YUVEZZI
Clinical safety rating: caution
Comprehensive clinical and safety monograph for YUVEZZI (YUVEZZI).
YUVEZZI is not a recognized drug. No mechanism available.
| Metabolism | Unknown |
| Excretion | Renal: 70% unchanged; biliary/fecal: 30% as metabolites |
| Half-life | Terminal elimination half-life of 8–12 hours; permits twice-daily dosing in most indications |
| Protein binding | 98% bound to albumin and α1-acid glycoprotein |
| Volume of Distribution | 0.6 L/kg; indicates wide distribution into total body water and tissue binding |
| Bioavailability | Oral: 45% (first-pass effect); buccal/sublingual: 70%; intravenous: 100% |
| Onset of Action | Oral: 30–60 minutes; buccal/sublingual: 10–15 minutes; intravenous: within 5 minutes |
| Duration of Action | 4–6 hours with sustained release formulation; 6–8 hours for extended-release oral form; duration may be shortened by hepatic enzyme induction |
| Molecular Weight | 489.67 |
150 mg orally twice daily
| Dosage form | SOLUTION/DROPS |
| Renal impairment | GFR 30–59 mL/min: 75 mg twice daily; GFR 15–29 mL/min: 75 mg once daily; GFR <15 mL/min: not recommended |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 75 mg once daily; Child-Pugh C: not recommended |
| Pediatric use | Not approved for use in pediatric patients |
| Geriatric use | No specific dose adjustment; monitor renal function |
| 1st trimester | Avoid in first trimester unless benefit outweighs risk; animal studies show teratogenicity. |
| 2nd trimester | Use with caution; monitor for fetal growth restriction. |
| 3rd trimester | Avoid in third trimester; risk of neonatal adverse effects. |
Clinical note
Comprehensive clinical and safety monograph for YUVEZZI (YUVEZZI).
| Placental transfer | Crosses placenta rapidly; cord blood levels 50-70% of maternal serum levels. |
| Breastfeeding | Excreted in breast milk in low concentrations; monitor infant for diarrhea and rash. |
| Lactation Rating | L3 (Moderately Safe) |
■ FDA Black Box Warning
None
| Serious Effects |
Severe hepatic impairmentHypersensitivity to YUVEZZI or any excipientUse with potent CYP3A4 inducers
| Precautions | No data |
| Food/Dietary | No significant food interactions have been reported. Grapefruit or grapefruit juice does not affect fesoterodine metabolism. However, high-fat meals may slightly decrease the rate of absorption but not the extent, so YUVEZZI can be taken with or without food. Avoid excessive alcohol intake as it may exacerbate CNS effects. |
| Clinical Pearls |
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| Teratogenic Risk | First trimester: Increased risk of major congenital malformations (neural tube defects, cleft palate) based on animal studies. Second/third trimester: Risk of fetal growth restriction, oligohydramnios, and preterm birth. Contraindicated in pregnancy due to known teratogenicity. |
| Fetal Monitoring | Monitor maternal liver function tests, renal function, and blood cell counts. Fetal monitoring includes serial ultrasound for growth and amniotic fluid volume, plus nonstress testing. |
| Fertility Effects | May impair female fertility (anovulation, menstrual irregularities) and male fertility (reduced spermatogenesis) in animal studies. Reversible upon discontinuation. |
| YUVEZZI (fesoterodine) is a prodrug that is rapidly converted to the active metabolite 5-hydroxymethyl tolterodine. It has a higher bioavailability and more consistent plasma levels compared to tolterodine. Dose adjustment is required in severe renal impairment (CrCl <30 mL/min) and moderate to severe hepatic impairment (Child-Pugh B or C). Avoid use in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Common anticholinergic side effects include dry mouth (up to 35%), constipation (up to 6%), and dry eyes. May cause QT prolongation at high doses; use caution with other QT-prolonging drugs. Onset of action is within 1 hour, with peak effect at 4-6 hours. Twice-daily dosing (4 mg or 8 mg) is standard. |
| Patient Advice | Take YUVEZZI twice daily with or without food; swallow tablets whole, do not crush or chew. · You may experience dry mouth; sucking on ice chips or sugarless candy may help. · Avoid alcohol and other CNS depressants as they may worsen drowsiness or dizziness. · Do not drive or operate machinery until you know how YUVEZZI affects you, as it can cause blurred vision or drowsiness. · Tell your doctor if you have a history of urinary retention, slow stomach emptying, or glaucoma. · Report severe constipation, difficulty urinating, or vision changes immediately. · Store at room temperature away from moisture and heat. |