Interactive Instructions for Use

Use this tool to help determine if BRONCHITOL® (mannitol) inhalation powder is appropriate for your patient

This electronic tool provides step-by-step instructions for performing the BRONCHITOL Tolerance Test (BTT) based on FDA-approved labeling. It will execute calculations routinely done in clinical practice. This tool is not intended to aid clinical decision making, to replace the judgement of a healthcare practitioner, or to perform any clinical assessment. This tool is not intended to replace the Healthcare Practitioner Instructions for Use (HCP IFU) or Patient Information located in the Full Prescribing Information.

The BTT identifies patients who are hyperresponsive to inhaled mannitol, the active ingredient in BRONCHITOL, through a series of monitored inhalations of increasing doses. The BTT must be performed by a healthcare practitioner who is able to manage acute bronchospasm if it were to occur.

STOP the BTT if your patient:

  • Has SpO2 or FEV1 measurements that fall below the STOP values calculated in STEP A
  • Shows any signs of significant bronchoconstriction requiring treatment with a bronchodilator, such as wheezing or shortness of breath
  • Experiences a distressing cough, vomiting, or any other signs that they are not tolerating BRONCHITOL
  • Has not inhaled the contents of a total of 10 capsules during STEPS C through F; schedule a repeat BTT

BRONCHITOL Tolerance Test carton includes:

BRONCHITOL Tolerance Test carton contents

Please ensure you have the following:

  • BRONCHITOL Tolerance Test carton
  • Bronchodilator (and spacer if needed)
  • Timer (one is provided in this tool)
  • Spirometer and nose clip
  • Pulse oximeter
  • Rescue medication and resuscitation equipment
  • Sink/hand washing station
  • Glass of water for patient to sip during BTT, if necessary

Begin

Step

A

Pre-assessment calculations

Measure baseline SpO2 and FEV1 values. STOP values will be calculated for you.

Today’s baseline

STOP values

SpO2 :

FEV1 :

%x 0.9 = #### %

Lx 0.8 = #### L

90-STOP
(90% of baseline SpO2)

80-STOP
(80% of baseline FEV1)

Step

B

Instruct patient to use an inhaled short-acting beta-agonist.

Wait 5–15 minutes, or use our optional timer:

While waiting, complete these steps:

Please check the boxes above to continue.

Step

C

Following steps 1–8 located below, instruct patient to inhale contents of 1 capsule.

Open inhaler, CONFIRM powder has been inhaled.

Wait 1 minute, or use our optional timer:

Record new SpO2:

%

Step

D

Following steps 3–8 located below, instruct patient to inhale contents of 2 capsules, one capsule at a time.

Open inhaler, CONFIRM powder has been inhaled.

Wait 1 minute, or use our optional timer:

Record new SpO2:

Record new FEV1:

%

L

Step

E

Following steps 3–8 located below, instruct patient to inhale contents of 3 capsules, one capsule at a time.

Open inhaler, CONFIRM powder has been inhaled.

Wait 1 minute, or use our optional timer:

Record new SpO2:

Record new FEV1:

%

L

Step

F

Following steps 3–8 located below, instruct patient to inhale contents of 4 capsules, one capsule at a time.

Open inhaler, CONFIRM powder has been inhaled.

Wait 1 minute, or use our optional timer:

Record new SpO2:

Record new FEV1:

%

L

The patient has passed the BTT.
BRONCHITOL may be prescribed.

Monitor until SpO2 and FEV1 return to baseline.

The recommended dosage of BRONCHITOL is 400 mg twice a day. This requires the inhalation of the contents of 10 capsules (blister pack x 1) twice a day.

Stop.

The patient has failed the BTT.
DO NOT continue the BTT.
DO NOT prescribe BRONCHITOL.

Wait 15 minutes, then monitor SpO2 and FEV1 to confirm recovery to baseline. Treat bronchospasm as needed.

90-STOP

90% of baseline SpO2

%

80-STOP

80% of baseline FEV1

L

5:00
Reset Timer

Start

Pause

Continue

Return to main screen

Download Results

Back
Inhaler use steps for inhalation of the contents of a single capsule
Step 1

Remove cap.

Step 2

Twist open inhaler by turning the mouthpiece.

Step 3

Take 1 capsule out of the package and put it in the chamber.

Do not put the capsule into the mouthpiece.

Step 4

Hold the inhaler upright and turn the mouthpiece until it locks in place.

Step 5

Push both buttons at the same time.

Keep the inhaler upright.

PUSH

THEN

Release both buttons at the same time.

Never keep buttons pressed.

RELEASE
Step 6

Exhale fully (do not exhale into inhaler).

Step 7

Close lips around mouthpiece and take a steady, deep breath.

INHALE

THEN

Remove the inhaler from mouth.

REMOVE

AND

Step 7 (continued)

Hold breath for 5 seconds before exhaling (do not exhale into the inhaler).

HOLD

You should hear a rattling sound while breathing in. If you do not, tap the bottom of the inhaler firmly and repeat steps 6 and 7.

Step 8

Open the inhaler. If powder is left in the capsule, repeat steps 6 and 7. Once empty, throw the capsule away.

CONFIRM
Step 1

Remove cap.

Step 2

Twist open inhaler by turning the mouthpiece.

Step 3

Take 1 capsule out of the package and put it in the chamber.

Do not put the capsule into the mouthpiece.

Step 4

Hold the inhaler upright and turn the mouthpiece until it locks in place.

Step 5

Push both buttons at the same time.

Keep the inhaler upright.

PUSH

THEN

Release both buttons at the same time.

Never keep buttons pressed.

RELEASE
Step 6

Exhale fully (do not exhale into inhaler).

Step 7

Close lips around mouthpiece and take a steady, deep breath.

INHALE

THEN

Remove the inhaler from mouth.

REMOVE

AND

Step 7 (continued)

Hold breath for 5 seconds before exhaling (do not exhale into the inhaler).

HOLD

You should hear a rattling sound while breathing in. If you do not, tap the bottom of the inhaler firmly and repeat steps 6 and 7.

Step 8

Open the inhaler. If powder is left in the capsule, repeat steps 6 and 7. Once empty, throw the capsule away.

CONFIRM
PP-BR-0024 v1.0

To use this tool please view this page on a desktop or tablet in landscape orientation.

See the Healthcare Practitioner Instructions for Use (HCP IFU) and Full Prescribing Information for more information.

Get an overview about the BRONCHITOL Tolerance Test

BRONCHITOL Inhaler and Blister PackSunglassesLip Balm

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 inhalation powder.

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.