Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile

Assessment of adverse reactions is based on experience in four Phase 3 clinical studies involving CF patients with chronic P. aeruginosa infection and post-marketing spontaneous reporting.
In the two Phase 3 placebo-controlled clinical studies where patients received Cayston for 28 days, the most frequently occurring adverse reactions to Cayston were cough (58%), nasal congestion (18%), wheezing (15%), pharyngolaryngeal pain (13.0%), pyrexia (12%) and dyspnoea (10%).

An acute reduction of ≥ 15% in FEV1 is a complication associated with nebulised therapies, including Cayston (see section 4.4).

Tabulated summary of adverse reactions

The adverse reactions considered at least possibly related to treatment from clinical study and post- marketing experience are listed below by body system organ class and frequency.

Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1000 to < 1/100).


Respiratory, thoracic and mediastinal disorders:
Very common:         cough, nasal congestion, wheezing, pharyngolaryngeal pain, dyspnoea Common:              bronchospasm1, chest discomfort, rhinorrhoea, haemoptysis1 Skin and subcutaneous tissue disorders:
Common:              rash1
Musculoskeletal and connective tissue disorders:
Common:              arthralgia
Uncommon:            joint swelling
General disorders and administration site conditions:
Very common:         pyrexia
Investigations:
Common:              lung function test decreased1
1
See section Description of selected adverse reactions

Description of selected adverse reactions

Bronchospasm
Nebulised therapies, including Cayston, may be associated with bronchospasm (an acute reduction of ≥ 15% in FEV1). Refer to section 4.4.

Haemoptysis

Inhalation of nebulised solutions may induce a cough reflex which could aggravate underlying conditions (see section 4.4).

Allergic reactions

Rash has been reported with the use of Cayston and may be indicative of an allergic reaction to aztreonam (see section 4.4).

Lung function test decreased

Lung function test decreased has been reported with use of Cayston, but was not associated with a sustained decrease in FEV1 (see section 5.1).

The following rare and severe adverse reactions have been reported after parenteral use of other aztreonam containing products: toxic epidermal necrolysis, anaphylaxis, purpura, erythema multiforme, exfoliative dermatitis, urticaria, petechiae, pruritus, diaphoresis.

Paediatric population

A total of 137 paediatric patients aged 6 to 17 years with chronic P. aeruginosa infection and FEV1 ≤ 75% predicted have received Cayston in Phase 2 and Phase 3 clinical studies (6-12 years, n = 35; 13-17 years, n = 102).

Pyrexia was observed at a higher incidence rate in paediatric patients aged 6 to 17 years compared to adults.

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. You can report any side effects to the Ministry of Health by clicking on the link "Report side effects due to medical treatment" that is located on the Ministry of Health homepage (www.health.gov.il) which redirects to the online form for reporting side effects or by clicking on the link: https://sideeffects.health.gov.il.