Patient information: uses, side effects, how to take - BEVESPI Aerosphere

What is BEVESPI AEROSPHERE?

BEVESPI AEROSPHERE combines an anticholinergic, glycopyrrolate, and a long-acting beta₂-adrenergic agonist (LABA) medicine, formoterol fumarate.

Anticholinergic and LABA medicines 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.
BEVESPI AEROSPHERE is a prescription medicine used to treat COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
BEVESPI AEROSPHERE is used long term as 2 inhalations, 2 times each day in the morning and in the evening, to improve symptoms of COPD for better breathing.
BEVESPI AEROSPHERE is not for use to treat sudden symptoms of COPD. Always have a rescue inhaler (an inhaled, short-acting bronchodilator) with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
BEVESPI AEROSPHERE is not for the treatment of asthma. It is not known if BEVESPI AEROSPHERE is safe and effective in people with asthma.
BEVESPI AEROSPHERE should not be used in children. It is not known if BEVESPI AEROSPHERE is safe and effective in children.

Do not use BEVESPI AEROSPHERE if you:

are allergic to glycopyrrolate, formoterol fumarate, or to any of the ingredients in BEVESPI AEROSPHERE. See the end of this Patient Information leaflet for a complete list of ingredients.
have asthma.

Before using BEVESPI AEROSPHERE, 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. BEVESPI AEROSPHERE may make your glaucoma worse.
have prostate or bladder problems, or problems passing urine. BEVESPI AEROSPHERE may make these problems worse.
are allergic to any other medicines or food products
have any other medical conditions
are pregnant or plan to become pregnant. It is not known if BEVESPI AEROSPHERE may harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if the medicines, glycopyrrolate and formoterol fumarate, in BEVESPI AEROSPHERE pass into your breast milk and if they can harm your baby.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BEVESPI AEROSPHERE 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, and umeclidinium)
other LABAs (including salmeterol, arformoterol, vilanterol, olodaterol, and indacaterol)
atropine

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How should I use BEVESPI AEROSPHERE?

Read the step-by-step instructions for using BEVESPI AEROSPHERE at the end of this Patient Information.

Do not use BEVESPI AEROSPHERE unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
Use BEVESPI AEROSPHERE exactly as prescribed. Do not use BEVESPI AEROSPHERE more often than prescribed.
Use 2 inhalations of BEVESPI AEROSPHERE, 2 times each day (in the morning and in the evening).
If you miss a dose of BEVESPI AEROSPHERE, take your next dose at the same time you normally do. Do not take more than your prescribed dose of BEVESPI AEROSPHERE.
If you take too much BEVESPI AEROSPHERE, call your healthcare provider or go to the nearest hospital emergency room right away if you have unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
Do not spray BEVESPI AEROSPHERE in your eyes. If BEVESPI AEROSPHERE gets in your eyes, rinse them well with water. If redness continues, call your healthcare provider.
Do not stop using BEVESPI AEROSPHERE unless told to do so by your healthcare provider because your symptoms might come back. Your healthcare provider will change your medicines as needed.
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 containing medicines.
BEVESPI AEROSPHERE does not relieve sudden symptoms of COPD. 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.

What are the possible side effects with BEVESPI AEROSPHERE?

BEVESPI AEROSPHERE can cause serious side effects, including:

people with asthma who take LABA medicines, such as formoterol fumarate (one of the medicines in BEVESPI AEROSPHERE), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death.
Call your healthcare provider if breathing problems worsen over time while using BEVESPI AEROSPHERE. 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
using too much of a LABA medicine may cause:

chest pain
fast and irregular heartbeat
tremor

increased blood pressure
headache
nervousness

COPD symptoms can get worse over time. If your COPD symptoms worsen over time, do not increase your dose of BEVESPI AEROSPHERE, instead call your healthcare provider.
sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using BEVESPI AEROSPHERE 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 the face, mouth, and tongue
breathing problems

effects on your heart:

increase blood pressure
a fast or irregular heartbeat

chest pain

effects on your nervous system:

tremor

nervousness

changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia) which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm.
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
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 BEVESPI AEROSPHERE 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 BEVESPI AEROSPHERE and call your healthcare provider right away before taking another dose.

Common side effects of BEVESPI AEROSPHERE include: urinary tract infection and cough.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of BEVESPI AEROSPHERE. For more information, ask your healthcare provider or pharmacist.

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

You may also report side effects to AstraZeneca at 1-800-236-9933.

How should I store BEVESPI AEROSPHERE?

Store BEVESPI AEROSPHERE at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
Do not put a hole in the BEVESPI AEROSPHERE canister.
Do not use or store BEVESPI AEROSPHERE near heat or a flame. Temperatures above 120ºF (49ºC) may cause the canister to burst.
Do not throw the BEVESPI AEROSPHERE canister into a fire or an incinerator.
Throw away BEVESPI AEROSPHERE 3 months after you open the foil pouch or when the dose indicator reaches zero “0”, whichever comes first.
Keep BEVESPI AEROSPHERE and all medicines out of the reach of children.

General Information about the safe and effective use of BEVESPI AEROSPHERE

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BEVESPI AEROSPHERE for a condition for which it was not prescribed. Do not give your BEVESPI AEROSPHERE 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 BEVESPI AEROSPHERE that is written for health professionals.

Active ingredients: micronized glycopyrrolate and micronized formoterol fumarate

Inactive ingredients: hydrofluoroalkane (HFA 134a) and porous particles (comprised of DSPC [1,2-Distearoyl-sn-glycero-3-phosphocholine] and calcium chloride)

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

For more information, call 1-800-236-9933 or go to www.BEVESPI.com.

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

Instructions for Use

BEVESPI AEROSPHERE^®

(be-VES-pee AIR-oh-sfeer)

(glycopyrrolate and formoterol fumarate)

Inhalation aerosol, for oral inhalation use

Read this Instructions for Use before you start using BEVESPI AEROSPHERE and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Important Information:

For oral inhalation use only.
Use BEVESPI AEROSPHERE exactly as your healthcare provider tells you to.
If you have any questions about the use of your inhaler, ask your healthcare provider or pharmacist.

Parts of your BEVESPI AEROSPHERE inhaler (See Figure 1):

BEVESPI AEROSPHERE comes as a canister that fits into an actuator with a dose indicator.
- Do not use the BEVESPI AEROSPHERE actuator with a canister of medicine from any other inhaler.
- Do not use the BEVESPI AEROSPHERE canister with an actuator from any other inhaler.

BEVESPI AEROSPHERE comes with a dose indicator located on the top of the canister (See Figure 1). The dose indicator display window will show you how many puffs of medicine you have left. A puff of medicine is released each time you press the center of the dose indicator.

Before you use BEVESPI AEROSPHERE for the first time make sure that the pointer on the dose indicator is pointing to the right of the “120” inhalation mark in the dose indicator display window (See Figure 1).

The pointer will be pointing to 120 after 10 puffs are delivered from BEVESPI AEROSPHERE. This means that there are 120 puffs of medicine left in the canister (See Figure 2a).
The pointer will be pointing between 100 and 120 after you take 10 more puffs. This means that there are 110 puffs of medicine left in the canister (See Figure 2b).
The pointer will be pointing to 100 after you take 10 more puffs. This means that there are 100 puffs of medicine left in the canister (See Figure 2c).

The dose indicator display window will continue to move after every 10 puffs. The number in the dose indicator display window will continue to change after every 20 puffs.

The color in the dose indicator display window will change to red, as shown in the shaded area, when there are only 20 puffs of medicine left in your inhaler (See Figure 2d).

Preparing your BEVESPI AEROSPHERE inhaler for use:

BEVESPI AEROSPHERE should be at room temperature before you use it.
Your BEVESPI AEROSPHERE inhaler comes in a foil pouch that contains a drying packet (desiccant).
- Take the BEVESPI AEROPSHERE inhaler out of the foil pouch.
- Throw away the pouch and the drying packet. Do not eat or breathe in the contents of the drying packet.

Priming your BEVESPI AEROSPHERE inhaler:

Before you use BEVESPI AEROSPHERE for the first time, you must prime the inhaler.

Remove the cap from the mouthpiece (See Figure 3). Check inside the mouthpiece for objects before use.
Hold the inhaler in the upright position away from your face and shake the inhaler well (See Figure 4).

Press down firmly on the center of the dose indicator until the canister stops moving in the actuator, to release a puff of medicine from the mouthpiece (See Figure 5). You may hear a soft click from the dose indicator as it counts down during use.

Repeat the priming steps 3 more times (See Figure 4 and Figure 5). Shake the inhaler well before each priming puff.
After priming 4 times, the dose indicator should be pointing to the right of “120” and your inhaler is now ready to use.

Using your BEVESPI AEROSPHERE inhaler:

Step 1: Remove the cap from the mouthpiece (See Figure 6).

Step 2: Shake the inhaler well before each use (See Figure 7).

Step 3: Hold the inhaler with the mouthpiece pointing towards you and breathe out as fully as you comfortably can through your mouth (See Figure 8).

Step 4: Close your lips around the mouthpiece and tilt your head back, keeping your tongue below the mouthpiece (See Figure 9).

Step 5: While breathing in deeply and slowly, press down on the center of the dose indicator until the canister stops moving in the actuator and a puff of medicine has been released (See Figure 10). Then stop pressing the dose indicator.

Step 6: When you have finished breathing in, remove the mouthpiece from your mouth. Hold your breath as long as you comfortably can, up to 10 seconds (See Figure 11).

Step 7: Breathe out gently (See Figure 12). Repeat steps 2 through 7 to take your second puff of BEVESPI AEROSPHERE.

Step 8: Replace the cap over the mouthpiece right away after use (See Figure 13).

How to clean your BEVESPI AEROSPHERE inhaler:

Clean the inhaler 1 time each week. It is very important to keep your inhaler clean so that medicine will not build-up and block the spray through the mouthpiece (See Figure 14).

Step 1: Take the canister out of the actuator (See Figure 15). Do not clean the canister or let it get wet.

Step 2: Take the cap off the mouthpiece.

Step 3: Hold the actuator under the faucet and run warm water through it for about 30 seconds. Turn the actuator upside down and rinse the actuator again through the mouthpiece for about 30 seconds (See Figure 16).

Step 4: Shake off as much water from the actuator as you can.

Step 5: Look into the actuator and the mouthpiece to make sure any medicine build-up has been completely washed away. If there is any build-up, repeat Steps 3 through 5 in the section “How to clean your BEVESPI AEROSPHERE inhaler”.

Step 6: Let the actuator air-dry overnight (See Figure 17). Do not put the canister back into the actuator if it is still wet.

Step 7: When the actuator is dry, gently press the canister down in the actuator (See Figure 18). Do not press down too hard on the canister. This could cause a puff of medicine to be released.

Step 8: Re-prime your BEVESPI AEROSPHERE inhaler after each cleaning. To re-prime the inhaler, shake the inhaler well and press down on the center of the dose indicator 2 times to release a total of 2 puffs into the air away from your face. Your inhaler is now ready to use.

If you do not use your BEVESPI AEROSPHERE for more than 7 days, you will need to re-prime it before use.

To re-prime the inhaler, shake the inhaler well and press down on the center of the dose indicator 2 times to release a total of 2 puffs into the air away from your face. Your inhaler is now ready to use.

BEVESPI and BEVESPI AEROSPHERE are registered trademarks of the AstraZeneca group of companies.

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

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

Revised: March 2023

BEVESPI Aerosphere: Uses, Side Effects and Dosage