Amikacin

LIMITED POPULATION: ARIKAYCE ® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease 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. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients. This indication is 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.

ARIKAYCE is an antibacterial drug.

For oral inhalation use only. Use ARIKAYCE vials only with the Lamira Nebulizer System. Pre-treatment with inhaled bronchodilator should be considered in patients with a history of hyperreactive airway disease. The recommended dosage in adults is once daily oral inhalation of the contents of one 590 mg/8.4 mL ARIKAYCE vial.

ARIKAYCE is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

Boxed warning (risk of increased respiratory adverse reactions arikayce): has been associated with an increased risk of respiratory adverse reactions including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases. Hypersensitivity Pneumonitis: Reported with ARIKAYCE treatment, if hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate. Hemoptysis: Higher frequency of hemoptysis has been reported with ARIKAYCE treatment. If hemoptysis occurs, manage the patients as medically appropriate. Bronchospasm: Higher frequency of bronchospasm has been reported with ARIKAYCE treatment. Treat patients as medically appropriate if this occurs during treatment with ARIKAYCE.

The following clinically significant adverse reactions are described in greater detail in other sections of labeling: Hypersensitivity pneumonitis Hemoptysis Bronchospasm Exacerbation of Underlying Pulmonary Disease Anaphylaxis and Hypersensitivity Reactions Ototoxicity Nephrotoxicity Neuromuscular Blockade Most common adverse reactions (incidence ≥10% and higher than control) in the patients with refractory MAC lung disease were: dysphonia, cough, bronchospasm, hemoptysis, musculoskeletal pain, upper airway irritation, ototoxicity, fatigue/asthenia, exacerbation of underlying pulmonary disease, diarrhea, nausea, and headache.

Drugs with Neurotoxic, Nephrotoxic, or Ototoxic Potential Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity.

Store ARIKAYCE vials refrigerated at 2°C to 8°C (36°F to 46°F) until expiration date on vial. Do not freeze. ARIKAYCE can be stored at room temperature up to 25°C (77°F) for up to 4 weeks. Once at room temperature, any unused drug must be discarded at the end of 4 weeks.