Ibrexafungerp

Ibrexafungerp

What is Ibrexafungerp?

Ibrexafungerp (BREXAFEMME), available as an oral tablet, contains ibrexafungerp citrate, a triterpenoid antifungal agent.

What are the uses of this medicine?

Ibrexafungerp (BREXAFEMME) is a triterpenoid antifungal indicated for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis

How does Ibrexafungerp work?

• Ibrexafungerp is a triterpenoid antifungal drug.
• Ibrexafungerp inhibits glucan synthase, an enzyme involved in the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall.
• Ibrexafungerp has concentration-dependent fungicidal activity against Candida species as measured by time kill studies.
• Ibrexafungerp retains in vitro antifungal activity when tested at pH 4.5 (the normal vaginal pH).
• Resistance The potential for resistance to ibrexafungerp has been evaluated in vitro and is associated with mutations of the fks-2 gene; the clinical relevance of these findings is unknown.

Who Should Not Use this medicine?

• Pregnancy
• Hypersensitivity to ibrexafungerp

Is Ibrexafungerp FDA approved?

Yes, in June of 2021, under brand name BREXAFEMME

How should Ibrexafungerp be used?

• The recommended dosage of Ibrexafungerp in adult and post-menarchal pediatric females is 300 mg (two tablets of 150 mg) twice a day for one day, for a total treatment dosage of 600 mg.
• Ibrexafungerp may be taken with or without food.
• Prior to initiating treatment, verify pregnancy status in females of reproductive potential.

What are the dosage forms and brand names of this medicine?

Tablets: 150 mg of ibrexafungerp

What side effects can this medication cause?

The most frequent adverse reactions (≥ 2%) reported with ibrexafungerp in clinical trials of vulvovaginal candidiasis treatment were:

• diarrhea
• nausea
• abdominal pain
• dizziness, and
• vomiting

What drug interactions can Ibrexafungerp cause?

• Simultaneous use of strong CYP3A inhibitors increases the exposure of ibrexafungerp.
• Reduce Ibrexafungerp dose with concomitant use of a strong CYP3A inhibitor to 150 mg twice daily for one day.
• Simultaneous use of strong and moderate CYP3A inducers may significantly reduce the exposure of ibrexafungerp.
• Avoid simultaneous administration of Ibrexafungerp with strong or moderate CYP3A inducers

What special precautions should I follow?

• Risk of Fetal Toxicity: May cause fetal harm based on animal studies.
• Advise females of reproductive potential to use effective contraception during treatment

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

There is no experience with overdosage of Ibrexafungerp. There is no specific antidote for ibrexafungerp. Treatment should be supportive with appropriate monitoring

Can Ibrexafungerp be used in pregnancy?

No. Based on findings from animal studies, BREXAFEMME use is contraindicated in pregnancy because it may cause fetal harm

Can Ibrexafungerp be used in children?

Not studied

What should I know about storage and disposal of this medication?

• Store BREXAFEMME at room temperature between 68°F to 77°F (20°C to 25°C).
• BREXAFEMME is supplied in child resistant packaging.
• Keep BREXAFEMME and all medicines out of reach of children.

What are the active and inactive ingredients in this medicine?

• Active ingredient: ibrexafungerp

Inactive ingredients

• Tablet core:butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, and microcrystalline cellulose.
• Tablet film coating: FD&C Blue #2, FD&C Red #40, hydroxypropyl cellulose, hydroxypropylmethyl cellulose 2910, talc and titanium dioxide.

• Dailymed label info on Ibrexafungerp
• FDA Ibrexafungerp