Amikacin

What it is used for

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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Side effects, and when to stop

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

Who should not take it

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

Storing it

Store ARIKAYCE vials refrigerated at 2°C to 8°C (36°F to 46°F) until expiration date on vial. Do not freeze. Once expired, discard any unused drug.

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.