aztreonam lysine

HOS-095296 · has-adverse-reaction-information · PDF-Seite 5

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). 5 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

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HOS-095292 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-095291 · has-indication-information · PDF-Seite 2

Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

HOS-095294 · has-interaction-information · PDF-Seite 4

No interaction studies have been performed. However, no evidence of any drug interactions with aztreonam were identified from clinical studies in which Cayston was taken concomitantly with bronchodilators, dornase alfa, pancreatic enzymes, azithromycin, tobramycin, oral steroids (less than 10 mg daily/20 mg every other day) and inhaled steroids. 4

HOS-095295 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no data from the use of aztreonam in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Systemic concentration of aztreonam following inhaled administration of Cayston is low compared to a standard dose of aztreonam for injection (approximately 1% of the concentration resulting from a dose of 500 mg aztreonam for injection). Cayston should not be used during pregnancy unless the clinical condition of the woman requires treatment with aztreonam. Breast-feeding Following administration of aztreonam for injection, aztreonam is excreted in human milk at very low concentrations. Systemic concentration of aztreonam following inhaled administration of Cayston is approximately 1% of the concentration resulting from a standard dose of aztreonam for injection. Therefore, and because of low oral absorption, aztreonam exposure in breast-fed infants due to mothers receiving Cayston is likely to be extremely low. Cayston can be used during breast-feeding. Fertility Non-clinical data for aztreonam for injection about fertility do not indicate any adverse effects.

HOS-095293 · has-warning-information · PDF-Seite 3

Allergic reactions If an allergic reaction to aztreonam does occur, stop administration of the medicinal product and initiate treatment as appropriate. The occurrence of rash may be indicative of an allergic reaction to aztreonam. Cross-reactivity may occur in patients with a history of allergy to beta-lactam antibiotics, such as penicillins, cephalosporins, and/or carbapenems. Animal and human data demonstrate low risk of cross-reactivity between aztreonam and beta-lactam antibiotics. Aztreonam, a monobactam, is only weakly immunogenic. Caution is advised when administering Cayston to patients if they have a history of beta-lactam allergy. 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. 3 Bronchospasm Bronchospasm (an acute reduction of ≥ 15% in FEV1) is a complication associated with nebulised therapies. Bronchospasm has been reported after Cayston administration (see section 4.8). Patients should use a bronchodilator before each dose of Cayston. If a case of bronchospasm is suspected to be part of an allergic reaction appropriate measures should be taken (see “allergic reactions” paragraph above). Haemoptysis Inhalation of nebulised solutions may induce a cough reflex. The use of Cayston in paediatric CF patients has been associated with haemoptysis during treatment cycles and could have aggravated underlying conditions. Administration of Cayston in CF patients with active haemoptysis should be undertaken only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage. Other precautions Efficacy has not been established in patients with FEV1 > 75% predicted. Patients with Burkholderia cepacia isolated from sputum within the previous 2 years were excluded from the clinical studies. Aztreonam for injection must not be used in the Altera or other nebulisers. Aztreonam for injection has not been formulated for inhalation, and contains arginine, a substance known to cause pulmonary inflammation. Resistance to aztreonam, other antibiotics and treatment-emergent microorganisms The development of antibiotic-resistant P. aeruginosa and superinfection with other pathogens represent potential risks associated with antibiotic therapy. Developmen

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