A nationwide recall has been issued for ibrexafungerp tablets (BREXAFEMME; SCYNEXIS)because of potential cross-contamination with a non-antibacterial ß-lactam drug substance.1
Takeaways
- The nationwide recall of ibrexafungerp tablets, marketed as BREXAFEMME, has been initiated due to potential cross-contamination with a non-antibacterial ß-lactam drug substance.
- As of now, there have been no reported adverse events resulting from this cross-contamination issue, according to SCYNEXIS, the manufacturer.
- Cross-contamination with the non-antibacterial beta-lactam drug substance can lead to hypersensitivity reactions, such as rash, swelling, urticaria, and potentially life-threatening reactions like anaphylaxis.
- Ibrexafungerp tablets are antifungal medications primarily used to treat vulvovaginal candidiasis and reduce the prevalence of recurrent vulvovaginal candidiasis (RVVC).
- Clinical studies have shown that ibrexafungerp tablets are effective at reducing RVVC, with a clinical success rate of 65.4% compared to 53.1% for the placebo group.
SCYNEXIS discovered the potential cross-contamination during a review of the manufacturing equipment.1 Currently, reports of adverse events occurring because of the cross contamination have not yet been reported to SCYNEXIS.
Risks from cross-contamination with the non-antibacterial beta-lactam drug substance include hypersensitivity reactions such as rash, swelling, and urticaria. Anaphylaxis, a potentially life-threatening adverse reaction, may also occur because of crosscontamination.
Ibrexafungerp tablets are antifungal tablets used to treat vulvovaginal candidiasis and reduce recurrent vulvovaginal candidiasis prevalence (RVVC). The initial approval was based on results from the phase 3 CANDLE study.2
The study found that monthly use of ibrexafungerp tablets were safe and effective at reducing the incidence of RVVC. Clinical success, defined as no recurrence through Week 24, was observed in 65.4% of patients taking ibrexafungerp tablets compared to 53.1% taking placebo. Ibrexafungerp tablets sustained an advantage over placebo during a 3-month follow-up period.
The ibrexafungerp tablet lots began distribution throughout the United States in December 2022. SXYNEXIS is now recalling the product on the consumer level with assistance from Sedgwick. Distributors of ibrexafungerp tablets will receive recall notification letters from Sedgwick and will arrange for returns of the lots from consumers, retailers, and distributors.
Consumers should contact Sedgwick to answer any questions about the product recall. Any problems related to taking or using ibrexafungerp tablets should be discussed with one’s health care provider.
The FDA has been made aware of the product recall. Adverse reactions or quality problems related to ibrexafungerp tablets should be reported online, by regular mail, or by fax to the FDA's MedWatch Adverse Event Reporting program.
Reference
- SCYNEXIS issues a voluntary nationwide recall of BREXAFEMME (ibrexafungerp tablets) due to potential for cross contamination with a non-antibacterial ß-lactam drug substance. Scynexis. September 27, 2023. Accessed September 28, 2023. https://ir.scynexis.com/news-events/press-releases/detail/325/scynexis-issues-a-voluntary-nationwide-recall-of
- Petronelli M. FDA approves ibrexafungerp for reduction in the incidence of RVVC. Contemporary OB/GYN. December 1, 2022. Accessed Septmber 28, 2023. https://www.contemporaryobgyn.net/view/fda-approves-ibrexafungerp-for-reduction-in-the-incidence-of-rvvc
