Version May 2024
Zaire ebolavirus infection (including newborns born to mothers RT-PCR positive for Z. ebolavirus infection): IV: 50 mg/kg as a single dose.
Zaire ebolavirus infection: Infants, Children, and Adolescents: IV: 50 mg/kg as a single dose.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
(For additional information see "Ansuvimab (United States: Available via manufacturer expanded access or public health distribution): Drug information")
Zaire ebolavirus infection: IV: 50 mg/kg as a single dose (Ref).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Infusion-related reactions commonly occurred with ansuvimab administration during clinical trials. Signs and symptoms may include fever, tachycardia, diarrhea, vomiting, hypotension, tachypnea, chills, or hypoxia. May require slowing of the infusion rate or treatment interruption; treatment discontinuation may be required for severe or life-threatening hypersensitivity reactions.
Mechanism: Not clearly established; clinicians should consider the impact of the underlying Zaire ebolavirus infection on the development of these symptoms.
Onset: Rapid; during or immediately following the infusion
Risk factors:
• Rate of infusion
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Endocrine & metabolic: Increased serum potassium (15%)
Gastrointestinal: Abdominal pain
Hepatic: Increased serum alanine aminotransferase (12%), increased serum aspartate aminotransferase (13%)
Renal: Increased serum creatinine (27%)
Miscellaneous: Fever (≥17%) (table 1), infusion related reaction (29%)
|
Drug (Ansuvimab) |
Comparator (Various) |
Dose |
Number of Patients (Ansuvimab) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|
|
17% |
58% |
50 mg/kg as a single infusion |
173 |
168 |
Reflects reactions that occurred during or immediately after infusion |
1% to 10%:
Cardiovascular: Hypotension (8%) (table 2), tachycardia (9%) (table 3)
|
Drug (Ansuvimab) |
Comparator (Various) |
Dose |
Number of Patients (Ansuvimab) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|
|
8% |
31% |
50 mg/kg as a single infusion |
173 |
168 |
Reflects reactions that occurred during or immediately after infusion |
|
Drug (Ansuvimab) |
Comparator (Various) |
Dose |
Number of Patients (Ansuvimab) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|
|
9% |
32% |
50 mg/kg as a single infusion |
173 |
168 |
Reflects reactions that occurred during or immediately after infusion |
Endocrine & metabolic: Decreased serum potassium (6%), decreased serum sodium (7%), increased serum sodium (5%)
Gastrointestinal: Diarrhea (≥9%) (table 4), vomiting (≥8%) (table 5)
|
Drug (Ansuvimab) |
Comparator (Various) |
Dose |
Number of Patients (Ansuvimab) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|
|
9% |
18% |
50 mg/kg as a single infusion |
173 |
168 |
Reflects reactions that occurred during or immediately after infusion |
|
Drug (Ansuvimab) |
Comparator (Various) |
Dose |
Number of Patients (Ansuvimab) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|
|
8% |
23% |
50 mg/kg as a single infusion |
173 |
168 |
Reflects reactions that occurred during or immediately after infusion |
Nervous system: Chills (5%) (table 6)
|
Drug (Ansuvimab) |
Comparator (Various) |
Dose |
Number of Patients (Ansuvimab) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|
|
5% |
33% |
50 mg/kg as a single infusion |
173 |
168 |
Reflects reactions that occurred during or immediately after infusion |
Respiratory: Hypoxia (3%) (table 7), tachypnea (6%) (table 8)
|
Drug (Ansuvimab) |
Comparator (Various) |
Dose |
Number of Patients (Ansuvimab) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|
|
3% |
11% |
50 mg/kg as a single infusion |
173 |
168 |
Reflects reactions that occurred during or immediately after infusion |
|
Drug (Ansuvimab) |
Comparator (Various) |
Dose |
Number of Patients (Ansuvimab) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|
|
6% |
28% |
50 mg/kg as a single infusion |
173 |
168 |
Reflects reactions that occurred during or immediately after infusion |
<1%: Hypersensitivity: Hypersensitivity reaction
There are no contraindications listed in the manufacturer's labeling.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Ebanga: FDA approved December 2020. Product will not be commercially available; will only be distributed for a public health emergency in the US.
Parenteral: IV: Must be reconstituted and further diluted prior to administration. If diluted solution is refrigerated following preparation, allow solution to come to room temperature prior to administration. Administer over 60 minutes using an in-line 1.2 micron filter extension set. Do NOT administer as an IV push or bolus. Flush line with compatible diluent following completion of infusion to ensure entire dose is administered; flush volume varies based on administration method (eg, syringe vs IV infusion bag). Slow or interrupt infusion if the patient develops any signs of infusion-associated events (eg, hypotension, chills, fever elevation) or other adverse events; if severe or life-threatening hypersensitivity reactions occur, immediately discontinue infusion and provide emergency care.
Syringe administration: Flush line with 2 to 5 mL compatible diluent; do not exceed total infusion volume.
IV bag administration: Flush line with ≥25 mL compatible diluent.
IV: If refrigerated, allow diluted infusion solution to come to room temperature prior to administration. Administer IV over 60 minutes with a 1.2 micron in-line filter extension set; may be infused via central or peripheral catheter. Do not administer IV push or bolus. May slow or interrupt infusion for signs of infusion-associated events or other adverse events. After infusion is complete, flush the line with ≥25 mL of diluent.
Store intact vials refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton. Protect from light; do not freeze or shake. The product expiration date will not be on the vial; expiration date is available via a product-specific website (www.ebanga.co) with the lot number printed on the box.
Prior to reconstitution, allow vial(s) to reach ambient temperature (15°C to 27°C [59°F to 81°F]) for ~20 minutes. If reconstitution cannot proceed immediately upon reaching ambient temperature, vials that have NOT been reconstituted may be kept at ambient temperature for ≤24 hours. Reconstituted vials and solutions diluted for infusion may be stored at 2°C to 8°C (36°F to 46°F); however, the total combined storage time following vial reconstitution and dilution for infusion in a compatible IV solution must be ≤4 hours. If a solution diluted for infusion has been refrigerated, allow ~20 minutes for solution to come to ambient temperature prior to administration. Protect from light at all times.
Treatment of infection caused by Zaire ebolavirus (FDA approved in all ages).
Limitations of use: Efficacy not established for other species of the Ebolavirus and Marburgvirus genera.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Ebola Zaire Vaccine (Live): Ebola-Directed Monoclonal Antibodies may diminish the therapeutic effect of Ebola Zaire Vaccine (Live). Management: Wait several months (3 to 6 months, and up to 11 months) after use of Ebola-directed antibodies before administering the live Ebola Zaire vaccine. Repeat vaccination may be required if antibody therapy and vaccination cannot be adequately separated. Risk D: Consider therapy modification
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Animal reproduction studies have not been conducted. Ansuvimab is a humanized monoclonal antibody (IgG1) and would be expected to cross the placenta. Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Outcome information following maternal use of ansuvimab during pregnancy is limited (Mulangu 2019; Ottoni 2020).
Following maternal infection, the Ebola virus can be detected in maternal body fluids and transmitted to the fetus. Maternal Ebola infection carries a high rate of mortality for both the fetus and the mother. Maternal Ebola virus infection typically results in miscarriage, stillbirth, and maternal and/or neonatal death (Olgun 2018). Treatment with ansuvimab should not be withheld due to pregnancy.
Pregnant health care providers should not care for patients with Ebola virus disease (CDC 2018).
Monitor for hypersensitivity or infusion-related reactions (eg, hypotension, chills, elevation of fever) during and after the infusion.
Ansuvimab is a recombinant human IgG1κ monoclonal antibody that binds to the glycan cap and inner chalice of the Z. ebolavirus (EBOV) glycoprotein 1 (GP1) subunit, blocking binding of EBOV GP1 to the Neiman Pick cell receptor 1 in host cells, inhibiting virus entry.
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