Breyna

Asthma Management

Breyna is used for the long-term maintenance treatment of asthma in adults and children aged 6 years and older. It is generally prescribed for patients whose asthma is not adequately controlled by a long-term asthma control medication alone, or for those whose condition is severe enough to require two types of treatment.

Chronic Obstructive Pulmonary Disease (COPD)

This medication is also indicated for the maintenance treatment of airflow obstruction in patients with COPD. This includes chronic lung conditions such as:

• Chronic bronchitis
• Emphysema

Using the medication regularly can help improve lung function and reduce the frequency of flare-ups associated with COPD.

Maintenance vs. Rescue Use

It is important to note that Breyna is intended for daily maintenance and should not be used as a rescue medication. It will not work fast enough to treat a sudden asthma attack or an acute episode of shortness of breath. Patients should always have a separate fast-acting rescue inhaler available for sudden symptoms.

Mechanism of Action

Breyna is a combination inhaler that uses two different types of medication to manage respiratory conditions like asthma and chronic obstructive pulmonary disease (COPD).

Reducing Inflammation

One component, budesonide, is a corticosteroid. It works by reducing and preventing inflammation within the lungs. By decreasing the swelling and irritation in the lining of the airways, it helps prevent symptoms such as wheezing and coughing over time.

Opening the Airways

The second component, formoterol, is a long-acting beta2-adrenergic agonist (LABA). It acts as a bronchodilator by relaxing the smooth muscles that surround the bronchial tubes in the lungs. This relaxation allows the airways to stay open for a longer period, which improves airflow and makes breathing less difficult.

Combined Effect

While the bronchodilator provides relaxation of the muscles, the corticosteroid works to treat the underlying inflammation. Together, these medications provide both maintenance of open airways and long-term control of airway sensitivity to help prevent flare-ups.

Common Side Effects

Many people using Breyna experience mild side effects. These may include:

• Headache
• Sore throat or throat irritation
• Upper respiratory tract infections
• Sinus inflammation (sinusitis)
• Back pain
• Stomach discomfort or vomiting
• Nasal congestion

Rinsing your mouth with water and spitting it out after each use can help prevent a fungal infection in the mouth or throat known as thrush (oral candidiasis).

Serious Side Effects

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

• Sudden breathing problems: Increased wheezing or difficulty breathing immediately after using the inhaler (paradoxical bronchospasm).
• Heart issues: Fast or irregular heartbeat, palpitations, chest pain, or increased blood pressure.
• Infections: An increased risk of pneumonia (especially in people with COPD) or other serious infections. Symptoms may include fever, chills, or increased mucus production.
• Adrenal gland problems: Symptoms like extreme tiredness, muscle weakness, or dizziness.
• Bone health: Long-term use of corticosteroids may lead to a decrease in bone mineral density.
• Vision changes: Increased risk of glaucoma, cataracts, or blurred vision.
• Electrolyte changes: Low potassium levels in the blood, which can cause muscle cramps, weakness, or abnormal heart rhythms.
• Allergic reactions: Severe rash, hives, or swelling of the face, lips, or tongue.

Acute Symptoms

Breyna is a maintenance medication and should not be used to treat sudden, severe symptoms of asthma or COPD. A separate rescue inhaler is required for acute breathing difficulties. Using more than the prescribed dose can lead to serious heart-related side effects.

Infection Risks

The corticosteroid in Breyna can suppress the immune system, making it harder to fight infections. Key concerns include:

• Oral Thrush: Fungal infections in the mouth and throat can occur. Rinsing the mouth with water and spitting it out after each dose is recommended to reduce this risk.
• Pneumonia: People with COPD may have an increased risk of developing pneumonia while using this medication.
• General Infections: Users may be more susceptible to viral infections like chickenpox or measles, which can be more severe in people using corticosteroids.

Long-Term Effects

Prolonged use of Breyna may lead to several systemic issues:

• Adrenal Suppression: Switching from oral steroids to Breyna or using high doses can affect the body's ability to produce natural cortisol, especially during periods of surgery or stress.
• Bone Density: Long-term use may decrease bone mineral density, which is a concern for those at risk for osteoporosis.
• Growth: Inhaled corticosteroids may slow the growth rate in children and adolescents.
• Eye Problems: There is a risk of developing glaucoma or cataracts with long-term use.

Heart and Metabolic Concerns

The medication can affect the heart and metabolism. It may cause increased pulse rate, high blood pressure, or abnormal heart rhythms. It can also lead to low potassium levels or high blood sugar in some patients.

Paradoxical Bronchospasm

In some cases, inhaling the medicine can cause an immediate worsening of breathing and wheezing. If this happens, the medication should be stopped immediately and a healthcare provider should be contacted.

Pregnancy

There are no adequate and well-controlled clinical studies of Breyna in pregnant women. However, maintaining control of asthma during pregnancy is important, as poorly controlled asthma can increase the risk of complications such as preeclampsia, low birth weight, and preterm delivery.

The two active ingredients in Breyna have different levels of available data:

• Budesonide: Extensive data from observational studies and many years of use suggest that inhaled budesonide does not increase the risk of major birth defects when used during pregnancy.
• Formoterol: There is limited information regarding the use of formoterol in pregnant women. In animal studies, very high doses of formoterol were associated with developmental issues.

Because formoterol is a beta-agonist, it may potentially interfere with uterine contractions during labor. Its use during labor and delivery should be discussed with a healthcare provider.

Breastfeeding

Budesonide is known to pass into human breast milk in small amounts. It is not currently known if formoterol passes into human breast milk, although it has been detected in the milk of animal subjects. Decisions regarding the use of Breyna while breastfeeding should involve a discussion with a healthcare professional to weigh the benefits of treatment for the mother against the potential risks to the infant.

Available Forms

Breyna is supplied as a pressurized metered-dose inhaler (MDI) for oral inhalation. The medication is contained within a canister that is used with a specific actuator provided by the manufacturer.

Device Features

• The inhaler includes a built-in dose counter to help track the number of inhalations remaining in the canister.
• The device is designed to deliver a combination of a corticosteroid and a long-acting beta2-adrenergic agonist directly to the lungs.

FDA Approval and Indications

Breyna is an FDA-approved inhalation aerosol containing budesonide and formoterol fumarate dihydrate. It is approved for the following conditions:

• Asthma: For patients 6 years of age and older whose condition is not well-controlled on a long-term asthma-control medication or whose disease severity requires two types of maintenance treatment.
• COPD: For the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

Regulatory Requirements

The FDA does not currently require a Risk Evaluation and Mitigation Strategy (REMS) for this medication. It is important to note that Breyna is approved for maintenance treatment and is not indicated for the treatment of acute asthma attacks or sudden worsening of COPD symptoms.

Breyna was approved as the first generic version of Symbicort, meeting the same rigorous standards for quality, safety, and effectiveness as the brand-name product.

Generic Availability

As a generic medication, Breyna contains the same active ingredients (budesonide and formoterol fumarate dihydrate) as the brand-name drug Symbicort. Generic drugs are generally available at a lower cost than their brand-name counterparts because the manufacturers do not have to repeat the initial clinical trials required for a new drug approval.

Factors Affecting Cost

The out-of-pocket cost for Breyna can vary based on several factors:

• Insurance Coverage: Most health insurance plans, including Medicare Part D and Medicaid, cover generic medications. Breyna may be placed on a lower cost-sharing tier than brand-name inhalers, which can reduce the patient's copayment.
• Pharmacy Choice: Prices may differ between retail pharmacies, and some may offer lower prices through mail-order programs or preferred network status.
• Dosage and Quantity: The total cost will depend on the strength of the inhaler prescribed and the number of units purchased at one time.

Financial Assistance

Patients who are uninsured or underinsured may be eligible for savings programs or patient assistance initiatives. Some manufacturers offer coupons or discount cards that can be used at the pharmacy to reduce the cost of the prescription. It is advisable to consult with a pharmacist or insurance provider to determine the most accurate pricing and available savings options.