Bayer has announced a voluntary recall of a single lot of its cancer therapy Vitrakvi (larotrectinib) oral solution 20mg/mL, available in 100mL glass bottles.
The consumer-level recall comes after the company detected cases of microbial contamination with Penicillium brevicompactum during routine stability inspections.
Vitrakvi treats NTRK gene fusion-positive solid tumours. Patients receiving the drug may therefore already be immunocompromised.
Penicillium brevicompactum has not been found to impact human pathology in the literature, but cases of invasive disease have been reported to be caused by such Penicillium species, especially in those with underlying immunosuppression.
In a press statement, Bayer said: “Therefore, there is a reasonable probability that ingestion of Penicillium brevicompactum in patients on Vitrakvi with underlying immunosuppression may result in invasive fungal infections of the blood or pneumonia that can be life-threatening.
“To date, Bayer has not received any adverse events related to this recall.”
The company asked anyone who has the recalled product lot to cease its usage immediately and reach out to their physician or healthcare provider if they face any issues or have queries.
Bayer is issuing this product recall with the US Food and Drug Administration’s knowledge.
The company has informed all distributors and pharmacies of the latest update and has selected Qualanex to handle the product recall at the consumer level.
Qualanex has notified distributors of Vitrakvi via a recall notification letter. The company will make arrangements for distributors, consumers and pharmacies to return the recalled product lot.
Any adverse reactions or quality-related issues encountered following the usage of Vitrakvi can be notified to the MedWatch Adverse Event Reporting programme of the FDA either online, by mail or by fax.