Public Alert No: 0007/2019 – Falsified ICLUSIG traded globally

The National Agency for Food and Drug Administration and Control (NAFDAC) has been notified of falsified versions of ICLUSIG 15mg and ICLUSIG 45mg circulating in the WHO Region of Europe and the WHO Region of the Americas.

The active pharmaceutical ingredient of the Genuine ICLUSIG is Ponatinib Hydrochloride, which is used to treat different forms of leukaemia.

 The existence of 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: upon verification, the market authorization holder confirmed these packs as falsified. Further investigation confirmed that there are two versions of falsified ICLUSIG being traded globally, including via internet sales, detailed in the below table:

Laboratory analysis of ICLUSIG 15mg with batch number 25A19E09 has confirmed that the product does not contain Ponatinib and instead contains paracetamol.  Laboratory analysis of ICLUSIG 45mg with batch number PR072875 has confirmed that the product does not contain Ponatinib and instead contains paracetamol.

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
Batch Number PR072875 25A19E09
Expiry Date 12/2019 10/2020
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 / market authorization holders 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

▪ The above batch numbers do not correspond to genuine manufacturing records.

 

NAFDAC advices wholesaler, distributor, and pharmacies that product should be obtained from authentic and reliable sources, increased vigilance is hereby encouraged within the supply chain to avoid infiltration of the falsified product.

NAFDAC implores healthcare providers to ensure vigilance to prevent the administration of the falsified products to unsuspecting patient.

Health care providers and the general public should notify the nearest NAFDAC office of any information concerning the distribution, sale, and use of the falsified two versions of ICLUSIG products.

Consumers are advised to report adverse events related to the use on any of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng

NAFDAC………….Safeguarding the health of the Nation!!!