Version July 2025
Orthoebolavirus zairense [formerly Zaire ebolavirus] infection : IV: 50 mg/kg each of atoltivimab, maftivimab, and odesivimab 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).
Refer to adult dosing.
(For additional information see "Atoltivimab, maftivimab, and odesivimab (United States: Available via manufacturer expanded access or public health distribution): Pediatric drug information")
Orthoebolavirus zairense (formerly Zaire ebolavirus) infection: Infants, Children, and Adolescents: IV: 50 mg/kg each of atoltivimab, maftivimab, and odesivimab 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).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Hypotension (15%), tachycardia (20%)
Endocrine & metabolic: Increased serum potassium (13%)
Gastrointestinal: Diarrhea (11%), vomiting (19%)
Hepatic: Increased serum aspartate aminotransferase (21%)
Nervous system: Chills (39%)
Renal: Increased serum creatinine (15%)
Respiratory: Tachypnea (19%)
Miscellaneous: Fever (54%)
1% to 10%:
Endocrine & metabolic: Decreased serum potassium (9%), decreased serum sodium (7%), increased serum sodium (9%)
Hepatic: Increased serum alanine aminotransferase (10%)
Respiratory: Hypoxia (10%)
Postmarketing:
Hypersensitivity: Hypersensitivity reaction
Miscellaneous: Infusion related reaction
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Hypersensitivity reactions: Hypersensitivity reactions, including life-threatening infusion-related reactions, have been reported during and after receipt of atoltivimab, maftivimab, and odesivimab. May slow or interrupt infusion for any signs of infusion-related reaction or other adverse effects; immediately discontinue for severe or life-threatening hypersensitivity reaction.
Other warnings/precautions:
• Immunizations: Avoid concurrent administration of a live vaccine during treatment with atoltivimab, maftivimab, and odesivimab.
Inmazeb: FDA approved October 2020. Product will not be commercially available; will only be distributed for a public health emergency in the US.
Regeneron will provide atoltivimab, maftivimab, and odesivimab in response to outbreaks in the Democratic Republic of the Congo through the Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) protocol for compassionate use and is actively working with non-governmental agencies to ensure continued access to atoltivimab, maftivimab, and odesivimab in low- and middle-income countries. See inmazeb.com for more information.
IV: Allow diluted infusion solution to come to room temperature prior to administration; preparations diluted with D5W may be infused at temperatures up to 35°C (95°F); if temperature is >25°C (>77°F) administer immediately after preparation. Administer IV with 0.2-micron filter. Infusion rate is based on total volume: for 250 mL to 1 L, infuse over 2 hours; for 2 L, infuse over 4 hours. May slow or interrupt infusion for signs of infusion-associated events or other adverse events.
IV: Must be diluted prior to administration. Allow diluted infusion to reach room temperature prior to administration; preparations diluted with D5W may be infused at temperatures up to 35°C (95°F), if temperature is >25°C (77°F) administer immediately after preparation. Administer through an IV line containing a 0.2-micron filter. Infusion time is based on patient weight. 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.
Infusion duration based on patient weight:
0.5 to <2 kg: Infuse over 4 hours.
2 to <16 kg: Infuse over 3 hours.
16 to <150 kg: Infuse over 2 hours.
≥150 kg: Infuse over 4 hours.
Orthoebolavirus zairense (formerly Zaire ebolavirus) infection: Treatment of infection caused by O. zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for O. zairense infection.
Limitations of use: Efficacy has not been established for other species of the Orthoebolavirus (formerly Ebolavirus) and Orthomarburgvirus (formerly Marburgvirus) genera. O. zairense can change over time, and factors such as emergence of resistance or changes in viral virulence could diminish the clinical benefit of antiviral agents. Consider available information on drug susceptibility patterns for circulating O. zairense strains when deciding on use.
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
Ebola Zaire Vaccine (Live): Ebola-Directed Monoclonal Antibodies may decrease therapeutic effects 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 decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Atoltivimab, maftivimab, and odesivimab are humanized IgG1κ monoclonal antibodies. Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Outcome data related to the use of atoltivimab, maftivimab, and odesivimab during pregnancy are limited (Mulangu 2019; Philpott 2023).
Following maternal infection, the Ebola virus crosses the placenta and can be detected in maternal body fluids and transmitted to the fetus. Ebola virus RNA can be detected in the amniotic fluid and fetal tissue for up to 32 days after maternal clearance of viremia (CDC 2024a). 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 atoltivimab/maftivimab/odesivimab for Ebola virus disease caused by O. zairense (formerly Zaire ebolavirus) should not be withheld due to pregnancy.
Pregnant health care providers should not care for patients with Ebola virus disease (CDC 2024a).
It is not known if atoltivimab, maftivimab, or odesivimab are present in breast milk; however, atoltivimab, maftivimab, and odesivimab are humanized IgG1κ monoclonal antibodies and IgG is known to be present in breast milk.
Following maternal infection, the Ebola virus can be detected in body fluids, including breast milk for up to 32 days after maternal clearance of viremia (CDC 2024a). Infected mothers can transmit the Ebola virus to their infant via breast milk (Olgun 2018; WHO 2020).
According to the manufacturer, patients treated with atoltivimab/maftivimab/odesivimab for Ebola virus disease caused by O. zairense (formerly Zaire ebolavirus) should not breastfeed. The Centers for Disease Control and Prevention also recommends neonates born to mothers with Ebola virus infection should not breastfeed (CDC 2024b). The World Health Organization recommends lactating patients with acute Ebola virus infection be separated from their breastfeeding child and milk substitutes be provided. Patients who have recovered from Ebola virus disease should have 2 consecutive negative Ebola virus breast milk tests by RT-PCR separated by 24 hours before feeding with breast milk is resumed (WHO 2020).
Monitor for infusion-related reactions (eg, fever, chills, and hypotension).
Atoltivimab, maftivimab, and odesivimab is an antiviral drug combination of 3 recombinant human IgG1κ monoclonal antibodies, each targeting the O. zairense (formerly Zaire ebolavirus) glycoprotein, which mediates viral attachment and host membrane fusion. Atoltivimab, maftivimab, and odesivimab can bind to the glycoprotein simultaneously. Maftivimab is a neutralizing antibody that blocks viral entry into host cells. Odesivimab is a non-neutralizing antibody that induces antibody-dependent effector function through FcyRIIIa signaling when bound to target; odesivimab also binds to soluble O. zairense glycoprotein. Atoltivimab combines both neutralization and FcyRIIIa signaling activities.
Distribution: Mean Vd, steady state: Atoltivimab: 58.2 mL/kg; Maftivimab: 57.6 mL/kg; Odesivimab: 56 mL/kg.
Half-life elimination: Atoltivimab: 21.2 days; Maftivimab: 22.3 days; Odesivimab: 25.3 days.
