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Bronchitol is a brand name for Mannitol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.
Verbatim from this product's EMA label. Tap a section to expand.
1). 8) including appropriate use of resuscitation equipment. The patient should be pre-medicated with a bronchodilator 5-15 minutes prior to the initiation dose but after the baseline FEV1 and SpO2 (Oxygen saturation in the blood) measurement.
All FEV1 measurements and SpO2 monitoring should be performed 60 seconds after dose inhalation. Training the patient to practice correct inhaler technique during the initiation dose assessment is important.
The initiation dose assessment must be performed according to the following steps:
Step 1: Patients baseline FEV1 and SpO2 is measured prior to the initiation dose Step 2: Patient inhales 40 mg (1x40 mg capsules) and SpO2 is monitored Step 3: Patient inhales 80 mg (2x40 mg capsules) and SpO2 is monitored Step 4: Patient inhales 120 mg (3x40 mg capsules), FEV1 is measured and SpO2 is monitored Step 5: Patient inhales 160 mg (4x40 mg capsules), FEV1 is measured and SpO2 is monitored Step 6: Patients FEV1 is measured 15 minutes post initiation dose.
3 Patients with asthma may experience reversible temporary mild bronchospasm after passing the initiation dose assessment and therefore all patients should be monitored until their FEV1 has returned to baseline levels. Therapeutic dose regimen The therapeutic dose regimen should not be prescribed until the initiation dose assessment has been performed.
The patient must complete and pass the initiation dose assessment before starting treatment with Bronchitol. A bronchodilator must be administered 5-15 minutes before each dose of Bronchitol. The recommended dose of Bronchitol is 400 mg twice a day.
This requires the inhalation of the contents of ten capsules via the inhaler device twice a day. The doses should be taken morning and night with the evening dose taken 2-3 hours before bedtime. For patients receiving several respiratory therapies, the recommended order is: 1.
Bronchodilator 2. Bronchitol 3. Physiotherapy/exercise 4. Dornase alfa (if applicable) 5. Inhaled antibiotics (if applicable) Special populations Elderly patients (≥65 years) There are insufficient data in this population to support a recommendation for or against dose adjustment.
Renal or hepatic impairment Bronchitol has not formally been studied in patients with impaired renal and hepatic function. Available data from studies DPM-CF-301 and 302 suggest that no dose adjustments are required for these patient populations.
Summary of the safety profile The safety profile of Bronchitol has been evaluated in clinical studies involving more than 1200 patients. (See Table 1). 4). 4). 4). 0% of patients in the control arm. 0% of patients in the Bronchitol treatment arm.
The most important adverse reaction associated with the use of Bronchitol is haemoptysis. 4% in the Bronchitol arms for studies 301, 302 and 303 respectively vs. 6% in the control arms. 4). Tabulated list of adverse reactions The safety profile of Bronchitol is based on the safety data from Phase III clinical studies (including data from the initiation dose assessment).
Frequencies are defined as:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (≥1/100,000 to <1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1:
Frequency of adverse reactions with Bronchitol in the phase 3 studies (initiation dose assessment and/or treatment phase) System organ class Frequency Adverse Reaction Infections and infestations Uncommon Bacterial disease carrier, Bronchitis, Bronchopneumonia, Lung infection, Oral candidiasis, Pharyngitis, Staphylococcal infection, Upper respiratory tract infection Metabolism and nutrition disorders Uncommon Decreased appetite, CF related diabetes, Dehydration Psychiatric disorders Uncommon Initial insomnia, Morbid thoughts Nervous system disorders Common Headache Uncommon Dizziness Ear and labyrinth disorders Uncommon Ear pain Respiratory, thoracic and mediastinal disorders Common Cough, Haemoptysis, Oropharyngeal pain, Wheezing Uncommon Productive cough, Throat irritation, Asthma, Bronchospasm, Forced expiratory volume decreased, Rhinorrhoea, Dyspnoea, Dysphonia, Hyperventilation, Obstructive airways disorder, Respiratory tract congestion, Sputum discoloured, Hypoxia Gastrointestinal disorders Common Post-tussive vomiting, Vomiting Uncommon Nausea, Diarrhoea, Eructation, Flatulence, Gastrooesophageal reflux disease, Glossodynia, Retching, Stomatitis, Abdominal pain upper, Aphthous Stomatitis, Odynophagia 7 Skin and subcutaneous tissue disorders Uncommon Acne, Cold sweat, Pruritus, Rash, Rash pruritic Musculoskeletal and connective tissue disorders Uncommon Musculoskeletal chest pain, Arthralgia, Back pain, Joint stiffness, Musculoskeletal pain Renal and urinary disorders Uncommon Urinary incontinence General disorders and administration site conditions Common Condition aggravated, Chest discomfort Uncommon Pyrexia, Fatigue, Influenza like illness, Hernia pain, Malaise, Chest pain Investigations Uncommon Blood alkaline phosphatase increased, Bacteria or fungus sputum test positive Adverse reactions that occurred only with the initiation dose assessment (MTT) are dehydration, forced expiratory volume decreased, hypoxia, diarrhoea, abdominal pain upper, aphthous stomatitis, odynophagia, chest pain and blood alkaline phosphatase increased.
Hyperresponsiveness to mannitol Patients must be monitored for bronchial hyperresponsiveness to inhaled mannitol during their initiation dose assessment before commencing the therapeutic dose regimen of Bronchitol. If the patient is unable to perform spirometry or complete the initiation dose assessment, they must not be prescribed Bronchitol.
3). 2). A patient is defined as hyperresponsive to inhaled mannitol and must not be prescribed the therapeutic dose regimen if they experience any of the following during the initiation dose assessment: - ≥10% fall from baseline in SpO2 at any point of the assessment; - FEV1 fall from baseline is ≥20% at 240 mg cumulative dose; - FEV1 has fallen 20-<50% (from baseline) at the end of the assessment and does not return to <20% within 15 minutes; - FEV1 has fallen ≥50% (from baseline) at the end of the assessment.
If a therapy induced hyperresponsive reaction is suspected, Bronchitol should be discontinued. All patients should be monitored until their FEV1 has returned to baseline levels. 8). Bronchospasm should be treated with a bronchodilator or as medically appropriate.
If there is evidence of therapy induced bronchospasm, the physician should carefully evaluate whether the benefits of continued use of Bronchitol outweigh the risks to the patient. All patients should be formally reviewed after approximately six weeks of Bronchitol treatment to assess for signs and symptoms suggestive of active substance induced bronchospasm.
2 should be repeated if uncertainty exists. Asthma The safety/efficacy of Bronchitol in patients with asthma has not been formally studied. Patients with asthma must be carefully monitored for worsening signs and symptoms of asthma after the initiation dose of Bronchitol.
Patients must be advised to report worsening signs and symptoms of asthma during therapeutic use to their physician. If there is evidence of therapy induced bronchospasm, the physician should carefully evaluate whether the benefits of continued use of Bronchitol outweigh the risks to the patient.
Hypersensitivity to the active substance. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Paediatric population The safety and efficacy of Bronchitol in children and adolescents aged 6 to 18 years has not yet been established. 2 but no recommendation on a posology can be made. The safety and efficacy of Bronchitol in children aged less than 6 years has not been established.
No data are available. Method of administration Bronchitol is for inhalation use, using the inhaler provided in the pack. It must not be administered by any other route or using any other inhaler. The capsules must not be swallowed. Each of the capsules is loaded into the device separately.
The contents of the capsules are inhaled via the inhaler device with one or two breaths. After inhalation, each empty capsule is discarded before inserting the next capsule into the inhaler device with as little delay as possible between capsules.
The inhaler device is to be replaced after one week of use. If the inhaler does require cleaning, it must be ensured that the device is empty, then it should be washed in warm water and before re-use,the inhaler should be allowed to thoroughly air dry.
Detailed instructions on how to use the inhaler can be found in the patient information leaflet. Patients should be advised to carefully read them. 4
1%) out of 486 patients in Study 303 had a positive (MTT). 6%) subjects. 6%). Paediatric population (6 to 17 years of age) Frequency, type and severity of adverse reactions in children are similar to those observed in adults. 8% of patients).
The most important adverse reaction associated with the use of Bronchitol during the initiation dose assessment with the paediatric population is bronchospasm. Therapeutic dose regimen(6 to 17 years of age) The most commonly observed adverse reaction associated with the use of Bronchitol is cough.
8% of patients in the control arm. The most important adverse reaction associated with the use of Bronchitol is haemoptysis.
Table 2:
Frequency of adverse reactions with Bronchitol in the phase 3 studies (initiation dose assessment and/or treatment phase) – paediatric population (6 to 17 years of age) System organ class Frequency Adverse Reaction Psychiatric disorders Uncommon Initial insomnia Nervous system Common Headache Uncommon Dizziness Ear and labyrinth disorders Uncommon Ear Pain Respiratory, thoracic and mediastinal disorders Common Cough, Condition aggravated, Haemoptysis, Oropharyngeal pain, Chest discomfort, Wheezing, Asthma, […]
Bronchospasm should be treated with a bronchodilator or as medically appropriate. Haemoptysis Haemoptysis has been commonly reported with Bronchitol in clinical studies. Bronchitol has not been studied in patients with a history of significant episodes of haemoptysis (>60 ml) in the previous three months.
As a consequence, these patients should be carefully monitored, and Bronchitol should be withheld in the event of massive haemoptysis. A massive/serious haemoptysis is considered to be: 5 • acute bleeding ≥240 ml in a 24-hour period • recurrent bleeding ≥100 ml/day over several days The reinstitution or withholding of Bronchitol following smaller episodes of haemoptysis should be based on clinical judgement.
8). Patients should be trained to practice correct inhaler technique during treatment and advised to report persistent cough with the use of Bronchitol to their physician. 1). The use of Bronchitol is not recommended in these patients.
Non-CF Bronchiectasis Efficacy and safety have not been established in non-CF bronchiectasis patients. Therefore, treatment with Bronchitol is not recommended.