Citations

Abstract Background Omadacycline (OMC) is an aminomethylcycline antibiotic in the tetracycline class that has been Food and Drug Administration-approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. OMC has been shown to have potent in vitro activity against a broad-spectrum of Gram-positive and Gram-negative organisms, as well as Nontuberculous Mycobacteria (NTM). Due to it’s unique activity and availability as an oral agent, off-label use of OMC has been increasing. We evaluated the real-world effectiveness and safety of OMC for a variety of infections. Methods This was a multicenter, retrospective, observational study that was conducted from January 2020 to June 2020. We included all patients ≥ 18 years of age that received OMC for ≥ 72 hours for any indication and/or pathogen. The primary outcome was clinical success, defined as a lack of 30-day (non-NTM) or 90-day (NTM) mortality or microbiologic recurrence and absence of therapy escalation or alteration. Reasons for OMC utilization and incidence of potential adverse effects attributable to OMC were also analyzed. Results A total of 18 patients were included from six geographically distinct academic health systems (median age: 56 (IQR, 49-60.5) years; 61% male; 72% Caucasian). The majority of OMC use was in NTM (61%; 100% Mycobacterium abscessus) and in Acinetobacter baumannii (22%) for bone/joint (39%) and respiratory tract (33%) infections. OMC was used primarily in the outpatient setting alone (83%) and most isolates did not have OMC susceptibility conducted (89%). Clinical success was reported in 83% of the total population (71% non-NTM and 91% NTM). The majority of patients were prescribed OMC due to antimicrobial resistance to previous antibiotic(s) (61%) and/or due to OMC’s availability as an oral agent (44%). Three patients experienced side effects while on therapy (serum creatinine elevation, AST/ALT increase, and gastrointestinal distress). Conclusion OMC appears to be effective and well-tolerated for a variety of infections caused by various pathogens, including M. abscessus and A. baumannii. Disclosures Michael J. Rybak, PharmD, MPH, PhD, Paratek (Grant/Research Support)

Abstract Purpose Transgender patients face considerable healthcare disparities. Improved means of recognizing transgender patients and understanding their medical needs is important to provide optimal care. The electronic medical record (EMR) of our health system allows for differentiation of gender identity, legal sex, and sex at birth. With EMR recognition of transgender patients, a recommendation for estimating creatinine clearance (CLcr) and ideal body weight (IBW) was needed to standardize medication dosing. Summary The literature was reviewed for evidence on the effect of gender-affirming hormone therapy on serum creatinine concentration and lean body mass. Findings informed a recommendation for drug dosing based on CLcr and IBW in transgender patients. Four studies that reported the effect of hormone therapy on biometric laboratory values were found. Three studies reported that values of transgender patients more closely resembled the standard values of their gender identity vs sex at birth after hormone therapy; 1 study reported a range of values that more closely resembled those associated with sex at birth while still overlapping with values associated with gender identity. Consequently, it was recommended that pharmacists dose medications based on CLcr and IBW calculations consistent with gender identity after a patient has been on hormone therapy for 6 months or longer. Conclusion Providing optimal care to transgender patients includes considering the effect of gender-affirming hormone therapy on overall physiology. Consistently using the appropriate CLcr and IBW calculations for each patient ensures safe and effective care. Additional studies are needed to confirm the effect of hormone therapy on renal clearance and lean body mass.