Difference between revisions of "Imatinib (Gleevec)"

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==General information==
 
==General information==
−
Class/mechanism: Tyrosine kinase inhibitor, inhibits multiple tyrosine kinases, including Bcr-Abl tyrosine kinase, the constitutively active tyrosine kinase resulting from the Philadelphia chromosome abnormality in CML; the receptor tyrosine kinases for platelet-derived growth factor (PDGF), stem cell factor (SCF), and c-kit, which is the activating mutation found in gastrointestinal stromal tumor (GIST) tumors.<ref name="insert">[https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/gleevec_tabs.pdf Imatinib (Gleevec) package insert]</ref><ref>[[Media:Imatinib.pdf | Imatinib (Gleevec) package insert (locally hosted backup)]]</ref><ref>[http://www.gleevec.com/ Gleevec manufacturer's website]</ref>
+
Class/mechanism: Tyrosine kinase inhibitor, inhibits multiple tyrosine kinases, including Bcr-Abl tyrosine kinase, the constitutively active tyrosine kinase resulting from the Philadelphia chromosome abnormality in CML; the receptor tyrosine kinases for platelet-derived growth factor (PDGF), stem cell factor (SCF), and c-kit, which is the activating mutation found in gastrointestinal stromal tumor (GIST) tumors.<ref name="insert">[https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/gleevec_tabs.pdf Imatinib (Gleevec) package insert]</ref><ref>[[:File:Imatinib.pdf | Imatinib (Gleevec) package insert (locally hosted backup)]]</ref><ref>[http://www.gleevec.com/ Gleevec manufacturer's website]</ref>
 
<br>Route: PO
 
<br>Route: PO
 
<br>Extravasation: n/a
 
<br>Extravasation: n/a
−
<br>Fertility: evidence of harm <ref>Pye SM, Cortes J, Ault P, Hatfield A, Kantarjian H, Pilot R, Rosti G, Apperley JF. The effects of imatinib on pregnancy outcome. Blood. 2008 Jun 15;111(12):5505-8. Epub 2008 Mar 5. [http://www.bloodjournal.org/content/111/12/5505.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/18322153 PubMed]</ref>
+
<br>Fertility: evidence of harm <ref>Pye SM, Cortes J, Ault P, Hatfield A, Kantarjian H, Pilot R, Rosti G, Apperley JF. The effects of imatinib on pregnancy outcome. Blood. 2008 Jun 15;111(12):5505-8. Epub 2008 Mar 5. [http://www.bloodjournal.org/content/111/12/5505.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/18322153/ PubMed]</ref>
  
 
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.<ref name="insert"></ref>  
 
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.<ref name="insert"></ref>  
Line 13: Line 13:
 
*Moderate renal impairment (CrCl 20 to 39): decrease starting dose by 50%, increase as tolerated but no greater than 400 mg/d
 
*Moderate renal impairment (CrCl 20 to 39): decrease starting dose by 50%, increase as tolerated but no greater than 400 mg/d
 
*Severe renal impairment: use with caution
 
*Severe renal impairment: use with caution
 +
 +
==Diseases for which it is established ''(work in progress)''==
 +
*[[B-cell_acute_lymphoblastic_leukemia,_Ph-positive|B-ALL, Ph+]]
 +
*[[Chronic myeloid leukemia]]
 +
*[[Hypereosinophilic syndrome]]
 +
*Soft tissue sarcoma
 +
**[[Dermatofibrosarcoma protuberans|Dermatofibrosarcoma protuberans (DFSP)]]
 +
**[[Gastrointestinal stromal tumor]]
 +
*[[Systemic mastocytosis]]
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
−
*[[B-cell_acute_lymphoblastic_leukemia,_Ph-positive|B-ALL, Ph+]]
 
−
*[[Chronic myelogenous leukemia]]
 
−
*[[Soft tissue sarcoma|Dermatofibrosarcoma protuberans (DFSP)]]
 
−
*[[Gastrointestinal stromal tumor]]
 
 
*[[Glioblastoma]]
 
*[[Glioblastoma]]
−
*[[Hypereosinophilic syndrome]]
 
 
*[[Melanoma]]
 
*[[Melanoma]]
−
*[[Systemic mastocytosis]]
+
*Soft tissue sarcoma
 +
**[[Desmoid tumors]]
  
 
==Patient drug information==
 
==Patient drug information==
 +
*[https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/gleevec_tabs.pdf Imatinib (Gleevec) package insert]<ref name="insert"></ref>
 
*[http://chemocare.com/bio/imatinib_mesylate.asp Imatinib (Gleevec) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/imatinib_mesylate.asp Imatinib (Gleevec) patient drug information (Chemocare)]</ref>
 
*[http://chemocare.com/bio/imatinib_mesylate.asp Imatinib (Gleevec) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/imatinib_mesylate.asp Imatinib (Gleevec) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/imatinib-gleevec-patient-drug-information Imatinib (Gleevec) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/imatinib-gleevec-patient-drug-information Imatinib (Gleevec) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/imatinib-gleevec-patient-drug-information Imatinib (Gleevec) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/imatinib-gleevec-patient-drug-information Imatinib (Gleevec) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
===[[Chronic myelogenous leukemia]]===
+
===[[Chronic myeloid leukemia]]===
−
*'''5/10/2001: Initial FDA approval''' for the treatment of patients with [[Chronic_myelogenous_leukemia|chronic myeloid leukemia (CML)]] in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
+
*'''2001-05-10: Initial accelerated approval''' for the treatment of patients with [[Chronic myeloid leukemia|chronic myeloid leukemia (CML)]] in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. ''(Based on Sawyers et al. 2002, STI571 0109, STIA 0110)
−
*12/20/2002: Additional indication for the treatment of newly diagnosed adult patients with [[Biomarkers#BCR-ABL1|Philadelphia chromosome positive]] [[Chronic_myelogenous_leukemia|chronic myeloid leukemia (CML)]]. ''(Indication expanded to first-line)''
+
**2003-12-08: Converted to regular approval.
−
*5/20/2003: Additional indication for the treatment of pediatric patients with [[Biomarkers#BCR-ABL1|Ph+]] chronic phase [[Chronic_myelogenous_leukemia|CML]] whose disease has recurred after stem cell transplant or who are resistant to interferon alpha therapy. ''(Indication expanded to the relapsed/refractory pediatric population)''
+
*2002-12-20: Additional accelerated approval for the treatment of newly diagnosed adult patients with [[Biomarkers#BCR-ABL1|Philadelphia chromosome positive]] [[Chronic myeloid leukemia|chronic myeloid leukemia (CML)]]. ''(Indication expanded to first-line; based on IRIS)''
−
*9/27/2006: Additional indication as a single agent for the treatment of pediatric patients with newly diagnosed [[Biomarkers#BCR-ABL1|Philadelphia chromosome positive]] [[Chronic_myelogenous_leukemia|chronic myelogenous leukemia]] (Ph+ CML). ''(Pediatric indication expanded to first-line)''
+
**2009-05-27: Converted to regular approval.
 +
*2003-05-20: Additional indication for the treatment of pediatric patients with [[Biomarkers#BCR-ABL1|Ph+]] chronic phase [[Chronic myeloid leukemia, pediatric|CML]] whose disease has recurred after stem cell transplant or who are resistant to interferon alpha therapy. ''(Indication expanded to the relapsed/refractory pediatric population; based on COG P9973)''
 +
*2006-09-27: Additional accelerated approval as a single agent for the treatment of pediatric patients with newly diagnosed [[Biomarkers#BCR-ABL1|Philadelphia chromosome positive]] [[Chronic myeloid leukemia, pediatric|chronic myelogenous leukemia]] (Ph+ CML). ''(Pediatric indication expanded to first-line; based on COG AAML0123)''
 +
**2011-04-01: Converted to regular approval.
  
−
===[[Soft tissue sarcoma|Dermatofibrosarcoma protuberans (DFSP)]]===
+
===[[Dermatofibrosarcoma protuberans|Dermatofibrosarcoma protuberans (DFSP)]]===
−
*10/19/2006: Additional indication for adult patients with unresectable, recurrent and/or metastatic [[Soft tissue sarcoma|dermatofibrosarcoma protuberans (DFSP)]]. ''(New disease entity)''
+
*2006-10-19: Additional indication for adult patients with unresectable, recurrent and/or metastatic [[Dermatofibrosarcoma protuberans|dermatofibrosarcoma protuberans (DFSP)]]. ''(New disease entity; based on EORTC 62027)''
  
 
===[[Gastrointestinal stromal tumor]]===
 
===[[Gastrointestinal stromal tumor]]===
−
*2/1/2002: Approved for the treatment of patients with [[Biomarkers#CD117|Kit (CD117)]] [[Biomarkers#Expression|positive]] unresectable and/or metastatic malignant [[Gastrointestinal stromal tumor|gastrointestinal stromal tumors (GIST)]]. ''(New disease entity)
+
*2002-02-01: Accelerated approval for the treatment of patients with [[Biomarkers#CD117|Kit (CD117)]] [[Biomarkers#Expression|positive]] unresectable and/or metastatic malignant [[Gastrointestinal stromal tumor|gastrointestinal stromal tumors (GIST)]]. ''(New disease entity; based on EORTC 62005 & SWOG S0033)
−
*12/19/2008: Granted accelerated approval for the adjuvant treatment of adult patients following complete gross resection of [[Biomarkers#CD117|Kit (CD117)]] [[Biomarkers#Expression|positive]] [[Gastrointestinal stromal tumor|gastrointestinal stromal tumor (GIST)]]. ''(Indication extended to the adjuvant setting)
+
**2008-09-26: Converted to regular approval.
−
*1/31/2012: Granted regular approval for the adjuvant treatment of adult patients following complete gross resection of [[Biomarkers#CD117|Kit (CD117)]] [[Biomarkers#Expression|positive]] [[Gastrointestinal stromal tumor|gastrointestinal stromal tumor (GIST)]]. ''(Converted from accelerated to regular approval)
+
*2008-12-19: Granted accelerated approval for the adjuvant treatment of adult patients following complete gross resection of [[Biomarkers#CD117|Kit (CD117)]] [[Biomarkers#Expression|positive]] [[Gastrointestinal stromal tumor|gastrointestinal stromal tumor (GIST)]]. ''(Indication extended to the adjuvant setting; based on ACOSOG Z9001 & SSG XVIII/AIO)
 +
**2012-01-31: Converted to regular approval.
  
 
===[[Hypereosinophilic syndrome (HES)]]===
 
===[[Hypereosinophilic syndrome (HES)]]===
−
*10/19/2006: Additional indications for:
+
*2006-10-19: Additional indications for adult patients with [[Hypereosinophilic_syndrome|hypereosinophilic syndrome (HES)]] and/or chronic eosinophilic leukemia (CEL) who have the [[Biomarkers#FIP1L1-PDGFRA|FIP1L1-PDGFRα fusion kinase]] (mutational analysis or FISH demonstration of CHIC2 allele deletion)
−
**Adult patients with [[Hypereosinophilic_syndrome|hypereosinophilic syndrome (HES)]] and/or chronic eosinophilic leukemia (CEL) who have the [[Biomarkers#FIP1L1-PDGFR.CE.B1|FIP1L1-PDGFRα fusion kinase]] (mutational analysis or FISH demonstration of CHIC2 allele deletion)
+
*2006-10-19: Additional indications for patients with [[Hypereosinophilic_syndrome|HES]] and/or CEL who are [[Biomarkers#FIP1L1-PDGFRA|FIP1L1-PDGFRα fusion kinase]] [[Biomarkers#Wild-type|negative]] or [[Biomarkers#Unknown|unknown]]. ''(New disease entity)''
−
**Patients with [[Hypereosinophilic_syndrome|HES]] and/or CEL who are [[Biomarkers#FIP1L1-PDGFR.CE.B1|FIP1L1-PDGFRα fusion kinase]] [[Biomarkers#Wild-type|negative]] or [[Biomarkers#Unknown|unknown]]. ''(New disease entity)''
 
  
 
===[[Myelodysplastic syndrome]]===
 
===[[Myelodysplastic syndrome]]===
−
*10/19/2006: Additional indication for adult patients with [[Myelodysplastic_syndrome|myelodysplastic/ myeloproliferative diseases (MDS/MPD)]] associated with [[Biomarkers#PDGFR|PDGFR (platelet-derived growth factor receptor) gene]] [[Biomarkers#Rearrangement|rearrangements]]. ''(New disease entity)''
+
*2006-10-19: Additional indication for adult patients with [[Myelodysplastic_syndrome|myelodysplastic/ myeloproliferative diseases (MDS/MPD)]] associated with [[Biomarkers#PDGFR|PDGFR (platelet-derived growth factor receptor) gene]] [[Biomarkers#Rearrangement|rearrangements]]. ''(New disease entity)''
  
 
===[[B-cell_acute_lymphoblastic_leukemia,_Ph-positive|Ph+ ALL]]===
 
===[[B-cell_acute_lymphoblastic_leukemia,_Ph-positive|Ph+ ALL]]===
−
*10/19/2006: Additional indication for adult patients with relapsed or refractory [[Biomarkers#BCR-ABL1|Philadelphia chromosome positive]] [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]] (Ph+ ALL). ''(New disease entity)''
+
*2006-10-19: Additional indication for adult patients with relapsed or refractory [[Biomarkers#BCR-ABL1|Philadelphia chromosome positive]] [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]] (Ph+ ALL). ''(New disease entity; based on Ottmann et al. 2002)''
−
*1/25/2013: Additional indication for pediatric patients with newly diagnosed [[Biomarkers#BCR-ABL1|Philadelphia chromosome positive]] [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]] (Ph+ ALL) in combination with chemotherapy. ''(Indication expanded to the first-line pediatric population)''
+
*2013-01-25: Additional indication for pediatric patients with newly diagnosed [[Biomarkers#BCR-ABL1|Philadelphia chromosome positive]] [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]] (Ph+ ALL) in combination with chemotherapy. ''(Indication expanded to the first-line pediatric population; based on COG AALL0031)''
  
 
===[[Systemic mastocytosis]]===
 
===[[Systemic mastocytosis]]===
−
*10/19/2006: Additional indication for adult patients with [[Systemic mastocytosis|aggressive systemic mastocytosis (ASM)]] '''without''' the [[Biomarkers#D816V|D816V]] [[Biomarkers#KIT|c-Kit]] mutation or with c-Kit mutational status unknown. ''(New disease entity)''
+
*2006-10-19: Additional indication for adult patients with [[Systemic mastocytosis|aggressive systemic mastocytosis (ASM)]] '''without''' the [[Biomarkers#D816V|D816V]] [[Biomarkers#KIT|c-Kit]] mutation or with c-Kit mutational status unknown. ''(New disease entity)''
 +
 
 +
==History of changes in EMA indication==
 +
*2001-11-07: Initial marketing authorization as Glivec.
 +
==History of changes in Health Canada indication==
 +
*2001-09-20: Initial notice of compliance with conditions
 +
*2004-12-29: Conditions were met
 +
==History of changes in PMDA indication==
 +
*2007-01-31: New indication and dosage for treatment of Philadelphia chromosome-positive [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]].
 +
*2012-02-22: New additional indications and a new dosage for the treatment of FIP1L1-PDGFRα-positive [[hypereosinophilic syndrome]] or [[chronic eosinophilic leukemia]].
  
 
==Also known as==
 
==Also known as==
−
*'''Code names:''' CGP 57148, CGP57148B, STI-571
+
*'''Code names:''' CGP-57148, CGP-57148B, STI-571
 
*'''Generic names:''' imatinib mesilate, imatinib mesylate
 
*'''Generic names:''' imatinib mesilate, imatinib mesylate
−
*'''Brand names:''' Enliven, Glivec, Gleevac, Gleevec, Imalek, Imatib, Temsan, Veenat
+
*'''Brand names:''' Celonib, Enliven, Glivec, Gleevac, Gleevec, Imalek, Imat, Imarech, Imatib, Mesylonib, Mitinab, Plivatinib, Shantinib, Temsan, Veenat
  
 
==References==
 
==References==
Line 77: Line 95:
  
 
[[Category:B-cell acute lymphoblastic leukemia medications]]
 
[[Category:B-cell acute lymphoblastic leukemia medications]]
−
[[Category:Chronic myelogenous leukemia medications]]
+
[[Category:Chronic myeloid leukemia medications]]
 +
[[Category:Dermatofibrosarcoma protuberans medications]]
 +
[[Category:Desmoid tumor medications]]
 
[[Category:Glioblastoma medications]]
 
[[Category:Glioblastoma medications]]
 
[[Category:Hypereosinophilic syndrome medications]]
 
[[Category:Hypereosinophilic syndrome medications]]
 
[[Category:Melanoma medications]]  
 
[[Category:Melanoma medications]]  
 
[[Category:Gastrointestinal stromal tumor medications]]  
 
[[Category:Gastrointestinal stromal tumor medications]]  
−
[[Category:Soft tissue sarcoma medications]]
 
 
[[Category:Systemic mastocytosis medications]]
 
[[Category:Systemic mastocytosis medications]]
  
 +
[[Category:EMA approved in 2001]]
 
[[Category:FDA approved in 2001]]
 
[[Category:FDA approved in 2001]]
 +
[[Category:Health Canada approved in 2001]]
 
[[Category:WHO Essential Cancer Medicine]]
 
[[Category:WHO Essential Cancer Medicine]]

Revision as of 14:15, 18 June 2024

General information

Class/mechanism: Tyrosine kinase inhibitor, inhibits multiple tyrosine kinases, including Bcr-Abl tyrosine kinase, the constitutively active tyrosine kinase resulting from the Philadelphia chromosome abnormality in CML; the receptor tyrosine kinases for platelet-derived growth factor (PDGF), stem cell factor (SCF), and c-kit, which is the activating mutation found in gastrointestinal stromal tumor (GIST) tumors.[1][2][3]
Route: PO
Extravasation: n/a
Fertility: evidence of harm [4]

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 Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Dose adjustments

  • Strong CYP3A4 inducers: increase starting dose by at least 50%, and carefully monitor
  • Mild to moderate hepatic impairment: no adjustment needed
  • Severe hepatic impairment: 25% decrease in recommended dose
  • Mild renal impairment (CrCl 40 to 59): dose no greater than 600 mg/d
  • Moderate renal impairment (CrCl 20 to 39): decrease starting dose by 50%, increase as tolerated but no greater than 400 mg/d
  • Severe renal impairment: use with caution

Diseases for which it is established (work in progress)

Diseases for which it is used

Patient drug information

History of changes in FDA indication

Chronic myeloid leukemia

  • 2001-05-10: Initial accelerated approval for the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. (Based on Sawyers et al. 2002, STI571 0109, STIA 0110)
    • 2003-12-08: Converted to regular approval.
  • 2002-12-20: Additional accelerated approval for the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (CML). (Indication expanded to first-line; based on IRIS)
    • 2009-05-27: Converted to regular approval.
  • 2003-05-20: Additional indication for the treatment of pediatric patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplant or who are resistant to interferon alpha therapy. (Indication expanded to the relapsed/refractory pediatric population; based on COG P9973)
  • 2006-09-27: Additional accelerated approval as a single agent for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML). (Pediatric indication expanded to first-line; based on COG AAML0123)
    • 2011-04-01: Converted to regular approval.

Dermatofibrosarcoma protuberans (DFSP)

Gastrointestinal stromal tumor

  • 2002-02-01: Accelerated approval for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (New disease entity; based on EORTC 62005 & SWOG S0033)
    • 2008-09-26: Converted to regular approval.
  • 2008-12-19: Granted accelerated approval for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumor (GIST). (Indication extended to the adjuvant setting; based on ACOSOG Z9001 & SSG XVIII/AIO)
    • 2012-01-31: Converted to regular approval.

Hypereosinophilic syndrome (HES)

Myelodysplastic syndrome

Ph+ ALL

Systemic mastocytosis

History of changes in EMA indication

  • 2001-11-07: Initial marketing authorization as Glivec.

History of changes in Health Canada indication

  • 2001-09-20: Initial notice of compliance with conditions
  • 2004-12-29: Conditions were met

History of changes in PMDA indication

Also known as

  • Code names: CGP-57148, CGP-57148B, STI-571
  • Generic names: imatinib mesilate, imatinib mesylate
  • Brand names: Celonib, Enliven, Glivec, Gleevac, Gleevec, Imalek, Imat, Imarech, Imatib, Mesylonib, Mitinab, Plivatinib, Shantinib, Temsan, Veenat

References

  1. ↑ 1.0 1.1 1.2 Imatinib (Gleevec) package insert
  2. ↑ Imatinib (Gleevec) package insert (locally hosted backup)
  3. ↑ Gleevec manufacturer's website
  4. ↑ Pye SM, Cortes J, Ault P, Hatfield A, Kantarjian H, Pilot R, Rosti G, Apperley JF. The effects of imatinib on pregnancy outcome. Blood. 2008 Jun 15;111(12):5505-8. Epub 2008 Mar 5. link to original article PubMed
  5. ↑ Imatinib (Gleevec) patient drug information (Chemocare)
  6. ↑ Imatinib (Gleevec) patient drug information (UpToDate)
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