Breo Ellipta

Breo Ellipta can cause serious side effects, including:

• increased risk of death. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as vilanterol, have an increased risk of death from asthma problems. It is not known whether fluticasone furoate, the other active ingredient in this medication, reduces the risk of death from asthma problems seen with LABA medicines. It is not known if LABA medicines, such as vilanterol, increase the risk of death in people with COPD. Call your healthcare provider if breathing problems worsen over time while using Breo Ellipta. Get emergency medical care if:
  • your breathing problems worsen quickly
  • you use your rescue inhaler, but it does not relieve your breathing problems.
• pneumonia. People with COPD have a higher chance of getting pneumonia. Breo Ellipta may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:
  • increase in mucus (sputum) production
  • change in mucus color
  • fever
  • chills
  • increased cough
  • increased breathing problems
• thrush (fungal infection) in mouth and throat. You may develop a yeast infection (Candida albicans) in your mouth or throat. Rinse your mouth with water without swallowing after using Breo Ellipta to help prevent thrush in your mouth and throat.
• serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
  • rash
  • hives
  • swelling of the face, mouth, and tongue
  • breathing problems
• sudden breathing problems immediately after inhaling your medicine
• effects on heart
  • increased blood pressure
  • a fast and/or irregular heartbeat
  • chest pain
• effects on nervous system
  • tremor
  • nervousness
• reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as Breo Ellipta). When your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
  • feeling tired (fatigue)
  • lack of energy
  • weakness
  • nausea and vomiting
  • low blood pressure
• changes in laboratory blood values (sugar, potassium)
• weakened immune system and increased chance of getting infections (immunosuppression)
• bone thinning or weakness (osteoporosis)
• eye problems including glaucoma and cataracts. You should have regular eye exams while using Breo Ellipta.

Breo Ellipta is not for use to treat sudden symptoms of COPD. Always have a rescue inhaler (an inhaled, short-acting bronchodilator) with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

Breo Ellipta should not be used in children. It is not known if Breo Ellipta is safe and effective in children.

Do not use Breo Ellipta if you:

• have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
• are allergic to fluticasone furoate, vilanterol, or any of the ingredients in Breo Ellipta

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. There are no good studies that have been done in humans with Breo Ellipta. However, animal reproduction studies with corticosteroids and beta2-agonists have shown an adverse effect on the fetus.

COPD: Use 1 inhalation of Breo Ellipta 100/25 1 time each day, at the same time each day.

Asthma: Use 1 inhalation of Breo Ellipta 100/25 or 200/25 1 time each day, at the same time each day.

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

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

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

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 fluticasone and vilanterol 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.

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. Follow all patient instructions for safe use.

It is not known whether this medicine 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.

Fluticasone and vilanterol is not approved for use by anyone younger than 18 years old.

In the U.S.

• Breo Ellipta

Available Dosage Forms:

• Powder

Therapeutic Class: Corticosteroid Combination

Pharmacologic Class: Fluticasone

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.

Inhaled fluticasone and vilanterol combination comes with patient directions or a Medication Guide. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

Use this medicine at the same time each day.

Do not stop using this medicine or other breathing medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

To use the inhaler:

• This medicine comes in a foil tray. Peel back the lid to open the tray.
• Slide the inhaler cover down until you hear a clicking sound. The inhaler is now ready to use. Do not open the cover of the inhaler until you are ready to use it. If you open and close the inhaler without inhaling the dose, you will lose the medicine.
• Turn your head away from the inhaler, and breathe out fully. Do not breathe into the inhaler.
• Put the mouthpiece between your lips, and close your lips around the mouthpiece. Do not block the air vent with your fingers.
• Breathe in through your mouth as deeply as you can until you have taken a full deep breath. Do not breathe through your nose.
• Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 3 or 4 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
• When you are finished, you may clean the mouthpiece with a dry tissue, if needed, before closing the inhaler cover.
• The inhaler has a window that shows the number of doses that are left. This tells you when you are getting low on medicine. When the inhaler has less than 10 doses left, the left half of the counter will show up in red to remind you to refill your prescription.

Rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. However, do not swallow the water after rinsing.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage form (powder):
  • For asthma and COPD:
    • Adults—One inhalation once a day.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Do not take more than 1 puff per day.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep this medicine in a dry place away from heat and sunlight. Throw away this medicine after 6 weeks it has been opened or when the counter reads "0".

• It is used to treat COPD (chronic obstructive pulmonary disease).
• It is used to treat asthma.
• This medicine is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

Breo Ellipta should be administered as 1 inhalation once daily by the orally inhaled route only.

Breo Ellipta should be used at the same time every day. Do not use Breo Ellipta more than 1 time every 24 hours.

After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.

More frequent administration or a greater number of inhalations (more than 1 inhalation daily) of the prescribed strength of Breo Ellipta is not recommended as some patients are more likely to experience adverse effects with higher doses. Patients using Breo Ellipta should not use additional LABA for any reason. [See Warnings and Precautions (5.3, 5.5, 5.8, 5.12).]

Chronic Obstructive Pulmonary Disease

Breo Ellipta 100/25 should be administered as 1 inhalation once daily. The maximum recommended dosage is 1 inhalation of Breo Ellipta 100/25 once daily, the only strength indicated for the treatment of COPD.

If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.

Asthma

If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.

The recommended starting dosage is Breo Ellipta 100/25 or Breo Ellipta 200/25 administered as 1 inhalation once daily. The maximum recommended dosage is 1 inhalation of Breo Ellipta 200/25 once daily.

The starting dosage is based on patients’ asthma severity. For patients previously treated with low- to mid-dose corticosteroid-containing treatment, Breo Ellipta 100/25 should be considered. For patients previously treated with mid- to high-dose corticosteroid-containing treatment, Breo Ellipta 200/25 should be considered.

The median time to onset, defined as a 100-mL increase from baseline in mean forced expiratory volume in 1 second (FEV1), was approximately 15 minutes after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to Breo Ellipta 100/25, increasing the dose to Breo Ellipta 200/25 may provide additional improvement in asthma control.

If a previously effective dosage regimen of Breo Ellipta fails to provide adequate improvement in asthma control, the therapeutic regimen should be reevaluated and additional therapeutic options (e.g., replacing the current strength of Breo Ellipta with a higher strength, adding additional inhaled corticosteroid, initiating oral corticosteroids) should be considered.

The use of Breo Ellipta is contraindicated in the following conditions:

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU pregnancy category: B3 US FDA pregnancy category: C Comments: Patients should contact their physician if pregnancy occurs while taking this drug.

No teratogenicity interactions between fluticasone and vilanterol were seen in animals at the maximum recommended human daily inhalation dose (MRHDID) alone or in combination. Vilanterol caused decreased or absent ossification in cervical vertebral centrum and metacarpals in animals at approximately 1,000 times the MRHDID. Hypoadrenalism occurred in infants born to mothers using corticosteroids during pregnancy. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.