Translational pharmacokinetic modelling and simulation for the assessment of duration of contraceptive use after treatment with miltefosine

The Journal of Antimicrobial Chemotherapy
Thomas P C DorloAlwin D R Huitema

Abstract

Use of miltefosine in the treatment of visceral leishmaniasis (VL) is hampered by its potential teratogenicity. The duration of adequate contraceptive cover in females of child-bearing potential after cessation of a potentially teratogenic drug therapy remains debated. The objective of this study was to provide a rational approach to suggest durations of contraceptive cover for various miltefosine regimens. A human reproductive safety threshold exposure limit was derived using animal-to-human dose conversion. Pharmacokinetic (PK) data for miltefosine in females are lacking; a previously developed population PK model and a comprehensive anthropometric dataset were used to simulate PK data for Indian female VL patients receiving miltefosine for 5, 7, 10 or 28 days. Probability of supra-threshold miltefosine exposure was used to evaluate adequate durations of post-treatment contraceptive cover for the various regimens. PK data were simulated for 465 treated Indian female VL patients of child-bearing potential with a median age of 25 years (IQR 16-31 years) and median weight of 38 kg (IQR 34-42 kg). From animal reproductive toxicity studies, a human reproductive safety threshold exposure limit was derived of 24.5 μg · day/mL. Proba...Continue Reading

References

Sep 1, 1983·Regulatory Toxicology and Pharmacology : RTP·M L Dourson, J F Stara
May 1, 1996·Clinical Pharmacokinetics·N H Holford
Oct 1, 1996·Regulatory Toxicology and Pharmacology : RTP·M L DoursonD Robinson
Dec 10, 1997·Clinical Pharmacokinetics·B J AndersonN H Holford
Aug 14, 1998·Journal of the American Academy of Dermatology·U W Wiegand, R C Chou
Feb 9, 2000·Clinical Genetics·J E Polifka, J M Friedman
Oct 19, 2001·Journal of the American Academy of Dermatology·H Nau
Jun 21, 2002·Clinical Pharmacokinetics·Blaz Rozman
Jun 24, 2004·Computer Methods and Programs in Biomedicine·Lars LindbomE Niclas Jonsson
Jul 15, 2005·Expert Opinion on Pharmacotherapy·Jonathan Berman
Sep 24, 2005·Clinical Pharmacokinetics·Sarayut JanmahasatianBruce Green
May 30, 2006·Transactions of the Royal Society of Tropical Medicine and Hygiene·H Sindermann, J Engel
Oct 5, 2007·Annual Review of Pharmacology and Toxicology·B J Anderson, N H G Holford
Oct 19, 2007·FASEB Journal : Official Publication of the Federation of American Societies for Experimental Biology·Shannon Reagan-ShawNihal Ahmad
Mar 8, 2008·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Thomas P C DorloJos H Beijnen
Jun 4, 2008·Antimicrobial Agents and Chemotherapy·Thomas P C DorloPeter J de Vries
Dec 3, 2009·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·P P A M van ThielP J de Vries
Jul 16, 2010·Computer Methods and Programs in Biomedicine·Ron J KeizerAlwin D R Huitema
Dec 7, 2010·Transactions of the Royal Society of Tropical Medicine and Hygiene·Shyam SundarByron Arana

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Citations

Dec 18, 2013·Der Hautarzt; Zeitschrift für Dermatologie, Venerologie, und verwandte Gebiete·R Dieterle, H Pillekamp
Mar 5, 2013·Journal of Pharmaceutical Sciences·Rodrigo Alves MoreiraAntonio Alonso
Apr 20, 2014·Journal of Travel Medicine·Johannes BlumDiana N J Lockwood
Mar 24, 2016·Contraception·Ganesh CheralaFrank Z Stanczyk
Nov 12, 2016·Survey of Ophthalmology·Linda Christian Carrijo-CarvalhoFabio Ramos de Souza Carvalho
Jan 30, 2014·Revista Da Sociedade Brasileira De Medicina Tropical·Juliana Saboia Fontenele e SilvaMarcus Tolentino Silva
Mar 20, 2018·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Margriet den BoerKoert Ritmeijer
Feb 23, 2013·Expert Review of Anti-infective Therapy·Sarfaraz Ahmad Ejazi, Nahid Ali
Oct 16, 2018·Anti-cancer Agents in Medicinal Chemistry·Ferda KaleağasıoğluMartin R Berger
Aug 2, 2017·Clinical Pharmacokinetics·Anke E KipThomas P C Dorlo
Dec 13, 2016·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Naomi AronsonAlan Magill
Oct 13, 2020·American Journal of Ophthalmology·Praneetha ThulasiElmer Y Tu
Jun 9, 2018·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·M Dolores Jiménez-AntónJosé Mª Alunda

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