Frequently Asked Questions
What is an expanded access program?
An expanded access program (EAP) makes an experimental drug available to those patients most in need of treatment before the approval process is complete. To be considered for an EAP by the FDA, the drug must treat health problems that are serious or life-threatening in people with limited or no treatment options currently available to them.
What is aztreonam lysine for inhalation?
Aztreonam lysine for inhalation is an antibiotic currently being studied in Phase III clinical trials as a treatment for people with cystic fibrosis (CF) who have the bacteria (germ) Pseudomonas aeruginosa in their lungs. The currently available form of aztreonam is given by an injection, either into a vein (IV) or into a muscle, to fight infections. The inhaled form of aztreonam is different from the injected form in that it has been specifically formulated with different ingredients for inhalation.
Which nebulizer is used with aztreonam lysine for inhalation?
An electronic nebulizer developed and made by PARI Pharma GmbH, called the eFlow® Electronic Nebulizer, is being used in the clinical trials for aztreonam lysine for inhalation. PARI Pharma GmbH and Gilead Sciences, Inc. worked together to design the handheld eFlow® specifically for aztreonam lysine for inhalation. The eFlow® has been used in all clinical trials for aztreonam lysine for inhalation to date.
Who may participate in the Aztreonam Lysine for Inhalation EAP?
This EAP makes aztreonam lysine for inhalation available to people with CF who have Pseudomonas aeruginosa in their lungs, who have limited or no treatment options and are at risk for disease progression. Click here for eligibility criteria.
Does insurance cover the costs of participating in an EAP?
Participants will be provided aztreonam lysine for inhalation and the eFlow® at no cost during the program. You may want to check with your insurance provider to ask about coverage for the screenings and office visits.
What is the purpose of an inhaled antibiotic for CF?
People with CF often have chronic (ongoing) lung infections, and their lung function gets worse over time. The lung infections are often caused by bacteria (germs). Taking antibiotics can help stop or slow down the growth of bacteria. The antibiotics may be given orally (by mouth), injected (a shot or IV) or inhaled as a mist. Antibiotics given orally or by injection treat the lung infection via the blood. Inhaled antibiotics directly target the site of infection within the lungs.