Difference between revisions of "Eculizumab (Soliris)"

Latest revision as of 00:15, 6 July 2024

General information

Class/mechanism: Complement inhibitor; monoclonal antibody that binds to complement protein C5, preventing its cleavage to C5a and C5b and the formation of the terminal complement complex C5b-9. Eculizumab is used in diseases involving abnormal complement-mediated activity, such as paroxysmal nocturnal hemoglobinuria (PNH) and complement-mediated thrombotic microangiopathy (TMA) in patients with atypical hemolytic uremic syndrome (aHUS).^[1]^[2]^[3]
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 such as Micromedex, UpToDate Lexidrug, Medscape, or the prescribing information.^[1]

Toxicity management

Soliris Risk Evaluation and Mitigation Strategy (REMS) Site^[4]

Diseases for which it is established (work in progress)

Diseases for which it is used

Cold agglutinin disease

Patient drug information

History of changes in FDA indication

2007-03-16: Initial approval for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. (Based on SHEPHERD & TRIUMPH)
2011-09-23: Additional indication for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. (Based on C08-002, C08-003, C10-004)

History of changes in EMA indication

2007-06-20: Initial authorization

History of changes in PMDA indication

2013-09-13: New additional indication and a new dosage for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Also known as

Brand name: Soliris

References

[insert-1] 1.0 ^1.1 ^1.2 Eculizumab (Soliris) package insert

[2] Eculizumab (Soliris) package insert (locally hosted backup)

[3] Soliris manufacturer's website

[4] Soliris Risk Evaluation and Mitigation Strategy (REMS) Site

[5] Eculizumab (Soliris) patient drug information (Chemocare)

[6] Eculizumab (Soliris) patient drug information (UpToDate)

[1]

[2]

[3]

[4]

[5]

[6]

@@ Line 1: / Line 1: @@
 ==General information==
-Class/mechanism: Complement inhibitor; monoclonal antibody that binds to complement protein C5, preventing its cleavage to C5a and C5b and the formation of the terminal complement complex C5b-9.  Eculizumab is used in diseases involving abnormal complement-mediated activity, such as paroxysmal nocturnal hemoglobinuria (PNH) and complement-mediated thrombotic microangiopathy (TMA) in patients with atypical hemolytic uremic syndrome (aHUS).<ref name="insert">[http://www.soliris.net/resources/pdf/soliris_pi_mg.pdf Eculizumab (Soliris) package insert]</ref><ref>[[Media:Eculizumab.pdf | Eculizumab (Soliris) package insert (locally hosted backup)]]</ref><ref>[http://soliris.net Soliris manufacturer's website]</ref>
+Class/mechanism: Complement inhibitor; monoclonal antibody that binds to complement protein C5, preventing its cleavage to C5a and C5b and the formation of the terminal complement complex C5b-9. Eculizumab is used in diseases involving abnormal complement-mediated activity, such as paroxysmal nocturnal hemoglobinuria (PNH) and complement-mediated thrombotic microangiopathy (TMA) in patients with atypical hemolytic uremic syndrome (aHUS).<ref name="insert">[http://www.soliris.net/resources/pdf/soliris_pi_mg.pdf Eculizumab (Soliris) package insert]</ref><ref>[[:File:Eculizumab.pdf | Eculizumab (Soliris) package insert (locally hosted backup)]]</ref><ref>[http://soliris.net Soliris manufacturer's website]</ref>
 <br>Route: IV
 <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 Micromedex, UpToDate Lexidrug, [http://reference.medscape.com/drug/soliris-eculizumab-342875 Medscape], or the prescribing information.<ref name="insert"></ref>
+==Toxicity management==
 *[http://www.solirisrems.com/ Soliris Risk Evaluation and Mitigation Strategy (REMS) Site]<ref>[http://www.solirisrems.com/ Soliris Risk Evaluation and Mitigation Strategy (REMS) Site]</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://reference.medscape.com/drug/soliris-eculizumab-342875 Medscape], [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 established ''(work in progress)''==
+*[[Atypical hemolytic uremic syndrome]]
+*[[Paroxysmal nocturnal hemoglobinuria]]
 ==Diseases for which it is used==
-*[[Atypical hemolytic uremic syndrome]]
 *[[Cold agglutinin disease]]
-*[[Paroxysmal nocturnal hemoglobinuria (PNH)]]
 ==Patient drug information==
 *[http://www.soliris.net/resources/pdf/soliris_pi_mg.pdf Eculizumab (Soliris) package insert]<ref name="insert"></ref>
-*[http://chemocare.com/chemotherapy/drug-info/eculizumab.aspx Eculizumab (Soliris) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/eculizumab.aspx Eculizumab (Soliris) patient drug information (Chemocare)]</ref>
+*[https://chemocare.com/druginfo/eculizumab.aspx Eculizumab (Soliris) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/eculizumab.aspx Eculizumab (Soliris) patient drug information (Chemocare)]</ref>
 *[http://www.uptodate.com/contents/eculizumab-patient-drug-information Eculizumab (Soliris) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/eculizumab-patient-drug-information Eculizumab (Soliris) patient drug information (UpToDate)]</ref>
 ==History of changes in FDA indication==
-* 3/16/2007: Initial FDA approval for "the treatment of patients with [[Paroxysmal nocturnal hemoglobinuria (PNH) | paroxysmal nocturnal hemoglobinuria (PNH)]] to reduce hemolysis."
+* 2007-03-16: Initial approval for the treatment of patients with [[Paroxysmal_nocturnal_hemoglobinuria | paroxysmal nocturnal hemoglobinuria (PNH)]] to reduce hemolysis. ''(Based on SHEPHERD & TRIUMPH)''
-* 9/23/2011: Additional indication for "the treatment of patients with [[Atypical hemolytic uremic syndrome|atypical hemolytic uremic syndrome (aHUS)]] to inhibit complement-mediated thrombotic microangiopathy."
+* 2011-09-23: Additional indication for the treatment of patients with [[Atypical hemolytic uremic syndrome|atypical hemolytic uremic syndrome (aHUS)]] to inhibit complement-mediated thrombotic microangiopathy. ''(Based on C08-002, C08-003, C10-004)''
+==History of changes in EMA indication==
+*2007-06-20: Initial authorization
+==History of changes in PMDA indication==
+*2013-09-13: New additional indication and a new dosage for the treatment of patients with [[Atypical hemolytic uremic syndrome|atypical hemolytic uremic syndrome (aHUS)]] to inhibit complement-mediated thrombotic microangiopathy.
 ==Also known as==
 *'''Brand name:''' Soliris
@@ Line 29: / Line 35: @@
 [[Category:Drugs]]
 [[Category:Intravenous medications]]
-[[Category:Antibody medications]]
 [[Category:Anti-C5 antibodies]]
@@ Line 38: / Line 44: @@
 [[Category:REMS program]]
+[[Category:EMA approved in 2007]]
 [[Category:FDA approved in 2007]]