Anoro Ellipta is an inhalation powder containing a combination of umeclidinium and vilanterol. Umeclidinium is an anticholinergic. Vilanterol is a bronchodilator. These medications work by relaxing muscles in the airways to improve breathing.
Anoro Ellipta is used to prevent airflow obstruction or bronchospasm in people with COPD (chronic obstructive pulmonary disease).
Anoro Ellipta may also be used for purposes not listed in this medication guide.
Important information
Anoro Ellipta is for use only in people with chronic obstructive pulmonary disease and should not be used to treat asthma.
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.
Anoro Ellipta will not work fast enough to treat a bronchospasm attack. Use only a fast acting inhalation medicine for an attack.
Before taking this medicine
You should not use this medicine if you are allergic to umeclidinium, vilanterol, or milk proteins. Anoro Ellipta is for use only in people with COPD and should not be used to treat asthma.
To make sure Anoro Ellipta is safe for you, tell your doctor if you have:
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heart disease, high blood pressure;
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epilepsy or other seizure disorder;
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liver disease;
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narrow-angle glaucoma;
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diabetes (or ketoacidosis);
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thyroid disorder; or
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bladder obstruction or other urination problems.
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.
FDA pregnancy category C. It is not known whether Anoro Ellipta will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether umeclidinium and vilanterol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Do not give Anoro Ellipta to anyone under 18 years old without medical advice.
How should I use Anoro Ellipta?
Use Anoro Ellipta exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
You may need to stop using other COPD medications you have been using in the past on a regular basis. Carefully follow your doctor"s dosing instructions.
The usual dose of this medicine is 1 inhalation per day. Use the medicine at the same time each day, and not more than once in a 24-hour period.
Anoro Ellipta will not work fast enough to treat a bronchospasm attack. Use only a fast-acting inhalation medicine for an attack. Tell your doctor if any of your medicines seem to stop working as well in controlling your COPD.
Anoro 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 Anoro Ellipta each time you use the inhaler. Follow the patient instructions provided with the inhaler device.
Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.
Store 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 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.
Anoro Ellipta dosing information
Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance:
1 inhalation once daily by the oral inhalation route only
Maximum dose: Do not use more than one time in 24 hours
Comments: Use at same time each day
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. Do not use more than 1 inhalation in a single day.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include fast heart rate, and feeling shaky or short of breath.
What should I avoid while using Anoro Ellipta?
Do not use a second inhaled bronchodilator similar to vilanterol, such as salmeterol (Advair, Serevent), formoterol or arformoterol (Foradil, Perforomist, Symbicort, Brovana) unless your doctor has told you to.
Anoro Ellipta side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Anoro Ellipta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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wheezing, choking, or other breathing problems after using this medication;
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fever, chills, cough with yellow or green mucus;
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stabbing chest pain, feeling short of breath;
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tremors, nervousness;
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blurred vision, tunnel vision, eye pain, or seeing halos around lights
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painful or difficult urination, little or no urinating;
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low potassium - confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or
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high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss.
Common Anoro Ellipta side effects may include:
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stuffy nose, sinus pain, sore throat;
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mild chest pain;
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diarrhea, constipation;
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muscle spasms; or
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pain in your neck, arms, or legs.
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 Anoro Ellipta?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Anoro Ellipta, especially:
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bladder or urinary medicines such as darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;
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bronchodilators such as aclidinium, ipratropium, or tiotropium; or
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cold or allergy medicine that contains an antihistamine.
This list is not complete. Other drugs may interact with Anoro Ellipta, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
