to use it. To avoid wasting doses after the inhaler is ready, do not close the cover until after you have inhaled the medicine.
  • To use a dose of Breo Ellipta powder, hold the inhaler away from your mouth and breathe out fully. Do not breathe out into the mouthpiece. Place the mouthpiece between your lips, and close your lips firmly around it. Take a long, deep breath through your mouth. Do not block the air vents of the inhaler with your fingers. Remove the inhaler from your mouth and hold your breath for about 3 to 4 seconds, or as long as comfortable for you. Breathe out slowly.
  • Before you close the cover, you may clean the mouthpiece with a dry tissue if needed. Slide the cover up and over the mouthpiece when you are done.
  • You may not taste or feel the medicine, even when you are using the inhaler correctly. Do NOT use another dose if you do not taste or feel the medicine. If you are not sure if you are receiving your dose, contact your doctor or pharmacist.
  • Rinse your mouth with water after using Breo Ellipta powder. DO NOT swallow the rinse solution. Spit the rinse water out.
  • If you are using other inhaled medicines, wait a few minutes between using Breo Ellipta powder and other inhalers, unless directed otherwise by your doctor.
  • Never wash the mouthpiece or any other part of the inhaler. Keep it dry. Store Breo Ellipta powder in a dry place.
  • Store Breo Ellipta powder in the unopened foil tray until right before the first use. Throw Breo Ellipta powder away 6 weeks after you opening the foil tray, or after the dose indicator reads "0," whichever comes first.
  • Use Breo Ellipta powder on a regular schedule to get the most benefit from it. Using Breo Ellipta powder at the same time each day will help you remember to use it. Do not stop using Breo Ellipta powder even if you feel better unless your doctor tells you to.
  • If you miss a dose of Breo Ellipta powder, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. Do not use Breo Ellipta powder more often than 1 time every 24 hours.

Ask your health care provider any questions you may have about how to use Breo Ellipta powder.

Important safety information:

  • Breo Ellipta powder will not stop sudden breathing problems once they have started. Always have a rescue inhaler (eg, albuterol) with you to use during sudden breathing problems. If you do not have a rescue inhaler or you have any questions about which medicines should be used during sudden breathing problems, check with your doctor or pharmacist.
  • If you have been regularly using a rescue inhaler, talk with your doctor about how to use it with Breo Ellipta powder. Rescue inhalers are normally only used with Breo Ellipta powder to treat breathing problems that may occur between doses.
  • Tell your doctor or dentist that you take Breo Ellipta powder before you receive any medical or dental care, emergency care, or surgery.
  • Tell your doctor at once if you notice your rescue inhaler does not work as well, if you need to use it more often than normal (eg, more than 4 times a day for more than 2 days in a row, or 1 whole canister within 8 weeks' time), or if you have a decrease in your peak meter flow results.
  • The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use Breo Ellipta powder in high doses. Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Do not stop using Breo Ellipta powder without checking with your doctor.
  • Breo Ellipta powder may sometimes cause severe breathing problems right after you use a dose. If this happens, use your rescue inhaler. Contact your doctor or seek other medical care at once.
  • An increase in how often people got pneumonia was seen with Breo Ellipta powder. There was also an increase in hospitalization from pneumonia. Some cases were fatal. Discuss any questions or concerns with your doctor.
  • Use caution if you switch from an oral steroid (eg, prednisone) to Breo Ellipta powder. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, a sudden asthma attack, or severe fluid or electrolyte loss. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.
  • If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Contact your doctor at once if you have contact with anyone who has these infections.
  • Check with your doctor before you receive any vaccine while you are using Breo Ellipta powder.
  • Diabetes patients - Breo Ellipta powder may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including lung function, bone density, and eye exams, may be performed while you use Breo Ellipta powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Breo Ellipta powder should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Breo Ellipta powder while you are pregnant. It is not known if Breo Ellipta powder is found in breast milk. If you are or will be breast-feeding while you use Breo Ellipta powder, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Breo Ellipta powder:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; mild sore throat; runny nose; sneezing.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred vision or other vision changes; chest pain; fast or irregular heartbeat; muscle pain, weakness, or cramps; nervousness; severe or persistent bone pain; severe or persistent dizziness or headache; severe or persistent nausea or vomiting; signs of infection (eg, fever, chills, cough, persistent sore throat, ear pain, increased mucus production, change in mucus color); symptoms of high blood sugar (eg, increased thirst, urination, or hunger; unusual weakness or drowsiness; confusion); tremor; unusual tiredness or weakness; white patches or sores in the mouth, or throat; worsening of COPD symptoms (eg, increased wheezing, coughing, chest tightness, shortness of breath).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Breo Ellipta powder:

Store Breo Ellipta powder between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Breo Ellipta powder out of the reach of children and away from pets.

General information:

  • If you have any questions about Breo Ellipta powder, please talk with your doctor, pharmacist, or other health care provider.
  • Breo Ellipta powder is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Breo Ellipta powder or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Breo Ellipta powder. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Breo Ellipta powder. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Breo Ellipta powder.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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