Ibrexafungerp
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Tejasvi Aryaputra
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Black Box Warning
|
RISK OF EMBRYO-FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
|
Overview
Ibrexafungerp is a triterpenoid antifungal that is FDA approved for the treatment of vulvovaginal candidiasis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea, dizziness, diarrhea, vomiting, and abdominal pain.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Treatment of VVC
- 300 mg Ibrexafungerp given 12 hours apart (600 mg in a day) for adult and post-menarchal pediatric females for one day of treatment.
- Total of four 150 mg tablets each day, two tablets every 12 hours for one day.
Reduction in the Incidence of RVVC
- 300 mg Ibrexafungerp given 12 hours apart (600 mg) for adult and post-menarchal pediatric females for one day.
- Dosages are given monthly for a total of 6 consecutive months of treatment.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ibrexafungerp in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ibrexafungerp in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Ibrexafungerp FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ibrexafungerp in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ibrexafungerp in pediatric patients.
Contraindications
- Pregnancy.
- Hypersensitive patients towards Ibrexafungerp.
Warnings
|
RISK OF EMBRYO-FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
|
Risk of Embryo-Fetal Toxicity
- Ibrexafungerp may cause fetal harm causing it to be contradicted in pregnancy.
- Absent ear pinna, absent forelimb, thoracogastroschisis, and absent hindpaw were some of the fetal malformations observed in pregnant rabbits given dosages that were greater or equal to 5 times the recommended dosage for humans.
- Advise female patients to take a pregnancy test before initiation of Ibrexafungerp treatment.
- Monitor a females pregnancy status throughout the treatment to ensure that female is not pregnant during treatment.
- Advise females of reproductive potential to use effective contraceptive methods during and for 4 days after the last dose of Ibrexafungerp treatment.
Adverse Reactions
Clinical Trials Experience
Clinical Trials Experience
- Because clinical trials are conducted under widely varying conditions and durations of follow up, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Treatment of VVC
- Trial 1 and 2 was made up of a population pool of 545 patients that were post-menarchal females with VVC.
- Patients were mostly White (68%) and ranged from 18 years of age to 76 years of age.
- Patients were given 300 mg of Ibrexafungerp 12 hours apart for one day (twice in the day).
- No serious adverse reactions reported by patients in the study.
- 2 patients had to discontinue Ibrexafungerp treatment due to dizziness and vomiting.
Table 1 summarizes Adverse Reactions with Rates ≥2% in BREXAFEMME-Treated Patients with VVC in Trials 1 and 2.
Insert Table 1
Other Adverse Reactions
- Flatulence, elevated transaminases, dysmenorrhea, rash/hypersensitivity reaction, and vaginal bleeding were also observed in Trial 1 and Trial 2.
Reduction in the Incidence of RVVC
- Trial 3 study was made up of a population pool of 130 patients that were post-menarchal females with RVVC.
- Patient population was mostly White (92%) and had ages ranging from 18 to 65 years of age.
- Patients were given 300 mg of Ibrexafungerp 12 hours apart for one day monthly for 6 consecutive months.
- No discontinuation or serious adverse reactions reported by patients in this trial.
Table 2 summarizes Adverse Reactions with Rates ≥2% in BREXAFEMME-Treated Patients with RVVC in Trial 3.
Insert Table 2
Postmarketing Experience
There is limited information regarding Ibrexafungerp Postmarketing Experience in the drug label.
Drug Interactions
- A substrate of CYP3A4 is Ibrexafungerp.
- Safety and efficacy of Ibrexafungerp can be altered, specifically plasma concentrations, by drugs that induce or inhibit CYP3A.
- P-gp, CYP3A4, and OATP1B3 transporter can be inhibited by Ibrexafungerp.
- Pharmacokinetic differences of P-gp, CYP3A4, and OATP1B3 transporters are not clinically significant during short treatment of VVC using Ibrexafungerp.
Table 3 summarizes Effect of Coadministered Drugs on Ibrexafungerp Pharmacokinetics.
Insert Table 3
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
Fetal harm may occur with Ibrexafungerp based on animal studies. Data on pregnant humans is insufficient when looking into Ibrexafungerp effects on any drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Absent ear pinna, absent forelimb, thoracogastroschisis, and absent hindpaw were some of the fetal malformations observed in pregnant rabbits given dosages that were greater or equal to 5 times the recommended dosage for humans (25 mg/kg/day of Ibrexafungerp). Increased litter incidence was observed in pregant rabbits receiving 50 mg/kg/day of Ibrexafungerp. Pregnant rats did not have any fetal malformations or changes in embryo-fetal survival or fetal body weights when given doses up to 50 mg/kg/day of Ibrexafungerp.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ibrexafungerp in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ibrexafungerp during labor and delivery.
Nursing Mothers
No current data has been done on the effects of Ibrexafungerp on the breastfed infant and the effects on milk production in women when treated with Ibrexafungerp. Advise nursing patients about any potential adverse effects caused by Ibrexafungerp on the child.
Pediatric Use
Post-menarchal pediatric patients usage of Ibrexafungerp is supported by clinical studies conducted on dult non-pregnant women with additional pharmacokinetic and safety data from post-menarchal pediatric females.
Geriatic Use
When looking at the pharmacokinetics of geriatric patients compared to younger adults, there are no clinically meaningful differences.
Gender
There is no FDA guidance on the use of Ibrexafungerp with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ibrexafungerp with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ibrexafungerp in patients with renal impairment.
Hepatic Impairment
Patients with mild or moderate hepatic impairment do not require dosage adjustment to Ibrexafungerp treatment.
Females of Reproductive Potential and Males
Fetal harm may occur when Ibrexafungerp is given to pregnant females. Advise female patients with reproductive potential to take a pregnancy test before and during Ibrexafungerp treatment. Advise female patients with reproductive potential to use effective contraception during and 4 days after Ibrexafungerp treatment for VVC. Advise female patients with reproductive potential to use effective contraception during 6 month treatment to reduce incidence of RVVC and 4 days after Ibrexafungerp treatment.
Immunocompromised Patients
There is no FDA guidance one the use of Ibrexafungerp in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Ibrexafungerp Administration in the drug label.
Monitoring
Dosage Modifications in Patients due to Concomitant Use of a Strong Inhibitor of Cytochrome P450 Isoenzymes (CYP) 3A
- Give 150 mg Ibrexafungerp 12 hours apart for one day with concomitant use of a strong CYP3A inhibitor.
- Concomitant use of a weak or moderate CYP3A inhibitor with Ibrexafungerp did not require a dosage adjustment.
- Verify a female patient with reproductive success is not pregnant before or during Ibrexafungerp treatment.
IV Compatibility
There is limited information regarding the compatibility of Ibrexafungerp and IV administrations.
Overdosage
- No experience of overdosage of Ibrexafungerp.
- No specific antidote for Ibrexafungerp.
Pharmacology
There is limited information regarding Ibrexafungerp Pharmacology in the drug label.
Mechanism of Action
- Ibrexafungerp is a triterpenoid antifungal drug.
Structure
- Ibrexafungerp has an empirical formula of C44H67N5O4•C6H8O7.
- Ibrexafungerp has a molecular weight of 922.18 g/mol.
Pharmacodynamics
- Ibrexafungerp
Pharmacokinetics
There is limited information regarding Ibrexafungerp Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Ibrexafungerp Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Ibrexafungerp Clinical Studies in the drug label.
How Supplied
There is limited information regarding Ibrexafungerp How Supplied in the drug label.
Storage
There is limited information regarding Ibrexafungerp Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Ibrexafungerp |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Ibrexafungerp |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Ibrexafungerp Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Ibrexafungerp interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Ibrexafungerp Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Ibrexafungerp Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.