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BRONCHITOL® (mannitol) inhalation powder safety and tolerability as reported in clinical trials

Across three 26-week studies,
BRONCHITOL demonstrated a
consistent safety profile1

Bronchitol adverse reactions
  • Serious adverse events occurred in 18.8% of patients treated with BRONCHITOL (vs 18.4% of patients treated with control)1
  • 12.3% of patients treated with BRONCHITOL discontinued due to adverse events (vs 8.6% of
    patients treated with control)1
BRONCHITOL Blister Pack and Inhaler

BRONCHITOL dosing
and administration

How to administer

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BRONCHITOL is not intended to be used as a rescue medication. Inhaler and blister pack are not actual size and are for representation only. Use an inhaled bronchodilator 5–15 minutes before taking BRONCHITOL.

Lungs

Review the data from BRONCHITOL clinical trials

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Important Safety
Information

BRONCHITOL is contraindicated in patients with hypersensitivity to mannitol or to any of the capsule components. BRONCHITOL is contraindicated in patients who fail to pass the BRONCHITOL Tolerance Test (BTT).

BRONCHITOL can cause bronchospasm, which can be severe in susceptible patients. Because of the risk of bronchospasm, prior to prescribing BRONCHITOL, patients must pass the BRONCHITOL Tolerance Test (BTT). The BTT must be administered under the supervision of a healthcare practitioner who can treat severe bronchospasm.

Patients who pass the BRONCHITOL tolerance test (BTT) may experience bronchospasm with add-on maintenance therapy with BRONCHITOL. Patients should premedicate with an inhaled short-acting bronchodilator prior to each administration of BRONCHITOL. If bronchospasm occurs, immediately discontinue BRONCHITOL and treat bronchospasm with an inhaled short-acting bronchodilator.

Hemoptysis can occur with BRONCHITOL use. Monitor patients with history of episodes of hemoptysis. If hemoptysis occurs, discontinue use of BRONCHITOL.

Most common adverse reactions (≥3%) include cough, hemoptysis, oropharyngeal pain, vomiting, bacteria sputum identified, pyrexia, and arthralgia.

Please see Full Prescribing Information.

Indication

BRONCHITOL® (mannitol) inhalation powder is a sugar alcohol indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis. Use BRONCHITOL only in adults who have passed the BRONCHITOL Tolerance Test.

Please see Full Prescribing Information.

Reference: 1. BRONCHITOL® (mannitol) inhalation powder Prescribing Information. 2020.