This crystallisation could possibly lead to incorrect dosing.
No other formulations of Sandimmune are affected.
The drug is intended for use as prophylaxis of organ rejection in allogeneic transplants of kidney, liver and heart.
It is also indicated to treat chronic rejection in patients who have received other immunosuppressive agents earlier.
Cyclosporine crystallisation in the Sandimmune Oral Solution may cause non-uniform dispersal of the cyclosporine in the product, leading to under-dosing or over-dosing.
In a press statement, Novartis said: “There is a reasonable probability that under-dosing may result in lower exposures and decrease in efficacy, which could ultimately lead to graft rejection and graft loss in transplant patients.
“Furthermore, over-dosage may manifest itself as cyclosporine toxicity in the long term if over-exposure continues.”
The impacted lot number is FX001691 with an expiration date of December 2025.
The company is recalling a lot of Sandimmune Oral Solutions with the US Food and Drug Administration’s knowledge.
Separately, Novartis will discontinue the development of gene therapy GT005 for geographic atrophy secondary to dry age-related macular degeneration.
Novartis gained rights to GT005 through its acquisition of Gyroscope from Syncona in February 2022.
The latest move comes after an Independent Data Monitoring Committee recommended suspending the programme development after reviewing data from the Phase II HORIZON clinical trial.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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