Anoro Ellipta

Given the two active ingredients, Anoro Ellipta works in two specific ways to reduce COPD-induced breathing problems and increase lung function. Umeclidinium is an anticholinergic agent that helps you breathe more easily by relaxing the muscles in your lung’s airways, while vilanterol is a long-acting beta2-adrenergic agonist (LABA) that helps open the airways in your lungs.

Follow all directions given by your doctor and read all Prescribing Information, FDA-approved product labeling, and Medication Guide before using Anoro Ellipta.

To use Anoro Ellipta, first, you must exhale away from the medication device. After you have emptied your lungs, firmly press and close your lips around the mouthpiece. Ensure you have not blocked the air vent at the top of the inhaler, and then take a steady, long breath through your mouth, inhaling the medicine. Hold your breath for three to four seconds, and then exhale away from the mouthpiece. Try your best to breathe out gently and slowly. Put the mouthpiece cover back on and close the inhaler.

If you miss a dose of Anoro 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 a double dose to make up for the missed one.

Most likely, Anoro Ellipta will be administered as a once-daily oral inhalation, prescribed to be taken every day at the same time. You should not take Anoro Ellipta more than once in 24 hours. You should also not take Anoro Ellipta more often or at a higher dose than the recommended dose given to you by your doctor.

In addition to the once-daily dose of Anoro Ellipta, you may be prescribed a short-acting bronchodilator such as Proair HFA (albuterol). This provides a quick relief of COPD symptoms.

The most common side effects of Anoro Ellipta in clinical trials compared to placebo include:

• Swelling of the sinuses
• Irregular heartbeat
• Sore throat and swelling of the throat (pharyngitis)
• Constipation
• Lower respiratory tract infection
• Headache
• Pain in your feet or hands
• Voice changes
• Diarrhea
• Dry mouth
• Neck pain
• Palpitations
• Muscle spasm
• Chest pain
• Urinary tract infection

Rarely, Anoro Ellipta may cause some serious side effects, including:

• Serious allergic reactions, which can be life-threatening.
• People who are allergic to milk proteins should not take Anoro Ellipta.
• Allergic reaction symptoms could include:
• Trouble breathing
• Hives
• Swelling of your face, lips, throat, or tongue
• Paradoxical bronchospasm (a tightening of your airways), with symptoms such as:
• Cough

-Trouble breathing after you use your inhaler

• Heart problems with symptoms such as:
• Chest pain

-High blood pressure

-Rapid heart rate

-Irregular heart rhythm

-Dizziness

• New or worsening eye problems, including narrow-angle glaucoma. Symptoms can include:

-Blurred vision

-Eye pain

-Seeing halos

• Hypokalemia (low potassium levels) with symptoms such as:

-Muscle spasms and weakness

-Palpitations

-Irregular heartbeat

You should receive medical advice from your healthcare professional if you experience any adverse effects while you are taking Anoro Ellipta. You have the option to report your adverse effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before starting Anoro Ellipta, you should be sure that your healthcare provider is aware of all your medical conditions, including if you:

• Have asthma (Anoro Ellipta must be taken with an inhaled corticosteroid if you have asthma)
• Have hypersensitivity to milk proteins or lactose
• Have a history of narrow-angle glaucoma
• Have a history of urinary retention
• Have high blood pressure or other heart problems
• Are pregnant, may become pregnant, or are breastfeeding
• Have any type of eye pain or vision problems
• Have a thyroid problem or disorder
• Have a history of seizures
• Have any worsening signs of a preexisting condition
• Are taking any anticholinergics (eg. tiotropium) or LABAs medications (salmeterol, formoterol, and indacaterol)

If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Anoro Ellipta may not be safe for you to take.

• Using it to treat asthma without an inhaled steroid
• Allergy to milk proteins

Anoro Ellipta should start working within 15 minutes of inhalation, with the maximum effect seen within 1-3 hours. It provides 24-hour bronchodilation, offering sustained relief from COPD symptoms throughout the day.

If you take Anoro Ellipta with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Some drug interactions with Anoro Ellipta include:

• Monoamine oxidase inhibitors
• Tricyclic antidepressants
• Any beta-blockers
• Potassium-sparing diuretics
• Strong cytochrome P450 3A4 inhibitors, including ketoconazole and ritonavir
• Fluconazole
• Caffeine

Anoro Ellipta is only taken as an oral inhalation. Each inhaler contains two foil blister strips that include powder. One blister strip is made of umeclidinium 62.5 mcg, and the other one is made of vilanterol 25 mcg. For the maintenance treatment of COPD, one inhalation daily is the normal dosage.

Keep Anoro Ellipta at room temperature in the moisture-protective foil tray until you are ready to use it. If the medication has been sitting out of the moisture-protective foil tray for more than six weeks, or the counter reads “0”, discard the remaining medication. Do not reuse the inhaler or take the inhaler apart.

It is manufactured by GlaxoSmithKline (GSK).

Currently, there is not a generic available for Anoro Ellipta in the United States.

To stop using Anoro Elipta, it's important to consult with your healthcare provider for a safe discontinuation plan. Stopping abruptly may cause withdrawal symptoms or a return of your symptoms. Your doctor will likely recommend gradually tapering your dose to reduce these risks and monitor your progress during the process.

It is recommended that you speak to your doctor if you plan to get pregnant or are already pregnant while on Anoro Ellipta. Your healthcare provider will help you decide what’s best for you and should only be used if the benefits outweigh the risks.

You should discuss the benefits and risks of breastfeeding with your healthcare provider if you are currently on Anoro Ellipta.