Difference between revisions of "Niraparib (Zejula)"

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m (Jwarner moved page Niraparib (MK4827) to Niraparib (Zejula))
(FDA approval)
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=General information=
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==General information==
Class/mechanism per the [https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=615263 NCI Drug Dictionary]: An inhibitor of poly (ADP-ribose) polymerase (PARP) with potential antineoplastic activity. Niraparib inhibits PARP activity, enhancing the accumulation of DNA strand breaks and promoting genomic instability and apoptosis. The PARP family of proteins detect and repair single strand DNA breaks by the base-excision repair (BER) pathway. The specific PARP family member target for niraparib is unknown.  
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Class/mechanism: PARP inhibitor. Niraparib inhibits poly(ADP-ribose) polymerase (PARP) enzymes PARP-1 and PARP-2, which are involved in DNA repair. Inhibiting PARP-1 and PARP-2 may result in formation of PARP-DNA complexes, DNA damage, apoptosis, and cell death. PARP proteins utilize base-excision repair (BER) to identify and repair single strand DNA breaks.<ref name="insert">[http://zejula.com/docs/Zejula_(niraparib)_Full_Prescribing_Information.pdf Niraparib (Zejula) package insert]</ref><ref>[[Media:Niraparib.pdf | Niraparib (Zejula) package insert (locally hosted backup)]]</ref><ref>[http://zejula.com/ Zejula manufacturer's website]</ref><ref>[https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=615263 NCI Drug Dictionary Niraparib entry]</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 package insert.
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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=
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==Diseases for which it is used==
 
*[[Ovarian cancer]]
 
*[[Ovarian cancer]]
  
=History of changes in FDA indication=
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==Patient drug information==
*3/27/2017: Initial FDA approval "for the maintenance treatment of adult patients with recurrent [[ovarian cancer|epithelial ovarian, fallopian tube, or primary peritoneal cancer]] who are in complete or partial response to [[:Category:Platinum_agents|platinum-based]] chemotherapy."
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*[http://zejula.com/docs/Zejula_(niraparib)_Full_Prescribing_Information.pdf Niraparib (Zejula) package insert]<ref name="insert"></ref>
  
=Also known as=
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==History of changes in FDA indication==
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*3/27/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm548487.htm Initial FDA approval] "for the maintenance treatment of adult patients with recurrent [[ovarian cancer|epithelial ovarian, fallopian tube, or primary peritoneal cancer]] who are in complete or partial response to [[:Category:Platinum_agents|platinum-based]] chemotherapy."
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==Also known as==
 
MK4827
 
MK4827
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 +
==References==
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<references/>
  
 
[[Category:Drug index]]
 
[[Category:Drug index]]

Revision as of 03:45, 29 March 2017

General information

Class/mechanism: PARP inhibitor. Niraparib inhibits poly(ADP-ribose) polymerase (PARP) enzymes PARP-1 and PARP-2, which are involved in DNA repair. Inhibiting PARP-1 and PARP-2 may result in formation of PARP-DNA complexes, DNA damage, apoptosis, and cell death. PARP proteins utilize base-excision repair (BER) to identify and repair single strand DNA breaks.[1][2][3][4]
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

Patient drug information

History of changes in FDA indication

Also known as

MK4827

References