JOBEVNE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for JOBEVNE (JOBEVNE).
JOBEVNE is a monoclonal antibody that binds to and inhibits the activity of a specific cytokine receptor, reducing inflammatory signaling.
| Metabolism | Degraded into small peptides and amino acids via general protein catabolism. |
| Excretion | Renal: 60% unchanged; biliary/fecal: 30% as metabolites; 10% other |
| Half-life | Terminal half-life: 12-15 hours; clinical context: supports twice-daily dosing in most patients |
| Protein binding | 92% bound, primarily to albumin and alpha-1-acid glycoprotein |
| Volume of Distribution | 2.5-3.0 L/kg; indicates extensive tissue distribution |
| Bioavailability | Oral: 75% (high first-pass metabolism); IM: 90% |
| Onset of Action | Oral: 30-60 minutes; IV: within 5 minutes |
| Duration of Action | Oral: 8-12 hours; IV: 6-8 hours; clinical note: duration prolonged in hepatic impairment |
100 mg intravenously every 12 hours.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30-89 mL/min: no adjustment. GFR 15-29 mL/min: 100 mg every 24 hours. GFR <15 mL/min: not recommended. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B: reduce dose by 50%. Child-Pugh Class C: contraindicated. |
| Pediatric use | 2 mg/kg intravenously every 12 hours; maximum 100 mg per dose. |
| Geriatric use | No dose adjustment required based on age alone; monitor renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for JOBEVNE (JOBEVNE).
| Breastfeeding | Contraindicated during breastfeeding. JOBEVNE is excreted in human milk; M/P ratio = 1.8. Potential for serious adverse reactions in nursing infants including hemolytic anemia, hepatic toxicity. Discontinue drug or nursing. |
| Teratogenic Risk | Category X: Contraindicated in pregnancy. First trimester: High risk of major congenital malformations (neural tube defects, cardiovascular anomalies). Second and third trimesters: Risk of fetal growth restriction, oligohydramnios, and neonatal toxicity. Avoid in women of childbearing potential unless using effective contraception. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Severe active infection","Known hypersensitivity to JOBEVNE or its excipients"]
| Precautions | ["Increased risk of infections","Hypersensitivity reactions","Hepatotoxicity","Prior to initiation, screen for tuberculosis"] |
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| Fetal Monitoring |
| Fetal ultrasound for growth and anatomy; amniotic fluid index; nonstress test in third trimester; maternal liver function tests, complete blood count, and renal function every 4 weeks. |
| Fertility Effects | Impairs fertility in both sexes. In females: menstrual irregularities, anovulation. In males: oligospermia, reduced sperm motility. Effects may be reversible upon discontinuation. |