Difference between revisions of "Lanreotide (Somatuline)"

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==General information==
 
==General information==
Class/mechanism: Octapeptide somatostatin analog which suppresses multiple endocrine, neuroendocrine, exocrine, and paracrine functions.  Lanreotide binds with high affinity to somatostatin receptors (SSTR) 2 and 5, with lower binding affinity for SSTR1, SSTR3, and SSTR4.  Binding to SSTR2 and SSTR5 is believed to cause growth hormone (GH) inhibition.  Lanreotide also results in reduction of IGF-1 (somatomedin C), motilin, gastric inhibitory peptide, pancreatic polypeptide, gastrin, cholecystokinin (CCK), duodenal bicarbonate and amylase concentrations, gastric acidity, gallbladder contractility, bile secretion, glucagon, and prolactin.  It also causes transient decreases in post-prandial insulin secretion and nocturnal release of thyroid-stimulating hormone (TSH).<ref name="insert">[http://somatulinedepot.com/pdf/somatuline-depot-full-prescribing-information.pdf Lanreotide (Somatuline) package insert]</ref><ref>[[Media:Lanreotide.pdf | Lanreotide (Somatuline) package insert (locally hosted backup)]]</ref><ref name="manufacturer">[http://somatulinedepot.com/ Somatuline manufacturer's website]</ref>
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Class/mechanism: Octapeptide somatostatin analog which suppresses multiple endocrine, neuroendocrine, exocrine, and paracrine functions.  Lanreotide binds with high affinity to somatostatin receptors (SSTR) 2 and 5, with lower binding affinity for SSTR1, SSTR3, and SSTR4.  Binding to SSTR2 and SSTR5 is believed to cause growth hormone (GH) inhibition.  Lanreotide also results in reduction of IGF-1 (somatomedin C), motilin, gastric inhibitory peptide, pancreatic polypeptide, gastrin, cholecystokinin (CCK), duodenal bicarbonate and amylase concentrations, gastric acidity, gallbladder contractility, bile secretion, glucagon, and prolactin.  It also causes transient decreases in post-prandial insulin secretion and nocturnal release of thyroid-stimulating hormone (TSH).<ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s011lbl.pdf Lanreotide (Somatuline) package insert]</ref><ref>[[:File:Lanreotide.pdf | Lanreotide (Somatuline) package insert (locally hosted backup)]]</ref><ref name="manufacturer">[http://somatulinedepot.com/ Somatuline manufacturer's website]</ref>
 
<br>Route: SC
 
<br>Route: SC
 
<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>  
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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==
 
==Diseases for which it is used==
*[[Neuroendocrine tumors]]
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*[[Neuroendocrine tumor]]
 
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*[[Pancreatic NET]]
==Clinical trials==
 
*[https://clinicaltrials.gov/ct2/show/NCT00353496 Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours (CLARINET)]<ref>Caplin ME, Pavel M, Ćwikła JB, Phan AT, Raderer M, Sedláčková E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. [http://www.nejm.org/doi/full/10.1056/NEJMoa1316158 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25014687 PubMed]</ref>
 
*[https://clinicaltrials.gov/ct2/show/NCT00842348 Study of Lanreotide Autogel 120mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour (NET729)]
 
  
 
==Patient drug information==
 
==Patient drug information==
*[http://somatulinedepot.com/pdf/somatuline-depot-full-prescribing-information.pdf Somatuline package insert]<ref name="insert"></ref>
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*[https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s011lbl.pdf Somatuline package insert]<ref name="insert"></ref>
 
*[http://www.uptodate.com/contents/lanreotide-patient-drug-information Lanreotide (Somatuline) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/lanreotide-patient-drug-information Lanreotide (Somatuline) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/lanreotide-patient-drug-information Lanreotide (Somatuline) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/lanreotide-patient-drug-information Lanreotide (Somatuline) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
*8/30/2007: FDA approved for "the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy."<ref name="insert"></ref>  
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*2007-08-30: FDA approved for the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.<ref name="insert"></ref>  
*12/16/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm427065.htm FDA approved] "for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival."
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*2014-12-16: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm427065.htm FDA approved] for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic [[Neuroendocrine tumor|gastroenteropancreatic neuroendocrine tumors (GEP-NETs)]] to improve progression-free survival. ''(Based on CLARINET)''
 
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==History of changes in PMDA indication==
 +
*2017-07-03: New additional indication and a new dosage indicated for the treatment of [[Neuroendocrine tumor|neuroendocrine tumors]] of the pancreas and gastrointestinal tract.
 
==Also known as==
 
==Also known as==
Ipstyl, Lanreotide, Lanreotide Acetate, lanreotide injection, Lanreotide Autogel (extended-release aqueous-gel formulation), Somatuline Autogel, Somatuline Depot, Somatuline LA, Somatuline LP, Somatuline P.R, Somatuline PR.
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*'''Generic names:''' lanreotide acetate
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*'''Brand names:''' Ipstyl, Lanreotide Autogel, Somatuline, Somatuline Autogel, Somatuline Depot, Somatuline LA, Somatuline LP, Somatuline PR
  
 
==References==
 
==References==
 
<references/>
 
<references/>
  
[[Category:Drug index]]
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[[Category:Drugs]]
[[Category:Endocrine therapy]]
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[[Category:Subcutaneous medications]]
 +
 
 
[[Category:Somatostatin analogs]]
 
[[Category:Somatostatin analogs]]
 
[[Category:Neuroendocrine tumor medications]]
 
[[Category:Neuroendocrine tumor medications]]
[[Category:Drugs FDA approved in 2007]]
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[[Category:Pancreatic NET medications]]
 +
[[Category:FDA approved in 2007]]

Revision as of 01:39, 11 June 2023

General information

Class/mechanism: Octapeptide somatostatin analog which suppresses multiple endocrine, neuroendocrine, exocrine, and paracrine functions. Lanreotide binds with high affinity to somatostatin receptors (SSTR) 2 and 5, with lower binding affinity for SSTR1, SSTR3, and SSTR4. Binding to SSTR2 and SSTR5 is believed to cause growth hormone (GH) inhibition. Lanreotide also results in reduction of IGF-1 (somatomedin C), motilin, gastric inhibitory peptide, pancreatic polypeptide, gastrin, cholecystokinin (CCK), duodenal bicarbonate and amylase concentrations, gastric acidity, gallbladder contractility, bile secretion, glucagon, and prolactin. It also causes transient decreases in post-prandial insulin secretion and nocturnal release of thyroid-stimulating hormone (TSH).[1][2][3]
Route: SC
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

  • 2007-08-30: FDA approved for the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.[1]
  • 2014-12-16: FDA approved for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. (Based on CLARINET)

History of changes in PMDA indication

  • 2017-07-03: New additional indication and a new dosage indicated for the treatment of neuroendocrine tumors of the pancreas and gastrointestinal tract.

Also known as

  • Generic names: lanreotide acetate
  • Brand names: Ipstyl, Lanreotide Autogel, Somatuline, Somatuline Autogel, Somatuline Depot, Somatuline LA, Somatuline LP, Somatuline PR

References