WARNINGS
Do not use ANORO ELLIPTA if you:
have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
are allergic to umeclidinium, vilanterol, or any of the ingredients in ANORO ELLIPTA. See the end of this Patient Information for a complete list of ingredients in ANORO ELLIPTA.
have asthma.
USES
What is ANORO ELLIPTA?
ANORO ELLIPTA combines 2 medicines in 1 inhaler, an anticholinergic medicine (umeclidinium) and a long-acting beta2-adrenergic agonist (LABA) medicine (vilanterol).
Anticholinergic medicines such as umeclidinium and LABA medicines such as vilanterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.
ANORO ELLIPTA is not used to relieve sudden breathing problems and will not replace a rescue inhaler.
ANORO ELLIPTA is a prescription medicine used long term (chronic) to treat people with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
ANORO ELLIPTA is used as 1 inhalation 1 time each day to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).
ANORO ELLIPTA is not for the treatment of asthma. It is not known if ANORO ELLIPTA is safe and effective in people with asthma.
ANORO ELLIPTA should not be used in children.
It is not known if ANORO ELLIPTA is safe and effective in children.
HOW TO USE
How should I use ANORO ELLIPTA?
Read the step-by-step instructions for using ANORO ELLIPTA at the end of this Patient Information.
Do not use ANORO ELLIPTA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
Use ANORO ELLIPTA exactly as your healthcare provider tells you to use it. Do not use ANORO ELLIPTA more often than prescribed.
Use 1 inhalation of ANORO ELLIPTA 1 time each day. Use ANORO ELLIPTA at the same time each day.
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 2 doses at 1 time.
If you take too much ANORO ELLIPTA, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
Do not use other medicines that contain a LABA or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic medicines.
Do not stop using ANORO 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.
ANORO ELLIPTA does not relieve sudden symptoms of COPD and you should not take extra doses of ANORO ELLIPTA to relieve these 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.
What are the possible side effects of ANORO ELLIPTA?
ANORO ELLIPTA can cause serious side effects, including:
serious problems in people with asthma. People with asthma who take LABA medicines, such as vilanterol (one of the medicines in ANORO ELLIPTA), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including death.
Call your healthcare provider if breathing problems worsen over time while using ANORO ELLIPTA. You may need a different treatment.
Get emergency medical care if:
your breathing problems worsen quickly.
you use your rescue inhaler medicine, but it does not relieve your breathing problems.
COPD symptoms that get worse over time. If your COPD symptoms worsen over time, do not increase your dose of ANORO ELLIPTA; instead call your healthcare provider.
symptoms of using too much of a LABA medicine, including:
chest pain
increased blood pressure
fast or irregular heartbeat
headache
tremor
nervousness
sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using ANORO ELLIPTA and call your healthcare provider right away.
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
swelling of your face, mouth, and tongue
hives
breathing problems
effects on heart.
increased blood pressure
chest pain
a fast or irregular heartbeat, awareness of heartbeat
effects on nervous system.
tremor
nervousness
new or worsening eye problems including acute narrow-angle glaucoma. You should have regular eye exams while using ANORO ELLIPTA. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
eye pain or discomfort
nausea or vomiting
blurred vision
seeing halos or bright colors around lights
red eyes
If you have these symptoms, call your healthcare provider right away before taking another dose.
urinary retention. People who take ANORO ELLIPTA may develop new or worse urinary retention. Symptoms of urinary retention may include:
difficulty urinating
painful urination
urinating frequently
urination in a weak stream or drips
If you have these symptoms of urinary retention, stop taking ANORO ELLIPTA and call your healthcare provider right away before taking another dose.
changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia).
Common side effects of ANORO ELLIPTA include:
sore throat
sinus infection
lower respiratory infection
common cold symptoms
constipation
diarrhea
pain in your arms or legs
muscle spasms
neck pain
chest pain
These are not all the possible side effects of ANORO ELLIPTA.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of ANORO ELLIPTA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use
ANORO ELLIPTA for a condition for which it was not prescribed. Do not give ANORO ELLIPTA to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about ANORO ELLIPTA that is written for health professionals.
What are the ingredients in ANORO ELLIPTA?
Active ingredients: umeclidinium, vilanterol
Inactive ingredients: lactose monohydrate (contains milk proteins), magnesium stearate
OVERDOSE
If you take too much ANORO ELLIPTA, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
MISSED DOSE
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 2 doses at 1 time.
STORAGE
How should I store ANORO ELLIPTA?
Store ANORO ELLIPTA at room temperature between 68-degrees F and 77-degrees F (20-degrees C and 25-degrees C). Keep in a dry place away from heat and sunlight.
Store ANORO ELLIPTA in the unopened tray and only open when ready for use.
Safely throw away ANORO ELLIPTA in the trash 6 weeks after you open the tray or when the counter reads “0”, whichever comes first. Write the date you open the tray on the label on the inhaler.
Keep ANORO ELLIPTA and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 10/2022
Prescribing Information: revision date 06/2023
1.) Inhibitors of Cytochrome P450 3A4
Vilanterol is a substrate of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to vilanterol. Caution should be exercised when considering the coadministration of ANORO ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors [see the section WARNINGS and PRECAUTIONS above].
2.) Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, and QTc Prolonging Drugs
Vilanterol, like other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents, because the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.
3.) Beta-adrenergic Receptor Blocking Agents
Beta-blockers not only block the pulmonary effect of beta-agonists, such as vilanterol, but may also produce severe bronchospasm in patients with COPD. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution.
4.) Non–Potassium-Sparing Diuretics
The electrocardiographic changes and/or hypokalemia that may result from the administration of non–potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non–potassium-sparing diuretics.
5.) Anticholinergics
There is potential for an additive interaction with concomitantly used anticholinergic medicines. Therefore, avoid coadministration of ANORO ELLIPTA with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects [see the section WARNINGS and PRECAUTIONS above].
Before using ANORO ELLIPTA, 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 eye problems such as glaucoma. ANORO ELLIPTA may make your glaucoma worse.
are allergic to milk proteins.
have prostate or bladder problems, or problems passing urine. ANORO ELLIPTA may make these problems worse.
are pregnant or plan to become pregnant. It is not known if ANORO ELLIPTA may harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if the medicines in ANORO ELLIPTA pass into your breast milk and if they can harm your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ANORO ELLIPTA and certain other medicines may interact with each other. This may cause serious side effects.
Especially tell your healthcare provider if you take:
anticholinergics (including tiotropium, ipratropium, aclidinium)
atropine
other LABAs (including salmeterol, formoterol, arformoterol, olodaterol, and indacaterol)
antifungal or anti-HIV medicines
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
