Bayer Recalls Oral Larotrectinib Solution Because of Microbial Contamination

Bayer has voluntarily recalled 1 lot of the larotrectinib (Vitrakvi) 20 mg/mL oral solution that is packaged in 100-mL glass bottles because of the presence of Penicillium brevicompactum contamination that was observed during ongoing, routine stability testing.¹

Larotrectinib is approved for the treatment of patients with solid tumors harboring NTRK gene fusions who may are expected to be immunocompromised while receiving the agent. Cases of invasive disease have been caused by Penicillium species similar to Penicillium brevicompactum, and often occur particularly in immunosuppressed patients. Therefore, ingestion of Penicillium brevicompactum may lead to pneumonia or invasive fungal blood infections, which may be life threatening.

As of November 21, 2023, Bayer has not been notified of any adverse effects (AEs) with larotrectinib related to this recall.

The recalled lot of larotrectinib is packaged in 100-mL glass bottles with National Drug Code number 50419-392-01, Lot number 2114228, and an expiration date of February 29, 2024. Lot number 2114228 was distributed to specialty pharmacies and wholesale retailers across the United StatesS between January 3, 2023, and February 13, 2023.

Bayer notified all distributors and pharmacies of this recall on November 8, 2023, and has partnered with Qualanex to manage this recall down to the consumer levels. Qualanex has sent a recall notification letter to distributors of larotrectinib and plans to arrange for the return of the recalled lot of the drug from distributors, specialty pharmacies, and consumers.

The FDA recommends that patients who have the recalled larotrectinib product immediately cease using that lot of the product. Patients should also contact their physician or healthcare provider if they have any questions or concerns, or if they have experienced any issues related to the product. Patients or prescribers with questions about this recall can contact the Bayer Medical Information Call Center at 1-888-842-2937 Monday through Friday from 8:30 AM through to 8 PM EST. Additionally, patients who have general questions about this recall can email Qualanex at Recall@qualanex.com or call toll-free at 888-280-2043 Monday through Friday from 7 AM through to 4 PM CST.

Patients and health professionals may report AEs or quality issues related to the use of larotrectinib to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting an online report; or by downloading the form; or by calling 1-800-332-1088 to request the form. Once completed, thed returning the completed form can be mailed to the address on the formlisted on the documentor faxeding it to 1-800-FDA-0178.

In 2018, larotrectinib received accelerated approval from the FDA for the treatment of adult and pediatric patients with solid tumors expressing an NTRK gene fusion without a known acquired resistance mutation.2Oral larotrectinib capsules are indicated for tumors that are metastatic or where surgical resection is likely to cause severe morbidity, and. Ppatients must have no satisfactory alternative treatments or have their disease that hasmust have progressed following after prior treatment.³ The recommended dosage of larotrectinib for adult and pediatric patients with a body surface area of at least 1 m² is 100 mg orally twice daily. The recommended dosage for pediatric patients with a body surface area of less than 1 m2 is 100 mg/m² orally twice daily.

References

1. Bayer issues voluntary recall nationwide of VITRAKVI (larotrectinib) oral solution 20 mg/mL due to presence of microbial contamination. News Release. FDA. November 21, 2023. Accessed November 22, 2023. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-issues-voluntary-recall-nationwide-vitrakvir-larotrectinib-oral-solution-20-mgml-due-presence?utm_medium=email&utm_source=govdelivery
2. FDA approves larotrectinib for solid tumors with NTRK gene fusions. News Release. FDA. November 26, 2018. Accessed November 22, 2023. https://www.fda.gov/drugs/fda-approves-larotrectinib-solid-tumors-ntrk-gene-fusions
3. Larotrectinib. Prescribing information. Bayer; 2023. Accessed November 22, 2023. https://labeling.bayerhealthcare.com/html/products/pi/vitrakvi_PI.pdf