Last reviewed · How we verify
Arikayce
At a glance
| Generic name | Arikayce |
|---|---|
| Also known as | Liposomal amikacin inhalation, LAI |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- 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) ] . WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS See full prescribing information for complete boxed warning. ARIKAYCE has been asso
Common side effects
- Dysphonia
- Cough
- Bronchospasm
- Hemoptysis
- Musculoskeletal pain
- Upper airway irritation
- Ototoxicity
- Fatigue/asthenia
- Exacerbation of underlying pulmonary disease
- Diarrhea
- Nausea
- Headache
Serious adverse events
- Serious adverse reactions (overall)
- Hospitalization
- Exacerbation of underlying pulmonary disease
- Lower respiratory tract infections/pneumonia
Key clinical trials
- Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex (PHASE3)
- Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection (PHASE2)
- Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex (PHASE3)
- A Study to Investigate Lung Deposition of Inhaled Amikacin-loaded Liposomes in Healthy Male Participants (PHASE1)
- Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) (PHASE1, PHASE2)
- Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase (PHASE2)
- Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection (PHASE3)
- Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Arikayce CI brief — competitive landscape report
- Arikayce updates RSS · CI watch RSS
- Centre Hospitalier Universitaire, Amiens portfolio CI