Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

An Open-label Treatment Use Protocol of Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

Currently there are no approved therapies for lung transplant recipients in the United States (US). Treatment with CIS following lung transplantation has previously been demonstrated to result in a clinically meaningful improvement in survival and chronic rejection-free survival compared to placebo, but additional data supporting its use is needed prior to Food and Drug Administration (FDA) approval. This treatment use protocol is a mechanism for providing eligible lung transplant recipients early access to CIS in advance of FDA approval.

Inclusion Criteria:

• Single-or double-lung transplant recipients who have a high risk for developing chronic rejection
• Single or double-lung transplant recipients who have developed chronic rejection
• Single or double-lung transplant recipients who have serious or life-threatening complications of systemic immunosuppressive therapy

Exclusion Criteria:

• Known hypersensitivity to cyclosporine or propylene glycol (PG)
• Females who are pregnant or are considering becoming pregnant
• Females who are breast feeding a child.