Patient information: uses, side effects, how to take - Fluticasone and Vilanterol

What is Fluticasone Furoate/Vilanterol ELLIPTA?

Fluticasone Furoate/Vilanterol ELLIPTA combines 2 medicines in 1 inhaler, an inhaled corticosteroid (ICS) medicine (fluticasone furoate), and a long-acting beta₂‑adrenergic agonist (LABA) medicine (vilanterol).
- ICS medicines such as fluticasone furoate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
- 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.
Fluticasone Furoate/Vilanterol ELLIPTA is not used to relieve sudden breathing problems and will not replace a rescue inhaler.
Fluticasone Furoate/Vilanterol ELLIPTA is a prescription medicine used long term (chronic) to treat people with:
Chronic Obstructive Pulmonary Disease (COPD):
1. o Fluticasone Furoate/Vilanterol ELLIPTA is a prescription medicine used to treat COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
2. o Fluticasone Furoate/Vilanterol ELLIPTA is used 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).
Asthma:
1. o Fluticasone Furoate/Vilanterol ELLIPTA is a prescription medicine used to prevent and control symptoms of asthma for better breathing and to prevent symptoms such as wheezing.
2. o Fluticasone Furoate/Vilanterol ELLIPTA contains vilanterol. LABA medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. Fluticasone Furoate/Vilanterol ELLIPTA contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
It is not known if Fluticasone Furoate/Vilanterol ELLIPTA is safe and effective in children younger than 5 years of age.

Do not use Fluticasone Furoate/Vilanterol ELLIPTA:

to treat sudden, severe symptoms of COPD or asthma.
if you have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
if you are allergic to fluticasone furoate, vilanterol, or any of the ingredients in Fluticasone Furoate/Vilanterol ELLIPTA. See the end of this Patient Information for a complete list of ingredients in Fluticasone Furoate/Vilanterol ELLIPTA.

Before using Fluticasone Furoate/Vilanterol 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 or have been told you have high blood sugar.
have liver problems.
have weak bones (osteoporosis).
have an immune system problem.
have eye problems such as glaucoma, increased pressure in your eye, cataracts, or other changes in vision.
are allergic to milk proteins.
have any type of viral, bacterial, fungal, or parasitic infection.
are exposed to chickenpox or measles.
are pregnant or plan to become pregnant. It is not known if Fluticasone Furoate/Vilanterol ELLIPTA may harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if the medicines in Fluticasone Furoate/Vilanterol 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. Fluticasone Furoate/Vilanterol ELLIPTA and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take

other LABA (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.

How should I use Fluticasone Furoate/Vilanterol ELLIPTA?

Read the step-by-step instructions for using Fluticasone Furoate/Vilanterol ELLIPTA at the end of this Patient Information.

Do not use Fluticasone Furoate/Vilanterol ELLIPTA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
Fluticasone Furoate/Vilanterol ELLIPTA comes in 2 different strengths. Your healthcare provider prescribed the strength that is best for you.
Use Fluticasone Furoate/Vilanterol ELLIPTA exactly as your healthcare provider tells you to use it. Do not use Fluticasone Furoate/Vilanterol ELLIPTA more often than prescribed.
Children may need help to use Fluticasone Furoate/Vilanterol ELLIPTA.
Use 1 inhalation of Fluticasone Furoate/Vilanterol ELLIPTA 1 time each day. Use Fluticasone Furoate/Vilanterol ELLIPTA at the same time each day.
If you miss a dose of Fluticasone Furoate/Vilanterol 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 Fluticasone Furoate/Vilanterol 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 for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
Do not stop using Fluticasone Furoate/Vilanterol 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.
Fluticasone Furoate/Vilanterol ELLIPTA does not relieve sudden symptoms of COPD or asthma and you should not take extra doses of Fluticasone Furoate/Vilanterol 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.
- your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.

What are the possible side effects of Fluticasone Furoate/Vilanterol ELLIPTA?

Fluticasone Furoate/Vilanterol ELLIPTA can cause serious side effects, including:

fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using Fluticasone Furoate/Vilanterol ELLIPTA to help reduce your chance of getting thrush.
pneumonia. People with COPD have a higher chance of getting pneumonia. Fluticasone Furoate/Vilanterol ELLIPTA may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:

increase in mucus (sputum) production
change in mucus color
fever

chills
increased cough
increased breathing problems

weakened immune system and increased chance of getting infections (immunosuppression).
reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an ICS (such as Fluticasone Furoate/Vilanterol ELLIPTA). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse COPD or asthma symptoms, adrenal insufficiency can get worse and may cause death.
Symptoms of adrenal insufficiency include:

feeling tired
lack of energy
weakness

nausea and vomiting
low blood pressure (hypotension)

sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using Fluticasone Furoate/Vilanterol 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

bone thinning or weakness (osteoporosis).
slowed growth in children. A child’s growth should be checked often.
eye problems including glaucoma, increased pressure in your eye, cataracts, or other changes in vision. You should have regular eye exams while using Fluticasone Furoate/Vilanterol ELLIPTA.
changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia).

Common side effects of Fluticasone Furoate/Vilanterol ELLIPTA include:

COPD:

runny nose and sore throat
upper respiratory tract infection
headache
thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
back pain
pneumonia

bronchitis
inflammation of the sinuses
cough
mouth and throat pain
joint pain
increased blood pressure
flu
fever

Asthma:

runny nose and sore throat
thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
headache
flu

respiratory tract infection
bronchitis
inflammation of the sinuses
mouth and throat pain
hoarseness and voice changes
cough

These are not all the possible side effects of Fluticasone Furoate/Vilanterol ELLIPTA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Fluticasone Furoate/Vilanterol ELLIPTA?

Store Fluticasone Furoate/Vilanterol ELLIPTA at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.
Store Fluticasone Furoate/Vilanterol ELLIPTA in the unopened tray and only open when ready for use.
Safely throw away Fluticasone Furoate/Vilanterol 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 Fluticasone Furoate/Vilanterol ELLIPTA and all medicines out of the reach of children.

General information about the safe and effective use of Fluticasone Furoate/Vilanterol ELLIPTA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Fluticasone Furoate/Vilanterol ELLIPTA for a condition for which it was not prescribed. Do not give Fluticasone Furoate/Vilanterol 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 Fluticasone Furoate/Vilanterol ELLIPTA that is written for health professionals.

What are the ingredients in Fluticasone Furoate/Vilanterol ELLIPTA?

Active ingredients: fluticasone furoate, vilanterol trifenatate

Inactive ingredients: lactose monohydrate (contains milk proteins), magnesium stearate

For more information about Fluticasone Furoate/Vilanterol ELLIPTA, call 1-866-525-0688 or visit our website at www.Prasco.com.

ELLIPTA is a registered trademark of the GSK group of companies.

Manufactured for:

Prasco Laboratories

Mason, OH 45040 USA

Manufactured by:

GlaxoSmithKline

Durham, NC 27701

BRE-PS:2PIL

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: August 2023

INSTRUCTIONS FOR USE Fluticasone Furoate/Vilanterol ELLIPTA inhalation powder (floo-tik’-a-sone fyoor’-oh-ate vye-lan’-ter-ol elip’-ta) 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 Fluticasone Furoate/Vilanterol ELLIPTA inhaler How to use your inhaler Fluticasone Furoate/Vilanterol ELLIPTA comes in a tray. Peel back the lid to open the tray. See Figure A. The tray contains a desiccant to reduce moisture. Do not eat or inhale. Throw it away in the household trash out of reach of children and pets. See Figure B.
Figure A	Figure B
Important Notes: Your inhaler contains 30 doses. Each time you fully open the cover of the inhaler (you will hear a clicking sound), a dose is ready to be inhaled. This is shown by a decrease in the number on the counter. If you open and close the cover without inhaling the medicine, you will lose the dose. The lost dose will be held in 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. Do not open the cover of the inhaler until you are ready to use it. To avoid wasting doses after the inhaler is ready, do not close the cover until after you have inhaled the medicine. Write the “Tray opened” and “Discard” dates on the inhaler label. The “Discard” date is 6 weeks from the date you open the tray. Check the counter. See Figure C.
Figure C	Before the inhaler is used for the first time, the counter should show the number 30. This is the number of doses in the inhaler. Each time you open the cover, you prepare 1 dose of medicine. The counter counts down by 1 each time you open the cover.
Prepare your dose: Wait to open the cover until you are ready to take your dose.
Figure D	Step 1. Open the cover of the inhaler. See Figure D. Slide the cover down to expose the mouthpiece. You should hear a “click.” The counter will count down by 1 number. You do not need to shake this kind of inhaler. Your inhaler is now ready to use. If the counter does not count down as you hear the click, the inhaler will not deliver the medicine. Call your healthcare provider or pharmacist if this happens.
Figure E	Step 2. Breathe out. See Figure E. While holding the inhaler away from your mouth, breathe out (exhale) fully. Do not breathe out into the mouthpiece.
Figure F	Step 3. Inhale your medicine. See Figure F. 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 one long, steady, deep breath in through your mouth. Do not breathe in through your nose.
Figure G	Do not block the air vent with your fingers. See Figure G.
Figure H	Remove the inhaler from your mouth and hold your breath for about 3 to 4 seconds (or as long as comfortable for you). See Figure H.
Figure I	Step 4. Breathe out slowly and gently. See Figure I. You may not taste or feel the medicine, even when you are using the inhaler correctly. Do not take another dose from the inhaler even if you do not feel or taste the medicine.
Figure J	Step 5. Close the inhaler. See Figure J. 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.
Figure K	Step 6. Rinse your mouth. See Figure K. Rinse your mouth with water after you have used the inhaler and spit the water out. Do not swallow the water.
Important Note: When should you get a refill?
Figure L	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. See Figure L. 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 Fluticasone Furoate/Vilanterol ELLIPTA or how to use your inhaler, call 1-866-525-0688 or visit our website at www.Prasco.com. ELLIPTA is a registered trademark of the GSK group of companies. Manufactured for: Prasco Laboratories Mason, OH 45040 USA Manufactured by: GlaxoSmithKline Durham, NC 27701 BRE-PS:2IFU