Comprehensive medication guide to Bronchitol including estimated pricing, availability information, side effects, and how to find it in stock at your local pharmacy.
Estimated Insurance Pricing
$100–$500+ per month copay on specialty tier with commercial insurance after prior authorization approval. Prior authorization is required by virtually all plans. Government-insured patients (Medicare, Medicaid) are not eligible for manufacturer copay cards but may qualify for the patient assistance program.
Estimated Cash Pricing
Approximately $3,826 for a 28-day supply (560 capsules) without insurance — over $45,000 per year. No generic is available. Chiesi CareConnect patient assistance may significantly reduce costs for eligible patients.
Medfinder Findability Score
72/100
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Bronchitol (mannitol inhalation powder) is an FDA-approved specialty medication used as add-on maintenance therapy to improve pulmonary function in adults 18 years of age and older with cystic fibrosis (CF). It was first approved by the FDA on October 30, 2020, making it the first inhaled dry powder mucoactive agent approved for CF in nearly 30 years.
Bronchitol is developed by Pharmaxis Ltd. and distributed in the United States exclusively by Chiesi USA, Inc. It comes as 40 mg mannitol capsules inhaled using a proprietary dry powder inhaler — no nebulizer, no refrigeration, and no routine device cleaning required, making it a more portable option compared to some other CF therapies.
The standard dose is 400 mg (10 capsules of 40 mg) twice daily by oral inhalation. Before treatment can begin, patients must pass the Bronchitol Tolerance Test (BTT) — a supervised test to confirm they do not experience bronchospasm when inhaling mannitol. Approximately 8% of patients fail the BTT and cannot be prescribed Bronchitol.
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Although the precise mechanism of action is listed as unknown in the FDA prescribing information, Bronchitol is understood to work as an osmotic agent. When inhaled into the airways, the mannitol particles create an osmotic gradient — they attract water from the surrounding airway tissues into the airway surface liquid (ASL).
In cystic fibrosis, CFTR gene mutations cause the airway surface to become dehydrated, resulting in thick, sticky mucus that clogs the airways and creates an environment where bacteria can thrive. By drawing water into the airway surface, Bronchitol rehydrates the mucus, making it thinner and easier for cilia and coughing to clear it from the lungs.
Clinical trials demonstrated that Bronchitol improves FEV1 (a key measure of lung function) in adults with CF. In one trial, it produced a statistically significant improvement of 6.5% in FEV1 compared to 2.4% in the placebo group, and a 35.4% reduction in pulmonary exacerbations. Bronchitol is metabolized via a CYP-independent glycolytic pathway and is primarily eliminated by the kidneys.
40 mg per capsule — Inhalation powder (hard gelatin capsule)
Standard maintenance dose: 400 mg (10 capsules) twice daily by oral inhalation. Each capsule is inhaled individually via the provided Bronchitol inhaler. Administer short-acting bronchodilator 5–15 minutes before each dose. Replace inhaler after 7 days of use.
Bronchitol is not on the FDA drug shortage list in the United States, and its U.S. supply through Chiesi USA's specialty pharmacy network is generally stable. However, the medication is not available at standard retail pharmacies — only through specialty pharmacies — which creates significant access friction for many patients.
Common reasons patients struggle to access Bronchitol include: prior authorization delays (required by virtually all insurance plans), prescriptions being sent to retail pharmacies that cannot fill it, incomplete Bronchitol Tolerance Test documentation, or the high cash cost creating an effective access barrier without patient assistance. In Europe, active supply shortages exist following a distributor transition by Pharmaxis Europe, with discontinuation in several EU countries from October 2025.
Bronchitol has a findability score of 72 out of 100 — generally available through specialty pharmacy channels, but with notable access hurdles. If you're having trouble locating Bronchitol, medfinder calls specialty pharmacies near you to check which ones can fill your prescription.
Bronchitol is not a controlled substance and has no DEA scheduling restrictions. However, because it requires the Bronchitol Tolerance Test (BTT) — a supervised in-office procedure to check for bronchospasm — prescribing must be done by or in consultation with a healthcare provider who can administer the BTT with appropriate bronchospasm management equipment on hand. Most insurance coverage criteria require prescribing by or in consultation with a CF specialist or pulmonologist.
Pulmonologists — primary prescribers; especially those specializing in CF at accredited CF care centers
CF care center physicians — CFF-accredited care centers are the primary sites for adult CF management and Bronchitol initiation; more than 130 centers across the U.S.
Nurse practitioners (NPs) and physician assistants (PAs) — advanced practice providers working within accredited CF care centers or in collaboration with CF specialists
Bronchitol cannot be initiated via telehealth because the Bronchitol Tolerance Test must be performed in person with bronchospasm management equipment available. Once a patient is established on Bronchitol, some follow-up visits may be possible via telehealth at the discretion of the CF care center. Use the CFF's Care Center Finder at cff.org to locate an accredited CF care center near you.
No. Bronchitol (inhaled mannitol) is not a controlled substance. It has no DEA schedule and is not subject to the additional prescribing restrictions, refill limitations, or monitoring requirements that apply to controlled substances such as Schedule II–V medications.
Bronchitol is a prescription medication, meaning it requires a written or electronic prescription from a licensed healthcare provider. However, unlike controlled substances, there are no mandatory prescription monitoring program (PMP) reports, no limits on the number of refills that can be issued, and no requirement for in-person prescribing visits specifically due to controlled substance regulations. The main access requirement is the Bronchitol Tolerance Test, which must be completed before the initial prescription.
The following side effects occurred in 3% or more of patients in clinical trials (400 mg twice daily):
Cough — most common side effect; often productive as mucus clears
Hemoptysis (coughing up blood) — small streaks common in CF; large amounts require stopping medication and contacting your doctor
Oropharyngeal pain — throat or mouth irritation
Vomiting
Bacteria identified in sputum
Pyrexia (fever)
Arthralgia (joint pain)
Severe bronchospasm — sudden severe airway tightening, wheezing, or difficulty breathing during or after inhalation; use rescue inhaler and seek emergency care
Significant hemoptysis — coughing up large amounts of blood; stop Bronchitol and contact your CF team or emergency services immediately
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Pulmozyme (dornase alfa)
Enzymatic mucolytic that breaks down DNA in CF mucus to reduce viscosity. CF Foundation strongly recommends for patients 6+ with moderate to severe disease. Requires nebulizer and refrigeration. Different mechanism from Bronchitol; can be used together.
Hypertonic Saline (7% or 3%)
Osmotic mucolytic that draws water into the airways; similar mechanism to Bronchitol but not FDA-approved for CF. Widely recommended by CF Foundation for patients 6+. Significantly less expensive. Requires nebulizer. Cannot be used concurrently with Bronchitol.
Trikafta (elexacaftor/tezacaftor/ivacaftor)
CFTR modulator triple therapy that targets the underlying CFTR protein defect rather than mucus symptoms. For patients with eligible mutations (most commonly F508del). Disease-modifying approach that complements rather than replaces mucolytic therapy.
Cayston (aztreonam lysine)
Inhaled antibiotic for management of Pseudomonas aeruginosa lung infections in CF patients. Not a mucolytic — addresses the infection component of CF lung disease. Often used alongside mucolytic therapy as part of a comprehensive CF regimen.
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Hypertonic Saline (inhaled)
moderateShould not be used concurrently with Bronchitol. Both work via osmotic mechanisms; the combination was excluded from all Phase 3 trials. Safety of concurrent use has not been established.
Short-acting bronchodilators (e.g., albuterol)
minorRequired co-administration: a short-acting bronchodilator must be inhaled 5–15 minutes BEFORE every dose of Bronchitol to prevent bronchospasm. This is a required pre-medication, not an interaction to avoid.
Nephrotoxic medications (e.g., aminoglycosides)
minorSince mannitol is primarily eliminated by the kidneys, patients on nephrotoxic medications should be monitored for renal function changes. No formal interaction studies have been conducted with Bronchitol.
Bronchitol represents an important option for adult CF patients who need additional mucolytic support. As the first dry powder inhaled mucoactive agent approved for CF in the U.S., it offers a portable, refrigeration-free alternative to nebulized therapies. Its osmotic mechanism complements the enzymatic approach of Pulmozyme (dornase alfa), and it can be used alongside CFTR modulators as part of a comprehensive CF regimen.
The biggest barriers to Bronchitol access in the U.S. are not supply-related but systemic: specialty pharmacy distribution only, mandatory prior authorization, the BTT requirement, and high cost without patient assistance. The Chiesi CareConnect program and the CFF Compass service are the most important resources for overcoming these barriers.
If you're having difficulty locating a specialty pharmacy that stocks Bronchitol, medfinder calls pharmacies on your behalf to find which ones can fill your prescription — saving you hours of time and making medication access easier for CF patients.
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Our medication guides are researched and written to help patients make informed decisions. All content is reviewed for accuracy and updated regularly. Learn more about our standards
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