The World Health Organization has warned consumers to be on vigil against fake versions of leukemia drug Iclusig sold in Europe and the Americas.
Genuine Iclusig containing the active pharmaceutical ingredient Ponatinib hydrochloride is manufactured by ARIAD, an indirect wholly-owned subsidiary of Takeda. Outside of the U.S. Iclusig is marketed by Incyte.
According to the WHO, there are 2 versions of counterfeit Iclusig being traded in Turkey, Argentina, and Switzerland and via internet sales, whose details are as follows:
— 45mg dosage; batch number PR072875 with an expiry date of 12/2019, and the stated manufacturer is INCYTE Biosciences UK Ltd.
— 15mg; batch number 25A19E09 with an expiry date of 10/2020, and the stated manufacturer is ARIAD Pharma Ltd.
Laboratory analysis of the fake ICLUSIG 15mg with batch number 25A19E09 has revealed that the product does not contain the active ingredient Ponatinib but instead has low quantities of paracetamol, and the fake ICLUSIG 45mg with batch number PR072875 does not at all contain Ponatinib.
A trader in Switzerland had purchased packs of ICLUSIG 15mg with batch number 25A19E09 last month, and it has been found to be counterfeit.
Iclusig is approved for use in chronic myeloid leukemia (CML) and Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL) patients who are resistant to or intolerant of certain second-generation BCR-ABL inhibitors and all patients who have T315I mutation.
A statement issued by Incyte on the WHO alert for Iclusig reads as “At this time, neither Incyte nor Takeda are aware of additional counterfeit product bearing different batch numbers, and to-date there are no known reported adverse reactions attributed to these falsified products.”