Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile

The most commonly reported respiratory adverse reactions were dysphonia (42.6%), cough (30.9%), dyspnoea (14.4%), haemoptysis (10.9%), oropharyngeal pain (9.2%), and bronchospasm (2.2%).
Other commonly reported non-respiratory adverse reactions included fatigue (7.2%), diarrhoea (6.4%), infective exacerbation of bronchiectasis (6.2%), and nausea (5.9%).

Most common serious adverse reactions included Chronic Obstructive Pulmonary Disease (COPD) (1.5%), haemoptysis (1.2%), and infective exacerbation of bronchiectasis (1.0%).

Tabulated list of adverse reactions

Adverse drug reactions in Table 1 are listed according to system organ classes in MedDRA based on clinical trials and post marketing data. Within each system organ class, the following definitions apply to the frequency terminology used hereafter: 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 (<1/10,000); not known: (cannot be estimated from the available data).

Table 1 – Summary of adverse reactions

System Organ Class              Adverse reactions                           Frequency category 
Infections and infestations     Infective exacerbation of bronchiectasis    Common Laryngitis                                  Common
Oral candidiasis                            Common

Immune system disorders         Anaphylactic reactions                      Not known Hypersensitivity reactions                  Not known

Psychiatric disorders           Anxiety                                     Uncommon 
Nervous system disorders        Headache                                    Common Dizziness                                   Common
Dysgeusia                                   Common
Aphonia                                     Common
Balance disorder                            Common

Ear and labyrinth disorders     Tinnitus                                    Common Deafness                                    Common
Respiratory, thoracic and       Dysphonia                                   Very common mediastinal disorders           Dyspnoea                                    Very common Cough                                       Very common
Haemoptysis                                 Very common
Oropharyngeal pain                          Common
Allergic alveolitis                         Common
Chronic Obstructive Pulmonary Disease       Common
Wheezing                                    Common
Productive cough                            Common
Sputum increased                            Common
Bronchospasm                                Common
Pneumonitis                                 Common
Vocal cord inflammation                     Common
Throat irritation                           Common

Gastrointestinal disorders      Diarrhoea                                   Common Nausea                                      Common
Vomiting                                     Common
Dry mouth                                    Common
Decrease of appetite                         Common

Skin and subcutaneous           Rash                                         Common tissue disorders                Pruritus                                     Common 
Musculoskeletal and             Myalgia                                      Common connective tissue disorders     Arthralgia                                   Common 
Renal and urinary disorders     Renal impairment                             Common 
General disorders and           Fatigue                                      Common administration site             Pyrexia                                      Common conditions                      Chest discomfort                             Common 
Investigations                  Weight decreased                             Common Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/