Bronchitol (mannitol)

• Bronchitol is a prescription medicine that is used along with other therapies to improve lung function in people 18 years of age and older with cystic fibrosis (CF).
• Bronchitol is only for adults who have passed the Bronchitol Tolerance Test (BTT). Your first dose of Bronchitol is given during the BTT by your healthcare provider and tests if Bronchitol is right for you. Your healthcare provider will use equipment to monitor you and have medicine ready if you have bronchospasms during the test. If you have bronchospasms during your BTT, then you should not be prescribed Bronchitol.

Bronchitol should not be used in children and adolescents. It is not known if Bronchitol is safe and effective in children under 18 years of age.

Bronchitol may cause serious side effects, including:

• sudden breathing problems immediately after inhaling your medicine. Use your short-acting bronchodilator or rescue medicine if you have sudden breathing problems. Get emergency medical care right away if your bronchodilator or rescue medicine does not relieve the symptoms.
• coughing up of blood (hemoptysis). This is a serious but common side effect. Coughing up blood in your mucus can happen while you are using Bronchitol. Call your healthcare provider or get emergency medical care right away if you cough up a large amount of blood.

The most common side effects of Bronchitol include:

• cough
• coughing up of blood
• pain or irritation in the back of your mouth and throat and discomfort when swallowing
• vomiting
• fever
• joint pain
• bacteria in your sputum

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Bronchitol. You can ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Chiesi USA, Inc. at 1-888-661-9260.

Required Testing And Evaluation Prior To Prescribing Bronchitol (Bronchitol Tolerance Test)

Prior to prescribing Bronchitol for treatment of cystic fibrosis, the Bronchitol Tolerance Test (BTT) must be administered and performed under the supervision of a healthcare practitioner who is able to manage acute bronchospasm, to identify patients who are suitable candidates for Bronchitol maintenance therapy.

• Perform BTT to identify patients who experience bronchospasm, a decrease in FEV₁, or a decrease in oxygen saturation with administration of Bronchitol. If a patient experiences any of these events during the BTT, the patient has failed the BTT. Do not prescribe Bronchitol. If a patient does not experience any of these events during BTT, the patient has passed the BTT and is a candidate for Bronchitol therapy.
• Ensure that rescue medication and resuscitation equipment are available for immediate use during the BTT.
• Do not perform the BTT if the patient is considered clinically unstable.

See the prescribing information for complete instructions and to avoid medication errors associated with BTT dosing and procedures.

Do not use Bronchitol add-on maintenance therapy in patients who fail the BTT.

Recommended Dosage For Treatment Of Cystic Fibrosis

• For patients who have passed the BTT, the recommended dosage of Bronchitol is 400 mg twice a day by oral inhalation (the contents of 10 capsules administered individually) via the inhaler [see Required Testing And Evaluation Prior To Prescribing Bronchitol (Bronchitol Tolerance Test)].
• A short-acting bronchodilator should be administered by oral inhalation, 5-15 minutes before every dose of Bronchitol.
• Bronchitol should be taken once in the morning and once in the evening, with the later dose taken at least 2-3 hours before bedtime.

Use And Maintenance Of Inhaler

• Instruct patients on safe hygiene practices (clean and dry hands thoroughly) and correct inhaler use, including loading of capsules and proper inhalation technique per the Patient Instructions for Use.
• The Bronchitol inhaler should be discarded and replaced after 7 days of use.
• If the inhaler does need to be washed, the patient should allow the inhaler to thoroughly air dry before next use.

• No formal drug interaction studies have been conducted with mannitol, the active ingredient in Bronchitol.

• There are no adequate and well-controlled studies of Bronchitol in pregnant women.
• The available data on Bronchitol use in pregnant women are not sufficient to inform any drug-associated risks for major birth defects and miscarriage.
• There are risks to the mother associated with cystic fibrosis in pregnancy.
• Bronchitol should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
• It is not known whether Bronchitol is excreted in human breast milk.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Bronchitol and any potential adverse effects on the breastfed child from Bronchitol or from the underlying maternal condition.