"BOXED WARNING(WHAT IS THIS?)
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 [see WARNINGS AND PRECAUTIONS (5.1, 5.2, 5.3, 5.4)].
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ARIKAYCE safely and effectively. See full prescribing information for ARIKAYCE.
ARIKAYCE � (amikacin liposome inhalation suspension), for oral inhalation use
Initial U.S. Approval: 2018
LIMITED POPULATION
WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
ARIKAYCE has been associated with a risk of increased respiratory adverse reactions, including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases. (5.1, 5.2, 5.3, 5.4)
INDICATIONS AND USAGE
LIMITED POPULATION: ARIKAYCE is an aminoglycoside antibacterial 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. (1)
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. (1)
Limitation of Use:
ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.
DOSAGE AND ADMINISTRATION
For oral inhalation use only. (2.1)
Use ARIKAYCE vials only with the Lamira Nebulizer System. (2.1)
The recommended dosage in adults is once daily oral inhalation of the contents of one 590 mg/8.4 mL ARIKAYCE vial. (2.2)
Pre-treatment with inhaled bronchodilator should be considered in patients with a history of hyperreactive airway disease. (2.1)
DOSAGE FORMS AND STRENGTHS
ARIKAYCE is supplied as a sterile, aqueous, liposome suspension for oral inhalation in a unit-dose glass vial containing amikacin 590 mg/8.4 mL. (3)
CONTRAINDICATIONS
ARIKAYCE is contraindicated in patients with a known hypersensitivity to any aminoglycoside. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Pneumonitis: Reported with ARIKAYCE treatment; if hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate. (5.1)
Hemoptysis: Higher frequency of hemoptysis has been reported with ARIKAYCE treatment. If hemoptysis occurs, manage the patients as medically appropriate. (5.2)
Bronchospasm: Higher frequency of bronchospasm has been reported with ARIKAYCE treatment. Treat patients as medically appropriate if this occurs during treatment with ARIKAYCE. (5.3)
Exacerbations of Underlying Pulmonary Disease: Higher frequency of exacerbations of underlying pulmonary disease has been reported with ARIKAYCE treatment. Treat patients as medically appropriate if this occurs during treatment with ARIKAYCE. (5.4)
Ototoxicity: Higher frequency of ototoxicity has been reported with ARIKAYCE treatment. Closely monitor patients with known or suspected auditory or vestibular dysfunction. If patients develop tinnitus this may be an early symptom of ototoxicity. (5.5)
Nephrotoxicity: Aminoglycosides can cause nephrotoxicity. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE. (5.6)
Neuromuscular Blockade: Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function. If neuromuscular blockade occurs, it may be reversed by the administration of calcium salts but mechanical assistance may be necessary. (5.7)
Embryo-Fetal Toxicity: Aminoglycosides can cause total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. (5.8, 8.1)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥10% and higher than control) in the patients with refractory MAC lung disease were: dysphonia, cough, bronchospasm, hemoptysis, ototoxicity, upper airway irritation, musculoskeletal pain, fatigue/asthenia and exacerbation of underlying pulmonary disease, diarrhea, and nausea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Insmed Incorporated at 1-844-4-INSMED or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 9/2018"
