• Anoro Ellipta is a brand (trade) name for a combination medication containing both umeclidinium and vilanterol that may be used to treat chronic obstructive pulmonary disease (COPD).
• The ingredients in Anoro Ellipta help to open the airways. Umeclidinium is a long-acting muscarinic antagonist (LAMA) that works by inhibiting M3 receptors in the smooth muscle of the bronchi to open up the airways (this is called bronchodilation). Umeclidinium may also be known as an anticholinergic agent.
• Vilanterol is a long-acting beta2-agonist (LABA) that works by stimulating the enzyme adenylyl cyclase which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cAMP). Increases in cyclic AMP cause relaxation of bronchial smooth muscle and inhibit the release of hypersensitivity mediators from mast cells in the lungs. Increases in cyclic AMP are associated with relaxation of bronchial smooth muscle and inhibition of release of hypersensitivity mediators from mast cells in the lungs.
• Anoro Ellipta belongs to the class of medicines known as bronchodilator combinations.

• May be used for long-term maintenance treatment of COPD.
• Anoro Ellipta is not a steroid (corticosteroid) medication and does not contain any steroids.
• Contains two inhaled bronchodilator agents that work in two different ways to open the airways. Umeclidinium is a long-acting muscarinic antagonist (LAMA, also known as an anticholinergic agent) and vilanterol, a long-acting beta2-agonist (LABA).
• Vilanterol is a selective LABA, which means that it preferentially targets beta2 receptors in smooth muscle. However, it may still have some cardiac effects because beta2 receptors in the heart comprise 10% to 50% of the total beta-adrenergic receptors.
• Long-acting.
• Given by inhalation once a day.
• Helps to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath.
• Well tolerated; side effects are uncommon.
• Anoro is unlikely to cause develop thrush as a side effect because it does not contain the corticosteroid fluticasone. Inhaled corticosteroids are associated with this side effect. This means you do not need to rinse your mouth out after using this inhaler.
• No dosage adjustment is needed for people with kidney disease, moderate liver disease, or seniors.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Side effects are uncommon and may include a sore throat, diarrhea, pain, sinusitis, or lower respiratory tract infections (but these occur in only 1% to 2% of people).
• Significant cardiovascular effects may occur with symptoms such as an increased pulse rate, high blood pressure, electrocardiographic changes, or other symptoms. Perform an ECG if required.
• Do not use in people who are severely allergic to milk proteins, umeclidinium, or vilanterol.
• Each inhaler is expensive, costing from $425 to $500 for one inhaler (with 60 blisters of 62.5 mg umeclidinium/25 mcg vilanterol). The price can vary between pharmacies and locations around the country and may be reduced by online discount coupons, prescription insurance, or copay coupons.
• Do not use to treat asthma, rapidly deteriorating or potentially life-threatening episodes of COPD, or in an emergency situation where people need to breathe quickly. A quick-acting (rescue) inhaler such as albuterol should be used for people needing immediate relief.
• Should not be used more often than recommended or at higher dosages than recommended because of the risk of significant cardiovascular events.
• May interact with several other medications. Do not use Anoro Ellipta with other inhalers that also contain LABAs such as Advair, Breo Ellipta, or inhalers containing salmeterol, formoterol fumarate, arformoterol tartrate, or indacaterol. Combining beta-agonists medications may lead to a fast heart rate (tachycardia), elevated blood pressure, irregular heart rhythm, and possibly death.
• Anoro Ellipta is not used to treat asthma.
• May cause paradoxical bronchospasm that can be life-threatening. If this occurs treat immediately with a fast-acting bronchodilator such as albuterol.
• A generic version of Anoro Ellipta is not currently available.
• Not for use in children.
• The combination of umeclidinium and vilanterol contained in Anoro Ellipta has not been studied in pregnant women, although the individual ingredients have been studied in animals, with no apparent detriment to the animal fetus. Weigh up the risks versus benefits before using Anoro Ellipta in pregnant or breastfeeding women.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Inhale Anoro Ellipta once a day to maintain good control of your chronic obstructive pulmonary disease (COPD) over the long term. Try to inhale at the same time each day.
• May not be suitable for people with seizure disorders, thyrotoxicosis, narrow-angle glaucoma, or urinary retention. May produce significantly low potassium levels and transiently high blood sugar levels.
• Ask your doctor or pharmacist to show you how to use your albuterol inhaler for your COPD and the maximum inhalations per day. Contact your doctor if your breathing problems do not improve.
• Anoro Ellipta comes in a tray. Peel back the lid to open the tray. Throw away the desiccant packet in the trash and out of reach of children and pets.
• Do not open the cover of the inhaler until you are ready to use it. If you open and close the cover without inhaling the medicine, you will lose one dose (you will see this on the dose counter).
• There is no need to shake the inhaler and it is not possible to accidentally take a double dose or an extra dose in 1 inhalation.
• To prepare your dose, slide the cover down on the inhaler to expose the mouthpiece. You should hear a click. If the counter does not count down as you hear the click, the inhaler will not deliver the medicine. Call your health care provider or pharmacist if this happens. While holding the inhaler away from your mouth, breathe out (exhale) fully. Do not breathe out into the mouthpiece. Do not block the air vent with your fingers. To inhale your medicine, put the mouthpiece between your lips, and close your lips firmly around it. Your lips should fit over the curved shape of the mouthpiece.
• Take 1 long, steady, deep breath in through your mouth. Do not breathe in through your nose. Once you have inhaled the medicine, remove the inhaler from your mouth and hold your breath for about 3 to 4 seconds (or as long as comfortable for you). Breathe out slowly and gently. You do not need to rinse your mouth. Do not take another dose from the inhaler even if you do not feel or taste the medicine. Close your inhaler cover You can clean the mouthpiece if needed, using a dry tissue, before you close the cover. Routine cleaning is not required. Slide the cover up and over the mouthpiece as far as it will go.
• When you have fewer than 10 doses remaining in your inhaler, the left half of the counter shows red as a reminder to get a refill. After you have inhaled the last dose, the counter will show “0” and will be empty. Throw the empty inhaler away in your trash. Keep out of reach of children and pets.
• Do not use Anoro if you suddenly become breathless. Fast-acting rescue medications such as those that contain albuterol or levalbuterol should be used in these circumstances. If you do not have a fast-acting inhaler, call your doctor for a prescription. Seek emergency medical treatment or call 911 if your breathing problems get worse quickly.
• Do not take Trelegy or Anoro with other medicines including other inhalers that contain a long-acting beta2-adrenergic agonist (LABA) or an anticholinergic. If you are not sure if your medicines contain these drugs, ask your doctor or pharmacist.
• Anoro Ellipta is for use only in people with COPD and should not be used to treat asthma. It works by relaxing muscles in the airways to improve breathing and to reduce the number of COPD flare-ups.
• May cause paradoxical bronchospasm that can be life-threatening. If this occurs treat immediately with a fast-acting bronchodilator such as albuterol.
• See your doctor if you develop an increased pulse rate, headache, or it feels as though your heart is skipping a beat or your pulse is irregular.
• One Anoro Ellipta Inhaler contains 30 doses. Discard once all 30 doses have been used or 6 weeks after opening the foil tray; whatever comes first.
• Tell your doctor if you are breastfeeding, pregnant, or intending to become pregnant before using Anoro Ellipta because it may not be suitable for you.

• When inhaled, Anoro Ellipta is absorbed into the lungs quickly (usually within 5 to 15 minutes) but is still not quick enough or effective enough to be used for sudden breathing problems.
• The effect of Anoro Ellipta lasts for 24 hours.
• Trials have shown that Anoro Ellipta may not be as effective as Trelegy which contains fluticasone, a corticosteroid medication, in addition to umeclidinium and vilanterol. Trelegy reduced flare-ups by 25% compared with Anoro Ellipta and improved lung function and forced expiratory volume in one second (FEV1). Triple therapy with Trelegy also resulted in a 34% lower rate of hospitalization due to COPD than with Anoro and a survey showed that the patient’s health-related quality of life was improved with regards to daily symptoms, daily activities, and perceived well-being.

Medicines that interact with Anoro Ellipta may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with Anoro Ellipta. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Anoro Ellipta interacts with over 460 medications and most of these interactions are considered major or moderate. Common medications that may interact with Anoro Ellipta include:

• aminophylline
• antibiotics, such as azithromycin
• anticholinergics, such as benztropine
• antidepressants, such as amitriptyline, imipramine, nortriptyline, or venlafaxine
• astemizole
• atomoxetine
• beta-blockers, such as atenolol or carvedilol
• digoxin
• diuretics, such as furosemide or HCTZ
• epinephrine
• linezolid
• medicines that increase the QT-interval, such as haloperidol
• monoamine oxidase inhibitors, such as selegiline, isocarboxazid, or phenelzine
• ondansetron
• other inhaled bronchodilators.

Use caution when administering with strong CYP3A4 inhibitors, such as ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, nefazodone, or voriconazole

Note that this list is not all-inclusive and includes only common medications that may interact with Anoro Ellipta. You should refer to the prescribing information for Anoro Ellipta for a complete list of interactions.