BREO ELLIPTA (Fluticasone furoate and vilanterol)
Breo Ellipta
Vilanterol Trifenatate, Fluticasone Furoate
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People who take BERO ELLIPTA have an increased risk of death from asthma-related problems. This is because of vilanterol, a long-acting beta2-adrenergic agonist. Therefore, it is essential to contact your healthcare provider if you experience worsening breathing while using BREO ELLIPTA. You should seek urgent medical care if you have a rapid worsening of your breathing, and your rescue inhaler does not help to relieve these symptoms.

BREO ELLIPTA is manufactured as a dry powder. It is presented in an inhaler that contains two blister strips filled with the powdered formulation. One of the strips contains fluticasone furoate 100 mcg or 200 mcg. The other strip contains vilanterol 25 mcg.

The dose of BREO ELLIPTA for the treatment of chronic obstructive pulmonary disease is one inhalation of the fluticasone furoate 100 mcg/vilanterol 25 mcg combination, taken once a day.

The dose of BREO ELLIPTA for the treatment of chronic asthma is one inhalation of the fluticasone furoate 200 mcg/vilanterol 25 mcg combination, taken once a day.

The BREO ELLIPTA comes in a sealed foil tray. To open the tray, peel back the lid. Each inhaler can dispense 30 doses. When you open the inhaler cover, you will hear a clicking sound, and the dose counter will decrease by one. Opening the cover primes the inhaler for delivery. Do not close the cover without inhaling the medication or you will lose the prepared dose. You cannot take a double dose because the prepared dose will become unavailable if you close the cover.

To inhale the dose, slide the cover down so that you can see the mouthpiece. You will hear a click, and the counter will go down by one number. You do not need to shake this inhaler. Hold the inhaler away from your mouth and breathe out completely. Make sure that you do not breathe into the mouthpiece. Now place the mouthpiece between your lips and take a long deep breath in through your mouth. Make sure that you do not breathe in through your nose. Also, ensure that your hands do not block the air vent on the inhaler. Hold your breath for three to four seconds after you have inhaled. When breathing in the powder, you may not taste or feel it. This does not mean that you have not received a dose. Once you have taken the required dose, close the inhaler by sliding the cover back into position.

It is important to rinse your mouth out once you have inhaled your dose. This is to prevent you from developing thrush in your mouth and throat. Make sure that you do not swallow the water.

BREO ELLIPTA is contraindicated in patients with a hypersensitivity to milk proteins, fluticasone furoate, or vilanterol.

BREO ELLIPTA is also contraindicated in patients with status asthmaticus or acute exacerbations of chronic obstructive pulmonary disease who may be requiring intensive management measures.

If you miss a dose of BREO ELLIPTA, try to take it as soon as possible, then continue with the usual medication schedule. However, if you are due to take your next dose, skip the dose you missed and continue with your regular medication schedule. Under no circumstances should you take a double dose of the medication to make up for the missed dose. If you are unsure about what to do, contact your doctor or local pharmacist to obtain advice.

BREO ELLIPTA is an inhaled corticosteroid. The most common side effect is related to the steroid’s immunosuppressive effect, which can cause thrush in the mouth and throat. This is generally easily treated by your doctor using antifungal therapy. Other side effects include:

  • Sinusitis
  • Headaches
  • Back pain
  • Fever
  • Chest infection
  • Changes in voice
  • Changes in taste
  • Difficulty sleeping
  • Thrush in the mouth and throat (Candida albicans)

Less common side effects include:

  • Pneumonia
  • Bronchitis
  • Suppression of the immune system
  • Reduction in bone density
  • Inhibition of growth in children
  • Glaucoma and cataracts
  • Systemic eosinophilia
  • Churg-Strauss syndrome
  • Anaphylaxis

Some side effects can be severe and require medical attention. Contact your doctor immediately if you notice any of the following:

  • worsening of your asthma
    • difficulty breathing
    • shortness of breath
    • tight chest
  • changes in your vision
  • swelling of your face with a skin rash
  • acute confusion or aggression
  • development of a temperature or other signs of an infection

If you experience severe side effects, immediately contact your doctor, or go to the nearest emergency health care facility.

BREO ELLIPTA should be stored away from children. It should be stored in a dry place at room temperature, away from heat and sunlight. It should be stored unopened in its foil pouch and only opened when ready for use.