| Revision as of 10:22, 31 October 2011 editBeetstra (talk | contribs)Edit filter managers, Administrators172,031 edits Script assisted update of identifiers for the Chem/Drugbox validation project (updated: 'DrugBank', 'ChEMBL').← Previous edit |
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{{Short description|Pharmaceutical drug}} |
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{{Drugbox |
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{{Drugbox |
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| IUPAC_name = Human Beta-glucocerebrosidase |
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| verifiedrevid = 458273717 |
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| image = |
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| image = |
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| alt = |
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<!--Clinical data--> |
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<!-- Clinical data --> |
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| tradename = |
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| tradename = Cerezyme |
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| Drugs.com = {{drugs.com|monograph|imiglucerase}} |
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| Drugs.com = {{drugs.com|monograph|imiglucerase}} |
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| MedlinePlus = a601149 |
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| MedlinePlus = a601149 |
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| licence_EU = Cerezyme |
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| licence_EU = yes |
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| licence_US = Imiglucerase |
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| DailyMedID = Imiglucerase |
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| pregnancy_category = |
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| pregnancy_category = |
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| legal_status = |
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| routes_of_administration = Intravenous |
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<!--Pharmacokinetic data--> |
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| bioavailability = |
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| protein_bound = |
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| metabolism = |
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| elimination_half-life = 3.6-10.4 min |
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<!--Identifiers--> |
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| ChemSpiderID = NA |
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| CAS_number = 143003-46-7 |
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| ATC_prefix = A16 |
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| ATC_prefix = A16 |
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| ATC_suffix = AB02 |
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| ATC_suffix = AB02 |
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| ATC_supplemental = |
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| ATC_supplemental = |
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| PubChem = |
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| legal_US = Rx-only |
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| legal_EU = Rx-only |
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| legal_EU_comment = <ref>{{cite web | title=Cerezyme EPAR | website=] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/cerezyme | access-date=18 January 2021}}</ref> |
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| routes_of_administration = ] |
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<!-- Pharmacokinetic data --> |
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| bioavailability = |
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| protein_bound = |
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| metabolism = probably ] |
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| elimination_half-life = 3.6–10.4 min |
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<!-- Identifiers --> |
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| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}} |
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| ChemSpiderID = none |
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| CAS_number_Ref = {{cascite|changed|CAS}} |
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| CAS_number = 154248-97-2 |
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| PubChem = |
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
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| DrugBank = DB00053 |
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| DrugBank = DB00053 |
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| UNII_Ref = {{fdacite|correct|FDA}} |
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| UNII_Ref = {{fdacite|correct|FDA}} |
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| UNII = Q6U6J48BWY |
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| UNII = Q6U6J48BWY |
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| KEGG_Ref = {{keggcite|correct|kegg}} |
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| KEGG = D02810 |
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| KEGG = D02810 |
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| ChEMBL_Ref = {{ebicite|changed|EBI}} |
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| ChEMBL = <!-- blanked - oldvalue: 1201632 --> |
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| ChEMBL = 1201632 |
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| C=2532 | H=3854 | N=672 | O=711 | S=16 |
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| molecular_weight = 55597.4 g/mol (un]d) |
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<!-- Chemical data --> |
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| IUPAC_name = Human beta-] |
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| C=2532 | H=3854 | N=672 | O=711 | S=16 |
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| molecular_weight = 55597.4 |
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| molecular_weight_comment = (un]d) |
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}} |
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}} |
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'''Imiglucerase''' is a medication used in the treatment of ].<ref name="pmid18627336">{{cite journal |author=Weinreb NJ |title=Imiglucerase and its use for the treatment of Gaucher's disease |journal=Expert Opin Pharmacother |volume=9 |issue=11 |pages=1987–2000 |year=2008 |month=August |pmid=18627336 |doi=10.1517/14656566.9.11.1987 |url=http://www.expertopin.com/doi/abs/10.1517/14656566.9.11.1987}}</ref><ref name="pmid17079176">{{cite journal |author=Starzyk K, Richards S, Yee J, Smith SE, Kingma W |title=The long-term international safety experience of imiglucerase therapy for Gaucher disease |journal=Mol. Genet. Metab. |volume=90 |issue=2 |pages=157–63 |year=2007 |month=February |pmid=17079176 |doi=10.1016/j.ymgme.2006.09.003 |url=http://linkinghub.elsevier.com/retrieve/pii/S1096-7192(06)00297-6}}</ref> |
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'''Imiglucerase''' is a medication used in the treatment of ].<ref name="pmid18627336">{{cite journal | vauthors = Weinreb NJ | title = Imiglucerase and its use for the treatment of Gaucher's disease | journal = Expert Opinion on Pharmacotherapy | volume = 9 | issue = 11 | pages = 1987–2000 | date = August 2008 | pmid = 18627336 | doi = 10.1517/14656566.9.11.1987 | s2cid = 72183308 }}</ref><ref name="pmid17079176">{{cite journal | vauthors = Starzyk K, Richards S, Yee J, Smith SE, Kingma W | title = The long-term international safety experience of imiglucerase therapy for Gaucher disease | journal = Molecular Genetics and Metabolism | volume = 90 | issue = 2 | pages = 157–163 | date = February 2007 | pmid = 17079176 | doi = 10.1016/j.ymgme.2006.09.003 }}</ref> |
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It is a ]-produced ] of human β-]. |
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'''Cerezyme''' is a ] medicine containing imiglucerase, manufactured by ]. It is given |
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] after reconstitution as a treatment for Type 1 ]. It is available in formulations containing 200 or 400 units per vial. The specific activity of highly purified human enzyme is 890,000 units/mg.<ref>{{cite journal|doi=10.1073/pnas.75.8.3970|journal=Proc. Natl. Acad. Sci. USA|volume=75|issue=8|pages=3970–3973|date=August 1978|title=Gaucher disease: Isolation and comparison of normal and mutant glucocerebrosidase from human spleen tissue|first5=SH|last5=Sorrell|first4=DE|last4=Britton|first3=HE|last3=Blair|first2=RO|last2=Brady|author=Pentchev et al.|pmid=29293|pmc=392911}}</ref> A typical dose is 2.5U/kg every two weeks, up to a maximum of 60 U/kg once every two weeks, and safety has been established from ages 2 and up.<ref>{{cite web|url=http://www.cerezyme.com/global/pi.pdf|title=Cerezyme® (imiglucerase for injection) Genzyme product data sheet}}</ref> It is one of the most expensive drugs sold, with an annual cost to U.S. patients of $200,000.<ref>Balancing innovation, access, and profits -- marketing exclusivity for biologics, Alfred B. Engelberg et al., N Engl J Med 361:1917</ref> Due to the low profitability (and high expense) of developing medications for rare conditions, imiglucerase has been granted ] status in the USA, Australia, and Japan.<ref>{{cite web|url=http://www.orpha.net/consor/cgi-bin/Drugs_Search.php?lng=EN&data_id=23&Substance=Imiglucerase&search=Drugs_Search_SubstanceTradename&data_type=Product&diseaseType=Drug&Typ=Sub&title=&diseaseGroup=|title=Imiglucerase on Orpha.net: The portal for rare diseases and orphan drugs.}}</ref> |
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It is a ]-produced ] of the human enzyme β-]. |
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Cerezyme was one of the drugs manufactured at Genzyme's Allston, Massachusetts plant, for which production was disrupted in 2009 after contamination with Vesivirus 2117.<ref>{{cite journal|url=http://www.boston.com/business/healthcare/articles/2009/06/17/genzyme_temporarily_halts_production_on_2_key_drugs/|title=Virus shuts Genzyme plant, holds up drugs for 8,000|journal=The Boston Globe|author=Erin Ailworth and Robert Weisman|date=June 17, 2009}}</ref> |
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'''Cerezyme''' is a ] medicine containing imiglucerase, manufactured by ]. It is given ] after reconstitution as a treatment for Type 1 and Type 3<ref name="AC">{{cite book|title=Austria-Codex|at=Cerezyme 400 U-Pulver für ein Konzentrat zur Herstellung einer Infusionslösung|publisher=Österreichischer Apothekerverlag|location=Vienna|year=2018|language=de}}</ref> Gaucher's disease. It is available in formulations containing 200 or 400 units per vial. The specific activity of highly purified human enzyme is 890,000 units/mg,<ref>{{cite journal | vauthors = Pentchev PG, Brady RO, Blair HE, Britton DE, Sorrell SH | title = Gaucher disease: isolation and comparison of normal and mutant glucocerebrosidase from human spleen tissue | journal = Proceedings of the National Academy of Sciences of the United States of America | volume = 75 | issue = 8 | pages = 3970–3973 | date = August 1978 | pmid = 29293 | pmc = 392911 | doi = 10.1073/pnas.75.8.3970 | doi-access = free | bibcode = 1978PNAS...75.3970P }}</ref> meanwhile the enzyme activity produced by recombinant DNA technology is approximately 40 units/mg.<ref>{{cite web|url=https://ec.europa.eu/health/documents/community-register/2017/20170602138065/anx_138065_en.pdf|title= Cerezyme Powder for concentrate for solution for infusion, Annex I: Summary of Product Characteristics | work = Sanofi-Aventis Latvia SIA | via = Ec.europa.eu|access-date=26 April 2022}}</ref> A typical dose is 2.5U/kg every two weeks, up to a maximum of 60 U/kg once every two weeks, and safety has been established from ages 2 and up.<ref>{{cite web|url=http://www.cerezyme.com/global/pi.pdf|title=Cerezyme (imiglucerase for injection) | work = Genzyme product data sheet|url-status=dead|archive-url=https://web.archive.org/web/20030605012113/http://www.cerezyme.com/global/pi.pdf|archive-date=2003-06-05}}</ref> It is one of more expensive medications, with an annual cost of $200,000 per person in the United States.<ref name="Engelberg">{{cite journal | vauthors = Engelberg AB, Kesselheim AS, Avorn J | title = Balancing innovation, access, and profits--market exclusivity for biologics | journal = The New England Journal of Medicine | volume = 361 | issue = 20 | pages = 1917–1919 | date = November 2009 | pmid = 19828525 | doi = 10.1056/NEJMp0908496 }}</ref> Imiglucerase has been granted ] status in the United States, Australia, and Japan.<ref>{{Cite web|url=https://www.orpha.net/consor/cgi-bin/Drugs_Search.php?lng=EN&data_id=23&Tradename=Imiglucerase&Typ=Sub&search=Drugs_Search_SubstanceTradename&data_type=Product&title=Imiglucerase&diseaseType=Drug&Drugs_Drugs_Search_ClinicalTrialPhase=&Drugs_Drugs_Search_GeographicType=&Drugs_Drugs_Search_country=&diseaseGroup= | title = Imiglucerase | work = Orphanet |access-date=26 April 2022}}</ref> |
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Cerezyme was one of the drugs manufactured at ] Allston, Massachusetts plant, for which production was disrupted in 2009 after contamination with ] 2017.<ref>{{cite journal |url= http://www.boston.com/business/healthcare/articles/2009/06/17/genzyme_temporarily_halts_production_on_2_key_drugs/ |title=Virus shuts Genzyme plant, holds up drugs for 8,000|journal=The Boston Globe| vauthors = Ailworth E, Weisman R |date=June 17, 2009}}</ref> |
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==See also== |
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==Side effects== |
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The most common side effect is ], which occurs in about 3% of patients. It is associated with symptoms such as cough, ], ], itching, and ]. Less common side effects include dizziness, headache, nausea, diarrhea, and reactions at the injection site; they are found in less than 1% of patients.<ref name="AC" /> |
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== Interactions == |
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No clinical interaction studies have been conducted.<ref name="AC" /> ] appears to increase the clearance of imiglucerase by 70%, resulting in decreased enzyme activity.<ref>{{cite web | url = https://www.drugs.com/drug-interactions/imiglucerase-with-miglustat-1322-0-1632-0.html?professional=1 | title = Drug interactions between imiglucerase and miglustat | work = Drugs.com | access-date = 11 April 2019 }}</ref> |
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== See also == |
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*Other drugs for the treatment of Gaucher's disease |
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*Other drugs for the treatment of Gaucher's disease |
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**] (development terminated) |
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==References== |
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== References == |
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{{reflist}} |
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{{gastrointestinal-drug-stub}} |
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