BOXED WARNING Increased respiratory adverse reactions—hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease, leading to hospitalization in some cases.
FDA dosing
Population
Start
Target
Max
Refractory Mycobacterium avium complex (MAC) lung disease (as part of a combination regimen)
Adult
590 mg inhaled QD
590 mg inhaled QD
590 mg QD
Renal Undefined
Hepatic No adjustment needed (amikacin is not hepatically metabolized).
Instructions
Oral inhalation only via the Lamira Nebulizer System.
Shake vial 10–15 s and bring to room temperature before use.
Consider pretreatment with a short-acting beta-2 agonist in hyperreactive airway disease.
Do not double the dose for a missed dose.
Contraindications
Known hypersensitivity to any aminoglycoside
Cautions
Hypersensitivity pneumonitis
Hemoptysis
Bronchospasm
Exacerbation of underlying pulmonary disease
Anaphylaxis/hypersensitivity
Ototoxicity (including with MT-RNR1 mitochondrial DNA variants)
Nephrotoxicity
Neuromuscular blockade
Embryo-fetal toxicity (congenital deafness)
Adverse reactions
Dysphonia
Cough
Bronchospasm
Hemoptysis
Musculoskeletal pain
Upper airway irritation
Ototoxicity
Fatigue/asthenia
Exacerbation of pulmonary disease
Diarrhea
Nausea
Headache
Pregnancy No human data; systemic aminoglycosides may cause total, irreversible, bilateral congenital deafness.
Lactation No data for inhaled use; amikacin is present in human milk by other routes—systemic absorption after inhalation expected to be low.