Adverse reactions : תופעות לוואי

4.8 UNDESIRABLE EFFECTS

Summary of the safety profile
The safety profile of Enerzair Breezhaler was based on a phase 3 study with a total of 1233 adult patients with asthma treated with Enerzair Breezhaler 114/46/136 micrograms once daily for up to 52 weeks.

The most common adverse drug reaction related to Enerzair Breezhaler was headache.

Tabulated summary of adverse drug reactions from clinical trials
Adverse drug reactions are listed by MedDRA system organ class. The frequency of the ADRs is based on study IRIDIUM. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): 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).



ENE API JUL22 V2.1                                                         Australian PI Dec2021 Table 1          Estimated cumulative incidence (%) of adverse drug reactions in study IRIDIUM at 52 weeks
Adverse drug                            Enerzair Breezhaler                 Frequency category reactions
114/46/136 micrograms once daily
High dose
Rate (%) [number of events] (95% CI) N=616



Infections and infestations

0.33 [2]                             Common
Candidiasis*1
(0.07, 1.14)
Urinary Tract                                3.57 [22]                             Common Infection*2                                 (2.28, 5.30)

Immune system disorders

Common
Hypersensitivity*   3                         1.17 [8]
(0.53, 2.31)
Metabolism and nutrition disorders

Uncommon
4
Hyperglycaemia*                               0.68 [4]
(0.23, 1.64)

Nervous system disorders
Common
Headache*5                                   4.24 [35]
(2.82, 6.09)

Cardiac disorders

Common
Tachycardia*6                                 1.34 [8]
(0.63, 2.53)
Respiratory, thoracic and mediastinal disorders

Oropharyngeal                                 3.02 [23]                            Common Pain*7                                      (1.86, 4.62)
4.12 [30]                            Common
Cough
(2.72, 5.96)
3.99 [26]                            Common
Dysphonia
(2.63, 5.78)

Gastrointestinal disorders

3.23 [22]                             Common
Gastroenteritis*8
(2.01, 4.89)
ENE API JUL22 V2.1                                                    Australian PI Dec2021 Adverse drug                                Enerzair Breezhaler                          Frequency category reactions
114/46/136 micrograms once daily
High dose
Rate (%) [number of events] (95% CI) N=616


Dry Mouth*9                                        0.67 [4]                                     Uncommon (0.23, 1.62)

Skin and subcutaneous tissue disorders

0.33 [2]                                    Uncommon
Rash*10
(0.07, 1.14)
0.68 [4]                                    Uncommon
Pruritus*11
(0.23, 1.65)
Musculoskeletal and connective tissue disorders

Musculoskeletal                                    3.05 [19]                                      Common Pain*12                                          (1.88, 4.67)
1.69 [11]                                      Common
Muscle Spasms
(0.87, 2.99)

Renal and Urinary disorder

Dysuria                                            0.17 [1]                                     Uncommon (0.02, 0.92)



General disorders and administration site conditions

Common
Pyrexia                                            2.90 [23]
(1.76, 4.50)
* Grouping of preferred terms (PTs).
1 oral candidiasis, oropharyngeal candidiasis.
2 asymptomatic bacteriuria, bacteriuria, cystitis, urethritis, urinary tract infection, urinary tract infection viral.
3 drug eruption, drug hypersensitivity, hypersensitivity, rash, rash pruritic, urticaria.
4 blood glucose increased, hyperglycaemia.
5 headache, tension headache.
6 sinus tachycardia, supraventricular tachycardia, tachycardia.
7 odynophagia, oropharyngeal discomfort, oropharyngeal pain, throat irritation.
8 chronic gastritis, enteritis, gastritis, gastroenteritis, gastrointestinal inflammation 9 dry mouth, dry throat.
10 drug eruption, rash, rash papular, rash pruritic.
11 eye pruritus, pruritus, pruritus genital.
12 back pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain.


ENE API JUL22 V2.1                                                               Australian PI Dec2021 Reporting suspected adverse effects
Reporting suspected adverse reactions after registration 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/.