The Pharmacy and Poisons Board has raised alarm over a falsified Lucentis (Ranibizumab) 0.3mg injection circulating in the Kenyan market, with batch numbers 18862110 and 18802112, misleadingly claiming to be manufactured by Genentech.
In a statement on Monday, the PPB said a comparison of the suspected falsified product with the genuine product supplied by Novartis Overseas Investment AG identified several differences, including that the product is labelled Lucentis, while the brand registered in Kenya is Patizra.
“The label states 0.3 mg, while the registered product is labelled 10 mg/mL,” said PPB.
The Board also said the product is packed in a dark amber vial, while the genuine product is packed in a clear glass vial. It added that the batch number, manufacturing date, and expiry date do not match those of the genuine product.
The agency warned that the falsified injection may contain incorrect amounts of the active ingredient, no active ingredient at all, harmful contaminants or undeclared substances, and may therefore fail to provide the intended therapeutic effect.
PPB has advised healthcare professionals to verify the authenticity of their stocks before dispensing and quarantine any suspected falsified products.
The Board has also urged hospitals, procurement agencies, distributors, healthcare professionals and members of the public to report any encounter with the affected batches.
Additionally, PPB said one person has been arrested after being found in possession of the falsified product, while investigations continue to establish its source, point of entry into Kenya and the extent of its distribution.
"Further investigations are ongoing to establish the source of the product, the point of entry into the country, and the extent of distribution within the supply chain," it said.
"The Board will continue to take firm regulatory and legal action against all persons found to be involved in the manufacture, importation, distribution or supply of falsified health products and technologies."
The Board has urged all stakeholders to procure health products and technologies only from licensed manufacturers, importers, distributors and retailers.
Lucentis, also known as ranibizumab, is a 0.3mg injection used to treat eye diseases linked to diabetes.
The medicine is used to treat swelling in the macula, the part of the retina responsible for sharp, central vision. This condition, known as diabetic macular edema (DME), is caused by leaking blood vessels linked to diabetes.
It is also used to treat diabetic retinopathy, a condition that affects blood vessels in the retina, in patients with DME.