Article
Microbiology
Antonio C. Arrieta, Michael Neely, J. Christopher Day, Susan R. Rheingold, Paul K. Sue, William J. Muller, Lara A. Danziger-Isakov, Julie Chu, Inci Yildirim, Grace A. McComsey, Haydar A. Frangoul, Tempe K. Chen, Victoria A. Statler, William J. Steinbach, Dwight E. Yin, Kamal Hamed, Mark E. Jones, Christopher Lademacher, Amit Desai, Kelley Micklus, Desiree Leiva Phillips, Laura L. Kovanda, Thomas J. Walsh
Summary: Isavuconazole, administered as the water-soluble prodrug isavuconazonium sulfate, was well tolerated and resulted in exposure in pediatric patients similar to that in adults. Covariate modeling did not show significant impact of age, sex, race, and body mass index on the pharmacokinetic parameters in pediatric patients. The target range of plasma drug exposures was achieved in over 80% and 76% of simulated pediatric patients following intravenous and oral administration, respectively.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2021)
Article
Immunology
Fouzia Naeem, Fred Laningham, Brenik Kuzmic, Patricia Clerkin, James McCarty
Summary: Coccidioidal meningitis is challenging to treat. Isavuconazole has shown effectiveness in treating invasive fungal diseases with fewer side effects, and has successfully stabilized and improved a case of refractory pediatric coccidioidal meningitis after other antifungal treatments failed.
PEDIATRIC INFECTIOUS DISEASE JOURNAL
(2021)
Article
Microbiology
James S. Lewis, Nathan P. Wiederhold, Morgan Hakki, George R. Thompson
Summary: Isavuconazole is a newly available antifungal drug that is effective against various fungi. It is FDA-approved for the treatment of invasive aspergillosis and mucormycosis. Isavuconazole has significant advantages over other antifungal drugs, such as lack of QTc interval prolongation, more predictable pharmacokinetics, a simpler drug interaction profile, and improved tolerability.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2022)
Article
Pharmacology & Pharmacy
Shinichiro Shirae, Yuri Tsuruya, Tomohito Kozaki, Junnosuke Mizuhata, Atsushi Ose
Summary: The objectives of this analysis were to develop a population PK model for Japanese patients, determine the probability of PK-PD target attainment, and evaluate the exposure-safety relationship of isavuconazole in Japanese patients. The results showed that the clinical dosing regimen is appropriate for the treatment of Japanese patients with deep-seated mycoses, as it can achieve the desired drug concentration and has no apparent safety issues.
JOURNAL OF CLINICAL PHARMACOLOGY
(2023)
Article
Infectious Diseases
Matthew R. Davis, Sandy Chang, Pryce Gaynor, Erin K. McCreary, Paul Allyn
Summary: Isavuconazole concentrations in cerebrospinal fluid (CSF) may be lower than plasma concentrations in patients with coccidioidal meningitis (CM), but detectable in lumbar CSF. More studies are needed to determine the efficacy of isavuconazole as salvage therapy for refractory CM.
Article
Pharmacology & Pharmacy
Shinichiro Shirae, Yoko Mori, Tomohito Kozaki, Atsushi Ose, Setsuo Hasegawa
Summary: This study confirmed the bioequivalence between different dosages and sizes of Isavuconazole oral formulations in healthy Japanese male subjects, with good tolerability demonstrated.
CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT
(2022)
Article
Microbiology
David C. Griffith, Elizabeth E. Morgan, Michael N. Dudley, Jeffery S. Loutit
Summary: The study showed that Biapenem exposure increased slightly more than dose proportionally after multiple doses, with no evidence of accumulation. Urinary recovery ranged from 14.2% at 250 mg to 42.3% at 1,250 mg. Biapenem was well tolerated up to 1,000 mg doses every 8 hours, but higher incidences of nausea, vomiting, and rash were reported at 1,250 mg.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2021)
Article
Medicine, General & Internal
Olivia Randazza, Kallie Erickson, Travis Denmeade, Vera Luther, Elizabeth Palavecino, James Beardsley
Summary: This case report presents a successful treatment of Candida nivariensis fungemia with oral isavuconazole, without fungal infection relapse.
CUREUS JOURNAL OF MEDICAL SCIENCE
(2022)
Article
Public, Environmental & Occupational Health
Rezika Mohammed, Mezgebu Silamsaw Asres, Esayas Kebede Gudina, Wondimagegn Adissu, Hilary Johnstone, Anne Claire Marrast, Cristina Donini, Stephan Duparc, Daniel Yilma
Summary: An open label, phase IIa study conducted in Ethiopia evaluated the efficacy, safety, tolerability, and pharmacokinetics of a single 120-mg dose of the phosphatidylinositol 4-kinase inhibitor MMV390048 in Plasmodium vivax malaria. The study was not completed for operational reasons and emerging teratotoxicity data. MMV390048 exposure in P. vivax patients was lower than previously observed for healthy volunteers. Single-dose MMV390048 (120 mg) rapidly cleared asexual parasites and gametocytes in patients with P. vivax malaria and was well tolerated.
AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE
(2023)
Article
Infectious Diseases
Lisa Kriegl, Stefan Hatzl, Christoph Zurl, Alexander Christian Reisinger, Gernot Schilcher, Philipp Eller, Yvonne Gringschl, Tina Muhr, Andreas Meinitzer, Juergen Prattes, Martin Hoenigl, Robert Krause
Summary: This study found that ECMO therapy may influence isavuconazole plasma concentrations, but not altered by the ECMO oxygenator. Patients achieved median plasma concentrations >1 μg/mL 24 hours after the first loading dose.
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
(2022)
Article
Chemistry, Medicinal
Tommy Tsang Cheung, Tu H. Mai, Yen Lin Chia, Desmond Y. H. Yap, Chi-Ho Lee, Cecil Chi-Keung Chen, Ying Huang, Yuwen Jin, James Johnston, Viktoria Werkstroem, Yuhui Yao, Xiaoyun Ge, Wenying Zheng
Summary: The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics of benralizumab in healthy Chinese individuals. The results showed that benralizumab was well tolerated by the participants, with dose-proportional pharmacokinetics and rapid depletion of eosinophils.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2023)
Article
Infectious Diseases
Thomas D. Dieringer, Joanna M. Schaenman, Matthew R. Davis
Summary: By retrospectively reviewing pharmacy records, we found that administration of crushed posaconazole DR tablets and opened isavuconazole capsules via enteral feeding tube (EFT) can achieve target plasma drug concentrations in the majority of patients, providing an alternative treatment option for patients unable to swallow medications.
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
(2022)
Article
Microbiology
Jon Bruss, Troy Lister, Vipul K. Gupta, Emily Stone, Lisa Morelli, Yang Lei, David Melnick
Summary: SPR206, a novel polymyxin derivative, shows potent activity against multidrug-resistant bacteria and demonstrates good safety and tolerability in healthy subjects. Drug exposure and excretion are dose-dependent, with minimal accumulation and no evidence of nephrotoxicity observed.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2021)
Article
Pharmacology & Pharmacy
Max Tsai, Emel Serap Monkul Nery, Lisa Kerr, Rashna Khanna, Mika Komori, Ellen B. Dennehy, Darren Wilbraham, Paul Winner
Summary: The study evaluated the pharmacokinetics, safety, and tolerability of lasmiditan in pediatric migraine patients aged 6 to <18 years, showing similar exposure to the drug between different weight cohorts but differences in certain pharmacokinetic parameters. Adverse events were mild and comparable to adult studies, supporting further investigation of lasmiditan as a potential treatment in pediatric patients with migraine.
CLINICAL PHARMACOKINETICS
(2021)
Article
Chemistry, Medicinal
Lei Sheng, Wei Cao, Pingping Lin, Weili Chen, Hongrong Xu, Chunjiu Zhong, Fei Yuan, Hanjing Chen, Hui Li, Chao Liu, Mengjie Yang, Xuening Li
Summary: The safety, tolerability, and pharmacokinetics of benfotiamine were evaluated in healthy subjects through single and multiple ascending doses. The results showed that benfotiamine was safe and well-tolerated, with moderate accumulation observed for TM and TDP with repeated administration.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)