Wixela Inhub

Asthma Treatment

Wixela Inhub is prescribed for the long-term treatment of asthma in adults and children 4 years of age and older. It is typically used for patients whose asthma is not well-controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or for those whose condition is severe enough to require two types of maintenance therapy.

Chronic Obstructive Pulmonary Disease (COPD)

This medication is also used for the maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. It is used to improve lung function and can help reduce the frequency of flare-ups or exacerbations in people with COPD.

Important Limitations of Use

• Not for acute symptoms: Wixela Inhub is a maintenance treatment and will not work fast enough to treat a sudden asthma attack or a COPD flare-up. A separate rescue inhaler must be used for sudden breathing problems.
• Regular use required: To be effective, the medication must be used every day as directed, even if the patient is not currently feeling symptoms.
• Specific patient groups: It is not intended for patients whose asthma is already well-controlled by a low- or medium-dose inhaled corticosteroid alone.

Mechanism of Action

Wixela Inhub is a combination medication used to manage chronic lung conditions like asthma and chronic obstructive pulmonary disease (COPD). It works through two different mechanisms to help keep the airways clear:

• Reducing Inflammation: One component, fluticasone propionate, is a corticosteroid. It works by decreasing swelling and irritation in the airways. This helps prevent the lungs from overreacting to triggers that cause breathing problems.
• Opening the Airways: The second component, salmeterol, is a long-acting bronchodilator. It works by relaxing the smooth muscles surrounding the airways in the lungs. This helps the airways stay open for at least 12 hours, making it easier for air to move in and out.

Because this medication is designed to provide long-term control, it must be used regularly to be effective. It does not work immediately and should not be used as a rescue inhaler to treat a sudden asthma attack or breathing emergency.

Common Side Effects

The most frequently reported side effects of Wixela Inhub include:

• Upper respiratory tract infections, such as the common cold or sinus pain.
• Throat irritation, hoarseness, or voice changes.
• Headache.
• Nausea and vomiting.
• Muscle, bone, or joint pain.
• Dizziness.

Serious Side Effects

Some side effects can be severe and may require medical attention:

• Pneumonia: This is a particular concern for individuals with COPD. Symptoms may include fever, chills, or changes in mucus color.
• Oral Thrush: A fungal infection in the mouth or throat, often appearing as white patches. Rinsing the mouth with water after use can help reduce this risk.
• Immune System Effects: Increased risk of infections and potential worsening of existing infections like tuberculosis or herpes simplex.
• Adrenal Suppression: Reduced ability of the body to produce natural steroid hormones, especially during times of stress or surgery.
• Paradoxical Bronchospasm: A sudden worsening of breathing or wheezing immediately after using the inhaler.
• Heart Problems: Increased heart rate, irregular heartbeat, or high blood pressure.
• Bone and Eye Changes: Long-term use may lead to reduced bone mineral density, cataracts, or glaucoma.
• Growth Delay: Inhaled steroids may slow the growth rate in children and adolescents.

Acute Symptoms and Proper Use

Wixela Inhub is not a rescue medication and should not be used to treat sudden episodes of shortness of breath or wheezing. A rapid-onset, short-acting bronchodilator is required for acute symptoms. Using more than the recommended dose can lead to serious cardiovascular effects, including increased heart rate and blood pressure.

Infection Risks

The use of inhaled corticosteroids is associated with several types of infections:

• Oropharyngeal Candidiasis: Fungal infections of the mouth and throat (thrush) may develop. Patients are advised to rinse their mouth with water and spit it out after each inhalation to reduce this risk.
• Pneumonia: Clinical studies have shown an increased risk of pneumonia in patients with COPD who use this medication.
• Immunosuppression: Individuals with weakened immune systems may be more susceptible to infections. Exposure to chickenpox or measles should be avoided, as these can be more severe in patients using corticosteroids.

Hormonal and Systemic Effects

Transitioning from systemic corticosteroids (such as oral prednisone) to Wixela Inhub requires caution due to the risk of adrenal insufficiency. This condition can be life-threatening during times of physical stress, such as surgery or severe infection. Additionally, long-term use of high doses may lead to hypercorticism or suppression of the hypothalamic-pituitary-adrenal (HPA) axis.

Long-Term Complications

Chronic use of inhaled corticosteroids may lead to several long-term health concerns:

• Bone Mineral Density: Decreases in bone density have been observed, which may increase the risk of fractures over time.
• Growth in Pediatrics: Inhaled steroids may slow the growth rate in children and adolescents. Regular monitoring of growth is recommended.
• Ocular Effects: Long-term use may increase the risk of developing glaucoma or cataracts.

Precautions for Specific Conditions

Wixela Inhub should be used with caution in patients with cardiovascular disorders, convulsive disorders, thyrotoxicosis, or diabetes. It may also cause paradoxical bronchospasm, a sudden worsening of breathing immediately after inhalation. If this occurs, the medication should be discontinued immediately and alternative therapy started.

Contraindications

This medication is contraindicated for the primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required. It is also contraindicated in patients with a severe hypersensitivity to milk proteins or any of the ingredients in the product.

Pregnancy

There is limited data on the use of Wixela Inhub in pregnant women. Decisions regarding its use involve balancing the potential risks of the medication against the risks of poorly controlled asthma. Uncontrolled asthma during pregnancy can lead to serious complications for both the mother and the baby, such as preeclampsia, premature birth, and low birth weight.

In animal studies, high doses of the individual components in Wixela Inhub were associated with developmental issues, including cleft palate. However, it is unclear if these findings apply to humans using standard inhaled doses. Additionally, because one of the active ingredients (salmeterol) can interfere with uterine contractions, its use during labor and delivery is generally limited to situations where it is medically necessary.

Breastfeeding

It is currently unknown if the medications in Wixela Inhub pass into human breast milk or how they might affect a nursing infant or milk production. Other similar medications have been found in breast milk in small amounts. If you are breastfeeding or planning to breastfeed, consult with a healthcare provider to evaluate the safety and necessity of using this inhaler.

Available Forms

Wixela Inhub is available as a dry powder for oral inhalation. It is supplied in a plastic inhaler device that contains the medication within a foil blister strip.

The device is designed to deliver the powder formulation directly to the lungs through the mouth. It is intended for oral inhalation only and is not used with a spacer.

FDA Approval Status

Wixela Inhub was approved by the U.S. Food and Drug Administration (FDA) in January 2019. It was the first generic version of Advair Diskus to receive approval, meaning it is therapeutically equivalent to the brand-name product in terms of safety, dosage, and effectiveness.

Approved Indications

The FDA has approved Wixela Inhub for the following uses:

• Asthma: For the twice-daily maintenance treatment of asthma in patients aged 4 years and older. It is intended for patients whose asthma is not adequately controlled on a long-term asthma-control medication or whose disease severity warrants treatment with both an inhaled corticosteroid and a long-acting beta2-adrenergic agonist (LABA).
• Chronic Obstructive Pulmonary Disease (COPD): For the maintenance treatment of airflow obstruction and to reduce the frequency of exacerbations in patients with COPD, including chronic bronchitis and emphysema.

Boxed Warning and Safety Communications

Previously, the FDA required a Boxed Warning for all medications containing a LABA due to risks of asthma-related death. However, after reviewing large safety trials, the FDA removed this Boxed Warning for combination products like Wixela Inhub that contain both an inhaled corticosteroid and a LABA. The trials demonstrated that when these two types of medicine are used together, there is no significant increase in the risk of serious asthma-related events compared to using an inhaled corticosteroid alone.

Regulatory Requirements

Wixela Inhub is a prescription-only medication. It is not approved for the treatment of acute symptoms, such as a sudden asthma attack or COPD flare-up, which require a rescue inhaler. There is currently no Risk Evaluation and Mitigation Strategy (REMS) required for this product.

Generic Pricing

As a generic medication containing fluticasone propionate and salmeterol, Wixela Inhub is typically less expensive than its brand-name counterpart, Advair Diskus. Generic drugs are required to meet the same standards for safety and effectiveness as brand-name drugs but are usually offered at a lower cost to consumers.

Factors Affecting Out-of-Pocket Costs

The amount you pay for Wixela Inhub can vary based on several factors:

• Insurance Coverage: Most insurance plans, including Medicare and Medicaid, cover generic inhalers. The specific tier placement on a plan's formulary will determine the copayment or coinsurance amount.
• Pharmacy Choice: Retail prices can differ between pharmacies. Some patients may find lower costs through mail-order pharmacy services or by using pharmacy discount cards.
• Dosage and Quantity: The medication is available in three strengths. The price may fluctuate depending on the specific strength prescribed and whether a 30-day or 90-day supply is purchased.

Financial Assistance Programs

For individuals who have difficulty affording their medication, financial assistance may be available. Some patients may qualify for manufacturer coupons or savings cards that reduce out-of-pocket expenses. Additionally, non-profit organizations and patient assistance programs may provide help for those who meet specific income or insurance requirements. It is advisable to consult with a pharmacist or insurance provider to determine the most current and accurate pricing information.