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Anoro Ellipta is an inhalation powder containing a combination of umeclidinium and vilanterol. Umeclidinium and vilanterol both work by relaxing muscles in the airways to improve breathing.
Anoro Ellipta is used to prevent airflow obstruction and reduce flare-ups in adults with COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema.
Anoro Ellipta is for use only in people with COPD and should not be used to treat asthma.
Anoro Ellipta is for use only in people with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.
Anoro Ellipta is not a rescue medicine. It will not work fast enough to treat an bronchospasm attack. Tell your doctor if any of your medicines seem to stop working as well in controlling your COPD.
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.
Anoro Ellipta will not work fast enough to treat a bronchospasm attack. Use only a fast acting inhalation medicine for an attack.
Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.
You should not use Anoro Ellipta if you are allergic to umeclidinium or vilanterol, or if you have a severe allergy to milk proteins.
To make sure Anoro Ellipta is safe for you, tell your doctor if you have ever had:/p>
heart disease, high blood pressure;
a seizure;
liver disease;
glaucoma;
diabetes;
a thyroid disorder; or
an enlarged prostate or urination problems.
Tell your doctor if you are pregnant or breastfeeding.
Anoro Ellipta is not approved for use by anyone younger than 18 years old.
Use Anoro exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides.
Anoro Ellipta is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these 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 is a powder that comes with a special Ellipta inhaler device preloaded with blister packs containing measured doses of the medicine. The Ellipta device opens and loads a blister of Anoro each time you use the inhaler. Follow the patient instructions provided with the inhaler device.
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 away 6 weeks after opening, or when the dose indicator shows a zero (whichever comes first).
Anoro Ellipta is given as 1 inhalation once daily at the same time every day. It should not be used more than once in 24 hours.
Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time. Do not use more than once in a 24-hour period.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include include headache, chest pain, fast heart rate, tremor, and feeling shaky or nervous.
Do not use a second inhaled bronchodilator that contains formoterol, arformoterol, indacaterol, olodaterol, salmeterol, or vilanterol.
Get emergency medical help if you have 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:
wheezing, choking, or other breathing problems after using this medicine;
painful or difficult urination, or urinating more often;
blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
high blood sugar - increased thirst or urination, hunger, dry mouth, fruity breath odor; or
low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling.
Common Anoro Ellipta side effects may include:
stuffy nose, sinus pain, sore throat;
chest pain, cough;
diarrhea, constipation;
muscle spasms; or
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.
Tell your doctor about all your other medicines, especially:
atropine;
antifungal, or antiviral medicine;
monoamine oxidase inhibitors, tricyclic antidepressants, drugs that prolong QT interval;
beta-blockers;
medicine to treat depression, anxiety, mood disorders, or mental illness;
cold or allergy medicine (Benadryl and others);
medicine to treat Parkinson's disease;
medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
medicine to treat overactive bladder; or
another bronchodilator medication.
This list is not complete. Other drugs may interact with umeclidinium and vilanterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Anoro Ellipta only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Anoro Ellipta (www.drugs.com/anoro-ellipta.html).
Note: This document contains side effect information about umeclidinium / vilanterol. Some of the dosage forms listed on this page may not apply to the brand name Anoro Ellipta.
For the ConsumerApplies to umeclidinium / vilanterol: inhalation powder
Inhalation route (Powder)
Asthma-related death: Long-acting beta(2)-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 the usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all LABA, including vilanterol, one of the active ingredients in the umeclidinium/vilanterol combination. The safety and efficacy of umeclidinium / vilanterol in patients with asthma have not been established. Umeclidinium / vilanterol is not indicated for the treatment of asthma.
Along with its needed effects, umeclidinium / vilanterol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking umeclidinium / vilanterol:
Less common
Rare
Some side effects of umeclidinium / vilanterol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Rare
For Healthcare Professionals
Applies to umeclidinium / vilanterol: inhalation powder
GeneralThe most common adverse reaction was nasopharyngitis (9%).
EndocrineCommon (1% to 10%): Diabetes Mellitus
GastrointestinalCommon (1% to 10%): Constipation, dry mouth, diarrhea, nausea, abdominal pain, toothache
Uncommon (0.1% to 1%): Dyspepsia, gastroesophageal reflux disease, vomiting
GenitourinaryCommon (1% to 10%): Urinary tract infection
Frequency not reported: Signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination)
MusculoskeletalCommon (1% to 10%): Pain in extremity, muscle spasms, neck pain, back pain, arthralgia
Uncommon (0.1% to 1%): Musculoskeletal chest pain
Nervous systemCommon (1% to 10%): Headache
Postmarketing reports: Dysgeusia, tremor
OtherCommon (1% to 10%): Vertigo
Uncommon (0.1% to 1%): Asthenia
RespiratoryCommon (1% to 10%): Pharyngitis, sinusitis, nasopharyngitis, lower respiratory tract infection, upper respiratory tract infections, cough, chest pain, pleuritic pain, viral respiratory tract infection, oropharyngeal pain
Uncommon (0.1% to 1%): Productive cough, chest discomfort
Frequency not reported: Paradoxical bronchospasm
CardiovascularUncommon (0.1% to 1%): Atrial fibrillation, ventricular extrasystoles, supraventricular extrasystoles, myocardial infarction, rhythm idioventricular, tachycardia, supraventricular tachycardia
Frequency not reported: Symptoms of increases in pulse rate, systolic or diastolic blood pressure
Postmarketing reports: Palpitations
DermatologicUncommon (0.1% to 1%): Pruritus, rash
OcularUncommon (0.1% to 1%): Conjunctivitis
Frequency not reported: Worsening of narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema)
HypersensitivityPostmarketing reports: Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria
PsychiatricPostmarketing reports: Anxiety
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Anoro Ellipta (www.drugs.com/anoro-ellipta.html).
October 19, 2020
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