Breztri Aerosphere: Alternatives, use for COPD, dosage, and more - Medical News Today

Posted: 07 Jan 2021 12:00 AM PST

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

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

Note: The Food and Drug Administration (FDA) tracks the side effects of drugs it has approved. If you would like to notify the FDA about a side effect you've had with Breztri Aerosphere, you can do so through MedWatch.

Mild side effects

Mild side effects* of Breztri Aerosphere can include:

upper respiratory tract infections, such as the common cold†
oral thrush (a fungal infection in the mouth and throat)†
urinary tract infections (UTIs)†
sinusitis (sinus inflammation)
cough
influenza (flu)
back pain
diarrhea
muscle spasms (twitching)
hoarse voice
tremor (shaking in one or more body parts)
nervousness
headache
nausea

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don't go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Breztri Aerosphere. To learn about other mild side effects, talk with your doctor or pharmacist, or view Breztri Aerosphere's patient information.
† For more information about these side effects, see "Side effect details" below.

Serious side effects

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

Serious side effects and their symptoms can include:

Changes in your heartbeat or blood pressure. Symptoms can include:
- fast or irregular heart rate (which may feel like your heart is racing or pounding)
Reduced adrenal gland function (which occurs when your body doesn't make enough of the hormone cortisol). Symptoms can include:
- tiredness or lack of energy
- nausea and vomiting
- low blood pressure, which can make you feel dizzy
Paradoxical bronchospasm (sudden, unexpected breathing problems immediately after inhaling the drug). Symptoms can include:
- trouble inhaling enough air
- chest tightness or pain
Urinary retention (trouble emptying your bladder). Symptoms can include:
- trouble urinating
- pain when urinating
- urinating more often than usual
- passing urine 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 levels. Symptoms can include:
- feeling thirsty
- feeling tired
- urinating more often than usual
- blurry vision
Weakened immune system and increased risk for infection.
Pneumonia (a type of lung infection).*
Reduced bone mineral density (weakened bones).*
Eye problems, such as glaucoma or cataracts.*
Allergic reaction.*

* For more information about these side effects, see "Side effect details" below.

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.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Breztri Aerosphere. It's not known how often allergic reactions occurred in clinical studies of Breztri Aerosphere.

Symptoms of a mild allergic reaction can include:

skin rash
itchiness
flushing (warmth, swelling, or redness in your skin)

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

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 an allergic reaction to Breztri Aerosphere, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you're having a medical emergency.

Increased risk of infection

It's possible to have an increased risk of infection while using Breztri Aerosphere. This is because Breztri Aerosphere contains a corticosteroid drug called budesonide. Corticosteroids can weaken your immune system and make your body less able to fight off infections.

This means that while using Breztri Aerosphere, you may have frequent infections or infections that take a long time to clear up. The most common infections seen with Breztri Aerosphere in clinical studies were:

Oral thrush

Some people may develop oral thrush when using Breztri Aerosphere.

Oral thrush is a fungal infection in your mouth and throat. In clinical studies, oral thrush occurred in:

3% of people using Breztri Aerosphere (which contains budesonide, glycopyrrolate, and formoterol)
1.1% of people using glycopyrrolate and formoterol
2.7% of people using budesonide and formoterol

Symptoms of oral thrush can include:

white spots or patches inside your mouth
redness, swelling, soreness, or a burning sensation inside your mouth
pain when swallowing

To reduce your risk for oral thrush, rinse your mouth with water after each time you use Breztri Aerosphere and spit the water out.*

If you have symptoms of oral thrush, contact your doctor. They can prescribe antifungal medication to treat this infection.

* See the "How to use Breztri Aerosphere" section below for more information about how to use the drug.

Upper respiratory tract infections

Breztri Aerosphere can cause upper respiratory tract infections, such as the common cold.

In clinical studies, upper respiratory tract infections occurred in:

5.7% of people using Breztri Aerosphere (which contains budesonide, glycopyrrolate, and formoterol)
4.8% of people using glycopyrrolate and formoterol
5.4% of people using budesonide and formoterol

Symptoms of upper respiratory tract infections may include:

runny nose
congested nose
sinus pain
sneezing
headache
cough
sore throat

To help prevent upper respiratory infections, make sure to wash your hands often, avoid contact with people who are sick, eat healthily, and get enough sleep.

Upper respiratory infections are usually mild and tend to resolve on their own after a week or two. If your symptoms are bothersome, various over-the-counter medications may help relieve symptoms. Your pharmacist can recommend a medication for you. But if your symptoms don't clear up after 2 weeks or start to get worse, see your doctor.

See your doctor right away if you start to develop symptoms of pneumonia (see below).

Pneumonia

Breztri Aerosphere increases your risk for pneumonia, which is a type of lung infection that can be serious. And people with chronic obstructive pulmonary disease (COPD) have an increased risk for pneumonia already.

In clinical studies, pneumonia occurred in:

4.6% of people using Breztri Aerosphere (which contains budesonide, glycopyrrolate, and formoterol)
2.9% of people using glycopyrrolate and formoterol
5.0% of people using budesonide and formoterol

Symptoms of pneumonia can include:

fever
chills (shivering)
coughing more than usual
producing more mucus than usual
change in the color of mucus
more trouble breathing than usual

To help prevent pneumonia, talk with your doctor about having a pneumococcal vaccine. This vaccine helps to protect against the most common forms of pneumonia. Having influenza (flu) can sometimes lead to pneumonia. For this reason, it's also important to have a flu vaccine every year.

It's important to note that the pneumococcal vaccine and the flu vaccine don't protect against all forms of these viruses. To further help prevent pneumonia and the flu, there are a few actions you can take. These include washing your hands often, avoiding contact with people who are sick, eating healthily, and getting enough sleep.

If you have symptoms of pneumonia, see your doctor right away. You may need treatment for the infection. In some cases, you may need treatment in the hospital.

Reduced bone mineral density

Long-term use of Breztri Aerosphere can cause reduced bone mineral density. Bone mineral density is a measurement of how strong your bones are.

Having reduced bone mineral density means that your bones are weakened. This can lead to osteoporosis. Osteoporosis occurs when your bones become weaker, and you have a higher risk for fractures.

In a clinical study, bone mineral density was measured using a type of X-ray called a DEXA scan. Compared with before treatment, bone mineral density after 1 year of treatment was:

reduced by an average of 0.1% in people using Breztri Aerosphere (which contains budesonide, glycopyrrolate, and formoterol)
increased by an average of 0.4% in people using glycopyrrolate and formoterol

Symptoms of reduced bone mineral density can include:

bone fractures that occur after a minor injury or without a clear cause
back pain
losing height over time

To help prevent the weakening of your bones, your doctor may prescribe calcium supplements or other medications that help protect your bones while you're taking Breztri Aerosphere. And they may monitor your bone mineral density during your treatment.

Glaucoma and cataracts

Long-term use of Breztri Aerosphere can sometimes cause eye problems. These problems may include increased pressure in your eye, glaucoma, and cataracts.

It's not known exactly how often these problems occurred in clinical studies of Breztri Aerosphere. In one study, cataracts occurred in 0.7% to 1% of people in the study, regardless of which COPD treatment was used. These treatments were either Breztri Aerosphere (which contains budesonide, glycopyrrolate, and formoterol), glycopyrrolate and formoterol, or budesonide and formoterol.

Symptoms of glaucoma and cataracts can include:

eye pain
red eye
blurry vision
nausea and vomiting
seeing halos around lights
trouble seeing at night
increased sensitivity to light and glare

If you have these symptoms or any other changes in your vision while using Breztri Aerosphere, contact your doctor. Medications such as eye drops can typically treat glaucoma and increased eye pressure. But cataracts may require surgery.

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