Difference between revisions of "Lomustine (CCNU)"

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==General information==
 
==General information==
−
Class/mechanism: Nitrosourea, alkylates DNA and RNA and may inhibit certain key enzymatic reactions by carbamoylation of amino acids in proteins.<ref name="insert">[http://packageinserts.bms.com/pi/pi_ceenu.pdf Lomustine (Ceenu) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/lomustine.pdf Lomustine (Ceenu) package insert (locally hosted backup)]</ref>
+
Class/mechanism: Nitrosourea, alkylates DNA and RNA and may inhibit certain key enzymatic reactions by carbamoylation of amino acids in proteins.<ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017588s042lbl.pdf Lomustine (Ceenu) package insert]</ref><ref>[https://hemonc.org/docs/packageinsert/lomustine.pdf Lomustine (Ceenu) package insert (locally hosted backup)]</ref>
 
<br>Route: PO
 
<br>Route: PO
 
<br>Extravasation: n/a
 
<br>Extravasation: n/a
  
−
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>  
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
 
*[[Acute myeloid leukemia]]
 
*[[Acute myeloid leukemia]]
−
*[[Central nervous system (CNS) cancer]]
+
*[[Anaplastic glioma]]
 
*[[CNS lymphoma]]
 
*[[CNS lymphoma]]
 +
*[[Glioblastoma]]
 +
*[[High-grade glioma, pediatric]]
 +
*[[Low-grade glioma]]
 +
*[[Medulloblastoma]]
 +
 +
==Diseases for which it was used==
 +
*[[Classical Hodgkin lymphoma_-_historical|Hodgkin lymphoma]]
 +
*[[Non-small cell lung cancer_-_historical|Non-small cell lung cancer]]
 +
*[[Ovarian cancer - historical|Ovarian cancer]]
 +
*[[Small cell lung cancer_-_historical|Small cell lung cancer]]
  
 
==Patient drug information==
 
==Patient drug information==
 +
*[https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017588s042lbl.pdf Lomustine (Ceenu) package insert]<ref name="insert"></ref>
 
*[http://chemocare.com/bio/lomustine.asp Lomustine (Ceenu) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/lomustine.asp Lomustine (Ceenu) patient drug information (Chemocare)]</ref>
 
*[http://chemocare.com/bio/lomustine.asp Lomustine (Ceenu) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/lomustine.asp Lomustine (Ceenu) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/lomustine-patient-drug-information Lomustine (Ceenu) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/lomustine-patient-drug-information Lomustine (Ceenu) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/lomustine-patient-drug-information Lomustine (Ceenu) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/lomustine-patient-drug-information Lomustine (Ceenu) patient drug information (UpToDate)]</ref>
  
 +
==History of changes in FDA indication==
 +
*1976-08-04: Initial approval
 +
*2009-04-30: (oldest available label) has been shown to be useful as a single agent in addition to other treatment modalities, or in established combination therapy with other approved chemotherapeutic agents in [[:Category:CNS cancers|brain tumors]] - both primary and metastatic, in patients who have already received appropriate surgical and/or radiotherapeutic procedures. ''(No supporting studies are cited)''
 +
*2009-04-30: (oldest available label) has been shown to be useful as a single agent in addition to other treatment modalities, or in established combination therapy with other approved chemotherapeutic agents in [[Classical Hodgkin lymphoma|Hodgkin’s Disease]]-secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. ''(No supporting studies are cited)''
 +
==History of changes in EMA indication==
 +
*1976-01-26: EURD
 
==Also known as==
 
==Also known as==
−
CCNU, MeCCNU.
+
*'''Generic names:''' CCNU
−
*In 10/2013, Bristol-Myers Squibb discontinued production of their Lomustine brand name, CeeNu.<ref>[http://www.ashp.org/DrugShortages/NotAvailable/bulletin.aspx?id=1023 Discontinued drug bulletin: Lomustine capsules (American Society of Health-System Pharmacists)]</ref>  Lomustine will be supplied as CCNU by NextSource Biotechnology.<ref>[http://www.elabs6.com/content/12347425/EP298498RDNW/nextsource5.index.html NextSource Biotechnology Lomustine (CCNU) update]</ref>
+
*'''Brand names:''' CeeNu, Gleostine
 +
**In 10/2013, Bristol-Myers Squibb discontinued production of their Lomustine brand name, CeeNu.<ref>[http://www.ashp.org/DrugShortages/NotAvailable/bulletin.aspx?id=1023 Discontinued drug bulletin: Lomustine capsules (American Society of Health-System Pharmacists)]</ref>  Lomustine is currently supplied as Gleostine by NextSource Biotechnology LLC.<ref>[http://www.elabs6.com/content/12347425/EP298498RDNW/nextsource5.index.html NextSource Biotechnology Lomustine (CCNU) update]</ref>
 +
 
 +
==COG ACNS0331 Lomustine Dosing Nomogram==
 +
 
 +
===Available Capsule Sizes===
 +
*10 mg
 +
*40 mg
 +
*100 mg
 +
 
 +
 
 +
{| class="wikitable" style="width: 40%; text-align:center;"
 +
! style="width: 25%" |Body Surface Area (m<sup>2</sup>)
 +
! style="width: 25%" |Ideal Dose (75 mg/m<sup>2</sup>/day once daily)
 +
! style="width: 25%" |Actual Dose to be Given
 +
|-
 +
|2.0
 +
|150 mg,
 +
|150 mg
 +
|-
 +
|1.9
 +
|143
 +
|140
 +
|-
 +
|1.8
 +
|135
 +
|130
 +
|-
 +
|1.7
 +
|128
 +
|130
 +
|-
 +
|1.6
 +
|120
 +
|120
 +
|-
 +
|1.5
 +
|112
 +
|110
 +
|-
 +
|1.4
 +
|105
 +
|100
 +
|-
 +
|1.3
 +
|98
 +
|100
 +
|-
 +
|1.2
 +
|90
 +
|90
 +
|-
 +
|1.1
 +
|82
 +
|80
 +
|-
 +
|1.0
 +
|75
 +
|80
 +
|-
 +
|0.95
 +
|71
 +
|70
 +
|-
 +
|0.9
 +
|68
 +
|70
 +
|-
 +
|0.85
 +
|64
 +
|60
 +
|-
 +
|0.8
 +
|60
 +
|60
 +
|-
 +
|0.75
 +
|56
 +
|60
 +
|-
 +
|0.7
 +
|53
 +
|50
 +
|-
 +
|0.65
 +
|49
 +
|50
 +
|-
 +
|0.6
 +
|45
 +
|40
 +
|-
 +
|0.55
 +
|41
 +
|40
 +
|-
 +
|0.5
 +
|38
 +
|40
 +
|-
 +
|0.45
 +
|34
 +
|30
 +
|-
 +
|0.4
 +
|30
 +
|30
 +
|-
 +
|0.35
 +
|26
 +
|30
 +
|-
 +
|0.3
 +
|23
 +
|20
 +
|}
  
 
==References==
 
==References==
 
<references/>
 
<references/>
  
−
[[Category:Drug index]]
+
[[Category:Drugs]]
−
[[Category:Chemotherapy]]
 
 
[[Category:Oral medications]]
 
[[Category:Oral medications]]
  
Line 29: Line 160:
  
 
[[Category:Acute myeloid leukemia medications]]
 
[[Category:Acute myeloid leukemia medications]]
−
[[Category:Central nervous system (CNS) cancer medications]]
+
[[Category:Anaplastic glioma medications]]
−
[[Category:Central nervous system (CNS) lymphoma medications]]
+
[[Category:CNS lymphoma medications]]
 +
[[Category:Glioblastoma medications]]
 +
[[Category:High-grade glioma, pediatric medications]]
 +
[[Category:Low-grade glioma medications]]
 +
[[Category:Medulloblastoma medications]]
 +
 
 +
[[Category:Classical Hodgkin lymphoma medications (historic)]]
 +
[[Category:Non-small cell lung cancer medications (historic)]]
 +
[[Category:Ovarian cancer medications (historic)]]
 +
[[Category:Small cell lung cancer medications (historic)]]
  
−
[[Category:Drugs FDA approved in 1976]]
+
[[Category:FDA approved in 1976]]
 +
[[Category:EMA approved in 1976]]

Revision as of 19:32, 23 June 2024

General information

Class/mechanism: Nitrosourea, alkylates DNA and RNA and may inhibit certain key enzymatic reactions by carbamoylation of amino acids in proteins.[1][2]
Route: PO
Extravasation: n/a

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]

Diseases for which it is used

Diseases for which it was used

Patient drug information

History of changes in FDA indication

  • 1976-08-04: Initial approval
  • 2009-04-30: (oldest available label) has been shown to be useful as a single agent in addition to other treatment modalities, or in established combination therapy with other approved chemotherapeutic agents in brain tumors - both primary and metastatic, in patients who have already received appropriate surgical and/or radiotherapeutic procedures. (No supporting studies are cited)
  • 2009-04-30: (oldest available label) has been shown to be useful as a single agent in addition to other treatment modalities, or in established combination therapy with other approved chemotherapeutic agents in Hodgkin’s Disease-secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. (No supporting studies are cited)

History of changes in EMA indication

  • 1976-01-26: EURD

Also known as

  • Generic names: CCNU
  • Brand names: CeeNu, Gleostine
    • In 10/2013, Bristol-Myers Squibb discontinued production of their Lomustine brand name, CeeNu.[5] Lomustine is currently supplied as Gleostine by NextSource Biotechnology LLC.[6]

COG ACNS0331 Lomustine Dosing Nomogram

Available Capsule Sizes

  • 10 mg
  • 40 mg
  • 100 mg


Body Surface Area (m2) Ideal Dose (75 mg/m2/day once daily) Actual Dose to be Given
2.0 150 mg, 150 mg
1.9 143 140
1.8 135 130
1.7 128 130
1.6 120 120
1.5 112 110
1.4 105 100
1.3 98 100
1.2 90 90
1.1 82 80
1.0 75 80
0.95 71 70
0.9 68 70
0.85 64 60
0.8 60 60
0.75 56 60
0.7 53 50
0.65 49 50
0.6 45 40
0.55 41 40
0.5 38 40
0.45 34 30
0.4 30 30
0.35 26 30
0.3 23 20

References

  1. ↑ 1.0 1.1 1.2 Lomustine (Ceenu) package insert
  2. ↑ Lomustine (Ceenu) package insert (locally hosted backup)
  3. ↑ Lomustine (Ceenu) patient drug information (Chemocare)
  4. ↑ Lomustine (Ceenu) patient drug information (UpToDate)
  5. ↑ Discontinued drug bulletin: Lomustine capsules (American Society of Health-System Pharmacists)
  6. ↑ NextSource Biotechnology Lomustine (CCNU) update
Retrieved from "https://hemonc.org/w/index.php?title=Lomustine_(CCNU)&oldid=86607"