TOPIC: VITRAKVI (larotrectinib) Oral Solution 20 mg/mL by Bayer: Recall - Due to Presence of Microbial Contamination
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: Bayer is recalling one lot of Vitrakvi (larotrectinib) Oral Solution 20 mg/mL in 100 mL glass bottles due to microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing.
Risk Statement: Given that Vitrakvi is indicated for the treatment of solid tumors that are NTRK gene fusion positive, it is expected that patients on Vitrakvi may be immunocompromised. Although there is little data in the literature on human pathology caused by Penicillium brevicompactum, there are cases of invasive disease caused by similar Penicillium species, particularly in patients with underlying immunosuppression. 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 impacted lot of Vitrakvi is packaged in a 100 mL glass bottle with NDC# 50419-392-01 and is identified with Lot# 2114228 and an expiration date of February 29, 2024. Lot# 2114228 was distributed to wholesale distributors and specialty pharmacies nationwide between January 3, 2023, and February 13, 2023.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Vitrakvi is indicated for the treatment of solid tumors that are NTRK gene fusion positive.
RECOMMENDATIONS:
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Patients who have the recalled Vitrakvi product should immediately stop use of this particular lot of product and contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to Vitrakvi Oral Solution 20 mg/mL.
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Patients or prescribers who have questions regarding the recall can contact Bayer Medical Information Call Center.
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Patients with general questions regarding this recall can contact Qualanex via email.
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