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Request more information about BRONCHITOL® (mannitol) inhalation powder

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    Medical Information

    To request specific medical information about BRONCHITOL or to report adverse events or product complaints, please contact the Medical Information Department.

    Adverse events may also be reported to the FDA’s MedWatch Program at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Mail:

    Chiesi USA, Inc.
    175 Regency Woods Place
    Suite 600 Cary, NC 27518

    Phone:

    1-888-661-9260

    Email:

    us.medical@chiesi.com

    Fax:

    (866) 443-3092

    Contact Chiesi CareDirect®

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    Phone:

    1-888-865-1222 toll-free,
    Monday–Friday
    from 9 am–6 pm EST

    Email:

    chiesicaredirect@caremetx.
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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.