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Safety and Tolerability of Single Dose Inhaled Dry Powder Tacrolimus in Healthy Subjects FREE TO VIEW

Stephanie Levine, MD; H. Singh, MD; R. Williams, PhD; A. Watts, PhD; A. Anzueto, MD; R. Talbert, PharmD; Jay Peters, MD
Author and Funding Information

University of Texas Health Science Center at San Antonio, San Antonio, TX

Chest. 2013;144(4_MeetingAbstracts):1011A. doi:10.1378/chest.1703205
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SESSION TITLE: Lung Transplantation Posters

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 30, 2013 at 01:30 PM - 02:30 PM

PURPOSE: Inhaled cryogenically engineered TAC:LAC, can produce high tacrolimus levels in the distal lung with low systemic concentrations (lung/blood concentrations of 50/1 in animal studies). The purpose of this study was to examine the safety and tolerability of a single dose of inhaled dry powder TAC:LAC in healthy adults.

METHODS: Ten adults (5 male; 5 female) were enrolled in the study. All subjects underwent baseline blood work for CBC, potassium, and metabolic profile (renal/liver function tests) prior to entering the study. Subjects inhaled 3 mg of tacrolimus (6 mg TAC: LAC) via a dry powder inhaler (HandiHaler®). Tacrolimus levels were obtained at 24 hours after inhalation. Spirometry was obtained prior to inhalation and at 1 hour after inhalation. A symptom diary was maintained and tolerability questionnaires completed at baseline, and at 1 and 24 hours following inhalation.

RESULTS: All 10 adults (mean age 35.1 ± 9.8 yrs) had normal lung exams and spirometry at baseline. All subjects completed tacrolimus inhalation without complication with a single inspiratory effort. Mean tacrolimus levels by radioimmunoassay were undetectable at 24 hours in 6/10 subjects and low in 4/10 subjects (2.5 +/- 0.5 ng/ml). Spirometry was unchanged at 1 hour post-inhalation in all subjects. Side effects during inhalation included cough (8/10), throat irritation (3/10) and distaste (8/10), and at 1 hour following inhalation included cough (9/10) and a mild-moderate distaste (10/10), and were tolerable in all subjects. At 24 hours all symptoms had resolved.

CONCLUSIONS: Inhaled dry powder tacrolimus (TAC:LAC) is well tolerated, and produced no changes in spirometry at 1 hour after inhalation. Systemic levels of tacrolimus were low or undetectable at 24 hours after inhalation.

CLINICAL IMPLICATIONS: Inhaled dry powder tacrolimus is relatively well tolerated in healthy adults. Inhaled tacrolimus should be considered a viable therapeutic option for immunosuppression for patients with lung disease, such as lung transplantation, without significant systemic absorption.

DISCLOSURE: R. Williams: Shareholder: Enavail LLC Jay Peters: Shareholder: Enavail LLC The following authors have nothing to disclose: Stephanie Levine, H. Singh, A. Watts, A. Anzueto, R. Talbert

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