Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT Amsterdam, Netherlands
Inaqovi 35 mg/100 mg film-coated tablets.
Pharmaceutical Form |
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Film-coated tablet (tablet). Red, oval biconvex shaped tablet, 14 mm diameter, plain on one side and debossed with ‘H35’ on the other side. |
Each film-coated tablet contains 35 mg decitabine and 100 mg cedazuridine.
Excipient with known effect: Each film-coated tablet contains 306 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
Active Ingredient | Description | |
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Cedazuridine |
Cedazuridine inhibits cytidine deaminase (CDA), an enzyme that is responsible for the degradation of cytidine nucleosides, including the cytidine analog decitabine. Oral administration of cedazuridine with decitabine increases the systemic exposure of decitabine via inhibition of first pass metabolism of decitabine in the gut and liver by CDA. |
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Decitabine |
Decitabine is a cytidine deoxynucleoside analogue that selectively inhibits DNA methyltransferases at low doses, resulting in gene promoter hypomethylation that can result in reactivation of tumour suppressor genes, induction of cellular differentiation or cellular senescence followed by programmed cell death. |
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Decitabine and Cedazuridine |
Decitabine is a nucleoside metabolic inhibitor that is believed to exert its antineoplastic effects after phosphorylation and direct incorporation into DNA and inhibition of DNA methyltransferase, causing hypomethylation of DNA and cellular differentiation and/or apoptosis. Cedazuridine inhibits cytidine deaminase (CDA), an enzyme that is responsible for the degradation of cytidine nucleosides, including the cytidine analog decitabine. Oral administration of cedazuridine with decitabine increases the systemic exposure of decitabine via inhibition of first pass metabolism of decitabine in the gut and liver by CDA. |
List of Excipients |
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Tablet core: Lactose monohydrate Film-coating: Polyvinyl alcohol (E1203) |
5 film-coated tablets in PVC/Aluminum blisters with laminated desiccant (3-ply cold formable aluminumplastic).
Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT Amsterdam, Netherlands
EU/1/23/1756/001
Date of first authorisation: 15 September 2023
Drug | Countries | |
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INAQOVI | Austria, Canada, Estonia, Croatia, Ireland, Italy, Lithuania |
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