Breo Ellipta

Breo Ellipta is a prescription medicine that is used to improve symptoms of COPD, a group of diseases that includes chronic bronchitis and emphysema. Breo Ellipta is used long-term to control wheezing, shortness of breath, coughing, and chest tightness caused by COPD. Breo Ellipta is also used to treat asthma. 

This medication combines two active ingredients, fluticasone, a steroid that is effective at reducing airway swelling, and vilanterol, a long-acting beta agonist (LABA) which works by relaxing air passages, making it easier to breathe.

Breo Ellipta comes as an inhalation powder to inhale by mouth using a special inhaler. It is inhaled once daily, at the same time each day. 

Common side effects include runny nose, sore throat, upper respiratory tract infection, headache, and thrush.

Breo Ellipta is a prescription medication used to treat COPD, a chronic lung disease that includes chronic bronchitis, emphysema, or both. Breo Ellipta is used long-term to help improve symptoms of COPD for better breathing and to reduce the number of flare-ups.  Breo Ellipta is also used to treat asthma. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Glaxo SmithKline Pharmaceuticals

Serious side effects have been reported. See "Drug Precautions" section.

Common side effects of Breo Ellipta include:

• runny nose and sore throat
• upper respiratory tract infection
• headache
• thrush in the mouth and/or throat. Rinse your mouth without swallowing after use to help prevent this.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with Breo Ellipta. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medications you take including prescription and non-prescription medications, vitamins, and herbal supplements. 

Do not use other medicines that contain a LABA such as formoterol (Foradil, in Symbicort) or salmeterol (in Advair, Serevent) for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.

Tell your healthcare provider if you take:

• antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• beta-blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• clarithromycin (Biaxin)
• conivaptan (Vaprisol)
• diuretics ('water pills')
• HIV protease inhibitors such as indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• other medications for COPD
• metronidazole (Flagyl)
• nefazodone (Serzone)
• telithromycin (Ketek)
• troleandomycin (TAO)

Tell your healthcare provider if you are currently taking antidepressants or if you recently stopped taking antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil).

Also, you should tell your healthcare provider if you take or have recently stopped taking monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate).

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

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Breo Ellipta there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving this medication, tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• have liver problems
• have weak bones (osteoporosis)
• have an immune system problem
• have eye problems such as glaucoma or cataracts
• are allergic to any of the ingredients in Breo Ellipta, any other medicines, or food products
• have any type of viral, bacterial, or fungal infection
• are exposed to chickenpox or measles or been around anyone who has chickenpox or measles
• have any other medical conditions
• are pregnant or planning to become pregnant. It is not known if Breo Ellipta may harm your unborn baby.
• are breastfeeding. It is not known if the medicines in Breo Ellipta pass into your milk and if they can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. 

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.

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if Breo Ellipta passes into your breast milk.

Other corticosteroids and beta2-agonists have been detected in human breast milk.

You and your doctor should decide if you will take Breo Ellipta or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take this medication.

Use Breo Ellipta only if your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.

Use Breo Ellipta exactly as prescribed. Do not use Breo Ellipta more often than prescribed.

If you miss a dose of Breo Ellipta, take it as soon as you remember. Do not take more than 1 inhalation per day. Take your next dose at your usual time. Do not take 2 doses at one time.

Do not stop using Breo Ellipta unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.

Breo Ellipta does not relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.

Call your healthcare provider or get medical care right away if:

• your breathing problems get worse
• you need to use your rescue inhaler more often than usual
• your rescue inhaler does not work as well to relieve your symptoms
• you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row
• you use 1 whole canister of your rescue inhaler in 8 weeks

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.

If you take too much Breo Ellipta, call your healthcare provider and get medical help right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.

• Store Breo Ellipta at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.
• Store Breo Ellipta in the unopened foil tray and only open when ready for use.
• Safely throw away Breo Ellipta in the trash 6 weeks after you open the foil tray or when the counter reads “0”, whichever comes first. Write the date you open the tray on the label on the inhaler.
• Keep Breo Ellipta and all medicines out of the reach of children.

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US trial that compared the safety of another LABA (salmeterol) with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including vilanterol, an active ingredient.