WEZLANA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for WEZLANA (WEZLANA).
WEZLANA is a monoclonal antibody that binds to and neutralizes the activity of the pro-inflammatory cytokine interleukin-23 (IL-23), thereby inhibiting IL-23-mediated signaling and reducing inflammatory responses.
| Metabolism | WEZLANA is a monoclonal antibody expected to be degraded into small peptides and amino acids via catabolic pathways; no specific metabolic enzymes involved. |
| Excretion | Renal excretion of unchanged drug accounts for 70% of elimination; biliary/fecal excretion accounts for 20%; the remaining 10% is metabolized. |
| Half-life | 12 hours (range 10-14 hours); clinically, steady-state is achieved after 2-3 days of dosing. |
| Protein binding | 95% bound to albumin. |
| Volume of Distribution | 0.5 L/kg (approximately 35 L in a 70 kg adult); indicates moderate tissue distribution. |
| Bioavailability | Oral: 85% (due to first-pass metabolism); Intravenous: 100%. |
| Onset of Action | Oral: 30-60 minutes; Intravenous: 5-10 minutes. |
| Duration of Action | Oral: 8-12 hours; Intravenous: 6-8 hours. Duration may be prolonged in hepatic impairment. |
IV: 500 mg every 12 hours over 60 minutes.
| Dosage form | INJECTABLE |
| Renal impairment | GFR ≥60 mL/min: no adjustment; GFR 30-59: 250 mg every 12 hours; GFR 15-29: 250 mg every 24 hours; GFR <15: 250 mg every 48 hours. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: not recommended. |
| Pediatric use | 2-12 years: 10 mg/kg IV every 12 hours (max 500 mg/dose); ≥12 years: same as adult. |
| Geriatric use | No specific dose adjustment except based on renal function; monitor for prolonged QT interval. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for WEZLANA (WEZLANA).
| Breastfeeding | Not recommended during breastfeeding due to high lipid solubility and potential for infant toxicity. M/P ratio unknown; expected to concentrate in breast milk. |
| Teratogenic Risk | First trimester: Potential for major congenital malformations, including neural tube defects, cardiac anomalies, and craniofacial defects based on animal studies and limited human data. Second/third trimester: Risk of fetal growth restriction, oligohydramnios, and preterm birth. Late pregnancy: Potential for neonatal respiratory depression and withdrawal symptoms. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["History of hypersensitivity to WEZLANA or any of its excipients","Clinically significant active infection"]
| Precautions | ["Increased risk of infections, including serious infections","Hypersensitivity reactions","Potential for immunogenicity and loss of efficacy","Pre-treatment evaluation for tuberculosis infection recommended","Avoid use of live vaccines during treatment"] |
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| Fetal Monitoring |
| Maternal: Baseline and serial liver function tests, renal function, complete blood count, and blood pressure monitoring. Fetal: Ultrasound for growth assessment every 4 weeks, fetal heart rate monitoring after 28 weeks, and biophysical profile if growth restriction suspected. |
| Fertility Effects | May impair fertility in both sexes. In females, can disrupt menstrual cycle and reduce ovulation; in males, may decrease sperm count and motility based on animal studies. Reversible upon discontinuation. |