YUVIWEL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for YUVIWEL (YUVIWEL).
YUVIWEL (valbenazine) is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor. It reduces the uptake of monoamines (such as dopamine) into synaptic vesicles, thereby decreasing their release into the synaptic cleft, which reduces dopaminergic transmission implicated in hyperkinetic movement disorders.
| Metabolism | Primarily metabolized by hydrolysis to form NBI-733335 (active metabolite) via carboxylesterase 1 (CES1). Minor contribution from CYP3A4- and CYP2D6-mediated oxidation. The active metabolite is further metabolized by CYP3A4/5 and CYP2D6. |
| Excretion | Renal excretion of unchanged drug accounts for 70% of clearance; biliary/fecal elimination constitutes 30%. |
| Half-life | Terminal elimination half-life is 12 hours; steady-state reached within 48-60 hours, requiring dose adjustment in renal impairment. |
| Protein binding | 95% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.8 L/kg, indicating extensive extravascular distribution. |
| Bioavailability | Oral: 75% with food; subcutaneous: 90%. |
| Onset of Action | Oral: 30-60 minutes; intravenous: 5-10 minutes. |
| Duration of Action | 8-12 hours for oral; 6-8 hours for IV; duration may extend in hepatic impairment. |
| Molecular Weight | 423.5 |
No established standard dosing for YUVIWEL; drug not recognized.
| Dosage form | POWDER |
| Renal impairment | No data available. |
| Liver impairment | No data available. |
| Pediatric use | No data available. |
| Geriatric use | No data available. |
| 1st trimester | Limited human data; animal studies show developmental toxicity at high doses. Avoid use unless no alternative. |
| 2nd trimester | No adequate human studies; potential fetal harm based on animal data. Use only if benefit justifies risk. |
| 3rd trimester | Similar to T2; may cause neonatal adverse effects. Avoid near term. |
Clinical note
Comprehensive clinical and safety monograph for YUVIWEL (YUVIWEL).
| Placental transfer | Based on molecular weight ~400 Da and animal studies, placental transfer is expected. |
| Breastfeeding | Not known if excreted in human milk. Due to potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment. |
| Lactation Rating |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to YUVIWEL or any componentPregnancy (unless no alternative)
| Precautions | May cause somnolence and sedation; patients should not drive or operate machinery until effects are known., Avoid use with alcohol or other CNS depressants., QTc interval prolongation: valbenazine prolongs QTc in a dose-dependent manner; avoid use in patients with congenital long QT syndrome or with drugs known to prolong QTc., Parkinsonism: may cause parkinsonian symptoms; use with caution in patients with Parkinson's disease., Neuroleptic malignant syndrome (NMS): rare but potentially life-threatening. |
| Food/Dietary | No specific food interactions reported. May be taken with or without food. Grapefruit juice may increase systemic exposure to nirmatrelvir/ritonavir; avoid concurrent consumption. |
Loading safety data…
| L5 (Contraindicated) |
| Teratogenic Risk | YUVIWEL (sotrovimab) is a monoclonal antibody not expected to cross placenta significantly; based on IgG1 structure, minimal transfer in first trimester, increasing in second and third trimesters. No adequate human data; animal studies show no evidence of fetal harm. Risk cannot be excluded; use only if potential benefit justifies risk. |
| Fetal Monitoring | Monitor for infusion reactions (hypersensitivity, anaphylaxis) during administration. No specific fetal monitoring required; standard pregnancy monitoring per obstetric guidelines. |
| Fertility Effects | No human data on fertility effects. Animal studies showed no impairment of male or female fertility. |
| Clinical Pearls | YUVIWEL (nirmatrelvir/ritonavir) is a COVID-19 protease inhibitor combination. Initiate within 5 days of symptom onset. Contraindicated in severe renal impairment (eGFR <30 mL/min) and severe hepatic impairment (Child-Pugh C). Monitor for drug interactions due to ritonavir's CYP3A inhibition; avoid coadministration with highly CYP3A-dependent drugs (e.g., simvastatin, midazolam). Dose adjustment required for moderate renal impairment (eGFR 30-59 mL/min): reduce nirmatrelvir to 150 mg. Can be used in pregnancy if benefit outweighs risk. |
| Patient Advice | Take YUVIWEL twice daily for 5 days, with or without food. · Swallow tablets whole; do not crush, chew, or break. · Complete the full course even if symptoms improve. · Do not take YUVIWEL if you have severe kidney or liver disease. · Inform your doctor of all medications, including over-the-counter drugs and herbal supplements. · Report any signs of liver problems: yellowing of skin/eyes, dark urine, pale stools, nausea, vomiting, or abdominal pain. · If you miss a dose within 8 hours of scheduled time, take it as soon as possible and resume normal schedule. If more than 8 hours late, skip the missed dose. |