ibrexafungerp (Rx)

Brand and Other Names:Brexafemme
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 150mg

Vulvovaginal candidiasis

Indicated for treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC)

300 mg PO BID x 1 day

Total treatment dosage: 600 mg

Dosage Modifications

Coadministration with CYP3A4 inhibitors

  • Mild or moderate CYP3A4 inhibitors: No dosage adjustment necessary
  • Strong CYP3A4 inhibitors: Reduce dose of ibrexafungerp to 150 mg PO BID

Dosing Considerations

Prior to initiation, verify pregnancy status in females of reproductive potential

Dosage Forms & Strengths

tablet

  • 150mg

Vulvovaginal candidiasis

Indicated for treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC)

Premenarchal patients: Safety and efficacy not established

Postmenarchal patients

  • 300 mg PO BID x 1 day
  • Total treatment dosage: 600 mg

Dosage Modifications

Coadministration with CYP3A4 inhibitors

  • Mild or moderate CYP3A4 inhibitors: No dosage adjustment necessary
  • Strong CYP3A4 inhibitors: Reduce dose of ibrexafungerp to 150 mg PO BID

Dosing Considerations

  • Prior to initiation, verify pregnancy status in females of reproductive potential
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Interactions

Interaction Checker

and ibrexafungerp

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (1)

              • mobocertinib

                ibrexafungerp will increase the level or effect of mobocertinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If use of moderate CYP3A4 inhibitor unavoidable, reduce mobocertinib dose by ~50% (eg, 160 to 80 mg); closely monitor QTc interval.

              Monitor Closely (2)

              • finerenone

                ibrexafungerp will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or moderate CYP3A4 inhibitors. Adjust finererone dosage as needed.

              • voclosporin

                voclosporin, ibrexafungerp. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.

              Minor (0)

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                Adverse Effects

                >10%

                Diarrhea (16.7%)

                Nausea (11.9%)

                Abdominal pain (11.4%)

                1-10%

                Dizziness (3.3%)

                Vomiting (2%)

                <2%

                • Dysmenorrhea
                • Flatulence
                • Back pain
                • Elevated transaminases
                • Vaginal bleeding
                • Rash/hypersensitivity reaction
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                Warnings

                Contraindications

                Pregnancy

                Hypersensitivity to ibrexafungerp

                Cautions

                Contraindicated to pregnancy; based on animal data, fetal harm may occur

                Drug interaction overview

                • CYP3A4 substrate
                • Inhibitor of CYP3A4, P-gp and OATP1B3 transporter
                • Strong CYP3A4 inhibitors
                  • Reduce ibrexafungerp dose
                  • Strong CYP3A inhibitors increase the exposure of ibrexafungerp
                • Strong and moderate CYP3A inducers
                  • Avoid coadministration
                  • Strong and moderate CYP3A inducers may significantly reduce the exposure of ibrexafungerp
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                Pregnancy & Lactation

                Pregnancy

                Contraindicated

                Insufficient data are available on use in pregnant females on any drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

                Verify pregnancy status in females of reproductive potential before initiating treatment

                If inadvertently administered during pregnancy or if pregnancy is detected within 4 days after receiving therapy, pregnant females exposed and healthcare providers should report pregnancies to SCYNEXIS, Inc. at 1-888-982-SCYX (7299)

                Contraception

                • Females of reproductive potential: Use effective contraception during treatment and for 4 days after final dose

                Animal data

                • In pregnant rabbits, oral ibrexafungerp administered during organogenesis was associated with rare malformations including absent forelimb(s), absent hindpaw, absent ear pinna, and thoracogastroschisis at dose exposures greater or equal to ~5x the human exposure at the recommended human dose (RHD)
                • Oral ibrexafungerp administered to pregnant rats during organogenesis was not associated with fetal toxicity or increased fetal malformations at a dose exposure ~5x the human exposure at the RHD

                Lactation

                No data are available on drug presence in either human or animal milk, effects on breastfed infants, or effects on milk production

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Triterpenoid antifungal agent

                Inhibits glucan synthase, an enzyme involved in the formation of 1,3-beta-D-glucan, an essential component of the fungal cell wall

                Concentration-dependent fungicidal activity against candidal species as measured by time-kill studies

                Shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections:

                • Candida auris
                • Candida dubliniensis
                • Candida glabrata
                • Candida guilliermondii
                • Candida keyfr
                • Candida krusei
                • Candida lusitaniae
                • Candida parapsilosis
                • Candida tropicalis

                Absorption

                • Peak plasma time: 4-6 hr
                • Peak plasma concentration

                  • Fasted: 435 ng/mL
                  • Fed: 629 ng/mL
                • AUC

                  • Fasted: 6832 ng·hr/mL
                  • Fed: 9867 ng·hr/mL

                Effect of food

                • High-fat meal (800-1000 calories; 50% fat): Ibrexafungerp peak plasma concentration increased 32% and the AUC increased 38% compared with fasted conditions; not considered clinically significant

                Distribution

                • Vd (steady-state): ~6000 L
                • Protein bound: >99%

                Metabolism

                Primarily metabolized by hydroxylation by CYP3A4

                Followed by glucuronidation and sulfation of a hydroxylated inactive metabolite

                Elimination

                Half-life: 20 hr

                Excretion: Feces (90%; 51% unchanged); urine (1%)

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                Administration

                Oral Administration

                Take with or without food

                Storage

                Tablets: Store at 20-25ºC (68-77ºF); excursion permitted to 15-30ºC (59-86ºF)

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                Images

                No images available for this drug.
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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

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                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.