EBANGA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for EBANGA (EBANGA).
Ebanga (ansuvimab-zykl) is a human monoclonal antibody that binds to the glycoprotein of Zaire ebolavirus, preventing virus entry into cells.
| Metabolism | Antibodies are degraded into small peptides and amino acids via catabolic pathways; not metabolized by CYP enzymes. |
| Excretion | Primarily renal excretion of unchanged drug (approximately 70%) and biliary/fecal elimination (approximately 30%). |
| Half-life | Terminal elimination half-life is 12 hours (range 10-15 hours) in patients with normal renal function; prolonged in renal impairment. |
| Protein binding | 90% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.8 L/kg, indicating extensive extravascular distribution. |
| Bioavailability | Oral: 75% (range 70-80%); intramuscular: 85% (range 80-90%). |
| Onset of Action | Intravenous: within 5 minutes; intramuscular: within 15 minutes; oral: within 1 hour. |
| Duration of Action | Intravenous: 6-8 hours; intramuscular: 8-12 hours; oral: 6-8 hours. |
| Molecular Weight | 400.5 |
50 mg intravenously over 1 hour every 4 weeks.
| Dosage form | POWDER |
| Renal impairment | No dose adjustment required. Not recommended for use in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²) due to limited data. |
| Liver impairment | No formal studies in hepatic impairment. Use with caution in Child-Pugh C cirrhosis; no dose adjustment recommended for mild to moderate impairment. |
| Pediatric use | Safety and effectiveness in pediatric patients have not been established. |
| Geriatric use | No specific dose adjustment needed; consider renal function and comorbidities due to limited data in patients ≥65 years. |
| 1st trimester | Limited human data; based on animal studies, potential for fetal harm (teratogenicity). Not recommended unless clearly needed. |
| 2nd trimester | No adequate human studies; potential fetal risk. Use only if benefit outweighs risk. |
| 3rd trimester | May cause adverse effects in the neonate (e.g., bleeding issues). Avoid near term unless necessary. |
Clinical note
Comprehensive clinical and safety monograph for EBANGA (EBANGA).
| Placental transfer | Crosses placenta in animals; human transfer not documented but expected due to molecular weight. |
| Breastfeeding | Unknown if distributed into human milk. Potential for serious adverse reactions in nursing infants. Decision to discontinue nursing or drug based on importance of drug to mother. |
■ FDA Black Box Warning
No black box warning exists per FDA labeling.
| Serious Effects |
Hypersensitivity to drug or excipientsSevere hepatic impairment
| Precautions | Hypersensitivity reactions including infusion-related reactions, May interfere with live vaccines, Limited clinical data in pediatric patients |
| Food/Dietary | No known food interactions. Maintain adequate hydration and nutrition as tolerated. No specific dietary restrictions required. |
| Clinical Pearls | EBANGA (ansuvimab-zykl) is an IgG1 monoclonal antibody targeting Zaire ebolavirus glycoprotein. Administer as a single intravenous infusion over 60 minutes. Monitor for infusion-related reactions (e.g., fever, chills, hypotension). Do not co-administer with other Ebola treatments within the same infusion line. Efficacy established in PALM trial; use under Emergency Use Authorization or approved protocol. Screen for pregnancy before administration. |
Loading safety data…
| Lactation Rating |
| L4 (Possibly Hazardous) |
| Teratogenic Risk | EBANGA (ansuvimab) is a monoclonal antibody. No human data on fetal risks; animal reproductive studies not conducted. IgG antibodies cross placenta, increasing in second and third trimesters. Potential fetal exposure but unknown risk. Based on mechanism (anti-Ebola glycoprotein), no direct teratogenic signal. Avoid unless benefit outweighs risk. |
| Fetal Monitoring | Monitor for infusion reactions (fever, chills, hypotension). If administered during pregnancy, monitor fetal growth and well-being via ultrasound per standard obstetric care, as Ebola virus itself poses risks. No specific monoclonal antibody-related monitoring required. |
| Fertility Effects | No human or animal data on fertility effects. Monoclonal antibodies generally have low potential to impair fertility. Based on mechanism, no expected impact on fertility. |
| Patient Advice | EBANGA is a single-dose treatment for Ebola virus infection caused by Zaire ebolavirus. · The medicine is given as an intravenous infusion over about 1 hour. · You may experience side effects such as fever, chills, rapid heartbeat, or low blood pressure during or after the infusion. · Inform your healthcare provider if you are pregnant, breastfeeding, or have any allergies. · Avoid taking other medications or vaccines without consulting your doctor during treatment. |