WARNING: RISK OF EMBRYO-FETAL TOXICITY BREXAFEMME is contraindicated in pregnancy because it may cause fetal harm based on findings from animal reproductive studies [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. For females of reproductive potential, verify that the patient is not pregnant prior to initiating BREXAFEMME treatment. Reassessing pregnancy status prior to each dose is recommended when BREXAFEMME is used monthly for 6 months for reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC) [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.3 )]. Advise females of reproductive potential to use effective contraception during treatment of vulvovaginal candidiasis (VVC) and throughout the 6-month treatment period for reduction in the incidence of RVVC with BREXAFEMME and, for 4 days after the last dose [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.3 )]. WARNING: RISK OF EMBRYO-FETAL TOXICITY See full prescribing information for the complete boxed warning. BREXAFEMME is contraindicated in pregnancy because it may cause fetal harm based on findings from animal reproductive studies. ( 4 , 5.1 ) For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment. Reassessing pregnancy status prior to each dose is recommended when BREXAFEMME is used monthly for 6 months for reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC). ( 2.3 , 5.1 ) Advise females of reproductive potential to use effective contraception during treatment of vulvovaginal candidiasis (VVC) and throughout the 6-month treatment period for reduction in the incidence of RVVC with BREXAFEMME and for 4 days after the last dose. ( 5.1 , 8.3 )
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings and cautions
5 WARNINGS AND PRECAUTIONS 5. 1 Risk of Embryo- Fetal Toxicity Based on findings from animal studies, BREXAFEMME use is contraindicated in pregnancy because it may cause fetal harm. In animal reproduction studies, ibrexafungerp administered orally to pregnant rabbits during organogenesis was associated with fetal malformations including absent forelimb(s), absent hindpaw, absent ear pinna, and thoracogastroschisis at dose exposures greater or equal to approximately 5 times the human exposure at the recommended human dose (RHD). For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment with BREXAFEMME. Reassessment of pregnancy status prior to each dose is recommended when BREXAFEMME is used monthly for 6 months for reduction in the incidence of RVVC. Advise females of reproductive potential to use effective contraception during treatment of VVC and throughout the 6-month treatment period for reduction in the incidence of RVVC with BREXAFEMME and, for 4 days after the last dose [see Use in Specific Populations ( 8.1 , 8.3 ) ] .
6 ADVERSE REACTIONS Treatment of VVC: The most frequent adverse reactions (incidence ≥ 2%) reported were diarrhea, nausea, abdominal pain, dizziness, and vomiting. ( 6.1 ) Reduction in the incidence of RVVC: The most frequent adverse reactions (incidence ≥ 2%) reported were headache, abdominal pain, diarrhea, nausea, urinary tract infection and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-7299 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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 A total of 545 patients were exposed to BREXAFEMME in two clinical trials of post-menarchal females with VVC (Trial 1 and Trial 2). The patients were treated with BREXAFEMME 300 mg (two 150 mg tablets) twice a day, 12 hours apart, for one day. The patients were 18 to 76 years of age (mean 34 years); 69% were White and 28% were Black or African American; 18% were of Hispanic or Latina ethnicity. The most frequently reported adverse reactions are presented in Table 1. There were no serious adverse reactions and 2 out of 545 (0.4%) patients discontinued treatment with BREXAFEMME due to vomiting (1 patient) and dizziness (1 patient). Table 1. Adverse Reactions with Rates ≥2% in BREXAFEMME-Treated Patients with VVC in Trials 1 and 2 Adverse Reaction BREXAFEMME N = 545 n (%) Placebo N = 275 n (%) Diarrhea Nausea Abdominal pain 1 Dizziness 2 Vomiting 91 (16.7%) 65 (11.9%) 62 (11.4%) 18 (3.3%) 11 (2.0%) 9 (3.3%) 11 (4.0%) 14 (5.1%) 7 (2.5%) 2 (0.7%) 1 Includes abdominal pain, abdominal pain upper, abdominal pain lower, and abdominal discomfort 2 Includes dizziness and postural dizziness Other Adverse Reactions The following adverse reactions occurred in < 2% of patients receiving BREXAFEMME in Trial 1 and Trial 2: dysmenorrhea, flatulence, back pain, elevated transaminases, vaginal bleeding, rash/hypersensitivity reaction. Reduction in the Incidence of RVVC A total of 130 patients were exposed to BREXAFEMME in a clinical trial of post-menarchal females with RVVC (Trial 3). The patients were treated with BREXAFEMME 300 mg (two 150 mg tablets) twice a day, 12 hours apart, for one day, monthly for six consecutive months. The patients were 18 to 65 years of age (mean 34 years), of which, 59% of patients were between 18 to 35 years, and 41% between 36 to 65 years. Ninety two percent (92%) were White, 7% were Black or African American, and 1% were Asian. Nine percent (9%) of patients were of Hispanic or Latina ethnicity. The most frequently reported adverse reactions are presented in Table 2. There were no serious adverse reactions and no patients discontinued treatment with BREXAFEMME due to adverse reaction. Table 2. Adverse Reactions with Rates ≥2% in BREXAFEMME-Treated Patients with RVVC in Trial 3 Adverse Reaction 1 BREXAFEMME N = 130 n (%) Placebo N = 130 n (%) Headache Abdominal pain 2 Diarrhea Nausea Urinary tract infection Fatigue 23 (17.6) 13 (10.0) 10 (7.7) 7 (5.4) 5 (3.8) 4 (3.1) 10 (7.6) 9 (6.9) 5 (3.8) 5 (3.8) 1(0.8) 0 1 A single patient may have had multiple instances of adverse reactions. Only one episode of adverse reaction is counted per patient. 2 Includes abdominal pain, abdominal pain upper, abdominal pain lower, and abdominal discomfort