STATOBEX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for STATOBEX (STATOBEX).
STATOBEX is a monoclonal antibody that binds to and inhibits the activity of signal transducer and activator of transcription 3 (STAT3), thereby blocking downstream signaling pathways involved in cell proliferation, survival, and angiogenesis.
| Metabolism | STATOBEX is a monoclonal antibody and is expected to be degraded into small peptides and amino acids via general protein catabolism; not metabolized by CYP450 enzymes. |
| Excretion | Primarily renal (60-70% unchanged), biliary/fecal (20-30%), with some enterohepatic recirculation. |
| Half-life | Terminal half-life approximately 8-10 hours in healthy adults; prolonged in renal impairment (up to 20 hours). |
| Protein binding | 90-95% bound primarily to albumin. |
| Volume of Distribution | 0.3-0.4 L/kg, indicating distribution primarily in extracellular fluid. |
| Bioavailability | Oral: 75-85% (first-pass metabolism reduces absolute bioavailability). |
| Onset of Action | Intravenous: 5-10 minutes; Oral: 30-60 minutes. |
| Duration of Action | 6-8 hours for IV; oral dosing every 8-12 hours maintains therapeutic levels. |
5 mg orally once daily, taken in the morning without regard to meals.
| Dosage form | CAPSULE |
| Renal impairment | For GFR 30-50 mL/min: reduce dose to 2.5 mg daily; for GFR <30 mL/min: not recommended (no data). |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 2.5 mg daily; Child-Pugh C: contraindicated. |
| Pediatric use | Weight-based: 0.1 mg/kg orally once daily, maximum 5 mg. For <10 kg: not established. |
| Geriatric use | Start at 2.5 mg daily; titrate cautiously due to increased sensitivity and renal function decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for STATOBEX (STATOBEX).
| Breastfeeding | STATOBEX is excreted in human breast milk; M/P ratio is 2.1. The American Academy of Pediatrics recommends avoiding breastfeeding due to potential serious adverse reactions in nursing infants. A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. |
| Teratogenic Risk | STATOBEX is contraindicated in pregnancy. First trimester exposure is associated with major congenital malformations including neural tube defects and craniofacial anomalies. Second and third trimester use may cause fetal growth restriction and oligohydramnios. Long-term neurodevelopmental impairment has been reported. |
■ FDA Black Box Warning
WARNING: HEPATOTOXICITY AND EMBRYO-FETAL TOXICITY. Severe hepatotoxicity including hepatic failure has occurred. Verify hepatic function before and during treatment. Can cause fetal harm; advise females of reproductive potential of effective contraception.
| Serious Effects |
["Known hypersensitivity to STATOBEX or any of its excipients","Active hepatic impairment (Child-Pugh class B or C)"]
| Precautions | ["Hepatotoxicity: Monitor liver enzymes prior to and periodically during treatment; interrupt or discontinue if elevations occur.","Embryo-fetal toxicity: Advise females of reproductive potential to use contraception during treatment and for 5 months after last dose.","Infusion-related reactions: Premedicate and monitor during infusion; slow or stop infusion if reactions occur.","Immunogenicity: May induce anti-drug antibodies, which may affect efficacy or safety."] |
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| Fetal Monitoring | Monitor maternal blood pressure, renal function, and liver enzymes every 2 weeks. Perform serial ultrasound assessments for fetal growth and amniotic fluid volume every 4 weeks. Nonstress test or biophysical profile weekly from 32 weeks. Monitor for signs of maternal toxicity including hepatotoxicity and teratogenicity. |
| Fertility Effects | STATOBEX has been shown to impair fertility in animal studies with decreases in mating and conception rates. In humans, reversible oligospermia and menstrual irregularities have been reported. Discontinuation may improve fertility potential. |