Xhance

Primary Indications

Xhance is specifically approved for use in adults 18 years of age and older for the following conditions:

• Nasal Polyps: It is used to treat and shrink nasal polyps, which are soft, noncancerous growths that form on the lining of the nasal passages or sinuses.
• Chronic Rhinosinusitis: It is used to manage chronic rhinosinusitis, a condition characterized by long-term inflammation and swelling of the sinuses. It is indicated for this use both with and without the presence of nasal polyps.

Symptoms Managed

By delivering medication deep into the nasal passages to reduce inflammation, Xhance helps relieve symptoms such as:

• Nasal congestion and stuffiness
• Sinus pressure and facial pain
• Runny nose or post-nasal drip
• Reduced sense of smell

While other forms of fluticasone nasal spray are commonly used for seasonal or year-round allergies (hay fever), Xhance is specifically designed and indicated for the treatment of polyps and chronic sinus inflammation.

Mechanism of Action

Xhance contains fluticasone propionate, which belongs to a class of medications known as corticosteroids. These drugs work by mimicking the effects of natural hormones in the body to decrease inflammation. When applied to the lining of the nose, the medication helps block the release of various natural substances that trigger inflammatory responses.

Reducing Swelling

By targeting inflammation directly in the nasal tissues, Xhance helps to:

• Shrink nasal polyps.
• Decrease swelling in the nasal passages.
• Relieve symptoms such as nasal congestion, sinus pressure, and a runny nose.

Exhalation Delivery System

Unlike standard nasal sprays, Xhance uses a specialized delivery method. When a person blows into the device's mouthpiece while activating the spray, the breath helps propel the medication deeper and higher into the nasal cavities and sinus regions. This mechanism is designed to deliver the medicine to the specific areas where nasal polyps and chronic inflammation typically occur.

Common Side Effects

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

• Nosebleeds
• Nasal congestion or irritation
• Sore throat
• Cough
• Headache
• Sinus pain
• Changes in taste or smell

Serious Side Effects

While less common, some side effects can be serious. Seek medical attention immediately if you notice:

• Severe or frequent nosebleeds
• Sores inside the nose that do not heal
• A whistling sound when breathing through the nose, which may indicate a hole in the nasal septum
• Vision changes, such as blurred vision, eye pain, or seeing halos around lights
• Signs of an allergic reaction, including rash, hives, swelling of the face or throat, or difficulty breathing
• Signs of infection, such as fever, chills, or white patches in the nose or throat
• Symptoms of adrenal gland suppression, such as extreme tiredness, muscle weakness, or unexplained weight loss

Local Nasal Effects

Xhance can cause several issues within the nasal cavity. These include:

• Nosebleeds (Epistaxis): Frequent or heavy bleeding from the nose.
• Nasal Ulceration: Sores or ulcers may develop on the nasal lining.
• Candida albicans Infection: A fungal infection, also known as thrush, can develop in the nose or throat.
• Nasal Septal Perforation: In rare cases, a hole may develop in the wall separating the nostrils.

Because corticosteroids can slow the healing process, this medication is typically not used until the nose has fully healed following recent surgery, nasal trauma, or nasal ulcers.

Vision Changes

Long-term use of nasal corticosteroids may increase the risk of glaucoma, cataracts, or increased pressure inside the eye. Individuals with a history of these conditions or those who notice changes in vision should undergo regular eye examinations.

Immune System Risks

This medication can weaken the immune system, making it harder to fight infections. Users should avoid exposure to chickenpox or measles if they are not immune. Existing infections, such as tuberculosis, fungal, bacterial, or viral infections, or ocular herpes simplex, may worsen while using this drug.

Adrenal Suppression and Systemic Effects

When used at higher than recommended doses or in sensitive individuals, the medication can be absorbed into the bloodstream. This may lead to systemic corticosteroid effects, such as hypercorticism or adrenal suppression, where the body does not produce enough natural steroid hormones. If these effects occur, the medication may need to be discontinued slowly under medical supervision.

Serious Allergic Reactions

Serious hypersensitivity reactions, including anaphylaxis, rash, and swelling of the face, tongue, or throat (angioedema), have been reported. Use is contraindicated in individuals with a known hypersensitivity to fluticasone propionate or any of the ingredients in the spray.

Drug Interactions

Using Xhance with certain other medications, particularly strong CYP3A4 inhibitors like ritonavir or ketoconazole, can increase the amount of fluticasone in the blood. This increases the risk of systemic side effects.

Pregnancy

There are no adequate and well-controlled studies of Xhance in pregnant women. In animal studies, corticosteroids like fluticasone propionate have been shown to cause birth defects when administered systemically at low doses. However, when used as a nasal spray, very little of the medication is absorbed into the bloodstream compared to oral or injected forms.

If you are pregnant or planning to become pregnant, discuss the use of Xhance with your doctor to evaluate the potential risks and benefits for your specific situation.

Breastfeeding

It is not known whether fluticasone propionate is excreted in human breast milk. Because other corticosteroids are known to pass into breast milk, caution is advised when Xhance is used by someone who is breastfeeding.

Speak with a healthcare provider to determine the best course of action while nursing, as they can help weigh the benefits of the medication against any potential risks to the infant.

Dosage Forms

Xhance is provided as a nasal spray. It features a unique delivery mechanism known as an exhalation delivery system, which consists of a nosepiece and a mouthpiece. This system is designed to use the force of the user's breath to help direct the medication into the nasal cavity.

• Nasal Spray: A liquid medication delivered through a metered-dose pump.

FDA Approval History

The U.S. Food and Drug Administration (FDA) first approved Xhance (fluticasone propionate) in September 2017. It was initially approved for the treatment of nasal polyps in patients 18 years of age and older.

Expanded Indications

In March 2024, the FDA expanded the approved use of Xhance to include the treatment of chronic rhinosinusitis without nasal polyps in adults. This approval made it the first medication specifically indicated for the treatment of chronic rhinosinusitis without nasal polyps.

Regulatory Status

Xhance is classified as a prescription medication. It is not a controlled substance and does not currently require a Risk Evaluation and Mitigation Strategy (REMS) or carry a boxed warning. The medication is delivered using a proprietary exhalation delivery system (EDS) intended to reach the upper and posterior regions of the nasal cavity.

Factors Affecting Cost

Several factors can influence the final price of Xhance, including:

• Insurance Coverage: Your out-of-pocket cost is largely determined by your insurance plan's formulary, which ranks drugs into different cost tiers.
• Pharmacy Selection: Prices can vary between retail pharmacies, and some mail-order pharmacies may offer different rates for a multi-month supply.
• Manufacturer Programs: The manufacturer may offer savings cards or coupons for patients with commercial insurance to help lower copayments.

Generic Availability

Xhance is a brand-name medication. While the active ingredient, fluticasone propionate, is available in many inexpensive generic nasal sprays, those products do not use the same specialized exhalation delivery system. Currently, there is no generic version of fluticasone propionate that uses the Xhance delivery device.

Financial Assistance

For individuals without insurance or those whose insurance does not cover the medication, patient assistance programs may be available. These programs typically have specific income and residency requirements to qualify for reduced-cost or free medication.