Bevespi Aerosphere (glycopyrrolate/formoterol fumarate)

Bevespi Aerosphere is a brand-name prescription medication. It’s used to treat chronic obstructive pulmonary disease (COPD) in adults.

COPD is a group of lung diseases that are chronic (long-lasting) and progressive (worsen over time). These diseases include emphysema and chronic bronchitis. COPD damages the airways in your lungs, making them inflamed and narrowed. This makes it harder to breathe.

Bevespi Aerosphere contains two active drugs:

• glycopyrrolate, which belongs to a class of drugs called anticholinergic agents
• formoterol fumarate, which belongs to a class of drugs called long-acting beta-agonists (LABAs)

Both of these drugs are long-acting bronchodilators. These medications open your airways and make it easier to breathe. Although it opens up the airways, Bevespi Aerosphere is not used to treat asthma.

Aerosphere is the name of the inhaler that Bevespi comes in. You use the inhaler to breathe the medication through your mouth and down into your lungs. You’ll use Bevespi Aerosphere twice each day to help keep your airways open.

Effectiveness

In clinical studies, Bevespi Aerosphere was more effective than a placebo (a treatment with no active drug) at improving how well your lungs work. Bevespi Aerosphere was also more effective than glycopyrrolate or formoterol when used on their own. These two drugs are the active ingredients in Bevespi.

Researchers studied the effect of Bevespi Aerosphere on a measure of lung function called FEV1. FEV stands for forced expiratory volume. FEV1 is the amount of air you can force from your lungs in one second. People with COPD have lower measures of FEV1 than people with healthy lungs. A higher FEV1 shows an improvement in lung function.

In one clinical study, FEV1 was measured before treatment and again after 24 weeks of treatment. Bevespi Aerosphere improved FEV1 by:

• 150 mL more than a placebo
• 59 mL more than glycopyrrolate used on its own
• 64 mL more than formoterol used on its own

People using Bevespi Aerosphere were also found to have better health-related quality of life than people using just glycopyrrolate, just formoterol, or a placebo. Health-related quality of life was assessed using a questionnaire. The questionnaire asked how often people got symptoms and how severe they were. It also asked how symptoms affected daily activities and mental health.

Not a rescue medication

Bevespi Aerosphere is a maintenance medication used to treat COPD long term. It doesn’t work the same as fast-acting bronchodilators (rescue inhalers) and isn’t meant for emergency use. If you have a breathing emergency, use your rescue inhaler (such as albuterol) as prescribed by your doctor. If your symptoms feel life-threatening, call 911 right away.

Bevespi Aerosphere is available only as a brand-name medication. It’s not currently available in generic form.

Bevespi Aerosphere contains two active drug ingredients: glycopyrrolate and formoterol fumarate. These are also available separately as brand-name drugs:

• Seebri Neohaler and Lonhala Magnair are the brand-name versions of glycopyrrolate. They’re used to treat COPD.
• Foradil Aerolizer and Perforomist are brand-name versions of formoterol fumarate. Perforomist is used to treat COPD. Foradil is used to treat asthma as well as COPD.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Bevespi Aerosphere is a metered-dose inhaler. Each puff delivers:

• 9 mcg of glycopyrrolate
• 4.8 mcg of formoterol fumarate

Dosage for COPD

The usual dosage for COPD is two puffs taken twice a day, in the morning and evening. Do not take more than this.

Note: Don’t take Bevespi Aerosphere to relieve sudden breathing problems. You need to use your rescue inhaler, such as albuterol, if you are breathless and need to quickly improve your breathing.

What if I miss a dose?

If you forget to take a dose, take your next dose as usual at your normal time. Don’t take extra puffs to make up for a missed dose.

To help make sure you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Bevespi Aerosphere is meant to be used as a long-term treatment. If you and your doctor decide that Bevespi Aerosphere is safe and effective for you, you’ll likely take it long term.

Bevespi Aerosphere can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Bevespi Aerosphere. These lists do not include all possible side effects.

For more information on the possible side effects of Bevespi Aerosphere, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

More common side effects

The more common side effects of Bevespi Aerosphere can include:

• urinary tract infection
• cough

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Bevespi Aerosphere aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Paradoxical bronchospasm (sudden, unexpected breathing problems immediately after inhaling the drug). Symptoms can include:
  • problems getting enough air
  • wheezing
  • coughing
  • chest tightness or pain
• Serious allergic reactions. Symptoms can include:
  • angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
  • swelling of your tongue, mouth, or throat
  • trouble breathing
• Effects on your heart. Symptoms can include:
  • fast or irregular heartbeat (arrhythmias)
  • chest pain
  • high blood pressure
• New or worsening closed-angle glaucoma (also called narrow-angle glaucoma), which means increased pressure in your eyes. Symptoms can include:
  • pain in your eyes
  • seeing halos around lights
  • red eyes
  • blurred vision
• New or worsening urinary retention (problems passing urine). Symptoms can include:
  • difficulty passing urine
  • pain passing urine
  • urinating more frequently
  • urinating with a weak flow or in drips
• Low level of potassium in your blood, which can cause muscle and heart problems. Symptoms can include:
  • muscle spasms (twitches)
  • muscle weakness
  • abnormal heart rhythm
• High blood sugar level, which can be a problem for people with diabetes.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Paradoxical bronchospasm

Paradoxical bronchospasm is a sudden narrowing of the airways in your lungs that causes sudden breathing problems. Paradoxical bronchospasm can happen right after taking a puff from any inhaler, including Bevespi Aerosphere.

It’s not known how often this side effect occurs with Bevespi Aerosphere. It occurred in the clinical studies, but no statistics were provided.

If you have paradoxical bronchospasm, you’ll notice that it becomes harder to breathe in and out right after taking a puff of Bevespi Aerosphere. You may wheeze and cough, and your chest may feel tight.

If you have this side effect, don’t use the Bevespi Aerosphere inhaler again. Instead, use your rescue inhaler, such as albuterol, right away to open your airways. And call your doctor as soon as possible so they can find you an alternative treatment.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Bevespi Aerosphere. Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have a severe allergic reaction to Bevespi Aerosphere. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Cough

In clinical studies, 4% of people using Bevespi Aerosphere reported a cough. This is compared with 2.7% of people using a placebo (a treatment with no active drug).

Coughing is a common symptom of COPD. However, talk to your doctor if you feel like your cough has gotten worse after starting Bevespi Aerosphere. Getting a new or worsening cough can sometimes be a sign that your COPD is getting worse or that you have a chest infection.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Bevespi Aerosphere, talk with your doctor. They can tell you about other medications that may work well for you.

Alternatives for COPD

Examples of other drugs that may be used for long-term maintenance treatment of COPD include:

• Long-acting beta-agonist (LABA) inhalers, such as:
  • arformoterol (Brovana)
  • indacaterol (Arcapta)
  • olodaterol (Striverdi)
  • salmeterol (Serevent)
• Long-acting anticholinergic inhalers, such as:
  • aclidinium (Tudorza)
  • tiotropium (Spiriva)
  • umeclidinium (Incruse Ellipta)
• Steroid and LABA combination inhalers, such as:
  • fluticasone and salmeterol (Advair, Seretide)
  • fluticasone and vilanterol (Breo)
  • budesonide and formoterol (Symbicort)
• Other bronchodilator combination inhalers, such as:
  • glycopyrrolate and indacaterol (Utibron)
  • tiotropium and olodaterol (Stiolto)
  • umeclidinium and vilanterol (Anoro)
• Triple combination inhalers such as:
  • fluticasone, umeclidinium, and vilanterol (Trelegy)

You may wonder how Bevespi Aerosphere compares to other medications that are prescribed for similar uses. Here we look at how Bevespi Aerosphere and Symbicort are alike and different.

Uses

Bevespi and Symbicort are both FDA-approved for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). Symbicort is also approved for reducing flare-ups of COPD. A flare-up happens when you get increased COPD symptoms, often because of a chest infection. The only strength of Symbicort approved for COPD is 160/4.5 mcg.

Bevespi Aerosphere is not approved to treat asthma. Symbicort is approved to treat asthma in adults and children ages 6 years and older.

Bevespi Aerosphere and Symbicort are not used as rescue medications (which relieve sudden attacks of breathlessness).

Drug forms and administration

Bevespi Aerosphere and Symbicort both come in a device called a metered-dose inhaler.

Bevespi Aerosphere contains two bronchodilators (drugs that open your airways). One drug is a long-acting beta-agonist (LABA) called formoterol. The other is a long-acting anticholinergic called glycopyrrolate.

Symbicort contains the long-acting bronchodilator formoterol. It also contains a corticosteroid (a drug that reduces inflammation) called budesonide.

The dosage for both Bevespi Aerosphere and Symbicort for COPD is two puffs twice a day, every day.

Side effects and risks

Bevespi Aerosphere and Symbicort both contain formoterol. Bevespi Aerosphere also contains glycopyrrolate, while Symbicort also contains budesonide. Because of these ingredients, the two medications can cause some similar and some different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Bevespi Aerosphere or Symbicort.

• Can occur with Bevespi Aerosphere:
  • urinary tract infection
  • cough
• Can occur with Symbicort:
  • throat irritation
  • thrush infection in the mouth and throat
  • sinusitis (inflammation of the sinuses)
  • upper respiratory tract infections, such as the common cold

Serious side effects

These lists contain examples of serious side effects that can occur with Bevespi Aerosphere, with Symbicort, or with both drugs (when taken individually).

• Can occur with Bevespi Aerosphere:
  • urinary retention (problems passing urine)
• Can occur with Symbicort:
  • lung infections such as pneumonia
  • weakened immune system and increased risk of getting infections
  • reduced bone mineral density (weakened bones)
  • cataracts (clouding of the lens in your eye)
  • reduced production of a hormone called cortisol by your adrenal glands
• Can occur with both Bevespi Aerosphere and Symbicort:
  • paradoxical bronchospasm (wheezing or trouble breathing right after using your inhaler)
  • severe allergic reactions
  • heart problems, such as fast or irregular heartbeat and chest pain
  • glaucoma (increased pressure in your eye)
  • low level of potassium in your blood
  • high blood sugar levels

Effectiveness

Bevespi Aerosphere and Symbicort have different FDA-approved uses, but they’re both used to treat COPD.

These drugs haven’t been directly compared in clinical studies. However, studies have found both Bevespi Aerosphere and Symbicort to be effective for long-term maintenance treatment of COPD.

Both medications are included in current treatment guidelines as options for COPD maintenance treatment.

Costs

Bevespi Aerosphere and Symbicort are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Bevespi Aerosphere and Symbicort generally cost about the same. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Bevespi Aerosphere and Anoro Ellipta are prescribed for similar uses. Below are details on how these medications are alike and different.

Uses

Bevespi Aerosphere and Anoro Ellipta are both FDA-approved for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD).

Neither drug is used for treating asthma. Also, neither is used as a rescue medication, which helps relieve sudden attacks of breathlessness.

Drug forms and administration

Bevespi comes in a metered-dose inhaler called an Aerosphere. To take a puff, you have to press down on the canister at the same time as you breathe in through the mouthpiece.

Anoro comes as a dry powder inhaler called an Ellipta. To take a puff, you open the cover and breathe in through the mouthpiece.

Bevespi Aerosphere and Anoro Ellipta are both bronchodilators (drugs that open your airways). They both contain a long-acting beta-agonist (LABA) with a long-acting anticholinergic.

Bevespi Aerosphere contains formoterol (a LABA) and glycopyrrolate (an anticholinergic). Anoro Ellipta contains vilanterol (a LABA) and umeclidinium (an anticholinergic).

The dosage for Bevespi Aerosphere is two puffs, twice a day. With Anoro Ellipta, you take one puff, once a day.

Side effects and risks

Bevespi Aerosphere and Anoro Ellipta both contain a LABA and an anticholinergic. Therefore, the medications can cause very similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Bevespi Aerosphere or Anoro Ellipta.

• Can occur with Bevespi Aerosphere:
  • urinary tract infections
  • cough
• Can occur with Anoro Ellipta:
  • diarrhea
  • constipation
  • sinusitis (inflammation of the upper sinuses)
  • pharyngitis (inflammation of the back of the throat)
  • pneumonia
  • muscle pain or spasm

Serious side effects

This list contains examples of serious side effects that can occur with both Bevespi Aerosphere and Anoro Ellipta (when taken individually).

• Can occur with both Bevespi Aerosphere and Anoro Ellipta:
  • paradoxical bronchospasm (wheezing or trouble breathing right after using your inhaler)
  • severe allergic reactions
  • heart problems, such as fast or irregular heartbeat and chest pain
  • closed-angle glaucoma (also called narrow-angle glaucoma), or increased pressure in your eyes
  • urinary retention (trouble passing urine)
  • low level of potassium in your blood
  • high blood sugar levels

Effectiveness

The only condition both Bevespi Aerosphere and Anoro are used to treat is COPD.

Studies have found both Bevespi Aerosphere and Anoro to be effective for treating COPD. They’re currently being directly compared in a clinical study. Once the results are analyzed, it may be known if one is more effective than the other.

Both medications are included in current treatment guidelines as options for COPD maintenance treatment.

Costs

Bevespi Aerosphere and Anoro are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Bevespi Aerosphere and Anoro generally cost about the same. The actual price you’ll pay for either drug will depend on your insurance plan, your location, and the pharmacy you use.

As with all medications, the cost of Bevespi Aerosphere can vary.

The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial assistance

If you need financial support to pay for Bevespi Aerosphere, help is available. AstraZeneca, the manufacturer of Bevespi Aerosphere, offers a Zero-Pay program. For more information and to find out if you’re eligible for support, call 800-236-9933 or visit the program website.

The Food and Drug Administration (FDA) approves prescription drugs such as Bevespi Aerosphere to treat certain conditions.

Bevespi Aerosphere for COPD

Bevespi Aerosphere is FDA-approved for the maintenance treatment (long-term everyday treatment) of chronic obstructive pulmonary disease (COPD). COPD is a lung condition that is chronic (long-lasting) and progressive (gets worse over time). People with COPD usually have varying degrees of emphysema and chronic bronchitis.

With COPD, damage to the lining of your lungs causes your airways to become narrowed and inflamed (swollen). You may also get a buildup of mucus in your airways that’s harder to cough up. All of these problems make it more difficult to breathe in and out. This trouble breathing makes it difficult to get enough oxygen, which leaves you feeling breathless.

You take Bevespi Aerosphere every day to open your airways and help keep them open all the time. This makes it easier to breathe, and easier to clear mucus from your airways.

Bevespi Aerosphere is only prescribed for adults. It has not been studied in children because COPD mainly affects adults over 40 years old.

Effectiveness

In two clinical studies of people with COPD, Bevespi Aerosphere improved lung function (how well your lungs work). It worked better than a placebo (a treatment with no active drug). It also worked better than its individual ingredients (glycopyrrolate and formoterol) when they were used on their own.

In the studies, researchers tested how well Bevespi Aerosphere improved FEV1. FEV stands for forced expiratory volume. FEV1 is the amount of air you can force from your lungs in one second. It helps show how well your lungs are working. The researchers measured the FEV1 before and after 24 weeks of treatment.

In the study, people were split into four groups. They all took different medications through the Aerosphere inhaler twice a day for 24 weeks. Each group took one of the following:

• Bevespi
• placebo (a treatment with no active drug)
• glycopyrrolate on its own
• formoterol on its own

After 24 weeks, people using Bevespi Aerosphere had a bigger improvement in their FEV1 than people in the other three groups. People using Bevespi Aerosphere had an average increase in their FEV1 of:

• 103–150 mL more than people using placebo
• 54–59 mL more than people using just glycopyrrolate
• 56–64 mL more than people using just formoterol

In the studies, people given Bevespi Aerosphere needed fewer doses of a rescue medication (which relieves sudden attacks of breathlessness) than people given a placebo.

They also reported a better health-related quality of life than people using the placebo, just glycopyrrolate, or just formoterol.

Health-related quality of life is assessed using a questionnaire. It looks at how often you get symptoms and how severe they are. It also takes into account how your symptoms affect your daily activities and your mental health.

Bevespi Aerosphere for other conditions

In addition to COPD, you may wonder if Bevespi Aerosphere is used for certain other conditions.

Bevespi Aerosphere for asthma (not an appropriate use)

Although Bevespi Aerosphere opens your airways, it is not used for treating asthma. It’s not known if Bevespi Aerosphere is safe or effective for use in people with asthma.

Bevespi Aerosphere contains formoterol, which is a type of drug called a long-acting beta-agonist (LABA). People with asthma who use LABA drugs without also using an inhaled steroid have an increased risk of serious asthma-related problems. These problems can lead to being hospitalized, intubation (having a tube inserted into the lungs to help breathing), and even death.

Bevespi Aerosphere is not used for asthma because it doesn’t contain a steroid medication with the formoterol. If someone with asthma used Bevespi Aerosphere to treat their asthma without also using a steroid inhaler, it would put them at risk of asthma-related death.

Several types of drugs are recommended in current guidelines for the maintenance treatment (long-term everyday treatment) of COPD. You might use Bevespi Aerosphere along with one or more of these other drugs. They include:

• Short-acting beta-agonists. These include albuterol (ProAir, Proventil, Ventolin) and levalbuterol (Xopenex). These are rescue medications (which relieve sudden attacks of breathlessness) and may be taken by inhaler or nebulizer. Bevespi Aerosphere is not a rescue medication.
• Methylxanthines. A common medication in this drug class is theophylline (Theo-24, Elixophyllin, Theochron), which comes as a pill or liquid. You take it regularly to help relax the muscles in your airways.
• Roflumilast (Daliresp). This is a tablet that’s taken regularly to help reduce inflammation in the lungs.
• Antibiotics to treat chest infections. A chest infection is a common cause of a COPD flare-up. It’s usually treated with a short course of antibiotics. Antibiotics may sometimes be used long term to prevent flare-ups.
• Oxygen therapy. This is when you breathe in extra oxygen, usually from a portable tank. You use a face mask or nasal cannula (a flexible tube that sits under your nose with two prongs that go inside your nostrils). This therapy is used if the oxygen level in your blood is too low.

Do not use Bevespi Aerosphere with other medications that contain a long-acting beta-agonist (LABA). LABA drugs include arformoterol (Brovana), indacaterol (Arcapta), and salmeterol (Serevent). These are also found in some combination inhalers for COPD. If you use Bevespi with another LABA drug, there is a risk of serious side effects on your heart. These effects can include fast or irregular heartbeat, high blood pressure, and chest pain.

You should take Bevespi Aerosphere according to your doctor’s or pharmacist’s instructions.

You take a puff from the Bevespi Aerosphere inhaler by pressing down on the canister at the same time as you breathe in through the mouthpiece. Your doctor or pharmacist will show you how to use the inhaler correctly. There are also detailed instructions and a video on the manufacturer’s website.

When to take

Use your Bevespi Aerosphere inhaler twice a day, every day. Take two puffs in the morning and two puffs in the evening.

To help make sure you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Important points about using Bevespi Aerosphere

• If you have sudden breathing problems immediately after inhaling a dose of Bevespi Aerosphere, use your rescue inhaler right away. Don’t use the Bevespi Aerosphere inhaler again. Call your doctor as soon as possible so they can find you an alternative treatment.
• Don’t take Bevespi Aerosphere to relieve sudden breathing problems. Use your rescue inhaler (a short-acting beta-agonist, such as albuterol) to quickly improve your breathing if you suddenly become breathless. Keep your rescue inhaler with you at all times.
• If you start needing to use your rescue inhaler more than usual, contact your doctor as soon as possible.
• If your rescue inhaler doesn’t relieve a sudden attack of breathlessness and you think you’re having a medical emergency, call 911 or go to the nearest emergency room.

At this time, drinking alcohol is not known to affect how Bevespi Aerosphere works. It’s also not known if regular or heavy alcohol use can worsen COPD or its symptoms.

If you have COPD and drink alcohol, talk with your doctor about how much is safe for you.

Bevespi Aerosphere can interact with several other medications.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Bevespi Aerosphere and other medications

Below is a list of medications that can interact with Bevespi Aerosphere. This list does not contain all drugs that may interact with Bevespi Aerosphere.

Before taking Bevespi Aerosphere, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Other long-acting beta-agonist (LABA) drugs

You should not use other LABA drugs with Bevespi Aerosphere because this could cause serious heart problems. Other LABA drugs include:

• arformoterol (Brovana)
• formoterol (Perforomist, Foradil)
• salmeterol (Serevent)
• indacaterol (Arcapta)
• olodaterol (Striverdi)

LABAs are also found in some combination inhalers used to treat COPD.

Make sure you tell your doctor about all the medications you take for COPD. They will check that you’re not using more than one LABA.

Corticosteroid medications (steroids)

Steroids are used to reduce inflammation and are sometimes used to treat COPD. However, taking a steroid with Bevespi Aerosphere could make the amount of potassium in your blood fall too low. This is called hypokalemia, and it can lead to problems with your heartbeat and muscles. Steroid drugs include:

• prednisolone
• prednisone (Rayos)
• hydrocortisone (Cortef)
• mometasone (Asmanex, Elocon)
• methylprednisolone (Medrol, Solu-Medrol)
• dexamethasone (Dextenza)

Steroids are also found in some combination inhalers used to treat COPD.

If you need to use a steroid drug with Bevespi Aerosphere, your doctor may want to monitor your blood potassium level.

Theophylline or aminophylline

Theophylline and aminophylline are both used to help relieve symptoms of asthma or other lung conditions that block your airways. These include chronic bronchitis and emphysema.

If you take theophylline or aminophylline with Bevespi Aerosphere, the amount of potassium in your blood could fall too low. This is called hypokalemia, and it can lead to problems with your heartbeat and muscles. Your doctor may want to monitor your blood potassium level if you take theophylline or aminophylline with Bevespi Aerosphere.

Certain diuretics (sometimes called water pills)

Loop diuretics and thiazide diuretics can make the amount of potassium in your blood fall too low (called hypokalemia). If you take one of these diuretics with Bevespi Aerosphere, your potassium level is more likely to fall too low. This can lead to problems with your heartbeat and muscles. Examples of diuretics that can cause hypokalemia include:

• hydrochlorothiazide (Microzide)
• chlorthalidone
• furosemide (Lasix)
• torsemide (Demadex)

Thiazide diuretics are also found in many combination drugs for high blood pressure.

If you need to take a diuretic with Bevespi Aerosphere, your doctor may want to monitor your blood potassium level.

Beta-blocker drugs

Beta-blocker drugs are mainly used to treat high blood pressure and certain heart conditions, such as angina and irregular heart rhythms. Some are also used to help with symptoms of an overactive thyroid gland or anxiety. Beta-blockers are also found in some eye drops for glaucoma (increased pressure in your eye).

Beta-blockers shouldn’t normally be used with Bevespi Aerosphere. This is because they can stop the formoterol in Bevespi Aerosphere from working and can cause your airways to narrow. However, certain beta-blockers can be used with caution if there are no other alternatives that are right for you. Examples of beta-blockers include:

• metoprolol (Lopressor, Toprol XL)
• carvedilol (Coreg)
• atenolol (Tenormin)
• propranolol (Inderal, Innopran XL)

Talk to your doctor if you’re concerned about being prescribed a beta-blocker with Bevespi Aerosphere.

Certain antidepressants

Certain antidepressants can increase the risk of getting an abnormal heart rhythm if they’re used with Bevespi Aerosphere. These include:

• amitriptyline
• desipramine (Norpramin)
• imipramine (Tofranil)
• doxepin (Silenor)
• nortriptyline
• selegiline (Emsam, Zelapar)
• phenelzine (Nardil)
• isocarboxazid (Marplan)

There are many other antidepressants available that are usually preferable for people taking Bevespi Aerosphere. Talk to your doctor if you’re concerned about taking an antidepressant with Bevespi Aerosphere.

Certain drugs for an irregular heartbeat

Certain drugs used to treat an irregular heartbeat can increase the risk of getting an abnormal heart rhythm if they are used with Bevespi Aerosphere. These include:

• amiodarone (Pacerone, Nexterone)
• dronedarone (Multaq)
• dofetilide (Tikosyn)
• sotalol (Betapace, Sorine, Sotylize)

If you need to take one of these medications with Bevespi Aerosphere, your doctor will monitor your heart function closely.

Certain drugs for an overactive bladder or urinary incontinence

Certain drugs used to treat urinary incontinence are called anticholinergics. One of the drugs in Bevespi Aerosphere is also an anticholinergic. If Bevespi Aerosphere is used with other anticholinergic drugs, there may be an increased risk of anticholinergic side effects. These include eye problems, such as glaucoma, or urinary problems, such as trouble urinating.

Examples of urinary incontinence drugs that may increase the risk of side effects if taken with Bevespi Aerosphere include:

• oxybutynin (Ditropan XL)
• tolterodine (Detrol)
• darifenacin (Enablex)
• solifenacin (VESIcare)
• fesoterodine (Toviaz)

If you need to take one of these medications to treat urinary incontinence, your doctor will monitor you closely. Tell them if you notice any side effects, such as changes to your vision or trouble urinating.

Bevespi Aerosphere is an inhaled medication that’s used to treat COPD (chronic obstructive pulmonary disease).

What happens in COPD

Chronic obstructive pulmonary disease (COPD) is a condition that makes it difficult to breathe. If you have COPD, you probably have a mixture of emphysema and chronic bronchitis.

With emphysema, there is damage to the small air sacs (called alveoli) that are deep in your lungs. This makes it difficult to breathe out (exhale).

With chronic bronchitis, there is inflammation (swelling) in your airways. Your airways also produce more mucus than usual. It’s hard to cough up this mucus because your airways are narrowed by the swelling. All of these factors make breathing difficult.

What Bevespi Aerosphere does

Bevespi Aerosphere contains two drugs that work in slightly different ways to open your airways. Formoterol is a long-acting beta-agonist (LABA) drug. Glycopyrrolate is a long-acting anticholinergic drug. This is also sometimes known as a long-acting muscarinic antagonist (LAMA).

Formoterol causes the muscles around your airways to relax, allowing the airways to open. When your airways open wider, it’s easier to breathe in and out. It also makes it easier to cough mucus out of your airways.

Glycopyrrolate stops a chemical messenger called acetylcholine from acting on the muscle cells around your airways. Acetylcholine normally makes your airways tighten. By blocking acetylcholine, glycopyrrolate helps keep your airways open.

How long does it take to work?

Bevespi Aerosphere starts to work about five minutes after you take a dose. It keeps your airways open for 12 hours.

Bevespi Aerosphere doesn’t work fast enough to be used as rescue medication for sudden attacks of breathlessness. Use a rescue inhaler (a short-acting beta-agonist, such as albuterol) to quickly open your airways and relieve breathlessness in an emergency.

Bevespi Aerosphere and the drugs it contains haven’t been studied enough in women who are pregnant. At this time, it’s not known if Bevespi Aerosphere is safe to use during pregnancy.

If you are pregnant or want to plan a pregnancy, talk with your doctor about the possible risks and benefits of using Bevespi Aerosphere. If you get pregnant while taking Bevespi Aerosphere, see your doctor as soon as possible.

Bevespi Aerosphere has not been studied in women who are breastfeeding. It’s not known if the drugs in Bevespi Aerosphere pass into breast milk.

If you’re breastfeeding, it’s important to discuss the potential risks and benefits of using Bevespi Aerosphere with your doctor.

Here are answers to some frequently asked questions about Bevespi Aerosphere.

Is Bevespi Aerosphere a steroid inhaler?

No, Bevespi Aerosphere doesn’t contain a steroid. Bevespi Aerosphere is an inhaler that contains two long-acting bronchodilators: formoterol and glycopyrrolate. Long-acting bronchodilators are drugs that open up your airways. They help keep your airways open all the time.

Like a steroid inhaler, you use Bevespi Aerosphere every day. However, unlike steroid inhalers, Bevespi Aerosphere doesn’t reduce inflammation (swelling) in your airways.

How many puffs are in Bevespi Aerosphere?

There are two sizes of the Bevespi Aerosphere inhaler. One contains 28 puffs, and the other contains 120 puffs.

Can I take Bevespi Aerosphere for COPD flare-ups?

No. If your COPD symptoms start to get worse, don’t increase your dosage of Bevespi Aerosphere.

You may be having a flare-up if you need to use your rescue inhaler more often than usual. If your rescue inhaler doesn’t seem to help your breathing as well as usual, this could also be a sign of a flare-up. If you think you’re having a flare-up, see your doctor as soon as possible. They will review your treatment and may prescribe extra medication.

If your doctor decides you should still use Bevespi Aerosphere, you should keep using it twice a day, every day, as usual. Don’t take more puffs of Bevespi Aerosphere than you normally do, and don’t use it more than twice a day.

Also, don’t take Bevespi Aerosphere to relieve sudden breathing problems during flare-ups. You still need to use your rescue inhaler (such as albuterol) to quickly open your airways if you are short of breath.

Is Bevespi Aerosphere safe to take for asthma?

Bevespi Aerosphere should not be used to treat asthma. Its safety in treating asthma has not been studied.

Bevespi Aerosphere contains formoterol, which belongs to a class of drugs called long-acting beta-agonists (LABAs). LABAs can cause serious problems if they are taken by people with asthma who are not also using a steroid inhaler (and Bevespi Aerosphere doesn’t contain a steroid). They can increase the risk of asthma-related death.

Do I need to rinse my mouth after using Bevespi Aerosphere?

No. You only need to rinse your mouth after using a steroid inhaler. Rinsing your mouth reduces the risk of getting a thrush infection in your mouth, which can be a problem with steroid inhalers. Bevespi Aerosphere is not a steroid inhaler.

This drug comes with several warnings.

Before taking Bevespi Aerosphere, talk with your doctor about your health history. Bevespi Aerosphere may not be right for you if you have certain medical conditions. These include:

• Asthma. Bevespi Aerosphere should not be used to treat asthma. It’s not known if Bevespi Aerosphere is safe or effective for use in people with asthma.
• An allergy to formoterol, glycopyrrolate, or any of the inactive ingredients in the inhaler. These are listed in the information that came with your inhaler. You shouldn’t use Bevespi Aerosphere if you’re allergic to any of its ingredients.
• Heart problems, such as heart failure, irregular heartbeat (arrhythmias), or angina (chest pain that happens when not enough blood reaches the heart). Bevespi Aerosphere could make your heart beat faster or increase your blood pressure. If you have existing heart problems, it could make these side effects worse.
• High blood pressure. Bevespi Aerosphere could increase your blood pressure further.
• An overactive thyroid gland. Bevespi Aerosphere could make some symptoms of this worse, such as a fast heartbeat.
• Seizure disorders such as epilepsy. Bevespi Aerosphere could make seizures worse.
• Diabetes. Other long-acting beta-agonist (LABA) drugs can increase your blood sugar level. This wasn’t seen in clinical studies of Bevespi Aerosphere, but your doctor might want to monitor your blood sugar after you start taking Bevespi Aerosphere.
• Narrow-angle glaucoma. Bevespi Aerosphere can cause new or worsening closed-angle glaucoma.
• Problems passing urine, such as those caused by a bladder problem or an enlarged prostate gland. Bevespi Aerosphere can cause new or worsening urinary retention (trouble passing urine), so it could make these problems worse.
• Severe kidney problems. Bevespi Aerosphere was not studied in people with severe kidney problems. It’s not known if Bevespi is safe to use if you have severe kidney problems.
• Liver problems. Your liver may not work as well to metabolize formoterol, one of the drugs in Bevespi Aerosphere. As a result, formoterol may build up in your body and could increase your risk of side effects.

Note: For more information about the potential negative effects of Bevespi Aerosphere, see the “Bevespi Aerosphere side effects” section above.

Using more than the recommended dosage of Bevespi Aerosphere can lead to serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

• chest pain
• fast or irregular heartbeat (arrhythmias)
• palpitations
• tremor (shaking)
• headache
• nervousness
• nausea
• vomiting
• dizziness
• blurred vision
• eye pain
• severe constipation
• difficulty passing urine
• muscle cramps
• seizures

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

An expiration date will be printed on the box your Bevespi Aerosphere inhaler comes in. It will also be printed on the inhaler itself. Don’t use the inhaler if it’s past the expiration date.

The expiration date helps guarantee the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Your Bevespi Aerosphere inhaler should be kept at room temperature.

If you have a 28-dose inhaler, it can be used for three weeks from the date you remove it from the foil pouch. If you have a 120-dose inhaler, it can be used for three months from the date you remove it from the foil pouch.

Safely dispose of the inhaler after this length of time, even if there is some medication left in it. See below to learn more.

Disposal

Used inhalers have a big environmental impact. Some of the chemical substances they contain are greenhouse gases. These gases are released into the atmosphere if inhalers are sent to landfills or are burned. However, the unused gas can be recovered and reused, and the plastic casing of the inhaler can be recycled.

When your Bevespi Aerosphere inhaler is empty, you should return it to your pharmacist. Some pharmacies offer a take-back program for inhalers so they can be recycled. Some pharmaceutical companies have also introduced inhaler recycling programs through local pharmacies. Ask your pharmacist or local recycling center if this is an option in your area.

If you no longer need to take Bevespi Aerosphere and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.