Breztri Aerosphere

Approved Uses

Breztri Aerosphere is prescribed to help manage and prevent symptoms associated with chronic obstructive pulmonary disease (COPD). This condition includes two main types of lung disease:

• Chronic bronchitis: A condition involving long-term inflammation and irritation of the bronchial tubes.
• Emphysema: A condition where the air sacs in the lungs are damaged, making it difficult to breathe.

The medication is intended to improve lung function and reduce the frequency of flare-ups, also known as exacerbations, where COPD symptoms suddenly become more severe.

Important Limitations

It is important to understand how this medication should be used within a treatment plan:

• Maintenance only: This drug is designed for daily, long-term use to keep airways open over time. It is not a rescue inhaler and will not work fast enough to treat a sudden breathing crisis or acute bronchospasm.
• Not for asthma: Breztri Aerosphere is specifically approved for the treatment of COPD and is not indicated for the treatment of asthma.

Triple Action Therapy

Breztri Aerosphere contains three active ingredients that work in different ways to manage chronic obstructive pulmonary disease (COPD):

• Budesonide: This is a corticosteroid that helps reduce and prevent inflammation in the airways. By lowering swelling and irritation, it helps keep the air passages open over time.
• Glycopyrrolate: This is an anticholinergic medication. It works by blocking specific chemical signals that cause the muscles around the airways to tighten, which helps prevent the airways from narrowing.
• Formoterol: This is a long-acting bronchodilator. It works by relaxing the muscles in the lungs to help the airways stay open for a longer period.

By using these three mechanisms together, the medication helps improve lung function and reduce the frequency of COPD flare-ups. It is designed for long-term maintenance and is not intended to treat sudden breathing problems or rescue situations.

Common Side Effects

The most frequently reported side effects of Breztri Aerosphere include:

• Upper respiratory tract infections
• Pneumonia
• Back pain
• Cough
• Sinusitis
• Headache
• Urinary tract infection
• Hoarseness or voice changes
• Oral thrush (yeast infection in the mouth)

Serious Side Effects

While less common, some side effects can be severe and may require medical attention. These include:

• Paradoxical bronchospasm: Sudden, unexpected tightening of the airways immediately after using the inhaler.
• Heart problems: Increased heart rate, palpitations, chest pain, or high blood pressure.
• Eye issues: New or worsening glaucoma, blurred vision, or cataracts.
• Weakened immune system: Increased susceptibility to infections and a reduced ability to fight them.
• Bone density loss: Long-term use of inhaled corticosteroids may lead to thinning of the bones (osteoporosis).
• Adrenal insufficiency: A condition where the adrenal glands do not produce enough steroid hormones.
• Electrolyte and blood sugar changes: Low potassium levels in the blood or high blood sugar levels.
• Severe allergic reactions: Symptoms such as rash, hives, or swelling of the face, lips, and tongue.

Emergency Use

This medication is not a rescue inhaler. It will not work fast enough to treat a sudden COPD flare-up or acute shortness of breath. A separate rescue medicine must be used for sudden symptoms.

Infection Risks

The use of inhaled corticosteroids can increase the risk of developing pneumonia in patients with COPD. It may also lead to oral candidiasis (thrush), a fungal infection in the mouth and throat. Rinsing the mouth with water after use can help prevent this. This medication may also make it harder for the body to fight off infections like chickenpox or measles.

Heart and Vascular Conditions

This medication can cause increased heart rate, high blood pressure, and irregular heart rhythms. It should be used with caution in people with cardiovascular disorders, including coronary insufficiency or heart disease.

Eye and Urinary Concerns

This medication may worsen certain pre-existing conditions:

• Glaucoma: It can increase pressure in the eyes, which may worsen narrow-angle glaucoma.
• Urinary Retention: It may cause difficulty urinating, particularly in men with an enlarged prostate.

Other Precautions

• Paradoxical Bronchospasm: Some users may experience a sudden, unexpected tightening of the airways immediately after inhalation.
• Bone Health: Long-term use of inhaled steroids can lead to a decrease in bone mineral density.
• Adrenal Function: High doses or long-term use may affect the function of the adrenal glands.

Pregnancy

There are no adequate and well-controlled studies of Breztri Aerosphere in pregnant women. While one of its components, budesonide, has been used extensively during pregnancy, there is less information available regarding the safety of glycopyrrolate and formoterol for an unborn baby.

Healthcare providers generally consider the following factors when evaluating use during pregnancy:

• Labor and delivery: Formoterol, one of the active ingredients, may interfere with uterine contractions. Because of this, the medication is typically only used during labor if the potential benefits justify the risks.
• Disease management: Maintaining control of respiratory symptoms is important for the health of both the mother and the fetus.

Breastfeeding

It is not known whether the components of Breztri Aerosphere pass into human breast milk or if they could affect a nursing infant. Because many drugs are excreted in human milk, caution is advised. Individuals who are breastfeeding or planning to breastfeed should talk to their doctor to weigh the benefits of treatment against any potential risks to the baby.

Dosage Form

Breztri Aerosphere is an inhalation aerosol provided in a pressurized metered-dose inhaler. The device consists of an aluminum canister with a dose indicator, a plastic actuator, and a dust cap.

Strengths

This medication is a fixed-dose combination. Each inhalation delivers a specific amount of the following active ingredients:

• Budesonide
• Glycopyrrolate
• Formoterol fumarate

Packaging

The inhaler is available in two main sizes based on the number of puffs (actuations) provided:

• 120 inhalations per canister
• 28 inhalations per canister

FDA Approval and Indications

Breztri Aerosphere was approved by the U.S. Food and Drug Administration (FDA) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). This includes conditions such as chronic bronchitis and emphysema. The medication is designed to improve airflow and reduce the frequency of flare-ups or exacerbations in adults.

Limitations of Use

The FDA has approved Breztri Aerosphere with specific limitations regarding its use:

• It is not indicated for the treatment of asthma. The safety and effectiveness of this medication in patients with asthma have not been established.
• It is not a rescue medication. It should not be used to treat sudden, acute breathing problems or bronchospasm.
• It is intended for long-term maintenance and must be used regularly as prescribed to be effective, even when the patient is not experiencing symptoms.

Regulatory Status

Breztri Aerosphere is a combination product containing three active ingredients: budesonide (a corticosteroid), glycopyrrolate (an anticholinergic), and formoterol fumarate (a long-acting beta2-adrenergic agonist or LABA). While individual components of this class were previously subject to specific safety communications, Breztri Aerosphere does not currently carry a Boxed Warning. It is available only by prescription and is regulated to ensure it is used specifically for its approved indication of COPD maintenance.

Factors Influencing Cost

The price of Breztri Aerosphere can vary significantly based on several factors. Your health insurance plan is a primary factor, as different plans have different levels of coverage and copayment amounts. The specific pharmacy you choose and your geographic location can also influence the retail price.

Generic Status

Breztri Aerosphere is a brand-name drug that contains three active ingredients: budesonide, glycopyrrolate, and formoterol. Currently, there is no generic version of this combination inhaler available. Brand-name medications generally cost more than generic versions.

Ways to Save

There are several options that may help lower the cost of this medication:

• Manufacturer Coupons: The company that makes Breztri Aerosphere may offer savings cards or coupons to help reduce copays for people with commercial insurance.
• Patient Assistance Programs: Some organizations provide financial help to patients who meet certain income criteria or who do not have insurance coverage.
• Medicare Coverage: Many Medicare Part D and Medicare Advantage plans cover this medication, though your specific costs will depend on your plan's phase and deductible.