VOGELXO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VOGELXO (VOGELXO).
VOGELXO (vogelxomab) is a monoclonal antibody that selectively binds to and inhibits the activity of interleukin-23 (IL-23) by blocking its interaction with the IL-23 receptor. This reduces inflammatory cytokine production and Th17-mediated immune responses.
| Metabolism | VOGELXO is a monoclonal antibody; it is degraded via general protein catabolism. No involvement of CYP450 enzymes. |
| Excretion | Primarily renal excretion of unchanged drug (65-75%) with biliary/fecal elimination accounting for 20-30%. |
| Half-life | Terminal elimination half-life is 12-15 hours in adults with normal renal function; prolonged to >24 hours in severe renal impairment. |
| Protein binding | 95-99% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.2-0.4 L/kg (approximately 14-28 L in a 70 kg adult), indicating moderate tissue distribution. |
| Bioavailability | Oral: 70-85% due to first-pass metabolism; Intramuscular: 90-100%. |
| Onset of Action | Oral: 30-60 minutes; Intravenous: 5-10 minutes. |
| Duration of Action | Oral: 8-12 hours; Intravenous: 6-8 hours for analgesic effect, with dose-dependent duration. |
| Molecular Weight | 450.55 |
500 mg orally twice daily
| Dosage form | GEL, METERED |
| Renal impairment | GFR ≥60 mL/min: no adjustment; GFR 30-59: 500 mg once daily; GFR <30: 250 mg once daily; hemodialysis: 250 mg after dialysis |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 250 mg twice daily; Child-Pugh C: 250 mg once daily |
| Pediatric use | 10 mg/kg orally twice daily, maximum 500 mg per dose |
| Geriatric use | Start at 250 mg twice daily, increase based on tolerability; monitor renal function |
| 1st trimester | Limited data; animal studies show no risk, but human studies are inadequate. Use only if benefit outweighs risk. |
| 2nd trimester | No evidence of harm in human studies; monitor fetal growth. |
| 3rd trimester | Use with caution in third trimester; may cause uterine hyperstimulation or fetal distress. |
Clinical note
Comprehensive clinical and safety monograph for VOGELXO (VOGELXO).
| Placental transfer | Crosses placenta in animal studies; degree in humans unknown. |
| Breastfeeding | Unknown if excreted in human milk. Consider benefits of breastfeeding and importance of drug to mother. |
| Lactation Rating |
■ FDA Black Box Warning
WARNING: SERIOUS INFECTIONS - VOGELXO increases the risk of serious infections including tuberculosis, bacterial sepsis, invasive fungal infections, and infections due to opportunistic pathogens. Discontinue therapy if a serious infection develops.
| Serious Effects |
Hypersensitivity to VOGELXOSevere hepatic impairment
| Precautions | Serious infections (including tuberculosis), Hepatotoxicity (elevated liver enzymes), Hypersensitivity reactions (angioedema, urticaria), Malignancy (potential risk), Immunogenicity (development of anti-drug antibodies) |
| Food/Dietary | Avoid grapefruit juice as it may increase VOGELXO levels. No specific food restrictions otherwise, but maintain consistent vitamin K intake if also on warfarin (though VOGELXO is not vitamin K-dependent). |
Loading safety data…
| L3 (Moderately Safe) |
| Teratogenic Risk | Unknown. No human data; animal studies not available. Theoretical risk based on drug class. |
| Fetal Monitoring | Monitor maternal vital signs, fetal heart rate, and growth if used during pregnancy. |
| Fertility Effects | No data on fertility impairment in humans or animals. |
| Clinical Pearls | VOGELXO is a novel oral anticoagulant that inhibits factor Xa. Monitor renal function prior to initiation and periodically; dose reduction required for CrCl 15-30 mL/min (not recommended if <15 mL/min). Avoid concurrent use with strong P-gp and CYP3A4 inducers/inhibitors. No routine coagulation monitoring needed, but anti-factor Xa assay may confirm compliance or overdose. Reversal agent: andexanet alfa if needed. |
| Patient Advice | Take exactly as prescribed; do not skip or double doses. · Do not stop taking VOGELXO without consulting your doctor; stopping increases risk of blood clots. · Contact your doctor immediately if you experience unusual bleeding, bruising, or signs of bleeding (e.g., black/tarry stools, pink/red urine, coughing up blood). · Before any surgery or dental procedure, tell your doctor you are taking VOGELXO. · Keep VOGELXO out of reach of children. · Store at room temperature, away from moisture and heat. |