Dosing & Uses
Dosing Forms & Strengths
liposome suspension for oral inhalation
590mg/8.4mL; single-use vial (623mg/8.4mL amikacin sulfate equivalent)
Mycobacterium Avium Complex Lung Disease
Indicated for Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in adults who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy
Limited data available on safety and efficacy; reserve use in adults who have limited or no alternative treatment options; drug is indicated for use in a limited and specific population of patients
590 mg/8.4 mL inhaled orally qDay
Dosage Modifications
Hepatic impairment
- Not studied
- No dose adjustments since amikacin is not hepatically metabolized
Renal impairment
- Not studied
- Given low systemic exposure to amikacin following administration, clinically relevant accumulation of amikacin is unlikely to occur
- Monitor renal function in patients with known or suspected renal impairment, including elderly patients with potential age-related decreases in renal function
Dosing Considerations
Accelerated approval
- Indication approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by month 6
- Clinical benefit has not yet been established; continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials
Limitation of use
- Use only 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
- Not recommended for patients with nonrefractory MAC lung disease
<18 years: Safety and efficacy not established
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (5)
- abobotulinumtoxinA
amikacin liposome inhalation increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- prabotulinumtoxinA
amikacin liposome inhalation increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of amikacin liposome inhalation by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of amikacin liposome inhalation by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
- voclosporin
voclosporin, amikacin liposome inhalation. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.
Minor (1)
- entecavir
amikacin liposome inhalation, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
Adverse Effects
>10%
Dysphonia (47%)
Cough (39%)
Bronchospasm (29%)
Hemoptysis (18%)
Ototoxicity (17%)
Upper airway irritation (17%)
Musculoskeletal pain (17%)
Fatigue and asthenia (16%)
Exacerbation of underlying pulmonary disease (15%)
Diarrhea (13%)
Nausea (12%)
1-10%
Pneumonia (10%)
Headache (10%)
Pyrexia (7%)
Vomiting (7%)
Rash (6%)
Weight decreased (6%)
Change in sputum (5%)
Chest discomfort (5%)
Anxiety (4.5%)
Oral fungal infection (4%)
Bronchitis (3.6%)
Hypersensitivity pneumonitis (3.6%)
Dysgeusia (3.1%)
Respiratory failure (2.7%)
Epistaxis (2.7%)
Neuromuscular disorder (2.2%)
Dry mouth (2.2%)
Pneumothorax (2.2%)
Exercise tolerance decreased (1.3%)
Balance disorder (1.3%)
Warnings
Black Box Warnings
Associated with risk of increased respiratory adverse reactions, including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations
Contraindications
Hypersensitivity to any aminoglycoside
Cautions
Hypersensitivity pneumonitis (eg, allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction) reported; if hypersensitivity pneumonitis occurs, discontinue drug and manage as medically appropriate
Hemoptysis reported; if hemoptysis occurs, manage as medically appropriate
Bronchospasm (eg, asthma, bronchial hyperreactivity, bronchospasm, dyspnea, exertional dyspnea, prolonged expiration, throat tightness, wheezing) reported; if bronchospasm occurs, treat as medically appropriate
Exacerbations of underlying pulmonary disease (eg, chronic obstructive pulmonary disease, infective exacerbation of chronic obstructive pulmonary disease, infective exacerbation of bronchiectasis) reported in clinical trials; if exacerbations of underlying pulmonary disease occur, treat as medically appropriate
Nephrotoxicity observed during clinical trials in patients with MAC lung disease; nephrotoxicity has been associated with the antimicrobials#aminoglycosides; closely monitor patients with known or suspected renal dysfunction
Patients with neuromuscular disorders were not enrolled in clinical trials; closely monitor patients with known or suspected neuromuscular disorders (eg, myasthenia gravis) since antimicrobials#aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions
Fetal harm may occur when administered to a pregnant woman (see Pregnancy)
Ototoxicity
- Ototoxicity (eg, deafness, dizziness, presyncope, tinnitus, vertigo) reported in clinical trials; closely monitor patients with known or suspected auditory or vestibular dysfunction; ototoxicity may occur in some patients even when their aminoglycoside serum levels are within recommended range
- Mitochondrial DNA variants are present in <1% of the general US population, and the proportion of the variant carriers who may develop ototoxicity as well as severity of ototoxicity is unknow
- In case of known maternal history of ototoxicity due to aminoglycoside use or a known mitochondrial DNA variant in the patient, consider alternative treatments other than antimicrobials#aminoglycosides unless increased risk of permanent hearing loss is outweighed by severity of infection and lack of safe and effective alternative therapies
Drug interactions overview
- Avoid use with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity
- Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue; avoid use with ethacrynic acid, furosemide, urea, or IV mannitol
Pregnancy
Pregnancy
There are no data on use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Although systemic absorption of amikacin following oral inhalation is expected to be low, systemic exposure to aminoglycoside antibacterial drugs, including inhaled amikacin, may be associated with total, irreversible, bilateral congenital deafness when administered to pregnant women
Advise pregnant women of the potential risk to a fetus
Animal data
- Animal reproductive toxicology studies have not been conducted with inhaled amikacin
- SC administration of amikacin to pregnant rats (up to 100 mg/kg/day) and mice (up to 400 mg/kg/day) during organogenesis was not associated with fetal malformations
- Ototoxicity was not adequately evaluated in offspring in animal studies
Lactation
There is no information regarding presence of inhaled amikacin in human milk, effects on the breastfed infant, or effects on milk production
Although limited published data on other routes of administration indicate that amikacin is present in human milk, systemic absorption following inhaled administration is expected to be low
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Bactericidal aminoglycoside enters bacterial cell by disrupting overall cell wall architecture
Disrupts and inhibits protein synthesis in target bacteria by binding to the 30S ribosomal subunit
Mechanism of resistance to amikacin in Mycobacteria linked to mutations in rrs gene of the 16S rRNA
Absorption
Bioavailability is expected to vary primarily from individual difference in nebulizer efficiency and airway pathology
Sputum concentrations (1-4 hr post inhalation): 1720 mcg/g (1 month), 884 mcg/g (3 months), and 1300 mcg/g (6 months)
Peak plasma concentration: 2.8 mcg/mL AUC: 23.5 mcg·hr/mL
After 48-72 hr post inhalation, amikacin sputum concentrations decreased to ~5% of those at 1-4 hr post inhalation
Distribution
Protein bound: ≤10%
Metabolism
Does not undergo appreciable metabolism
Elimination
Half-life: 5.9-19.5 hr
Excretion: Urine (7.42%, unchanged)
Systemically absorbed amikacin following administration is eliminated principally via glomerular filtration
Unabsorbed amikacin, following inhalation, is probably eliminated primarily by cellular turnover and expectoration
Administration
Oral Inhalation Preparation
Suspension should be at room temperature before use
Shake vial well for at least 10-15 seconds until contents appear uniform and well mixed
Pour suspension into medication reservoir of nebulizer handset
Oral Inhalation Administration
For oral inhalation use only
Administer by nebulization only with Lamira Nebulizer System (refer to prescribing information)
If patient also uses a bronchodilator, instruct them to first use bronchodilator (according to bronchodilator instructions) before using amikacin liposome inhalation
Consider pretreatment with short-acting selective beta-2 agonists for patients with known hyperreactive airway disease, chronic obstructive pulmonary disease, asthma, or bronchospasm
Missed dose: Administer next dose the next day; do not double dose to make up for missed dose
Storage
Refrigerate 2-8°C (36-46°F) until expiration date on vial; do not freeze
May be stored at room temperature (up to 25°C [77°F]) for up to 4 weeks
Once at room temperature, discard any unused drug at end of 4 weeks
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