Product Details

Quinsair

Levofloxacin
240 mg/2.4 mL (100 mg/mL)
Solution for Inhalation
Single-Use 2.4-mL Ampoule (Preservative Free)

DIN/PIN/NPN

02442302

Manufacturer

Horizon Therapeutics Ireland DAC

Formulary Listing Date

2019-02-04  

Unit Price

64.4887

Amount MOH Pays

64.4887

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

J01MA12

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Anti-Infectives

Levofloxacin hemihydrate

  • Brand(s): Quinsair
  • Dosage Form/Strength: 240mg/ 2.4mL solution for inhalation

For the management of adult cystic fibrosis patients with chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infections who meet the following criteria: 

  • Documented diagnosis of Cystic Fibrosis; AND

  • Patient is 18 years of age or older; AND

  • Chronic infection with Pseudomonas aeruginosa (PsA) [confirmed by 2 (two) PsA positive sputum cultures taken at least 1 month apart]; AND

  • Patient has failed treatment with inhalational tobramycin and demonstrates deteriorating clinical condition despite treatment with inhaled tobramycin; AND

  • Request is from a prescriber experienced in the diagnosis and treatment of cystic fibrosis.

Exclusion criteria:

  • Use in combination (sequential or cycled during off-treatment periods) with other inhaled antibiotics to treat P. aeruginosa will not be funded.

  • Funding will not be provided for conditions outside of cystic fibrosis.

Approval duration: 1 year

Renewal requests: Patient demonstrates response to therapy.

Approval duration: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph