Version July 2025
Amikacin oral inhalation has been associated with an increased risk of respiratory adverse reactions including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases.
Note: For dosing of amikacin injection formulation via nebulization, refer to Amikacin (Systemic) monograph.
Mycobacterium abscessus pulmonary disease (off-label use): Suspension for inhalation: One vial (590 mg) via nebulizer once daily as part of an appropriate combination regimen during the continuation phase of treatment; consult an infectious diseases specialist for specific recommendations, including duration (Ref).
Mycobacterium avium complex pulmonary disease, refractory: Suspension for inhalation: One vial (590 mg) via nebulizer once daily as part of an appropriate combination regimen; consult an infectious diseases specialist for specific recommendations, including duration (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Note: Although systemic concentrations of orally inhaled liposomal amikacin are substantially lower than parenterally administered amikacin, monitoring of kidney function, along with periodic trough concentrations, is recommended for patients with chronic kidney disease (eg, eGFR <60 mL/minute/1.73 m2) or receiving kidney replacement therapies (Ref).
Altered kidney function: Oral inhalation: No dosage adjustment likely to be necessary for any degree of kidney impairment (low systemic absorption) (Ref).
Hemodialysis, intermittent (thrice weekly): Oral inhalation: No supplemental dose or dosage adjustment necessary (low systemic absorption) (Ref).
Peritoneal dialysis: Oral inhalation: No supplemental dose or dosage adjustment necessary (low systemic absorption) (Ref).
CRRT: Oral inhalation: No dosage adjustment necessary (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): Oral inhalation: No dosage adjustment necessary (Ref).
No dosage adjustment necessary; does not undergo hepatic metabolism.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Gastrointestinal: Diarrhea (13%), nausea (12%)
Nervous system: Asthenia (≤16%), fatigue (≤16%), voice disorder (48%; including aphonia)
Neuromuscular & skeletal: Musculoskeletal pain (18%)
Otic: Ototoxicity (17%; including deafness, dizziness [6%], sensorineural hearing loss, hypoacusis, tinnitus [8%], vertigo)
Respiratory: Bronchospasm (29%), cough (40%), exacerbation of pulmonary symptoms (15%; including bronchiectasis, chronic obstructive pulmonary disease), hemoptysis (18%), upper respiratory system symptoms (18%; including laryngitis, oropharyngeal pain, pharyngeal edema, throat irritation, upper respiratory tract inflammation)
1% to 10%:
Cardiovascular: Chest discomfort (5%)
Dermatologic: Skin rash (6%)
Endocrine & metabolic: Weight loss (7%)
Gastrointestinal: Dysgeusia (3%), oral candidiasis (4%), vomiting (7%), xerostomia (3%)
Nervous system: Anxiety (5%), balance impairment (1%), headache (10%)
Neuromuscular & skeletal: Neuromuscular symptoms (1%; including myasthenia, peripheral neuropathy)
Respiratory: Bronchitis (4%), change in bronchial secretions (6%; including discoloration of sputum, increased bronchial secretions), epistaxis (3%), hypersensitivity pneumonitis (3%), pneumonia (9%), pneumothorax (2%), respiratory failure (3%)
Miscellaneous: Decreased exercise tolerance (1%), fever (8%)
Frequency not defined: Renal: Nephrotoxicity
Postmarketing:
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis)
Respiratory: Interstitial lung disease (Hashimoto 2023)
Hypersensitivity to aminoglycosides
Concerns related to adverse effects :
• Anaphylaxis/hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, have been reported. Carefully screen for previous hypersensitivity reactions to aminoglycosides prior to administration.
• Bronchospasm: Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, exertional dyspnea, prolonged expiration, throat tightness, wheezing) has been reported; manage as medically appropriate.
• Hemoptysis: Hemoptysis has been reported; manage as medically appropriate.
• Hypersensitivity pneumonitis: Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction) has been reported; manage as medically appropriate.
• Nephrotoxicity: Nephrotoxicity has been reported with aminoglycosides; use with caution in patients with known or suspected renal dysfunction.
• Neuromuscular blockade: May cause neuromuscular blockade and aggravate muscle weakness. Neuromuscular blockade is reversible but may require treatment (eg, administration of calcium salts, mechanical respiratory assistance).
• Ototoxicity: Ototoxicity (including deafness, dizziness, presyncope, tinnitus, vertigo) has been reported. Use with caution in patients with known or suspected auditory or vestibular dysfunction; if ototoxicity occurs, manage as medically appropriate.
Disease-related concerns :
• Neuromuscular disorders: Use with caution in patients with neuromuscular disorders, including myasthenia gravis; patients with neuromuscular disorders were not studied.
• Pulmonary disease: Exacerbation of underlying pulmonary disease (reported as chronic obstructive pulmonary disease, infective exacerbation of chronic obstructive pulmonary disease, infective exacerbation of bronchiectasis) has been reported; manage as medically appropriate.
Special populations:
• Patients with genomic variants in MT-RNR1: Carriers of certain variants in the MT-RNR1 gene (eg, m.1555A>G) may be at increased risk for aminoglycoside-induced ototoxicity, including potentially significant hearing loss that may be irreversible, even when serum levels are within the normal range.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Inhalation, as sulfate:
Arikayce: 590 mg/8.4 mL (8.4 mL)
No
Suspension (Arikayce Inhalation)
590MG/8.4ML (per mL): $82.01
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Inhalation: To be inhaled using the Lamira Nebulizer System over 14 to 20 minutes. Vial should be at room temperature prior to use (if refrigerated, remove at least 45 minutes before use). Shake vial for at least 10 to 15 seconds (until contents appear uniform and well mixed) prior to opening. Refer to the manufacturer's labeling for detailed administration instructions using the nebulizer system. Patients instructed to also use a bronchodilator should administer the bronchodilator prior to using the nebulizer.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Arikayce: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356s004lbl.pdf#page=15
Mycobacterium avium complex pulmonary disease, refractory: Treatment of Mycobacterium avium complex (MAC) pulmonary disease in adults who have limited or no alternative treatment options, as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy.
Limitation of use: Amikacin oral inhalation has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of amikacin is not recommended for patients with non-refractory MAC lung disease.
Mycobacterium abscessus pulmonary disease
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Loop Diuretics: May increase nephrotoxic effects of Amikacin Liposome (Oral Inhalation). Loop Diuretics may increase ototoxic effects of Amikacin Liposome (Oral Inhalation). Risk C: Monitor
Mannitol (Systemic): Amikacin Liposome (Oral Inhalation) may increase nephrotoxic effects of Mannitol (Systemic). Risk X: Avoid
Aminoglycosides may cause fetal harm if administered during pregnancy. Systemic absorption of amikacin following oral inhalation is expected to be low compared to intravenous administration; however, systemic exposure was associated with total irreversible bilateral congenital deafness in children whose mothers received a different aminoglycoside during pregnancy.
Refer to the Amikacin (Systemic) monograph for details.
It is not known if amikacin is present in breast milk following oral inhalation.
Amikacin is present in breast milk following injection (Matsuda 1984). Systemic absorption following oral inhalation is expected to be low compared to IV administration. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Inhaled antibiotics used for the treatment of cystic fibrosis are considered compatible with breastfeeding (Panchaud 2016).
Also refer to the Amikacin (Systemic) monograph.
Kidney function and periodic amikacin trough concentrations, especially in patients with underlying known or suspected renal dysfunction (Schultheis 2023; manufacturer’s labeling).
Inhibits protein synthesis in susceptible bacteria by binding to 30S ribosomal subunits
Absorption: Variable
Protein binding: ≤10%
Half-life elimination: ~5.9 to 19.5 hours
Excretion: Urine (7.42% as unchanged drug)
