Difference between revisions of "Amrubicin (Calsed)"

Latest revision as of 01:02, 29 June 2024

General information

Class/mechanism: Synthetic third generation anthracycline and topoisomerase II inhibitor.^[1]^[2]
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information.

Diseases for which it is used

Patient drug information

No information available.

History of changes in PMDA indication

2002-04-11: Initial approval for the treatment of small cell and non-small cell lung cancer.

Also known as

Code name: SM-5887
Generic names: AMR, amrubicin HCI
Brand name: Calsed

References

[1] Sumitomo Pharmaceuticals Co. press release about launch of amrubicin (Calsed) on 12/6/2002

[2] Dainippon Sumitomo Pharma submits an application for anticancer antibiotic amrubicin HCI (Brand name in Japan: CALSED®) in China, 9/5/2012

[1]

[2]

@@ Line 4: / Line 4: @@
 <br>Extravasation: no information
-For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer.  Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.
+For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information.
 ==Diseases for which it is used==
+*[[Non-small cell lung cancer]]
 *[[Small cell lung cancer]]
-==Clinical trials==
-*[http://clinicaltrials.gov/ct2/show/NCT01033032 Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer]
-*[http://clinicaltrials.gov/ct2/show/NCT00890955 Amrubicin + Cyclophosphamide in Advanced Solid Organ Malignancies]
-*[http://clinicaltrials.gov/ct2/show/NCT00547651 AMR PH GL 2007 CL 001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy]
-*[http://clinicaltrials.gov/ct2/show/NCT01076504 A Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer]
-*[http://clinicaltrials.gov/ct2/show/NCT00915083 A Phase I Study to Assess the Safety, Pharmacokinetics, and Potential Effects of Amrubicin on the QT/QTc Interval in Cancer Patients With Advanced Solid Tumors.]
-*[http://clinicaltrials.gov/ct2/show/NCT00388960 Study of Amrubicin With or Without Cisplatin Versus Etoposide-cisplatin for Extensive Stage Small Cell Lung Cancer]
-*[http://clinicaltrials.gov/ct2/show/NCT00319969 Study Comparing Amrubicin Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Responded to Prior Therapy.]
-*[http://clinicaltrials.gov/ct2/show/NCT00375193 Study of Amrubicin in Patients With Small Cell Lung Cancer Refractory or Progressive to Prior Therapy]
-*[http://clinicaltrials.gov/ct2/show/NCT01364727 A Phase II Study of Amrubicin in Relapsed or Refractory Thymic Malignancies]
-*[http://clinicaltrials.gov/ct2/show/NCT01355705 Phase I/II Amrubicin in Combo With Lenalidomide + Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma]
-*[http://clinicaltrials.gov/ct2/show/NCT01259375 Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma (ARSARC-PI-0010)]
-*[http://clinicaltrials.gov/ct2/show/NCT01331824 Trial of Amrubicin as Second-Line Therapy in Patients With Advanced/Metastatic Refractory Urothelial Carcinoma]
-*[http://clinicaltrials.gov/ct2/show/NCT00660504 Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer]
-*[http://clinicaltrials.gov/ct2/show/NCT00132054 Amrubicin and Irinotecan in Treating Patients With Recurrent or Relapsed Extensive Stage Small Cell Lung Cancer]
-*[http://clinicaltrials.gov/ct2/show/NCT01207011 Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer]
-*[http://clinicaltrials.gov/ct2/show/NCT00286169 Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)]
 ==Patient drug information==
 No information available.
+==History of changes in PMDA indication==
+*2002-04-11: Initial approval for the treatment of [[Small cell lung cancer|small cell]] and [[non-small cell lung cancer]].
 ==Also known as==
@@ Line 38: / Line 24: @@
 <references/>
-[[Category:Drug index]]
+[[Category:Drugs]]
 [[Category:Intravenous medications]]
 [[Category:Anthracyclines]]
-[[Category:Topoisomerase inhibitors]]
+[[Category:Topoisomerase II inhibitors]]
+[[Category:Non-small cell lung cancer medications]]
 [[Category:Small cell lung cancer medications]]
 [[Category:PMDA approved drugs]]