T Middleton1, L Turner1, C Fennell1, S Savkovic1, V Jayadev1, A J Conway1, D J Handelsman2. 1. Andrology DepartmentANZAC Research Institute, Concord Hospital, University of Sydney, Sydney, New South Wales 2139, Australia. 2. Andrology DepartmentANZAC Research Institute, Concord Hospital, University of Sydney, Sydney, New South Wales 2139, Australia djh@anzac.edu.au.
Abstract
OBJECTIVE: Injectable testosterone undecanoate (TU) was marketed within the last decade, but its complications in routine clinical practice are not well defined. DESIGN AND METHODS: Prospective observational study of consecutive TU injections in an Andrology Clinic to estimate the incidence of i) immediate cough/syncope due to pulmonary oil microembolisation (POME), ii) post-injection haematoma and iii) the prevalence of secondary polycythaemia. RESULTS: In 3022 injections given to 347 patients over 3.5 years, POME was observed after 56 injections (66% mild, 19% severe; 40% with onset before injection completed) in 43 patients. The incidence of 19 (95% CI 14-24) per 1000 injections did not differ between three experienced nurse injectors, but recurrences were more frequent than by chance. No post-injection haematoma was reported including after 269 injections to men taking antiplatelet, anticoagulant or both drugs (upper 95% confidence limit 1%) with 56 not withholding drugs prior to TU administration (upper 95% confidence limit 5.4%). Mean haematocrit was 0.44±0.04 (s.d.) with 25 (7%) >0.50, 14 (4%) >0.52 and 3 (1%) >0.54. CONCLUSION: TU injections produce a low incidence of POME with injections by experienced nurses, but recurrence is more frequent than by chance. Post-injection haematoma was not observed even among men using anticoagulant and/or antiplatelet drugs, and polycythaemia was a minor problem rarely requiring treatment other than optimising inter-injection interval.
OBJECTIVE: Injectable testosterone undecanoate (TU) was marketed within the last decade, but its complications in routine clinical practice are not well defined. DESIGN AND METHODS: Prospective observational study of consecutive TU injections in an Andrology Clinic to estimate the incidence of i) immediate cough/syncope due to pulmonary oil microembolisation (POME), ii) post-injection haematoma and iii) the prevalence of secondary polycythaemia. RESULTS: In 3022 injections given to 347 patients over 3.5 years, POME was observed after 56 injections (66% mild, 19% severe; 40% with onset before injection completed) in 43 patients. The incidence of 19 (95% CI 14-24) per 1000 injections did not differ between three experienced nurse injectors, but recurrences were more frequent than by chance. No post-injection haematoma was reported including after 269 injections to men taking antiplatelet, anticoagulant or both drugs (upper 95% confidence limit 1%) with 56 not withholding drugs prior to TU administration (upper 95% confidence limit 5.4%). Mean haematocrit was 0.44±0.04 (s.d.) with 25 (7%) >0.50, 14 (4%) >0.52 and 3 (1%) >0.54. CONCLUSION:TU injections produce a low incidence of POME with injections by experienced nurses, but recurrence is more frequent than by chance. Post-injection haematoma was not observed even among men using anticoagulant and/or antiplatelet drugs, and polycythaemia was a minor problem rarely requiring treatment other than optimising inter-injection interval.
Authors: Jarren A Adam; Alexander W Pastuszak; Michael B Christensen; Rachel Spencer; Ashlynn Sandberg; James M Hotaling; Larry I Lipshultz Journal: Int J Impot Res Date: 2022-05-24 Impact factor: 2.896
Authors: Carlos Martinez; Samy Suissa; Stephan Rietbrock; Anja Katholing; Ben Freedman; Alexander T Cohen; David J Handelsman Journal: BMJ Date: 2016-11-30
Authors: Leo Turner; Lam P Ly; Reena Desai; Gurmeet K S Singh; Timothy D Handelsman; Sasha Savkovic; Carolyn Fennell; Veena Jayadev; Ann Conway; David J Handelsman Journal: J Endocr Soc Date: 2019-06-28