Pharmacokinetic Assessment of Drug‐Drug Interactions of Isavuconazole With the Immunosuppressants Cyclosporine, Mycophenolic Acid, Prednisolone, Sirolimus, and Tacrolimus in Healthy Adults
This report summarizes phase 1 studies that evaluated pharmacokinetic interactions between the novel triazole antifungal agent isavuconazole and the immunosuppressants cyclosporine, mycophenolic acid, prednisolone, sirolimus, and tacrolimus in healthy adults. Healthy subjects received single oral do...
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| Published in | Clinical pharmacology in drug development Vol. 6; no. 1; pp. 76 - 85 |
|---|---|
| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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United States
Wiley Subscription Services, Inc
01.01.2017
John Wiley and Sons Inc |
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| Online Access | Get full text |
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| Abstract | This report summarizes phase 1 studies that evaluated pharmacokinetic interactions between the novel triazole antifungal agent isavuconazole and the immunosuppressants cyclosporine, mycophenolic acid, prednisolone, sirolimus, and tacrolimus in healthy adults. Healthy subjects received single oral doses of cyclosporine (300 mg; n = 24), mycophenolate mofetil (1000 mg; n = 24), prednisone (20 mg; n = 21), sirolimus (2 mg; n = 22), and tacrolimus (5 mg; n = 24) in the presence and absence of clinical doses of oral isavuconazole (200 mg 3 times daily for 2 days; 200 mg once daily thereafter). Coadministration with isavuconazole increased the area under the concentration‐time curves (AUC0–∞) of tacrolimus, sirolimus, and cyclosporine by 125%, 84%, and 29%, respectively, and the AUCs of mycophenolic acid and prednisolone by 35% and 8%, respectively. Maximum concentrations (Cmax) of tacrolimus, sirolimus, and cyclosporine were 42%, 65%, and 6% higher, respectively; Cmax of mycophenolic acid and prednisolone were 11% and 4% lower, respectively. Isavuconazole pharmacokinetics were mostly unaffected by the immunosuppressants. Two subjects experienced elevated creatinine levels in the cyclosporine study; most adverse events were not considered to be of clinical concern. These results indicate that isavuconazole is an inhibitor of cyclosporine, mycophenolic acid, sirolimus, and tacrolimus metabolism. |
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| AbstractList | This report summarizes phase 1 studies that evaluated pharmacokinetic interactions between the novel triazole antifungal agent isavuconazole and the immunosuppressants cyclosporine, mycophenolic acid, prednisolone, sirolimus, and tacrolimus in healthy adults. Healthy subjects received single oral doses of cyclosporine (300 mg; n = 24), mycophenolate mofetil (1000 mg; n = 24), prednisone (20 mg; n = 21), sirolimus (2 mg; n = 22), and tacrolimus (5 mg; n = 24) in the presence and absence of clinical doses of oral isavuconazole (200 mg 3 times daily for 2 days; 200 mg once daily thereafter). Coadministration with isavuconazole increased the area under the concentration-time curves (AUC0-[infin]) of tacrolimus, sirolimus, and cyclosporine by 125%, 84%, and 29%, respectively, and the AUCs of mycophenolic acid and prednisolone by 35% and 8%, respectively. Maximum concentrations (Cmax) of tacrolimus, sirolimus, and cyclosporine were 42%, 65%, and 6% higher, respectively; Cmax of mycophenolic acid and prednisolone were 11% and 4% lower, respectively. Isavuconazole pharmacokinetics were mostly unaffected by the immunosuppressants. Two subjects experienced elevated creatinine levels in the cyclosporine study; most adverse events were not considered to be of clinical concern. These results indicate that isavuconazole is an inhibitor of cyclosporine, mycophenolic acid, sirolimus, and tacrolimus metabolism. This report summarizes phase 1 studies that evaluated pharmacokinetic interactions between the novel triazole antifungal agent isavuconazole and the immunosuppressants cyclosporine, mycophenolic acid, prednisolone, sirolimus, and tacrolimus in healthy adults. Healthy subjects received single oral doses of cyclosporine (300 mg; n = 24), mycophenolate mofetil (1000 mg; n = 24), prednisone (20 mg; n = 21), sirolimus (2 mg; n = 22), and tacrolimus (5 mg; n = 24) in the presence and absence of clinical doses of oral isavuconazole (200 mg 3 times daily for 2 days; 200 mg once daily thereafter). Coadministration with isavuconazole increased the area under the concentration‐time curves (AUC0–∞) of tacrolimus, sirolimus, and cyclosporine by 125%, 84%, and 29%, respectively, and the AUCs of mycophenolic acid and prednisolone by 35% and 8%, respectively. Maximum concentrations (Cmax) of tacrolimus, sirolimus, and cyclosporine were 42%, 65%, and 6% higher, respectively; Cmax of mycophenolic acid and prednisolone were 11% and 4% lower, respectively. Isavuconazole pharmacokinetics were mostly unaffected by the immunosuppressants. Two subjects experienced elevated creatinine levels in the cyclosporine study; most adverse events were not considered to be of clinical concern. These results indicate that isavuconazole is an inhibitor of cyclosporine, mycophenolic acid, sirolimus, and tacrolimus metabolism. This report summarizes phase 1 studies that evaluated pharmacokinetic interactions between the novel triazole antifungal agent isavuconazole and the immunosuppressants cyclosporine, mycophenolic acid, prednisolone, sirolimus, and tacrolimus in healthy adults. Healthy subjects received single oral doses of cyclosporine (300 mg; n = 24), mycophenolate mofetil (1000 mg; n = 24), prednisone (20 mg; n = 21), sirolimus (2 mg; n = 22), and tacrolimus (5 mg; n = 24) in the presence and absence of clinical doses of oral isavuconazole (200 mg 3 times daily for 2 days; 200 mg once daily thereafter). Coadministration with isavuconazole increased the area under the concentration‐time curves (AUC 0–∞ ) of tacrolimus, sirolimus, and cyclosporine by 125%, 84%, and 29%, respectively, and the AUCs of mycophenolic acid and prednisolone by 35% and 8%, respectively. Maximum concentrations (C max ) of tacrolimus, sirolimus, and cyclosporine were 42%, 65%, and 6% higher, respectively; C max of mycophenolic acid and prednisolone were 11% and 4% lower, respectively. Isavuconazole pharmacokinetics were mostly unaffected by the immunosuppressants. Two subjects experienced elevated creatinine levels in the cyclosporine study; most adverse events were not considered to be of clinical concern. These results indicate that isavuconazole is an inhibitor of cyclosporine, mycophenolic acid, sirolimus, and tacrolimus metabolism. This report summarizes phase 1 studies that evaluated pharmacokinetic interactions between the novel triazole antifungal agent isavuconazole and the immunosuppressants cyclosporine, mycophenolic acid, prednisolone, sirolimus, and tacrolimus in healthy adults. Healthy subjects received single oral doses of cyclosporine (300 mg; n = 24), mycophenolate mofetil (1000 mg; n = 24), prednisone (20 mg; n = 21), sirolimus (2 mg; n = 22), and tacrolimus (5 mg; n = 24) in the presence and absence of clinical doses of oral isavuconazole (200 mg 3 times daily for 2 days; 200 mg once daily thereafter). Coadministration with isavuconazole increased the area under the concentration‐time curves (AUC 0–∞ ) of tacrolimus, sirolimus, and cyclosporine by 125%, 84%, and 29%, respectively, and the AUCs of mycophenolic acid and prednisolone by 35% and 8%, respectively. Maximum concentrations (C max ) of tacrolimus, sirolimus, and cyclosporine were 42%, 65%, and 6% higher, respectively; C max of mycophenolic acid and prednisolone were 11% and 4% lower, respectively. Isavuconazole pharmacokinetics were mostly unaffected by the immunosuppressants. Two subjects experienced elevated creatinine levels in the cyclosporine study; most adverse events were not considered to be of clinical concern. These results indicate that isavuconazole is an inhibitor of cyclosporine, mycophenolic acid, sirolimus, and tacrolimus metabolism. This report summarizes phase 1 studies that evaluated pharmacokinetic interactions between the novel triazole antifungal agent isavuconazole and the immunosuppressants cyclosporine, mycophenolic acid, prednisolone, sirolimus, and tacrolimus in healthy adults. Healthy subjects received single oral doses of cyclosporine (300 mg; n = 24), mycophenolate mofetil (1000 mg; n = 24), prednisone (20 mg; n = 21), sirolimus (2 mg; n = 22), and tacrolimus (5 mg; n = 24) in the presence and absence of clinical doses of oral isavuconazole (200 mg 3 times daily for 2 days; 200 mg once daily thereafter). Coadministration with isavuconazole increased the area under the concentration-time curves (AUC ) of tacrolimus, sirolimus, and cyclosporine by 125%, 84%, and 29%, respectively, and the AUCs of mycophenolic acid and prednisolone by 35% and 8%, respectively. Maximum concentrations (C ) of tacrolimus, sirolimus, and cyclosporine were 42%, 65%, and 6% higher, respectively; C of mycophenolic acid and prednisolone were 11% and 4% lower, respectively. Isavuconazole pharmacokinetics were mostly unaffected by the immunosuppressants. Two subjects experienced elevated creatinine levels in the cyclosporine study; most adverse events were not considered to be of clinical concern. These results indicate that isavuconazole is an inhibitor of cyclosporine, mycophenolic acid, sirolimus, and tacrolimus metabolism. |
| Author | Lademacher, Christopher Mandarino, Debra Lewis, William Akhtar, Shahzad Desai, Amit Howieson, Corrie Kowalski, Donna Townsend, Robert Pearlman, Helene Groll, Andreas H. Han, David Yamazaki, Takao Kato, Kota |
| AuthorAffiliation | 4 Analysis & Pharmacokinetics Research Laboratories Astellas Pharma Inc Osaka Japan 2 Astellas Pharma Global Development, Inc Northbrook IL USA 1 Department of Paediatric Haematology/Oncology University Children's Hospital Münster Münster Germany 5 Covance Madison WI USA 3 PAREXEL Los Angeles CA USA |
| AuthorAffiliation_xml | – name: 2 Astellas Pharma Global Development, Inc Northbrook IL USA – name: 5 Covance Madison WI USA – name: 4 Analysis & Pharmacokinetics Research Laboratories Astellas Pharma Inc Osaka Japan – name: 3 PAREXEL Los Angeles CA USA – name: 1 Department of Paediatric Haematology/Oncology University Children's Hospital Münster Münster Germany |
| Author_xml | – sequence: 1 givenname: Andreas H. surname: Groll fullname: Groll, Andreas H. organization: University Children's Hospital Münster – sequence: 2 givenname: Amit surname: Desai fullname: Desai, Amit organization: Astellas Pharma Global Development, Inc – sequence: 3 givenname: David surname: Han fullname: Han, David organization: PAREXEL – sequence: 4 givenname: Corrie surname: Howieson fullname: Howieson, Corrie organization: Astellas Pharma Global Development, Inc – sequence: 5 givenname: Kota surname: Kato fullname: Kato, Kota organization: Astellas Pharma Inc – sequence: 6 givenname: Shahzad surname: Akhtar fullname: Akhtar, Shahzad organization: Astellas Pharma Global Development, Inc – sequence: 7 givenname: Donna surname: Kowalski fullname: Kowalski, Donna organization: Astellas Pharma Global Development, Inc – sequence: 8 givenname: Christopher surname: Lademacher fullname: Lademacher, Christopher organization: Astellas Pharma Global Development, Inc – sequence: 9 givenname: William surname: Lewis fullname: Lewis, William organization: Covance – sequence: 10 givenname: Helene surname: Pearlman fullname: Pearlman, Helene organization: Astellas Pharma Global Development, Inc – sequence: 11 givenname: Debra surname: Mandarino fullname: Mandarino, Debra organization: Covance – sequence: 12 givenname: Takao surname: Yamazaki fullname: Yamazaki, Takao organization: Astellas Pharma Global Development, Inc – sequence: 13 givenname: Robert surname: Townsend fullname: Townsend, Robert email: Robert.Townsend@astellas.com organization: Astellas Pharma Global Development, Inc |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27273343$$D View this record in MEDLINE/PubMed |
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| Keywords | cyclosporine prednisolone mycophenolate mofetil isavuconazole tacrolimus sirolimus |
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| SubjectTerms | Acids Adult Area Under Curve cyclosporine Cyclosporine - administration & dosage Drug dosages Drug Interactions Female Healthy Volunteers Humans isavuconazole Male Middle Aged mycophenolate mofetil Mycophenolic Acid - administration & dosage Nitriles - administration & dosage Nitriles - pharmacokinetics Original Manuscript prednisolone Prednisolone - administration & dosage Prescription drugs Pyridines - administration & dosage Pyridines - pharmacokinetics sirolimus Sirolimus - administration & dosage tacrolimus Tacrolimus - administration & dosage Triazoles - administration & dosage Triazoles - pharmacokinetics Young Adult |
| Title | Pharmacokinetic Assessment of Drug‐Drug Interactions of Isavuconazole With the Immunosuppressants Cyclosporine, Mycophenolic Acid, Prednisolone, Sirolimus, and Tacrolimus in Healthy Adults |
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