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{{Short description|Antiviral drug}} |
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{{Drugbox| |
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{{Drugbox |
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|IUPAC_name = |
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| image=Fomivirsen composite.png |
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| verifiedrevid = 407239066 |
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| IUPAC_name = |
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| image = Fomivirsen composite.png |
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| width = 250 |
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| width = 250 |
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<!-- Clinical data --> |
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| CAS_number=160369-77-7 |
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| tradename = |
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| ATC_prefix=S01 |
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| Drugs.com = {{drugs.com|CONS|fomivirsen}} |
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| ATC_suffix=AD08 |
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| pregnancy_AU = B2 |
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| ATC_supplemental= |
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| legal_status = Withdrawn |
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| PubChem= |
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| routes_of_administration = Intravitreal ] |
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| DrugBank= |
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<!-- Pharmacokinetic data --> |
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| KEGG = D02736 |
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| bioavailability = |
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| C = 204 | H = 263 | N = 63 | O = 114 | P = 20 | S = 20 |
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| molecular_weight = 6682.4 g/mol |
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| bioavailability= |
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| metabolism = |
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| excretion = |
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<!-- Identifiers --> |
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| excretion = |
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| CAS_number_Ref = {{cascite|correct|??}} |
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| pregnancy_category = B2 |
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| CAS_number = 160369-77-7 |
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| legal_status = |
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| UNII_Ref = {{fdacite|correct|FDA}} |
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| routes_of_administration= Intravitreal ] |
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| UNII = 3Z6W3S36X5 |
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| ATC_prefix = S01 |
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| ATC_suffix = AD08 |
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
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| DrugBank = DB06759 |
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| KEGG_Ref = {{keggcite|correct|kegg}} |
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| KEGG = D02736 |
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| ChEMBL_Ref = {{ebicite|changed|EBI}} |
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| ChEMBL = 1201688 |
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| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}} |
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| ChemSpiderID = none |
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<!-- Chemical data --> |
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| C=204 | H=263 | N=63 | O=114 | P=20 | S=20 |
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}} |
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'''Fomivirsen''' (brand name '''Vitravene''') is an ]. It is used in the treatment of ] (CMV) in ] patients, including those with ]. It was licenced by the FDA for CMV in Aug 1998. |
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'''Fomivirsen''' (brand name '''Vitravene''') is an ] ] that was used in the treatment of ] (CMV) in ] patients, including those with ]. It was administered via intraocular injection.<ref name="isbn0-07-145153-6">{{cite book | vauthors = Trevor AJ, Katzung BG, Knuidering-Hall M, Masters S | title = Katzung & Trevor's Pharmacology | edition = 10th | publisher = McGraw-Hill Medical Publishing Division | location = New York | year = 2012 | pages = 429 | isbn = 978-0-07-178923-3 }}</ref> |
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It was discovered at the NIH and was licensed and initially ] by ], which subsequently licensed it to ].<ref name=AJMC>{{cite journal | vauthors = Bubela T, McCabe C | title = Value-engineered translation: developing biotherapeutics that align with health-system needs | journal = The American Journal of Managed Care | volume = 20 | issue = 10 Spec No | pages = E3 | date = July 2014 | pmid = 25830190 | url = http://www.ajmc.com/journals/evidence-based-diabetes-management/2014/july-august-2014/value-engineered-translation-developing-biotherapeutics-that-align-with-health-system-needs/p-2 | authorlink1 = Tania Bubela | access-date = 2017-01-02 | archive-date = 2017-09-29 | archive-url = https://web.archive.org/web/20170929232202/http://www.ajmc.com/journals/evidence-based-diabetes-management/2014/july-august-2014/value-engineered-translation-developing-biotherapeutics-that-align-with-health-system-needs/p-2 | url-status = dead }}</ref> It was licensed by the FDA for CMV in Aug 1998, and was the first antisense drug that was approved.<ref>{{cite news|last1=Jiang|first1=Kevin | name-list-style = vanc |title=Biotech comes to its 'antisenses' after hard-won drug approval : Spoonful of Medicine|url=http://blogs.nature.com/spoonful/2013/02/biotech-comes-to-its-antisenses-after-hard-won-drug-approval.html|work=Nature Medicine: Spoonful of Medicine Blog|date=February 19, 2013}}</ref> |
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It is a synthetic 21 member ] with ] linkages (which are resistant to degradation by ]s) and has the sequence: |
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Novartis withdrew the marketing authorization in the EU in 2002<ref>{{cite web|title=Public Statement on Vitravene (fomiversen): Withdrawal of the Marketing Authorization in the European Union|url=http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2009/12/WC500018346.pdf|publisher=EMA|date=August 6, 2002|access-date=January 2, 2017|archive-date=May 23, 2018|archive-url=https://web.archive.org/web/20180523014710/http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2009/12/WC500018346.pdf|url-status=dead}}</ref> and in the US in 2006.<ref>{{cite web|title=Initiating Coverage: Rexahn Pharmaceuticals (RNN)|url=http://www.baystreet.ca/articles/research_reports/lifesci/Rexahn052416.pdf|publisher=LifeSci Capital|date=May 23, 2016}}</ref> The drug was withdrawn because while there was a high unmet need for drugs to treat CMV when the drug was initially discovered and developed due to the CMV arising in people with ], the development of ] dramatically reduced the number of cases of CMV.<ref name=AJMC/> |
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It is an ] ] -- a synthetic 21 member ] with ] linkages (which are resistant to degradation by ]s) and has the sequence: |
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* 5'-GCG TTT GCT CTT CTT CTT GCG-3' |
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* 5'-GCG TTT GCT CTT CTT CTT GCG-3' |
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<ref name="pmid9559825">{{cite journal | vauthors = Mulamba GB, Hu A, Azad RF, Anderson KP, Coen DM | title = Human cytomegalovirus mutant with sequence-dependent resistance to the phosphorothioate oligonucleotide fomivirsen (ISIS 2922) | journal = Antimicrobial Agents and Chemotherapy | volume = 42 | issue = 4 | pages = 971–973 | date = April 1998 | pmid = 9559825 | pmc = 105584 | doi = 10.1128/AAC.42.4.971 }}</ref> It blocks ] of viral mRNA by binding to the complementary sequence of the mRNA transcribed from the template segment of a key CMV gene UL123, which encodes the CMV protein IE2. It was the first ] antiviral approved by the FDA.<ref name="pmid9182327">{{cite journal | vauthors = Roush W | title = Antisense aims for a renaissance | journal = Science | volume = 276 | issue = 5316 | pages = 1192–1193 | date = May 1997 | pmid = 9182327 | doi = 10.1126/science.276.5316.1192 | s2cid = 6983051 }}</ref> |
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== Mechanism == |
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It is an ]<ref name="pmid9559825">{{cite journal |author=Mulamba GB, Hu A, Azad RF, Anderson KP, Coen DM |title=Human cytomegalovirus mutant with sequence-dependent resistance to the phosphorothioate oligonucleotide fomivirsen (ISIS 2922) |journal=Antimicrob. Agents Chemother. |volume=42 |issue=4 |pages=971–3 |year=1998 |month=April |pmid=9559825 |pmc=105584 |doi= |url=http://aac.asm.org/cgi/pmidlookup?view=long&pmid=9559825}}</ref> that blocks ] of viral mRNA by binding to a coding segment of a key CMV gene. It was the first ] antiviral approved by the FDA.<ref name="pmid9182327">{{cite journal | author = Roush W | title = Antisense aims for a renaissance | journal = Science | volume = 276 | issue = 5316 | pages = 1192–3 | year = 1997 | month = May | pmid = 9182327 | doi = 10.1126/science.276.5316.1192 | url = | issn = }}</ref> |
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== Administration == |
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It is available as an intraocular injection in a concentration of 6.6 mg/mL.<ref name="isbn0-07-145153-6">{{cite book | author = Katzung, Bertram G. | authorlink = | editor = | others = | title = Basic and Clinical Pharmacology | edition = 10th | language = | publisher = McGraw-Hill Medical Publishing Division | location = New York | year = 2006 | origyear = | pages = 817 | quote = | isbn = 0-07-145153-6 | oclc = | doi = | url = | accessdate = }}</ref> |
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==See also== |
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* ] |
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== References == |
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== References == |
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== Further reading == |
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== Further reading == |
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{{refbegin | 2}} |
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{{refbegin | 2}} |
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* {{cite journal | author = | title = Fomivirsen. | journal = Drugs Today (Barc) | volume = 37 | issue = 4 | pages = 245–255 | year = 2001 | pmid = 12768225 | last1 = Grillone | first1 = LR | last2 = Lanz | first2 = R}} |
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* {{cite journal | vauthors = Grillone LR, Lanz R | title = Fomivirsen | journal = Drugs of Today | volume = 37 | issue = 4 | pages = 245–255 | date = April 2001 | pmid = 12768225 | doi = 10.1358/dot.2001.37.4.620590 }} |
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* {{cite journal | author = Geary R, Henry S, Grillone L | title = Fomivirsen: clinical pharmacology and potential drug interactions. | journal = Clin Pharmacokinet | volume = 41 | issue = 4 | pages = 255–60 | year = 2002 | pmid = 11978144}} |
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* {{cite journal | vauthors = Geary RS, Henry SP, Grillone LR | title = Fomivirsen: clinical pharmacology and potential drug interactions | journal = Clinical Pharmacokinetics | volume = 41 | issue = 4 | pages = 255–260 | year = 2002 | pmid = 11978144 | doi = 10.2165/00003088-200241040-00002 | s2cid = 22134649 }} |
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* {{cite journal | author = | title = Randomized dose-comparison studies of intravitreous fomivirsen for treatment of cytomegalovirus retinitis that has reactivated or is persistently active despite other therapies in patients with AIDS. | journal = Am J Ophthalmol | volume = 133 | issue = 4 | pages = 475–83 | year = 2002 | pmid = 11931781| doi = 10.1016/S0002-9394(02)01326-0 | last1 = Vitravene Study | first1 = Group}} |
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* {{cite journal | vauthors = Boyer DS, Cowen SJ, Danis RP, Diamond JG, Fish RH, Goldstein DA, etal | collaboration = Vitravene Study Group | title = Randomized dose-comparison studies of intravitreous fomivirsen for treatment of cytomegalovirus retinitis that has reactivated or is persistently active despite other therapies in patients with AIDS | journal = American Journal of Ophthalmology | volume = 133 | issue = 4 | pages = 475–483 | date = April 2002 | pmid = 11931781 | doi = 10.1016/S0002-9394(02)01326-0 }} |
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* {{cite journal | author = Roehr B | title = Fomivirsen approved for CMV retinitis. | journal = J Int Assoc Physicians AIDS Care | volume = 4 | issue = 10 | pages = 14–6 | year = 1998 | pmid = 11365956}} |
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* {{cite journal | vauthors = Roehr B | title = Fomivirsen approved for CMV retinitis | journal = Journal of the International Association of Physicians in AIDS Care | volume = 4 | issue = 10 | pages = 14–16 | date = October 1998 | pmid = 11365956 }} |
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{{refend}} |
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==External links== |
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== External links == |
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* {{MedlinePlusDrugInfo|uspdi|203675}} |
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* {{MedlinePlusDrugInfo|uspdi|203675}} |
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* {{DiseasesDB|31313}} |
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* {{DiseasesDB|31313}} |
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* {{cite web | url = http://www.rxlist.com/cgi/generic2/fomivirsen.htm | title = Vitravene (Fomivirsen) Drug Information: Uses, Side Effects, Drug Interactions and Warning | author = | authorlink = | coauthors = | date = 2004-12-08| format = | work = | publisher = RxList | pages = | language = | archiveurl = | archivedate = | quote = | accessdate = 2009-05-20}} |
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{{antimicrobial-stub}} |
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{{Antivirals}} |
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{{Antivirals}} |
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{{Ophthalmological anti-infectives}} |
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