Breztri

The active ingredients in Breztri Aerosphere include an inhaled corticosteroid (ICS) called budesonide, a long-acting muscarinic antagonist (LAMA) called glycopyrrolate bromide, and formoterol fumarate, a long-acting beta 2-adrenergic agonist (LABA). As an ICS/LAMA/LABA combination, Breztri Aerosphere works as a bronchodilator to reduce swelling in the lungs and relax the muscles around the airways and to reduce flare-ups (exacerbations) and other COPD symptoms.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Breztri Aerosphere. However, the following is a synopsis of the general guidelines for the use of Breztri Aerosphere:

• Use this medication exactly as directed by your physician.
• Priming the inhaler is essential to ensure appropriate drug content in each actuation.
• Usual dosage: Inhale 2 puffs 2 times each day.
• Rinsing the mouth with water without swallowing after inhalation is crucial to help reduce the risk of oral thrush.

The most common side effects of Breztri Aerosphere seen in clinical trials include:

• Upper respiratory tract infection.
• Pneumonia.
• Hoarseness.
• Back pain.
• Oral thrush.
• Flu.
• Muscle spasms.
• Urinary tract infection.
• Cough.
• Inflammation of the sinuses.
• Diarrhea.

Some individuals may experience serious side effects while using Breztri Aerosphere. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Fungal infection in the mouth or throat (thrush).
• Pneumonia - increase in sputum production, change in mucus color, increased cough.
• Weakened immune system.
• Reduced adrenal function (adrenal insufficiency).
• Sudden breathing problems.
• Severe allergic reaction - hives, itching, swelling, rash.
• Heart problems, like increased blood pressure, irregular heartbeat, and chest pain.
• Bone weakness.
• Acute narrow-angle glaucoma and cataracts - worsening vision problems.
• Urinary retention.
• Changes in laboratory blood values - high levels of blood sugar (hyperglycemia), low levels of potassium (hypokalemia).

These are not all of the possible side effects of Breztri Aerosphere. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Breztri Aerosphere, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• Heart problems.
• High blood pressure (hypertension).
• Seizures.
• Problems with your thyroid, kidneys, prostate, bladder, or liver.
• Osteoporosis.
• Glaucoma.
• Cataracts.
• Diabetes.
• History of immune problems or severe infections.

Previous allergic reaction/hypersensitivity to budesonide, glycopyrrolate, formoterol fumarate, or to any of the excipients.

Breztri Aerosphere was proven to improve lung function starting within 5 minutes. However, it may take a few weeks before you see a decrease in the number of COPD flare-ups you have.

When Breztri Aerosphere is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Strong cytochrome P450 3A4 inhibitors.
• Adrenergic drugs.
• Diuretics.
• Monoamine oxidase inhibitors.
• Beta-blockers.
• Anticholinergics.

Breztri Aerosphere inhaler comes in the dosage forms listed below, including:

• Pressurized metered dose inhaler for oral inhalation - budesonide (160 mcg), glycopyrrolate (9 mcg), formoterol fumarate (4.8 mcg).

Store this medication at room temperature and keep it out of reach of children.

AstraZeneca is the pharmaceutical company that manufactures Breztri Aerosphere.

There are no lower-cost generics available for the brand-name Breztri Aerosphere.

Do not stop or adjust your use of this medication without first consulting with your doctor. Stopping this medication suddenly can increase your risk of COPD symptoms and sudden breathing problems.

It is unknown if or how Breztri Aerosphere could affect pregnancy or harm an unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown if Breztri Aerosphere passes into breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.