Arikayce FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 3, 2018.
FDA Approved: Yes (First approved September 28, 2018)
Brand name: Arikayce
Generic name: amikacin liposome
Dosage form: Inhalation Suspension
Company: Insmed, Inc.
Treatment for: Mycobacterium Avium Complex (MAC) Lung Disease
Arikayce (amikacin liposome inhalation suspension) is an aminoglycoside antibacterial indicated for the treatment of Mycobacterium avium complex (MAC) lung disease in adults who have limited or no alternative treatment options.
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.
Arikayce is administered once daily as an oral inhalation via the Lamira Nebulizer System.
Arikayce is contraindicated in patients with a known hypersensitivity to any aminoglycoside.
WARNINGS AND PRECAUTIONS
- Hypersensitivity Pneumonitis and Bronchospasm Patients should advise their healthcare provider if they experience shortness of breath or wheezing after administration of Arikayce.
- Hemoptysis or Cough Patients should advise their healthcare provider if they cough up blood or experience episodic cough either during or after Arikayce administration, particularly during the first month of treatment.
- Exacerbations of Underlying Pulmonary Disease Patients should advise their healthcare provider if they experience worsening of their lung disease.
- Dysphonia or Difficulty Speaking Patients should advise their healthcare provider if they experience difficulty speaking.
- Ototoxicity (Ringing in the Ears) Aminoglycosides such as Arikayce have been associated with hearing loss. Patients should advise their healthcare provider if they experience ringing in the ears, dizziness, or any changes in hearing.
- Nephrotoxicity or Kidney Damage Aminoglycosides have been associated with kidney damage. Patients should advise their health care provider if they have kidney problems.
- Neuromuscular Blockade Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function. Patients should advise their healthcare provider of known neuromuscular disease (e.g., myasthenia gravis).
- Embryo-Fetal Toxicity Aminoglycosides can cause total, irreversible, bilateral congenital deafness when administered during pregnancy.
The most common adverse reactions (incidence ≥10% and higher than control) include dysphonia, cough, bronchospasm, hemoptysis, ototoxicity, upper airway irritation, musculoskeletal pain, fatigue/asthenia and exacerbation of underlying pulmonary disease, diarrhea, and nausea.
Development Timeline for Arikayce
|Sep 28, 2018||Approval FDA Approves Arikayce (amikacin liposome inhalation suspension) to treat Mycobacterium Avium Complex (MAC) Lung Disease|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.