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 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.

ARIKAYCE Classification:


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.

Generic Drug Availability:


How Supplied:

Kit—1 (28-vials [10mL] + Lamira Nebulizer w. supplies)