Version May 2024
Ibrexafungerp is contraindicated in pregnancy because it may cause fetal harm based on findings from animal reproductive studies.
For females of reproductive potential, verify that the patient is not pregnant prior to initiating ibrexafungerp treatment. Reassessing pregnancy status prior to each dose is recommended when ibrexafungerp is used monthly for 6 months for reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC).
Advise females of reproductive potential to use effective contraception during treatment of vulvovaginal candidiasis and throughout the 6-month treatment period for reduction in the incidence of RVVC with ibrexafungerp and for 4 days after the last dose.
Candidiasis, vulvovaginal:
Acute infection, treatment (alternative agent):
Note: For mild/moderate infection in immunocompetent patients (Ref); some experts also use for patients with severe infection (Ref). Reserve for those who cannot take fluconazole or have infection that is refractory or resistant to fluconazole (Ref).
Oral: 300 mg every 12 hours for 1 day (2 doses) (Ref).
Recurrent infection, reduction in incidence: Oral: 300 mg every 12 hours for 1 day (2 doses); repeat monthly for a total of 6 months. Note: In clinical trials, participants had experienced ≥3 episodes in the previous year and received fluconazole for symptomatic treatment of their recurrent episode prior to initiating ibrexafungerp for reducing incidence of recurrent infection.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
Mild to moderate impairment (Child-Pugh classes A and B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Ibrexafungerp: Pediatric drug information")
Candidiasis, vulvovaginal: Postmenarchal Children and Adolescents: Oral: 300 mg every 12 hours for 2 doses.
Candidiasis, vulvovaginal, recurrent (reduction in incidence): Postmenarchal Children and Adolescents: Oral: 300 mg every 12 hours for 1 day (2 doses); repeat monthly for 6 months. Note: In clinical trials, participants had experienced ≥3 episodes in the previous year and received fluconazole treatment for symptomatic treatment of their recurrent episode prior to initiating ibrexafungerp.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
Postmenarchal Children and Adolescents:
Mild to moderate impairment (Child-Pugh classes A and B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Gastrointestinal: Abdominal pain (10% to 11%), diarrhea (8% to 17%), nausea (5% to 12%)
Nervous system: Headache (18%)
1% to 10%:
Dermatologic: Skin rash (<2%)
Gastrointestinal: Flatulence (<2%), vomiting (2%)
Genitourinary: Dysmenorrhea (<2%), urinary tract infection (4%), vaginal hemorrhage (<2%)
Hepatic: Increased serum transaminases (<2%)
Hypersensitivity: Hypersensitivity reaction (<2%)
Nervous system: Fatigue (3%)
Neuromuscular & skeletal: Back pain (<2%)
Hypersensitivity to ibrexafungerp or any component of the formulation; pregnancy.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as citrate:
Brexafemme: 150 mg [contains fd&c blue #2 (indigotine,indigo carmine), fd&c red #40 (allura red ac dye)]
No
Tablets (Brexafemme Oral)
150 mg (per each): $163.09
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: Administer with or without food. Administer doses ~12 hours apart (eg, in the morning and in the evening).
Oral: Administer without regard to food; doses should be separated by ~12 hours.
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214900s002lbl.pdf#page=18, must be dispensed with this medication.
Candidiasis, vulvovaginal: Treatment of vulvovaginal candidiasis (VVC) and reduction in the incidence of recurrent VVC in adult and postmenarchal pediatric patients.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
Substrate of CYP3A4 (major), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CYP3A4 Inducers (Moderate): May decrease the serum concentration of Ibrexafungerp. Risk X: Avoid combination
CYP3A4 Inducers (Strong): May decrease the serum concentration of Ibrexafungerp. Risk X: Avoid combination
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Ibrexafungerp. Management: Decrease the ibrexafungerp dose to 150 mg every 12 hours for 2 doses in patients receiving strong CYP3A4 inhibitors. Risk D: Consider therapy modification
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Saccharomyces boulardii: Antifungal Agents (Systemic and Oral [Non-Absorbable]) may diminish the therapeutic effect of Saccharomyces boulardii. Risk X: Avoid combination
Verify pregnancy status prior to treatment initiation and also reassess prior to each monthly dose when used for recurrent vulvovaginal candidiasis (VVC).
When used for the single-day treatment of VVC, patients who may become pregnant should use effective contraception during therapy and for 4 days after the last ibrexafungerp dose. When used for recurrent VVC, effective contraception should be used throughout the 6-month treatment period and for 4 days after the last dose of ibrexafungerp.
Based on data from animal reproduction studies, in utero exposure to ibrexafungerp may cause fetal harm. Use during pregnancy is contraindicated.
Data collection to monitor pregnancy and infant outcomes following exposure to ibrexafungerp is ongoing. Health care providers are encouraged to enroll patients exposed to ibrexafungerp during pregnancy in the Pregnancy Registry (1-888-982-7299). Patients whose pregnancy is detected within 4 days after exposure should also be enrolled.
It is not known if ibrexafungerp is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Pregnancy testing prior to initiating treatment; reassess pregnancy status prior to each dose when used monthly for reduction in incidence of recurrent vulvovaginal candidiasis.
Ibrexafungerp is a triterpenoid antifungal that inhibits glucan synthase, an enzyme involved in the formation of an essential component of the fungal cell wall (1,3-beta-D-glucan).
Absorption: Administration with a high-fat meal (800 to 1,000 calories; 50% fat) increased Cmax by 32% and AUC by 38%, compared to fasting.
Distribution: Vdss: ~600 L.
Protein binding: >99%, primarily to albumin.
Metabolism: Hydroxylation by CYP3A4, followed by glucuronidation and sulfation of a hydroxylated inactive metabolite.
Half-life elimination: ~20 hours.
Time to peak: 4 to 6 hours.
Excretion: Feces: 90% (51% as unchanged drug); Urine: 1%.
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