Difference between revisions of "Obinutuzumab (Gazyva)"

Revision as of 09:15, 14 April 2016

General information

Class/mechanism: Glyco-engineered anti-CD20 IgG1 type II monoclonal antibody. Engineered with a modified elbow hinge residue (valine instead of leucine at Kabat position 11) and a glyco-engineered Fc region, which is postulated to enhance its immunomodulatory effect.^[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, Lexicomp, UpToDate (courtesy of Lexicomp), or the package insert.^[1]

Diseases for which it is used

Patient drug information

No information available.

History of changes in FDA indication

11/1/2013: Granted FDA approval for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
2/26/2016: FDA approval expanded "for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen."

Also known as

GA101, R7159, RO5072759, Afutuzumab.

References

[insert-1] 1.0 ^1.1 Obinutuzumab (Gazyva) package insert

[2] Obinutuzumab (Gazyva) package insert (locally hosted backup)

[3] Gazyva manufacturer's website

[1]

[2]

[3]

@@ Line 1: / Line 1: @@
 ==General information==
-Class/mechanism: Glyco-engineered anti-[http://en.wikipedia.org/wiki/CD20 CD20] IgG1 type II monoclonal antibody.  Engineered with a modified elbow hinge residue (valine instead of leucine at Kabat position 11) and a glyco-engineered Fc region, which is postulated to enhance its immunomodulatory effect.
+Class/mechanism: Glyco-engineered anti-[http://en.wikipedia.org/wiki/CD20 CD20] IgG1 type II monoclonal antibody.  Engineered with a modified elbow hinge residue (valine instead of leucine at Kabat position 11) and a glyco-engineered Fc region, which is postulated to enhance its immunomodulatory effect.<ref name="insert">[http://www.gene.com/download/pdf/gazyva_prescribing.pdf Obinutuzumab (Gazyva) package insert]</ref><ref>[[Media:Obinutuzumab.pdf|Obinutuzumab (Gazyva) package insert (locally hosted backup)]]</ref><ref>[http://www.gazyva.com/ Gazyva 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 [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 package insert.
+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 package insert.<ref name="insert"></ref>
 ==Diseases for which it is used==