Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Anaphylaxis and hypersensitivity reactions
Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking inhaled liposomal amikacin.

Before therapy with inhaled liposomal amikacin is instituted, an evaluation for previous hypersensitivity reactions to aminoglycosides should take place. If anaphylaxis or a hypersensitivity reaction occurs, inhaled liposomal amikacin should be discontinued and appropriate supportive measures should be instituted.
Allergic alveolitis
Allergic alveolitis and pneumonitis have been reported with the use of inhaled liposomal amikacin in clinical studies (see section 4.8).

If allergic alveolitis occurs, treatment with inhaled liposomal amikacin should be discontinued and patients should be treated as medically appropriate.

Bronchospasm
Bronchospasm has been reported with the use of inhaled liposomal amikacin in clinical studies. In patients with a history of reactive airway disease, asthma or bronchospasm, inhaled liposomal amikacin should be administered after using a short-acting bronchodilator. If there is evidence of bronchospasm due to inhaled liposomal amikacin inhalation, the patient may be pre-treated with bronchodilators (see section 4.8).

Exacerbation of underlying pulmonary disease
In clinical trials, exacerbation of underlying pulmonary disease (chronic obstructive pulmonary disease, infective exacerbation of chronic obstructive pulmonary disease, infective exacerbation of bronchiectasis) was reported with a higher frequency in patients treated with inhaled liposomal amikacin compared with patients not receiving inhaled liposomal amikacin. Caution should be exercised when initiating inhaled liposomal amikacin in patients presenting with these underlying conditions. Discontinuation of treatment with inhaled liposomal amikacin should be considered if signs of exacerbation are observed.

Ototoxicity
In clinical trials, ototoxicity, (including deafness, dizziness, presyncope, tinnitus, and vertigo) was reported with a higher frequency in patients treated with inhaled liposomal amikacin compared with patients not receiving inhaled liposomal amikacin. Tinnitus was the most commonly reported ototoxicity related adverse reaction.

Auditory and vestibular function should be monitored periodically in all patients and frequent monitoring is advised in patients with known or suspected auditory or vestibular dysfunction.

If ototoxicity occurs during treatment, consideration should be given to discontinuing inhaled liposomal amikacin.

Nephrotoxicity
Nephrotoxicity was reported in clinical trials in patients treated with inhaled liposomal amikacin.
Renal function should be monitored periodically during treatment in all patients and frequent monitoring is advised in patients with pre-existing renal dysfunction.
Consideration should be given to stopping inhaled liposomal amikacin in patients who develop evidence of nephrotoxicity on treatment.
Use in patients with severe renal impairment is contraindicated (see section 4.3).

Neuromuscular blockade
In clinical trials, neuromuscular disorders (reported as muscle weakness, neuropathy peripheral and balance disorder) have been reported with inhaled liposomal amikacin. Aminoglycosides may aggravate muscle weakness because of a curare-like effect at the neuromuscular junction. Use of inhaled liposomal amikacin in patients with myasthenia gravis is not recommended. Patients with any known or suspected neuromuscular disorders should be closely monitored.

Co-administration with other medicinal products
Co-administration of inhaled liposomal amikacin with other aminoglycosides is contraindicated (see section 4.3).

Co-administration with any other medicinal product affecting auditory function, vestibular function or renal function (including diuretics) is not recommended.

Effects on Driving

4.7    Effects on ability to drive and use machines

Amikacin has minor influence on the ability to drive and use machines. The administration of inhaled liposomal amikacin can cause dizziness and other vestibular disturbances (see section 4.8). Patients should be advised not to drive or operate machinery while using inhaled liposomal amikacin.