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{{Short description|Pharmaceutical drug}}
{{Drugbox {{Drugbox
| Verifiedfields = changed
⚫ | IUPAC_name = Human Beta-glucocerebrosidase
| verifiedrevid = 458273717
| image = | image =
| alt =


<!--Clinical data--> <!-- Clinical data -->
| tradename = | tradename = Cerezyme
| Drugs.com = {{drugs.com|monograph|imiglucerase}} | Drugs.com = {{drugs.com|monograph|imiglucerase}}
| MedlinePlus = a601149 | MedlinePlus = a601149
| licence_EU = Cerezyme | licence_EU = yes
| licence_US = Imiglucerase | DailyMedID = Imiglucerase
| pregnancy_category = | pregnancy_category =
| legal_status =
⚫ | routes_of_administration = Intravenous

⚫ <!--Pharmacokinetic data-->
⚫ | bioavailability =
⚫ | protein_bound =
⚫ | metabolism =
⚫ | elimination_half-life = 3.6-10.4 min

⚫ <!--Identifiers-->
⚫ | ChemSpiderID = NA
⚫ | CAS_number = 143003-46-7
| ATC_prefix = A16 | ATC_prefix = A16
| ATC_suffix = AB02 | ATC_suffix = AB02
| ATC_supplemental = | ATC_supplemental =

⚫ | PubChem =
| DrugBank = BTD00026 | legal_US = Rx-only
| legal_EU = Rx-only
| 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>
⚫ | routes_of_administration = ]

⚫ <!-- Pharmacokinetic data -->
⚫ | bioavailability =
⚫ | protein_bound =
⚫ | metabolism = probably ]
⚫ | elimination_half-life = 3.6–10.4 min

⚫ <!-- Identifiers -->
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
⚫ | ChemSpiderID = none
| CAS_number_Ref = {{cascite|changed|CAS}}
⚫ | CAS_number = 154248-97-2
⚫ | PubChem =
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB00053
| UNII_Ref = {{fdacite|correct|FDA}} | UNII_Ref = {{fdacite|correct|FDA}}
| UNII = Q6U6J48BWY | UNII = Q6U6J48BWY
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D02810 | KEGG = D02810
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = 1201632 | ChEMBL = 1201632


<!--Chemical data--> <!-- Chemical data -->
⚫ | IUPAC_name = Human beta-]
| C=2532 | H=3854 | N=672 | O=711 | S=16 | C=2532 | H=3854 | N=672 | O=711 | S=16
| molecular_weight = 55597.4 g/mol (un]d) | molecular_weight = 55597.4
| molecular_weight_comment = (un]d)
}} }}
⚫ '''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>


⚫ '''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>
⚫ It is a ]-produced ] of human β-].
'''Cerezyme''' is a ] medicine containing imiglucerase, manufactured by ]. It is given
] 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>


⚫ It is a ]-produced ] of the human enzyme β-].
⚫ 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>
'''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>


⚫ 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>
⚫ ==See also==

==Side effects==
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" />

== Interactions ==

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>

⚫ == See also ==
*Other drugs for the treatment of Gaucher's disease *Other drugs for the treatment of Gaucher's disease
**] (development terminated)
**]
**]
**] **]
**]
**]


==References== == References ==
{{reflist}} {{reflist}}


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] ]
]

]

]
{{gastrointestinal-drug-stub}}

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Latest revision as of 13:38, 13 November 2023

Pharmaceutical drug Pharmaceutical compound
Imiglucerase
Clinical data
Trade namesCerezyme
AHFS/Drugs.comMonograph
MedlinePlusa601149
License data
Routes of
administration		Intravenous infusion
ATC code
Legal status
Legal status
Pharmacokinetic data
Metabolismprobably proteolysis
Elimination half-life3.6–10.4 min
Identifiers
IUPAC name
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC2532H3854N672O711S16
Molar mass55597.4 g·mol (unglycosylated)
  (what is this?)  (verify)

Imiglucerase is a medication used in the treatment of Gaucher's disease.

It is a recombinant DNA-produced analogue of the human enzyme β-glucocerebrosidase. Cerezyme is a freeze-dried medicine containing imiglucerase, manufactured by Genzyme Corporation. It is given intravenously after reconstitution as a treatment for Type 1 and Type 3 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, meanwhile the enzyme activity produced by recombinant DNA technology is approximately 40 units/mg. 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. It is one of more expensive medications, with an annual cost of $200,000 per person in the United States. Imiglucerase has been granted orphan drug status in the United States, Australia, and Japan.

Cerezyme was one of the drugs manufactured at Genzyme's Allston, Massachusetts plant, for which production was disrupted in 2009 after contamination with Vesivirus 2017.

Side effects

The most common side effect is hypersensitivity, which occurs in about 3% of patients. It is associated with symptoms such as cough, shortness of breath, rashes, itching, and angiooedema. Less common side effects include dizziness, headache, nausea, diarrhea, and reactions at the injection site; they are found in less than 1% of patients.

Interactions

No clinical interaction studies have been conducted. Miglustat appears to increase the clearance of imiglucerase by 70%, resulting in decreased enzyme activity.

See also

References

  1. "Cerezyme EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 18 January 2021.
  2. Weinreb NJ (August 2008). "Imiglucerase and its use for the treatment of Gaucher's disease". Expert Opinion on Pharmacotherapy. 9 (11): 1987–2000. doi:10.1517/14656566.9.11.1987. PMID 18627336. S2CID 72183308.
  3. Starzyk K, Richards S, Yee J, Smith SE, Kingma W (February 2007). "The long-term international safety experience of imiglucerase therapy for Gaucher disease". Molecular Genetics and Metabolism. 90 (2): 157–163. doi:10.1016/j.ymgme.2006.09.003. PMID 17079176.
  4. ^ Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag. 2018. Cerezyme 400 U-Pulver für ein Konzentrat zur Herstellung einer Infusionslösung.
  5. Pentchev PG, Brady RO, Blair HE, Britton DE, Sorrell SH (August 1978). "Gaucher disease: isolation and comparison of normal and mutant glucocerebrosidase from human spleen tissue". Proceedings of the National Academy of Sciences of the United States of America. 75 (8): 3970–3973. Bibcode:1978PNAS...75.3970P. doi:10.1073/pnas.75.8.3970. PMC 392911. PMID 29293.
  6. "Cerezyme Powder for concentrate for solution for infusion, Annex I: Summary of Product Characteristics" (PDF). Sanofi-Aventis Latvia SIA. Retrieved 26 April 2022 – via Ec.europa.eu.
  7. "Cerezyme (imiglucerase for injection)" (PDF). Genzyme product data sheet. Archived from the original (PDF) on 2003-06-05.
  8. Engelberg AB, Kesselheim AS, Avorn J (November 2009). "Balancing innovation, access, and profits--market exclusivity for biologics". The New England Journal of Medicine. 361 (20): 1917–1919. doi:10.1056/NEJMp0908496. PMID 19828525.
  9. "Imiglucerase". Orphanet. Retrieved 26 April 2022.
  10. Ailworth E, Weisman R (June 17, 2009). "Virus shuts Genzyme plant, holds up drugs for 8,000". The Boston Globe.
  11. "Drug interactions between imiglucerase and miglustat". Drugs.com. Retrieved 11 April 2019.
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