FLEQSUVY
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FLEQSUVY (FLEQSUVY).
FLEQSUVY (fosfomycin tromethamine) is a bactericidal antibiotic that inhibits bacterial cell wall synthesis by inactivating the enzyme UDP-N-acetylglucosamine-3-enolpyruvyltransferase (MurA), which catalyzes the first step of peptidoglycan biosynthesis.
| Metabolism | Fosfomycin is not metabolized by the liver; it is primarily excreted unchanged in urine via glomerular filtration and tubular secretion. |
| Excretion | Primarily renal excretion as unchanged drug (approximately 70%). Fecal elimination accounts for roughly 20%, with less than 5% as metabolites. |
| Half-life | Terminal elimination half-life is approximately 12 hours (range 10–14 hours) in healthy adults. This supports once-daily dosing in most patients. |
| Protein binding | Approximately 92% bound to serum albumin. |
| Volume of Distribution | Volume of distribution is about 1.2 L/kg, indicating extensive extravascular distribution. |
| Bioavailability | Oral bioavailability is approximately 65–70%. |
| Onset of Action | Oral administration: onset of clinical effect occurs within 1–2 hours post-dose. |
| Duration of Action | Duration of therapeutic effect is approximately 24 hours, consistent with once-daily dosing intervals. |
500 mg orally twice daily, preferably with food.
| Dosage form | SUSPENSION |
| Renal impairment | eGFR 30-89 mL/min/1.73 m²: 500 mg once daily; eGFR <30 mL/min or ESRD: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B or C: not studied, use with caution. |
| Pediatric use | Not approved for pediatric use; safety and efficacy not established. |
| Geriatric use | No specific dose adjustment required; monitor renal function and adjust per renal guidelines. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FLEQSUVY (FLEQSUVY).
| Breastfeeding | FLEQSUVY is excreted in human milk. M/P ratio is 0.85. Potential for serious adverse reactions in breastfed infants, including excess sedation, hypotonia, and feeding difficulties. Breastfeeding is not recommended during treatment and for 5 days after the last dose. |
| Teratogenic Risk | FLEQSUVY is contraindicated in pregnancy. First trimester: High risk of major congenital malformations, including neural tube defects, craniofacial abnormalities, and cardiovascular anomalies. Second/third trimester: Increased risk of spontaneous abortion, preterm birth, and fetal growth restriction. Oligohydramnios and fetal renal impairment may occur. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to fosfomycin or any component of the formulation.
| Precautions | Hypersensitivity reactions including anaphylaxis and urticaria. Clostridioides difficile-associated diarrhea (CDAD). Renal impairment may require dose adjustment. Oral formulation may cause gastrointestinal disturbances. |
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| Fetal Monitoring | Monitor maternal blood pressure, heart rate, and respiratory status. Assess fetal heart rate and amniotic fluid volume via ultrasound every 4 weeks. Nonstress test and biophysical profile weekly after 32 weeks. Monitor for signs of preterm labor. |
| Fertility Effects | FLEQSUVY may impair female fertility by disrupting menstrual cyclicity and ovulation. Reversible upon discontinuation. In males, oligospermia and reduced sperm motility have been reported. Effects on fertility are dose-dependent and typically resolve after cessation. |