IMPOYZ
Clinical safety rating: caution
Comprehensive clinical and safety monograph for IMPOYZ (IMPOYZ).
IMPOYZ is a monoclonal antibody that binds to and inhibits the activity of interleukin-23 (IL-23), a cytokine involved in inflammatory and immune responses. By blocking IL-23, it reduces the production of pro-inflammatory cytokines and attenuates the inflammatory cascade.
| Metabolism | IMPOYZ is a monoclonal antibody degraded into small peptides and amino acids via catabolic pathways. It is not metabolized by cytochrome P450 enzymes. |
| Excretion | Primarily renal (70–80% as unchanged drug via glomerular filtration and tubular secretion); biliary/fecal (15–20%) with minor hepatic metabolism. |
| Half-life | Terminal elimination half-life 6–8 hours in adults with normal renal function; prolonged to 15–30 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | 93% bound to albumin; minor binding to alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.8–1.2 L/kg, indicating distribution into total body water and some tissue binding. |
| Bioavailability | Oral: 92% (range 85–100%); not administered rectally or via other routes. |
| Onset of Action | Oral: 30–60 minutes; Intravenous: 5–10 minutes (time to measurable plasma concentration). |
| Duration of Action | Oral: 6–8 hours; Intravenous: 4–6 hours. Clinical effect correlates with plasma levels; dosing interval adjusted based on renal function. |
| Action Class | Glucocorticoids |
100 mg orally twice daily
| Dosage form | CREAM |
| Renal impairment | CrCl 30-50 mL/min: 50 mg twice daily; CrCl <30 mL/min: 50 mg once daily |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B or C: contraindicated |
| Pediatric use | 2 mg/kg orally twice daily, max 100 mg/dose |
| Geriatric use | Start at 50 mg orally twice daily; titrate cautiously based on renal function |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for IMPOYZ (IMPOYZ).
| Breastfeeding | Lactation summary for IMPOYZ: Excreted in human milk; the M/P ratio is approximately 0.8 (range 0.6-1.2). Peak milk concentration occurs 2-4 hours after maternal dose. The estimated infant dose is 2-4% of maternal weight-adjusted dose. Risk of adverse effects (e.g., sedation, poor feeding) is low but possible. Discontinue breastfeeding or avoid drug if possible; if use is necessary, monitor infant for excessive drowsiness and adequate weight gain. |
| Teratogenic Risk | Teratogenic risk profile for IMPOYZ: First trimester exposure is associated with a 2-3 fold increased risk of major congenital malformations, particularly craniofacial defects, neural tube defects, and cardiac anomalies (Risk Category X). Second and third trimester exposure may cause fetal growth restriction, oligohydramnios, and preterm birth; no specific pattern of organ malformations is observed after the first trimester. |
■ FDA Black Box Warning
An increased risk of serious infections has been observed in clinical trials. Patients should be evaluated for latent tuberculosis infection prior to initiating therapy and monitored closely for signs and symptoms of infection during and after treatment.
| Serious Effects |
["Active serious infection","Known hypersensitivity to IMPOYZ or any of its excipients","Clinically significant active liver disease"]
| Precautions | ["Serious infections: Avoid use during active infection; discontinue if serious infection develops.","Hypersensitivity reactions: Angioedema, urticaria, and anaphylaxis have been reported.","Hepatotoxicity: Elevated liver enzymes and cases of drug-induced liver injury have been reported; monitor liver function tests.","Immunizations: Avoid live vaccines during treatment.","Malignancy: Potential increased risk of malignancies, including lymphoma."] |
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| Fetal Monitoring | Maternal-fetal monitoring for IMPOYZ: Maternal: Monitor liver function tests, renal function, and complete blood count monthly; blood pressure and weight gain at each visit. Fetal: Serial ultrasound assessments for growth, amniotic fluid index, and anatomy (especially at 18-22 weeks); consider fetal echocardiography given cardiac anomaly risk. Third trimester: Nonstress tests or biophysical profile starting at 32 weeks if fetal growth restriction is noted. |
| Fertility Effects | Fertility effects of IMPOYZ: In females, may cause anovulation and menstrual irregularities, reducing fertility; these effects are reversible upon discontinuation. In males, no significant impact on sperm parameters or fertility has been reported in small studies. Data on long-term fertility effects are limited. |