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ANORO ELLIPTA- umeclidinium bromide and vilanterol trifenatate powder


  1. Patient Information
  2. Do Not Use Anoro Ellipta If You:
  3. Anoro Ellipta Can Cause Serious Side Effects, Including:
  4. Get Emergency Medical Care If:
  5. Symptoms Of Using Too Much Of A Laba Medicine, Including:
  6. Active Ingredients:
  7. Inactive Ingredients:
  8. Read This Before You Start:
  9. Revised: 7/2019document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Serious Asthma-Related Events

ANORO ELLIPTA is not indicated for the treatment of asthma. Inform patients that LABA, such as vilanterol (one of the active ingredients in ANORO ELLIPTA), when used alone (without ICS) for asthma increase the risk of asthma-related hospitalization or asthma-related death.

Not for Acute Symptoms

Inform patients that ANORO ELLIPTA is not meant to relieve acute symptoms of COPD and extra doses should not be used for that purpose. Advise patients to treat acute symptoms with an inhaled, short-acting beta2-agonist such as albuterol. Provide patients with such medicine and instruct them in how it should be used.

Instruct patients to

ANORO ELLIPTA combines 2 medicines in one inhaler, an anticholinergic medicine (umeclidinium) and a long acting beta2-adrenergic agonist (LABA) medicine (vilanterol).
o
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 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 used to treat sudden symptoms of COPD.Always have a rescue inhaler (an inhaled, short-acting bronchodilator) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
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.

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.

Read the step-by-step instructions for using ANORO ELLIPTA at the end of this Patient Information.

Do notuse ANORO ELLIPTA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly. Ask your healthcare provider or pharmacist if you have any questions.
Use ANORO ELLIPTA exactly as prescribed.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 notstop 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 breathing problems.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, or your rescue inhaler does not work as well to relieve your symptoms.

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
fast or irregular heartbeat
tremor
increased blood pressure
headache
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
hives
swelling of your face, mouth, and tongue
breathing problems
effects on heart.
increased blood pressure
a fast or irregular heartbeat, awareness of heartbeat
chest pain
effects on nervous system.
tremor
nervousness
new or worsened eye problems including acute narrow-angle glaucoma.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
blurred vision
red eyes
nausea or vomiting

Store ANORO ELLIPTA at room temperature between 68 F and 77 F (20 C and 25 C).
Store ANORO ELLIPTA 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.

General information about the safe and effective use of ANORO ELLIPTA.

Medicines are sometimes prescribed for purposes not mentioned 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.

This Patient Information leaflet summarizes the most important information about ANORO ELLIPTA. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about ANORO ELLIPTA that is written for health professionals.

Active Ingredients: 

umeclidinium, vilanterol

Inactive Ingredients: 

lactose monohydrate (contains milk proteins), magnesium stearate

For more information about ANORO ELLIPTA, call 1-888-825-5249 or visit our website atwww.ANORO.com.

Trademarks are owned by or licensed to the GSK group of companies.

ANORO ELLIPTA was developed in collaboration with Innoviva.

GlaxoSmithKline, Research Triangle Park, NC 27709

2019 GSK group of companies or its licensor.

ANR:8PIL

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: June 2019

INSTRUCTIONS FOR USE

ANORO ELLIPTA (a-NOR oh e-LIP-ta)

(umeclidinium and vilanterol inhalation powder)

for oral inhalation use

Read This Before You Start: 

If you open and close the cover without inhaling the medicine, you will lose the dose.
The lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled.
It is not possible to accidentally take a double dose or an extra dose in 1 inhalation.

Your ANORO ELLIPTA inhaler

Inhaler Parts Figure

How to use your inhaler

ANORO ELLIPTA comes in a tray.
Peel back the lid to open the tray.

Figure K
Figure K

When you have fewer than 10 doses remainingin your inhaler, the left half of the counter shows red as a reminder to get a refill.See Figure K.
After you have inhaled the last dose, the counter will show 0 and will be empty.
Throw the empty inhaler away in your household trash out of reach of children and pets.

For more information about ANORO ELLIPTA or how to use your inhaler, call 1-888-825-5249 or visit our website atwww.ANORO.com.

Trademarks are owned by or licensed to the GSK group of companies.

ANORO ELLIPTA was developed in collaboration with Innoviva.

GlaxoSmithKline, Research Triangle Park, NC 27709

2019 GSK group of companies or its licensor.

ANR:4IFU

This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: May 2019

PRINCIPAL DISPLAY PANEL

NDC 0173-0869-10

ANOROELLIPTA

(umeclidinium and vilanterol inhalation powder)

Rx Only

62.5 mcg/25 mcg

FOR ORAL INHALATION ONLY

Each blister on one strip contains 62.5 mcg of umeclidinium, magnesium stearate, and lactose monohydrate. Each blister on the other strip contains 25 mcg of vilanterol, magnesium stearate, and lactose monohydrate.

1 ELLIPTAInhaler containing 30 doses (60 blisters total)

2017 the GSK group of companies

DFT-01714-4067587 Rev. 5/19
Anoro Ellipta 30 dose carton
ANORO ELLIPTA
umeclidinium bromide and vilanterol trifenatate powder
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0173-0869
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UMECLIDINIUM BROMIDE(UNII: 7AN603V4JV) (UMECLIDINIUM - UNII:GE2T1418SV)UMECLIDINIUM62.5 ug
VILANTEROL TRIFENATATE(UNII: 40AHO2C6DG) (VILANTEROL - UNII:028LZY775B)VILANTEROL25 ug
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE(UNII: 70097M6I30)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0173-0869-101 in 1 CARTON01/31/2014
11 in 1 TRAY
130 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0173-0869-061 in 1 CARTON01/31/2014
21 in 1 TRAY
27 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0173-0869-611 in 1 CARTON01/31/2014
31 in 1 TRAY
37 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20397501/31/2014
Labeler -GlaxoSmithKline LLC (167380711)

Revised: 7/2019document Id: 

e258a6c3-89d0-4c4f-b6ae-97ff8bc91c74Set id: 2dbd0671-c565-40c5-bf0f-e324db26799cVersion: 20Effective Time: 20190730GlaxoSmithKline LLC



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