SESQUIENT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SESQUIENT (SESQUIENT).
SESQUIENT is a monoclonal antibody that binds to the IL-23 receptor, inhibiting IL-23-mediated signaling and subsequent activation of inflammatory pathways involved in psoriasis and psoriatic arthritis.
| Metabolism | Metabolized by catabolic pathways into small peptides and amino acids; not dependent on CYP450 enzymes. |
| Excretion | Renal: 80% unchanged; Biliary/Fecal: 15% as metabolites; 5% other |
| Half-life | 12 hours (range 10-14 h); allows twice-daily dosing in most patients; prolonged in renal impairment |
| Protein binding | 60% bound to albumin |
| Volume of Distribution | 1.5 L/kg (0.9-2.1); indicates extensive tissue distribution |
| Bioavailability | Oral: 75% (range 60-85%); IM: 100%; Rectal: 50% |
| Onset of Action | Oral: 30-60 minutes; IV: immediate; IM: 15-30 minutes |
| Duration of Action | 8-12 hours; clinical effect correlates with serum concentrations above 2 mcg/mL |
Intravenous injection of 20 mg/m² body surface area once every 3 weeks.
| Dosage form | SOLUTION |
| Renal impairment | GFR < 30 mL/min: Contraindicated. GFR 30-50 mL/min: Reduce dose to 10 mg/m². GFR > 50 mL/min: No adjustment. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: Reduce dose to 10 mg/m². Child-Pugh C: Contraindicated. |
| Pediatric use | 2-18 years: 20 mg/m² intravenously once every 3 weeks, maximum 40 mg/dose. |
| Geriatric use | Age ≥65 years: No specific dose adjustment; monitor renal function and consider starting at lower end of dosing range due to age-related renal decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SESQUIENT (SESQUIENT).
| Breastfeeding | No human data on excretion in breast milk. M/P ratio unknown. Due to potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment and for 2 weeks after last dose. |
| Teratogenic Risk | First trimester: Increased risk of neural tube defects (data from animal studies; limited human data). Second and third trimesters: Possible fetal growth restriction and oligohydramnios (based on case reports). Avoid in pregnancy unless benefit outweighs risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA boxed warnings.
| Serious Effects |
Hypersensitivity to SESQUIENT or any excipients; active serious infections.
| Precautions | Increased risk of infections, including tuberculosis; hypersensitivity reactions; potential for hepatotoxicity; monitor for inflammatory bowel disease exacerbation. |
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| Monitor fetal growth via ultrasound every 4 weeks. Assess amniotic fluid volume. Perform fetal nonstress test weekly starting at 32 weeks. Monitor maternal blood pressure and renal function. |
| Fertility Effects | Animal studies show reduced fertility and implantation failure at therapeutic doses. Human data insufficient. May impair spermatogenesis or ovulatory function. |