Bacterial infections:
Indications for: ARIKAYCE
Treatment of Mycobacterium avium complex (MAC) lung disease, as part of a combination antibacterial regimen, in adults with limited or no alternative treatment options who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen.
Limitations of Use:
Only studied in patients with refractory MAC lung disease. Not recommended for patients with non-refractory MAC lung disease.
Adult Dosage:
Use with Lamira Nebulizer system only. Consider pre-treatment with short-acting selective beta-2 agonist in known hyperreactive airway disease, COPD, asthma or bronchospasm. ≥18yrs: Inhale orally contents of 1 vial (590mg) once daily.
Children Dosage:
<18yrs: not established.
Boxed Warning:
Risk of increased respiratory adverse reactions.
ARIKAYCE Warnings/Precautions:
Increased risk for respiratory adverse reactions potentially leading to hospitalizations. Discontinue if hypersensitivity pneumonitis, anaphylaxis or hypersensitivity reaction occurs; manage appropriately. Auditory/vestibular dysfunction; monitor closely; if ototoxicity occurs, manage and discontinue if appropriate. Risk for ototoxicity (known maternal history of ototoxicity due to aminoglycoside use or mitochondrial DNA variants); consider alternative therapies. Renal dysfunction or neuromuscular disorders (eg, myasthenia gravis); monitor closely. Elderly: monitor renal function. Embryo-fetal toxicity. Pregnancy: avoid use. Nursing mothers.
ARIKAYCE Classification:
Aminoglycoside.
ARIKAYCE Interactions:
Avoid concomitant with neurotoxic, nephrotoxic, and ototoxic drugs. Avoid concomitant furosemide, ethacrynic acid, urea, IV mannitol. Diuretics may increase toxicity.
Adverse Reactions:
Dysphonia, cough, bronchospasm, hemoptysis, ototoxicity, upper airway irritation, musculoskeletal pain, fatigue/asthenia, exacerbation of underlying pulmonary disease, diarrhea, nausea, pneumonia, headache, pyrexia, vomiting, rash, weight decreased, change in sputum, chest discomfort; nephrotoxicity, neuromuscular blockade, anaphylaxis.
Drug Elimination:
Principally via glomerular filtration. Renal (7.42%). Half-life: ~5.9–19.5 hours.
Generic Drug Availability:
NO
How Supplied:
Kit—1 (28-vials [10mL] + Lamira Nebulizer w. supplies)
