Provider Briefing: Brexafemme Kit (Ibrexafungerp) Availability in 2026

For clinicians who prescribe antifungal therapy for vulvovaginal candidiasis (VVC) and recurrent VVC (RVVC), the ongoing unavailability of Brexafemme Kit (Ibrexafungerp) represents a meaningful gap in the treatment landscape. As the only FDA-approved oral glucan synthase inhibitor for VVC and RVVC, its absence limits therapeutic options — particularly for patients with azole-resistant Candida infections.

This briefing provides a concise clinical update on the shortage timeline, prescribing considerations, alternative therapies, and tools to support your patients during this period.

Timeline of Key Events

• June 1, 2021: FDA approval of Brexafemme (Ibrexafungerp) 150 mg tablets for acute VVC in adult and postmenarchal pediatric females
• November 30, 2022: FDA approval of supplemental indication for reduction in incidence of RVVC (monthly dosing for 6 months)
• 2024: FDA clinical hold placed on Ibrexafungerp clinical studies, disrupting commercial supply
• May 2025: FDA clinical hold lifted; first new patient dosed in Phase 3 MARIO study
• November 2025: Scynexis completed transfer of the Brexafemme NDA to GSK
• Early 2026: Drug remains listed as temporarily unavailable per ASHP; no confirmed return date

Prescribing Implications

The temporary unavailability of Brexafemme Kit has several clinical implications:

Azole-Resistant VVC

Brexafemme's mechanism of action — inhibition of β-1,3-D-glucan synthase — made it a critical option for patients with Fluconazole-resistant Candida species, including certain strains of C. albicans, C. glabrata, and C. auris. Without Ibrexafungerp, providers managing resistant infections may need to consider:

• Intravaginal Boric acid suppositories (600 mg daily for 14–21 days)
• Topical Amphotericin B compounded formulations
• Topical Flucytosine (compounded)
• Referral to infectious disease for complex or refractory cases

RVVC Prevention

Brexafemme was uniquely positioned as the only FDA-approved treatment specifically for RVVC prevention (monthly 600 mg single-day dosing for 6 months). Alternative approaches include:

• Oteseconazole (Vivjoa): FDA-approved for RVVC in patients not of reproductive potential. Different mechanism (CYP51 inhibition) and dosing regimen
• Maintenance Fluconazole: 150 mg weekly for 6 months (off-label but well-established in clinical practice)

Pregnancy Considerations

Both Brexafemme and Oteseconazole (Vivjoa) are contraindicated in pregnancy. Providers should continue to verify pregnancy status before initiating either therapy and counsel patients on effective contraception during treatment.

Current Availability Picture

As of March 2026:

• Brexafemme Kit is not orderable through standard pharmaceutical wholesalers
• Existing pharmacy inventory is exhausted or near-exhausted
• Scynexis has provided no estimated return date
• GSK now holds the NDA and commercialization rights but has not announced distribution plans
• No generic Ibrexafungerp product is FDA-approved

Cost and Access Considerations

When Brexafemme Kit was available, cost was a significant barrier for many patients:

• Cash price: $450–$600 per treatment course
• Manufacturer copay card: Reduced cost to as little as $30 for eligible commercially insured patients
• Insurance: Many plans covered Brexafemme but required prior authorization or step therapy (Fluconazole first)
• Medicare Part D: Covered by some plans, subject to the $2,000 annual out-of-pocket cap

When the drug returns to market under GSK, pricing and access programs may change. Providers should anticipate the need to support patients with prior authorization paperwork and savings program enrollment.

For a detailed cost guide: How to Help Patients Save Money on Brexafemme Kit: A Provider's Guide.

Tools and Resources for Your Practice

Medfinder for Providers

Medfinder for Providers helps clinicians and care teams locate medications with limited availability. You can search for Brexafemme Kit and direct patients to pharmacies that may have stock — particularly useful when the drug returns to limited distribution.

Patient Education Resources

Share these guides with patients who have questions about the shortage:

• Brexafemme Kit Shortage Update: What Patients Need to Know
• Alternatives to Brexafemme Kit
• Brexafemme Kit Side Effects: What to Expect

ASHP Drug Shortage Database

Monitor the ASHP Drug Shortage database for the latest manufacturer updates on Ibrexafungerp tablets availability.

Looking Ahead

Several developments suggest Brexafemme Kit may eventually return:

• The FDA clinical hold was lifted in May 2025
• The Phase 3 MARIO study has resumed with new patient enrollment
• The NDA transfer to GSK was completed in November 2025, with milestone payments triggered
• GSK has the commercial infrastructure to support a broader launch when manufacturing resumes

However, no firm return date has been established. Providers should plan for continued unavailability in the near term and ensure patients have adequate alternative treatment plans in place.

Final Thoughts

The loss of Brexafemme Kit from the formulary is particularly felt in the management of RVVC and azole-resistant VVC — precisely the patient populations that had the fewest options to begin with. While the clinical hold has been resolved and the NDA is now with GSK, the path to resumed availability remains unclear.

In the interim, lean on established alternatives, consider specialty referrals for resistant cases, and use Medfinder for Providers to support your patients in locating available treatments. We'll continue to update this page as new information becomes available.