TOPIC: BREXAFEMME (ibrexafungerp tablets) by SCYNEXIS: Recall - Due to Potential for Cross Contamination with a Non-Antibacterial ßlactam Drug Substance
AUDIENCE: Consumer, Patient, Health Professional, OB/GYN
ISSUE: SCYNEXIS is recalling of 2 lots of BREXAFEMME (ibrexafungerp tablets) due to potential cross contamination with a non- antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the BREXAFEMME tablets. During a review of manufacturing equipment and cleaning activities at a supplier, SCYNEXIS was made aware of potential cross-contamination risk with a non-antibacterial beta-lactam drug substance. The press release provides additional details on the voluntary product recall recently disclosed by SCYNEXIS.
The affected BREXAFEMME lots include the following lots and expiration dates: LF21000008 (expiration date 11/2023) and LF22000051 (expiration date 11/2025). The recalled lots were distributed nationwide to wholesalers across the US, beginning in December 2022.
Risk Statement: The potential cross contamination with a non-antibacterial beta-lactam drug substance could lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis, a potentially life-threatening adverse reaction.
To date, SCYNEXIS has not received any reports of adverse events established to be due to the possible beta-lactam cross contamination.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: BREXAFEMME is an antifungal product indicated for the treatment of vulvovaginal candidiasis (VVC) and the reduction of the incidence of recurrent vulvovaginal candidiasis (RVVC).
RECOMMENDATIONS:
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Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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Consumers with questions regarding this recall can contact the company.
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