The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians of falsified versions of ICLUSIG 15mg and ICLUSIG 45mg circulating in the WHO Region of Europe and the WHO Region of the Americas.
The falsified product was reported to WHO on 15 January 2019, by health authorities in Switzerland that a local wholesaler had purchased packs of ICLUSIG 15mg.
Verification reveals that the products are falsified and that there are two versions of falsified ICLUSIG being traded globally according to the market authorization holder. Laboratory analysis conducted for ICLUSIG 15mg with batch number 25A19E09 confirmed that the product does not contain Ponatinib and instead contains paracetamol while that of ICLUSIG 45mg with batch number PR072875 confirmed that the product does not contain Ponatinib but instead contains paracetamol.
The active pharmaceutical ingredient of the Genuine ICLUSIG is Ponatinib Hydrochloride, which is used to treat different forms of leukaemia.
The details of the two version of falsified ICLUSIG are:
|Product Name||ICLUSIG 45mg (30 tablets||ICLUSIG 15mg (60 tablets|
|Stated manufacturer||INCYTE Biosciences UK Ltd.||ARIAD Pharma Ltd|
|Language on packaging||English||English|
|Laboratory analysis||Does not contain Ponatinib; Paracetamol identified.||Does not contain Ponatinib; Paracetamol identified|
ICLUSIG is commercialized by different stakeholders in different parts of the world. The pharmaceutical companies TAKEDA and INCYTE are the genuine manufacturers for ICLUSIG in the regions in which the above falsified versions have been discovered to date and they have both confirmed to WHO that they did not manufacture or supply the above products and that the above batch numbers do not correspond to genuine manufacturing records.
NAFDAC advices wholesaler, distributor, and pharmacies to be vigilant and purchase the product from reliable sources while also imploring health care providers and the general public to notify the nearest NAFDAC office of any information concerning the distribution, sale, and use of the falsified two versions of ICLUSIG products.