Dosing overview

BRONCHITOL® (mannitol) inhalation powder
Tolerance Test

Before starting patients on BRONCHITOL, a trained healthcare practitioner must administer the BRONCHITOL Tolerance Test (BTT)1

Purposes of the BTT:

  • Identify patients who may be hyperresponsive to BRONCHITOL to ensure that only appropriate patients are prescribed treatment
  • Enable patients to practice the correct inhaler technique before receiving their BRONCHITOL prescription

A healthcare practitioner must perform the BTT and be able to manage acute bronchospasm, if it were to occur.

The BTT involves:

  • Obtaining baseline measurements of SpO2 and FEV1
  • Administration of a bronchodilator
  • A series of monitored inhalations of increasing doses of BRONCHITOL
  • Measurement of FEV1 and SpO2 after each step for comparison to respective calculated STOP values

This is a summary of the steps; please see the Healthcare Practitioner Instructions for Use (HCP IFU) for full
directions on administering the BTT.

BRONCHITOL® (mannitol) inhalation powder
dosing and administration information1

Inhaler
  • An inhaled short-acting bronchodilator should be administered 5–15 minutes
    before every dose of BRONCHITOL
400 mg twice a day visual
  • The recommended dosage of BRONCHITOL is 400 mg twice a day
  • This requires inhalation of the contents of 10 capsules via the inhaler, twice a day
Day/Night
  • BRONCHITOL should be taken once in the morning and once in the evening
  • The later dose should be taken at least 2–3 hours before bedtime
Calendar
  • The inhaler should be discarded and replaced after 7 days of use
  • If the inhaler needs to be washed, allow it to thoroughly air dry before next use
Personal Items: mobile phone, penwatch
BRONCHITOL Blister Pack and Inhaler

Administer the BRONCHITOL
Tolerance Test before prescribing

This test must always be administered to identify patients who are hyperresponsive to inhaled mannitol. It also allows patients to practice proper inhalation technique under the supervision of a trained healthcare practitioner.

Learn more about the BTT


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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.

 

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. 2024.