BREXAFEMME (ibrexafungerp citrate)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Pregnancy

There are 0 severe contraindications.

There are 0 moderate contraindications.

There are 2 severe adverse reactions.

More Frequent	Less Frequent
None.	Abnormal hepatic function tests

Rare/Very Rare
Hypersensitivity drug reaction

There are 10 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Diarrhea Dizziness Nausea Vomiting	Abnormal vaginal bleeding Back pain Dysmenorrhea Flatulence Skin rash

Rare/Very Rare
None.

There is insufficient evidence with ibrexafungerp in pregnant females to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Based on findings from animal studies, ibrexafungerp is contraindicated in pregnancy because it may cause fetal harm. In pregnant rabbits, oral ibrexafungerp administered during organogenesis (gestation days 7 through 19) was associated with rare malformations including absent forelimb(s), absent hindpaw, absent ear pinna, absent thyroid gland, craniorachischisis, thoracogastroschisis, and trunk kyphosis at dosages up to 50 mg/kg per day (greater than or equal to approximately 5 times the human exposure at the recommended human dose).

No changes in embryo-fetal survival or fetal body weights were observed. Oral ibrexafungerp administered to pregnant rats during organogenesis (gestation days 6 through 17) was not associated with fetal toxicity or increased fetal malformations at dosages up to 50 mg/kg per day (approximately 5 times the human exposure at the recommended human dosage). In a pre-postnatal study in rats, ibrexafungerp administered from gestation day 6 through the lactation period (until lactation day 20) demonstrated no maternal toxicity or adverse effects on survival, growth, behavior, or reproduction of first-generation offspring at dosages up to 50 mg/kg per day.

There is a pregnancy safety study for ibrexafungerp. If ibrexafungerp is inadvertently administered during pregnancy or if pregnancy is detected within 4 days after a patient receives ibrexafungerp, pregnant females exposed to ibrexafungerp and their clinician should report pregnancies to the manufacturer (SCYNEXIS, Inc.) at 888-982-7299 .

There are no data on the presence of ibrexafungerp in human or animal milk, the effects on the breast-fed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ibrexafungerp and any potential adverse effects on the breast-fed child from ibrexafungerp or from the underlying maternal condition.

Clinical studies with ibrexafungerp did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. No clinically meaningful differences in the pharmacokinetics of ibrexafungerp were observed in geriatric patients compared to younger adults.