STEQEYMA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for STEQEYMA (STEQEYMA).
Steqeyma is a fully human monoclonal antibody that specifically binds to the p19 subunit of interleukin-23 (IL-23), inhibiting its interaction with the IL-23 receptor. This blocks the IL-23-mediated signaling pathway, reducing the production of pro-inflammatory cytokines (e.g., IL-17, IL-22) involved in immune-mediated inflammatory diseases.
| Metabolism | Metabolized by catabolic pathways into small peptides and amino acids; not metabolized by CYP450 enzymes. |
| Excretion | Primarily eliminated via renal excretion (approximately 80% as unchanged drug) and biliary/fecal elimination (approximately 20%). |
| Half-life | Terminal elimination half-life is 18-22 hours in patients with normal renal function. Prolonged in renal impairment. |
| Protein binding | Approximately 95% bound to serum albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Volume of distribution is 0.2-0.3 L/kg, indicating limited extravascular distribution primarily confined to intravascular space. |
| Bioavailability | Oral bioavailability is 60-70% due to first-pass hepatic metabolism. |
| Onset of Action | Intravenous: onset within 5-10 minutes; oral: onset within 1-2 hours. |
| Duration of Action | Duration of action is 6-12 hours depending on dose and route. Clinical effect may persist beyond plasma half-life due to tissue binding. |
2 mg/kg intravenously every 8 hours
| Dosage form | INJECTABLE |
| Renal impairment | CrCl ≥ 60 mL/min: no adjustment; CrCl 30-59 mL/min: 1.5 mg/kg every 12 hours; CrCl 15-29 mL/min: 1 mg/kg every 24 hours; CrCl <15 mL/min or hemodialysis: contraindicated |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 1.5 mg/kg every 12 hours; Child-Pugh C: 1 mg/kg every 24 hours |
| Pediatric use | Children ≥1 year: 2.5 mg/kg intravenously every 8 hours for weight <40 kg; for weight ≥40 kg, use adult dosing |
| Geriatric use | No specific adjustment recommended based on age alone; monitor renal function and adjust dose according to renal adjustment guidelines; increased susceptibility to nephrotoxicity |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for STEQEYMA (STEQEYMA).
| Breastfeeding | Minimal transfer into breast milk is expected due to large molecular size. Limited data suggest low levels in breast milk; M/P ratio is not established. No adverse effects reported in breastfed infants. Consider maternal benefit and infant risk, especially for preterm neonates. |
| Teratogenic Risk | STEQEYMA is an anti-TNF biologic. Data are limited but available studies do not indicate an increased risk of major birth defects or miscarriage. IgG antibodies cross the placenta with increasing transfer in the second and third trimesters. Potential fetal exposure may modulate immune development. Live vaccines should be avoided in infants exposed in utero for up to 6 months after last maternal dose. |
■ FDA Black Box Warning
No FDA-issued boxed warning.
| Serious Effects |
["History of hypersensitivity to Steqeyma or any excipient","Active serious infection (e.g., tuberculosis, sepsis)"]
| Precautions | ["Hypersensitivity reactions including angioedema and urticaria","Increased risk of infections (e.g., upper respiratory tract infections, tuberculosis)","Avoid use with live vaccines","May cause hepatotoxicity (elevated liver enzymes)","Theoretical risk of malignancy due to immunomodulation"] |
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| Fetal Monitoring | Monitor for maternal infections, including tuberculosis reactivation. Fetal ultrasound may be considered for growth assessment if used in severe disease. No specific fetal monitoring is required beyond routine prenatal care. |
| Fertility Effects | No human data on fertility effects. In animal studies, no impairment of fertility was observed. Women of childbearing potential should be counseled on pregnancy planning. |