INAQOVI Film-coated tablet Ref.[51639] Active ingredients: Cedazuridine Decitabine Decitabine and Cedazuridine

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT Amsterdam, Netherlands

Product name and form

Inaqovi 35 mg/100 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Red, oval biconvex shaped tablet, 14 mm diameter, plain on one side and debossed with ‘H35’ on the other side.

Qualitative and quantitative composition

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
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.

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.

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

Tablet core:

Lactose monohydrate
Hypromellose (E464)
Croscarmellose sodium (E466)
Silica, colloidal anhydrous
Magnesium stearate (E572)

Film-coating:

Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Polyethylene glycol (E1521)
Talc (E553b)
Iron oxide red (E172)

Pack sizes and marketing

5 film-coated tablets in PVC/Aluminum blisters with laminated desiccant (3-ply cold formable aluminumplastic).

Marketing authorization holder

Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT Amsterdam, Netherlands

Marketing authorization dates and numbers

EU/1/23/1756/001

Date of first authorisation: 15 September 2023

Drugs

Drug Countries
INAQOVI Austria, Canada, Estonia, Croatia, Ireland, Italy, Lithuania

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