Difference between revisions of "Pegylated liposomal doxorubicin (Doxil)"

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m (Warner-admin moved page Doxorubicin liposomal (Doxil) to Pegylated liposomal doxorubicin (Doxil): correct terminology)
m (Text replacement - "[http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or" to "or")
 
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==General information==
 
==General information==
−
Class/mechanism: Anthracycline; binds and intercalates into DNA, inhibiting nucleotide replication and DNA/RNA polymerase activity. Causes DNA cleavage through interaction with topoisomerase II.
+
Class/mechanism: Anthracycline; binds and intercalates into DNA, inhibiting nucleotide replication and DNA/RNA polymerase activity. Causes DNA cleavage through interaction with topoisomerase II.
  
−
Doxorubicin is encapsulated in long-circulating STEALTH® liposomes, which are microscopic vesicles made of a phospholipid bilayer. The liposomes are pegylated with surface-bound methoxypolyethylene glycol (MPEG) to increase circulation time and protect them from detection by the mononuclear phagocyte system (MPS). Their 100 nm size and long circulation may aid their ability to penetrate the altered vasculature of tumors. Exact mechanism of release of the active drug contained within the liposome is not understood.<ref name="insert">[http://www.doxil.com/assets/DOXIL_PI_Booklet.pdf Doxorubicin liposomal (Doxil) package insert]</ref><ref>[[Media:Doxorubicinliposomal.pdf | Doxorubicin liposomal (Doxil) package insert (locally hosted backup)]]</ref><ref>[http://doxil.com/ Doxil manufacturer's website]</ref>
+
Doxorubicin is encapsulated in long-circulating STEALTH® liposomes, which are microscopic vesicles made of a phospholipid bilayer. The liposomes are pegylated with surface-bound methoxypolyethylene glycol (MPEG) to increase circulation time and protect them from detection by the mononuclear phagocyte system (MPS). Their 100 nm size and long circulation may aid their ability to penetrate the altered vasculature of tumors. Exact mechanism of release of the active drug contained within the liposome is not understood.<ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050718s029lbl.pdf Pegylated liposomal doxorubicin (Doxil) package insert]</ref><ref>[[:File:Doxorubicinliposomal.pdf | Pegylated liposomal doxorubicin (Doxil) package insert (locally hosted backup)]]</ref><ref>[http://doxil.com/ Doxil manufacturer's website]</ref>
 
<br>Route: IV
 
<br>Route: IV
 
<br>Extravasation: [[irritant]]
 
<br>Extravasation: [[irritant]]
  
−
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 Micromedex, Lexicomp, or the prescribing information.<ref name="insert"></ref>  
 +
 
 +
==Diseases for which it is established ''(work in progress)''==
 +
*[[Ovarian cancer]]
 +
**[[Low-grade serous ovarian cancer]]
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
 
*[[Breast cancer]]
 
*[[Breast cancer]]
−
*[[Diffuse large B-cell lymphoma]]
+
*[[Endometrial cancer]]
 
*[[Esophageal cancer]]
 
*[[Esophageal cancer]]
 
*[[Hemophagocytic lymphohistiocytosis]]
 
*[[Hemophagocytic lymphohistiocytosis]]
−
*[[HIV-associated lymphoma]]
+
*Lymphoma
−
*[[Hodgkin lymphoma]]
+
**[[Diffuse large B-cell lymphoma]]
 +
**[[HIV-associated lymphoma]]
 +
**[[Classical Hodgkin lymphoma]]
 +
*[[Kaposi sarcoma]]
 
*[[Multiple myeloma]]
 
*[[Multiple myeloma]]
 
*[[Plasma cell leukemia]]
 
*[[Plasma cell leukemia]]
−
*[[Ovarian cancer]]
+
*Soft tissue sarcoma
−
*[[Soft tissue sarcoma]]
+
**[[Desmoid tumors]]
−
*[[Uterine cancer]]
 
  
 
==Patient drug information==
 
==Patient drug information==
−
*[http://chemocare.com/chemotherapy/drug-info/doxorubicin-liposomal.aspx Doxorubicin liposomal (Doxil) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/doxorubicin-liposomal.aspx Doxorubicin liposomal (Doxil) patient drug information (Chemocare)]</ref>
+
*[https://chemocare.com/druginfo/doxorubicin-liposomal.aspx Pegylated liposomal doxorubicin (Doxil) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/doxorubicin-liposomal.aspx Pegylated liposomal doxorubicin (Doxil) patient drug information (Chemocare)]</ref>
−
*Brief patient counseling information can be found in [http://www.doxil.com/assets/DOXIL_PI_Booklet.pdf the Doxorubicin liposomal (Doxil) package insert]<ref name="insert"></ref>
+
*Brief patient counseling information can be found in [https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050718s029lbl.pdf the Pegylated liposomal doxorubicin (Doxil) package insert]<ref name="insert"></ref>
−
*[http://www.uptodate.com/contents/liposomal-doxorubicin-patient-drug-information Doxorubicin liposomal (Doxil) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/liposomal-doxorubicin-patient-drug-information Doxorubicin liposomal (Doxil) patient drug information (UpToDate)]</ref>
+
*[http://www.uptodate.com/contents/liposomal-doxorubicin-patient-drug-information Pegylated liposomal doxorubicin (Doxil) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/liposomal-doxorubicin-patient-drug-information Pegylated liposomal doxorubicin (Doxil) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
*11/17/1995: Initial FDA approval for "treatment of AIDS-related Kaposi’s sarcoma in patients with disease that has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy."
+
===[[Kaposi sarcoma|AIDS-related Kaposi’s sarcoma]]===
−
*6/28/1999: [http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50718s06lbl.pdf FDA approved] for "treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens. Refractory disease is defined as disease that has progressed while on treatment, or within 6 months of completing treatment."
+
*1995-11-17: Initial approval for treatment of [[Kaposi sarcoma|AIDS-related Kaposi’s sarcoma]] in patients with disease that has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy. ''(Based on Harrison et al. 1995)''
−
*5/17/2007: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm129249.htm FDA approved] "for use in combination with bortezomib in patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy."
+
**2008-06-10: Converted to regular approval.
 +
*2013-02-04: Approved for [[Kaposi sarcoma|AIDS-related Kaposi’s sarcoma]] after failure of prior systemic chemotherapy or intolerance to such therapy. ''(Requirement for prior combination chemotherapy removed)''
 +
 
 +
===[[Multiple myeloma]]===
 +
*2007-05-17: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm129249.htm Approved] for use in combination with [[Bortezomib (Velcade)|bortezomib]] in patients with [[multiple myeloma]] who have not previously received bortezomib and have received at least one prior therapy. ''(Based on MMY-3001)''
 +
 
 +
===[[Ovarian cancer]]===
 +
*1999-06-28: Accelerated approval for treatment of metastatic [[Ovarian cancer|carcinoma of the ovary]] in patients with disease that is refractory to both paclitaxel- and [[Regimen_classes#Platinum-based_regimen|platinum-based]] chemotherapy regimens. Refractory disease is defined as disease that has progressed while on treatment, or within 6 months of completing treatment. ''(Based on Muggia et al. 1997 & Gordon et al. 2000)''
 +
**2005-01-28: Converted to regular approval for metastatic [[Ovarian cancer|ovarian carcinoma]] refractory to paclitaxel and platinum-based chemotherapy. ''(Based on Doxil Study 30-49)''
 +
*2013-02-04: Approved for the treatment of [[ovarian cancer]] in patients whose disease has progressed or recurred after [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]]. ''(Approval extended to platinum-sensitive disease)''
 +
 
 +
==History of changes in EMA indication==
 +
*1996-06-20: Initial marketing authorization as Caelyx.
 +
==History of changes in Health Canada indication==
 +
*1998-07-20: Initial notice of compliance
 +
==History of changes in PMDA indication==
 +
*2009-04-22: New indication and a new dosage for the treatment of [[ovarian cancer]] which has progressed after cancer chemotherapy.
  
 
==Also known as==
 
==Also known as==
−
Caelyx, doxorubicin HCl liposome injection, Myocet, pegylated liposomal doxorubicin (PLD).
+
*'''Generic names:''' doxorubicin HCl liposome injection, PLD
 +
*'''Brand names:''' Caelyx, Celdoxome, Doxil, Doxosome, Doxulip, i-dox, Lipodox, Lippod, Natdox, Pegadria, Pegdoxine, Peglidox, Peg-Doxorub, Zolsketil
  
 
==References==
 
==References==
 
<references/>
 
<references/>
  
−
[[Category:Drug index]]
+
[[Category:Drugs]]
−
[[Category:Chemotherapy]]
 
 
[[Category:Intravenous medications]]
 
[[Category:Intravenous medications]]
−
[[Category:Irritant chemotherapy]]
+
[[Category:Irritant]]
 +
[[Category:Liposomal chemotherapy]]
 +
[[Category:Pegylated medications]]
  
 
[[Category:Anthracyclines]]
 
[[Category:Anthracyclines]]
−
[[Category:Topoisomerase inhibitors]]
+
[[Category:Topoisomerase II inhibitors]]
  
 
[[Category:Breast cancer medications]]
 
[[Category:Breast cancer medications]]
 
[[Category:Burkitt lymphoma medications]]
 
[[Category:Burkitt lymphoma medications]]
 +
[[Category:Desmoid tumor medications]]
 
[[Category:Diffuse large B-cell lymphoma medications]]
 
[[Category:Diffuse large B-cell lymphoma medications]]
 
[[Category:Esophageal cancer medications]]
 
[[Category:Esophageal cancer medications]]
 
[[Category:Hemophagocytic lymphohistiocytosis medications]]
 
[[Category:Hemophagocytic lymphohistiocytosis medications]]
 
[[Category:HIV-associated lymphoma medications]]
 
[[Category:HIV-associated lymphoma medications]]
−
[[Category:Hodgkin lymphoma medications]]
+
[[Category:Classical Hodgkin lymphoma medications]]
 +
[[Category:Low-grade serous ovarian cancer medications]]
 
[[Category:Multiple myeloma medications]]
 
[[Category:Multiple myeloma medications]]
 
[[Category:Ovarian cancer medications]]
 
[[Category:Ovarian cancer medications]]
 
[[Category:Plasma cell leukemia medications]]
 
[[Category:Plasma cell leukemia medications]]
−
[[Category:Soft tissue sarcoma medications]]
+
[[Category:Endometrial cancer medications]]
−
[[Category:Uterine cancer medications]]
+
[[Category:Kaposi sarcoma medications]]
  
−
[[Category:Drugs FDA approved in 1995]]
+
[[Category:EMA approved in 1996]]
 +
[[Category:FDA approved in 1995]]
 +
[[Category:Health Canada approved in 1998]]

Latest revision as of 00:15, 6 July 2024

General information

Class/mechanism: Anthracycline; binds and intercalates into DNA, inhibiting nucleotide replication and DNA/RNA polymerase activity. Causes DNA cleavage through interaction with topoisomerase II.

Doxorubicin is encapsulated in long-circulating STEALTH® liposomes, which are microscopic vesicles made of a phospholipid bilayer. The liposomes are pegylated with surface-bound methoxypolyethylene glycol (MPEG) to increase circulation time and protect them from detection by the mononuclear phagocyte system (MPS). Their 100 nm size and long circulation may aid their ability to penetrate the altered vasculature of tumors. Exact mechanism of release of the active drug contained within the liposome is not understood.[1][2][3]
Route: IV
Extravasation: irritant

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, or the prescribing information.[1]

Diseases for which it is established (work in progress)

Diseases for which it is used

Patient drug information

History of changes in FDA indication

AIDS-related Kaposi’s sarcoma

  • 1995-11-17: Initial approval for treatment of AIDS-related Kaposi’s sarcoma in patients with disease that has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy. (Based on Harrison et al. 1995)
    • 2008-06-10: Converted to regular approval.
  • 2013-02-04: Approved for AIDS-related Kaposi’s sarcoma after failure of prior systemic chemotherapy or intolerance to such therapy. (Requirement for prior combination chemotherapy removed)

Multiple myeloma

  • 2007-05-17: Approved for use in combination with bortezomib in patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. (Based on MMY-3001)

Ovarian cancer

  • 1999-06-28: Accelerated approval for treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens. Refractory disease is defined as disease that has progressed while on treatment, or within 6 months of completing treatment. (Based on Muggia et al. 1997 & Gordon et al. 2000)
    • 2005-01-28: Converted to regular approval for metastatic ovarian carcinoma refractory to paclitaxel and platinum-based chemotherapy. (Based on Doxil Study 30-49)
  • 2013-02-04: Approved for the treatment of ovarian cancer in patients whose disease has progressed or recurred after platinum-based chemotherapy. (Approval extended to platinum-sensitive disease)

History of changes in EMA indication

  • 1996-06-20: Initial marketing authorization as Caelyx.

History of changes in Health Canada indication

  • 1998-07-20: Initial notice of compliance

History of changes in PMDA indication

  • 2009-04-22: New indication and a new dosage for the treatment of ovarian cancer which has progressed after cancer chemotherapy.

Also known as

  • Generic names: doxorubicin HCl liposome injection, PLD
  • Brand names: Caelyx, Celdoxome, Doxil, Doxosome, Doxulip, i-dox, Lipodox, Lippod, Natdox, Pegadria, Pegdoxine, Peglidox, Peg-Doxorub, Zolsketil

References

  1. ↑ 1.0 1.1 1.2 Pegylated liposomal doxorubicin (Doxil) package insert
  2. ↑ Pegylated liposomal doxorubicin (Doxil) package insert (locally hosted backup)
  3. ↑ Doxil manufacturer's website
  4. ↑ Pegylated liposomal doxorubicin (Doxil) patient drug information (Chemocare)
  5. ↑ Pegylated liposomal doxorubicin (Doxil) patient drug information (UpToDate)
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