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.
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.
<18yrs: not established.
Risk of increased respiratory adverse reactions.
Increased risk of respiratory adverse reactions potentially leading to hospitalizations. Discontinue if hypersensitivity pneumonitis, anaphylaxis or hypersensitivity reaction occurs; manage appropriately. Known or suspected auditory/vestibular dysfunction; monitor closely; if ototoxicity occurs, manage and discontinue if appropriate. Known or suspected renal dysfunction or neuromuscular disorders (eg, myasthenia gravis); monitor closely. Elderly: monitor renal function. Embryo-fetal toxicity. Pregnancy: avoid use. Nursing mothers.
Avoid concomitant with neurotoxic, nephrotoxic, and ototoxic drugs. Avoid concomitant furosemide, ethacrynic acid, urea, IV mannitol. Diuretics may increase toxicity.
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.
Renal. Half-life: ~5.9–19.5 hours.
Kit—1 (28-vials [10mL] + Lamira Nebulizer w. supplies)