Difference between revisions of "Alemtuzumab (Campath)"

Revision as of 12:41, 10 December 2021

General information

Class/mechanism: Anti-CD52 antibody that is believed to cause antibody-dependent cell-mediated cytotoxicity of cells that express the CD52 antigen on their surface: B and T lymphocytes, most monocytes, macrophages, natural killer (NK) cells, and a subpopulation of granulocytes.^[1]^[2]^[3]
Route: IV
Extravasation: neutral

Use of alemtuzumab (Lemtrada) requires participation in the Lemtrada REMS program.

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

Diseases for which it is used

Patient drug information

Alemtuzumab (Campath) patient drug information (Chemocare)^[4]
Brief patient counseling information can be found at the end of page 2 of the Alemtuzumab (Campath) package insert
Alemtuzumab (Campath) patient drug information (UpToDate)^[5]

History of changes in FDA indication

5/7/2001: Initial accelerated approval for the treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy.^[6]
9/19/2007: Converted to regular approval and indication expanded to include use as a single agent for treatment of B-cell chronic lymphocytic leukemia (B-CLL)
October 2012: Genzyme withdraws drug from USA and EU (still available for B-CLL patients, however). See Lancet editorial.^[7]

Also known as

Code name: LDP03
Brand names: Campath, Campath-1H, Lemtrada, Mabcampath

References

[insert-1] 1.0 ^1.1 Alemtuzumab (Campath) package insert

[2] Alemtuzumab (Campath) package insert (locally hosted backup)

[3] Campath manufacturer's website

[4] Alemtuzumab (Campath) patient drug information (Chemocare)

[5] Alemtuzumab (Campath) patient drug information (UpToDate)

[6] FDA approval letter dated May 7th, 2001

[7] Alemtuzumab for multiple sclerosis

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 ==History of changes in FDA indication==
-*5/7/2001: Initial approval for the treatment of patients with [[Chronic lymphocytic leukemia | B-cell chronic lymphocytic leukemia]] who have been treated with [[Regimen_classes#Alkylator-based_regimen|alkylating agents]] and who have failed [[Regimen_classes#Fludarabine-based_regimen| fludarabine therapy]].<ref>[http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/alemmil050701L.htm FDA approval letter dated May 7th, 2001]</ref>
+*5/7/2001: Initial accelerated approval for the treatment of patients with [[Chronic lymphocytic leukemia | B-cell chronic lymphocytic leukemia]] who have been treated with [[Regimen_classes#Alkylator-based_regimen|alkylating agents]] and who have failed [[Regimen_classes#Fludarabine-based_regimen| fludarabine therapy]].<ref>[http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/alemmil050701L.htm FDA approval letter dated May 7th, 2001]</ref>
-*9/19/2007: Indication expanded to include use as a single agent for treatment of [[Chronic lymphocytic leukemia | B-cell chronic lymphocytic leukemia (B-CLL)]]
+*9/19/2007: Converted to regular approval and indication expanded to include use as a single agent for treatment of [[Chronic lymphocytic leukemia | B-cell chronic lymphocytic leukemia (B-CLL)]]
 *October 2012: Genzyme withdraws drug from USA and EU (still available for B-CLL patients, however). See Lancet editorial.<ref>[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)61776-0/fulltext Alemtuzumab for multiple sclerosis]</ref>