Retrospective comparison of posaconazole levels in patients taking the delayed-release tablet versus the oral suspension

Antimicrobial Agents and Chemotherapy

Volumn 59, Issue 8, 2015, Pages 4914-4918

  Durani, Urshila ^a   Tosh, Pritish K ^a   Barreto, Jason N ^a   Estes, Lynn L ^a   Jannetto, Paul J ^a   Tande, Aaron J ^a  

^a MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

POSACONAZOLE; ANTIFUNGAL AGENT; DELAYED RELEASE FORMULATION; SUSPENSION; TABLET; TRIAZOLE DERIVATIVE;

ADULT; ARTICLE; COHORT ANALYSIS; DELAYED RELEASE FORMULATION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RETROSPECTIVE STUDY; STEADY STATE; SUSPENSION; TABLET; BIOAVAILABILITY; BLOOD; COMPARATIVE STUDY; MEDICINAL CHEMISTRY; MIDDLE AGED; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PHARMACOKINETICS; PROCEDURES;

ADMINISTRATION, ORAL; ADULT; ANTIFUNGAL AGENTS; BIOLOGICAL AVAILABILITY; CHEMISTRY, PHARMACEUTICAL; DELAYED-ACTION PREPARATIONS; FEMALE; HEALTHY VOLUNTEERS; HUMANS; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; SUSPENSIONS; TABLETS; TRIAZOLES;

EID: 84939856980     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.00496-15     Document Type: Article

References (17)

1. Cornely OA, Maertens J, Winston DJ, Perfect J, Ullmann AJ, Walsh TJ, Helfgott D, Holowiecki J, Stockelberg D, Goh YT, Petrini M, Hardalo C, Suresh R, Angulo-Gonzalez D. 2007. Posaconazole vs. fluconazole or itraconazole prophylaxis in patients with neutropenia. N Engl J Med 356:348-359. http://dx.doi.org/10.1056/NEJMoa061094.
2. Kung HC, Johnson MD, Drew RH, Saha-Chaudhuri P, Perfect JR. 2014. Clinical effectiveness of posaconazole versus fluconazole as antifungal prophylaxis in hematology-oncology patients: a retrospective cohort study. Cancer Med 3:667-673. http://dx.doi.org/10.1002/cam4.225.
3. Gross BN, Ihorst G, Jung M, Wasch R, Engelhardt M. 2013. Posaconazole therapeutic drug monitoring in the real-life setting: a single-center experience and review of the literature. Pharmacotherapy 33:1117-1125. http://dx.doi.org/10.1002/phar.1328.
4. Dolton MJ, Ray JE, Chen SC, Ng K, Pont L, McLachlan AJ. 2012. Multicenter study of posaconazole therapeutic drug monitoring: exposure-response relationship and factors affecting concentration. Antimicrob Agents Chemother 56:5503-5510. http://dx.doi.org/10.1128/AAC.00802-12.
5. Walsh TJ, Raad I, Patterson TF, Chandrasekar P, Donowitz GR, Graybill R, Greene RE, Hachem R, Hadley S, Herbrecht R, Langston A, Louie A, Ribaud P, Segal BH, Stevens DA, van Burik JA, White CS, Corcoran G, Gogate J, Krishna G, Pedicone L, Hardalo C, Perfect JR. 2007. Treatment of invasive aspergillosis with posaconazole in patients who are refractory to or intolerant of conventional therapy: an externally controlled trial. Clin Infect Dis 44:2-12. http://dx.doi.org/10.1086/508774.
6. Krishna G, Ma L, Martinho M, O'Mara E. 2012. Single-dose phase I study to evaluate the pharmacokinetics of posaconazole in new tablet and capsule formulations relative to oral suspension. Antimicrob Agents Chemother 56:4196-4201. http://dx.doi.org/10.1128/AAC.00222-12.
7. Cornely OA, Duarte RF, Haider S, Chandrasakar P, Helfgott D, Lopez J, Van Iersel M, Connelly N, Waskin H. 2013. Phase 3 pharmacokinetics (PK) and safety study of posaconazole (POS) tablet in patients at risk for invasive fungal infection, abstr LB2966. ECCMID 2013.
8. Jung DS, Tverdek FP, Kontoyiannis DP. 2014. Switching from posaconazole suspension to tablets increases serum drug levels in leukemia patients without clinically relevant hepatotoxicity. Antimicrob Agents Chemother 58:6993-6995. http://dx.doi.org/10.1128/AAC.04035-14.
9. Gubbins PO, Krishna G, Sansone-Parsons A, Penzak SR, Dong L, Martinho M, Anaissie EJ. 2006. Pharmacokinetics and safety of oral posaconazole in neutropenic stem cell transplant recipients. Antimicrob Agents Chemother 50:1993-1999. http://dx.doi.org/10.1128/AAC.00157-06.
10. Krishna G, Martinho M, Chandrasekar P, Ullmann AJ, Patino H. 2007. Pharmacokinetics of oral posaconazole in allogeneic hematopoietic stem cell transplant recipients with graft-versus-host disease. Pharmacotherapy 27:1627-1636. http://dx.doi.org/10.1592/phco.27.12.1627.
11. Dolton MJ, Bruggemann RJ, Burger DM, McLachlan AJ. 2014. Understanding variability in posaconazole exposure using an integrated population pharmacokinetic analysis. Antimicrob Agents Chemother 58:6879-6885. http://dx.doi.org/10.1128/AAC.03777-14.
12. I. Merck & Co. 2006. Noxafil® (posaconazole) injection 18mg/mL, delayed-release tablets 100 mg, and oral suspension 40 mg/mL. I. Merck & Co., Whitehouse Station, NJ.
13. Duarte RF, Lopez-Jimenez J, Cornely OA, Laverdiere M, Helfgott D, Haider S, Chandrasekar P, Langston A, Perfect J, Ma L, van Iersel ML, Connelly N, Kartsonis N, Waskin H. 2014. Phase 1b study of new posaconazole tablet for prevention of invasive fungal infections in high-risk patients with neutropenia. Antimicrob Agents Chemother 58:5758-5765. http://dx.doi.org/10.1128/AAC.03050-14.
14. Krishna G, Moton A, Ma L, Medlock MM, McLeod J. 2009. Pharmacokinetics and absorption of posaconazole oral suspension under various gastric conditions in healthy volunteers. Antimicrob Agents Chemother 53:958-966. http://dx.doi.org/10.1128/AAC.01034-08.
15. Walravens J, Brouwers J, Spriet I, Tack J, Annaert P, Augustijns P. 2011. Effect of pH and comedication on gastrointestinal absorption of posaconazole: monitoring of intraluminal and plasma drug concentrations. Clin Pharmacokinet 50:725-734. http://dx.doi.org/10.2165/11592630-000000000-00000.
16. Cornely OA, Helfgott D, Langston A, Heinz W, Vehreschild JJ, Vehreschild MJ, Krishna G, Ma L, Huyck S, McCarthy MC. 2012. Pharmacokinetics of different dosing strategies of oral posaconazole in patients with compromised gastrointestinal function and who are at high risk for invasive fungal infection. Antimicrob Agents Chemother 56:2652-2658. http://dx.doi.org/10.1128/AAC.05937-11.
17. Courtney R, Radwanski E, Lim J, Laughlin M. 2004. Pharmacokinetics of posaconazole coadministered with antacid in fasting or nonfasting healthy men. Antimicrob Agents Chemother 48:804-808. http://dx.doi.org/10.1128/AAC.48.3.804-808.2004.