Dosing & Uses
Dosage Forms & Strengths
atoltivimab/maftivimab/odesivimab
injection, solution
- 241.7mg/241.7mg/241.7mg per 14.5mL (16.67mg/16.67mg/16.67mg per mL)
- 483.3mg/483.3mg/483.3mg per 14.5mL (33.33mg/33.33mg/33.33mg per mL)
Ebola Virus Infection
Indicated for treatment of Zaire ebolavirus (Ebola virus) infection
50 mg atoltivimab/50 mg maftivimab/50 mg odesivimab per kg IV as a single infusion
Dosage Modifications
Renal or hepatic impairment
- Effect of renal or hepatic impairment on pharmacokinetics of the monoclonal antibodies is unknown
Dosing Considerations
Limitations of use
- Efficacy not established for other species of the Ebolavirus and Marburgvirus genera
- Zaire ebolavirus can change over time, and factors (eg, emergence of resistance, viral virulence) could diminish clinical benefit of antiviral drugs
- Consider available information on drug susceptibility patterns for circulating Zaire ebolavirus strains when considering use
Dosage Forms & Strengths
atoltivimab/maftivimab/odesivimab
injection, solution
- 241.7mg/241.7mg/241.7mg per 14.5mL (16.67mg/16.67mg/16.67mg per mL)
- 483.3mg/483.3mg/483.3mg per 14.5mL (33.33mg/33.33mg/33.33mg per mL)
Ebola Virus Infection
Indicated for treatment of Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients, including neonates born to a mother who is reverse-transcriptase polymerase chain reaction (RT-PCR) positive for Zaire ebolavirus infection
50 mg atoltivimab/50 mg maftivimab/50 mg odesivimab per kg IV as a single infusion
Dosage Modifications
Renal or hepatic impairment
- Effect of renal or hepatic impairment on pharmacokinetics of the monoclonal antibodies is unknown
Dosing Considerations
Limitations of use
- Efficacy not established for other species of the Ebolavirus and Marburgvirus genera
- Zaire ebolavirus can change over time, and factors (eg, emergence of resistance, viral virulence) could diminish clinical benefit of antiviral drugs
- Consider available information on drug susceptibility patterns for circulating Zaire ebolavirus strains when considering use
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (26)
- adenovirus types 4 and 7 live, oral
atoltivimab/maftivimab/odesivimab decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- axicabtagene ciloleucel
atoltivimab/maftivimab/odesivimab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- BCG vaccine live
atoltivimab/maftivimab/odesivimab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- brexucabtagene autoleucel
atoltivimab/maftivimab/odesivimab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cholera vaccine
atoltivimab/maftivimab/odesivimab decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- ciltacabtagene autoleucel
atoltivimab/maftivimab/odesivimab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- dengue vaccine
atoltivimab/maftivimab/odesivimab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- Ebola Zaire vaccine
atoltivimab/maftivimab/odesivimab decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- idecabtagene vicleucel
atoltivimab/maftivimab/odesivimab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent, intranasal
atoltivimab/maftivimab/odesivimab decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- lisocabtagene maraleucel
atoltivimab/maftivimab/odesivimab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- measles (rubeola) vaccine
atoltivimab/maftivimab/odesivimab decreases effects of measles (rubeola) vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- measles mumps and rubella vaccine, live
atoltivimab/maftivimab/odesivimab decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- measles, mumps, rubella and varicella vaccine, live
atoltivimab/maftivimab/odesivimab decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- poliovirus vaccine live oral trivalent
atoltivimab/maftivimab/odesivimab decreases effects of poliovirus vaccine live oral trivalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- rotavirus oral vaccine, live
atoltivimab/maftivimab/odesivimab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- rubella vaccine
atoltivimab/maftivimab/odesivimab decreases effects of rubella vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- smallpox (vaccinia) and monkeypox vaccine, live, nonreplicating
atoltivimab/maftivimab/odesivimab decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- smallpox (vaccinia) vaccine, attenuated
atoltivimab/maftivimab/odesivimab decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- smallpox (vaccinia) vaccine, live
atoltivimab/maftivimab/odesivimab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- tisagenlecleucel
atoltivimab/maftivimab/odesivimab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- typhoid polysaccharide vaccine
atoltivimab/maftivimab/odesivimab decreases effects of typhoid polysaccharide vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- typhoid vaccine live
atoltivimab/maftivimab/odesivimab decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- varicella virus vaccine live
atoltivimab/maftivimab/odesivimab decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- yellow fever vaccine
atoltivimab/maftivimab/odesivimab decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- zoster vaccine live
atoltivimab/maftivimab/odesivimab decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
Monitor Closely (3)
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of atoltivimab/maftivimab/odesivimab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- isavuconazonium sulfate
atoltivimab/maftivimab/odesivimab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- ublituximab
ublituximab and atoltivimab/maftivimab/odesivimab both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
Minor (0)
Adverse Effects
>10%
*Indicates adverse effect incidence is less than placebo
Pyrexia (54%)*
Chills (39%)
AST ≥5x ULN (21%)
Tachycardia (20%)*
Tachypnea (19%)*
Vomiting (19%)*
Hypotension (15%)*
Serum creatinine ≥1.8x ULN (15%)*
Serum potassium ≥6.5 mmol/L (13%)
Diarrhea (11%)*
1-10%
*Indicates adverse effect incidence is less than placebo
Hypoxia (10%)*
ALT ≥5x ULN (10%)
Serum sodium ≥154 mmol/L (9%)
Serum potassium <2.5 mmol/L (9%)
Serum sodium <125 mmol/L (7%)*
Warnings
Contraindications
None
Cautions
Hypersensitivity reactions reported, including infusion-associated events during and postinfusion
Monitor for signs and symptoms, including, but not limited to, hypotension, chills, and elevation of fever, during and following infusion
If severe or life-threatening hypersensitivity reaction occurs, discontinue monoclonal antibodies immediately and administer appropriate emergency care
Drug interaction overview
- Avoid coadministration of live vaccine during treatment
- Potential for monoclonal antibodies to inhibit replication of live vaccine virus indicated for prevention of Zaire ebolavirus infection and possibly reduce vaccine efficacy
- Follow current immunization guidelines for interval needed between monoclonal antibodies and administering live vaccine
Pregnancy & Lactation
Pregnancy
Zaire ebolavirus infection is life-threatening for both the mother and fetus and treatment should not be withheld during pregnancy; majority of such pregnancies result in maternal death with miscarriage, stillbirth, or neonatal death
Data from clinical trials and an expanded access program demonstrate a high rate of maternal and fetal/neonatal morbidity consistent with published literature regarding the risk associated with underlying maternal Zaire ebolavirus infection
Data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal/fetal outcome
Animal reproduction studies have not been conducted
Human monoclonal antibodies cross the placenta; therefore, monoclonal antibodies can potentially be transferred from mother to fetus
Lactation
CDC recommends patients with confirmed Zaire ebolavirus not breastfeed their infants to reduce the risk of postnatal transmission
Data are not available on presence in human or animal milk, effects on breastfed infants, or effects on milk production
Maternal IgG is known to be present in human milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Combination of 3 monoclonal recombinant human IgG1-kappa monoclonal antibodies that simultaneously bind to the glycoprotein on the Ebola virus surface and block attachment and entry of the virus on the host cell membranes
Maftivimab: Neutralizing antibody that blocks entry of the virus into susceptible cells
Odesivimab: Non-neutralizing antibody that induces antibody-dependent effector function through FcyRIIIa signaling when bound to its target; also binds to the soluble form of Zaire ebolavirus glycoprotein (sGP)
Atoltivimab: Combines both neutralization and FcyRIIIa signaling activities
Absorption
Peak plasma concentration
- Atoltivimab: 1,220 mg/L
- Maftivimab: 1,280 mg/L
- Odesivimab: 1,260 mg/L
AUC
- Atoltivimab: 17,100 mgday/L
- Maftivimab: 18,700 mgday/L
- Odesivimab: 25,600 mgday/L
Distribution
Vd
- Atoltivimab: 58.2 mL/kg
- Maftivimab: 57.6 mL/kg
- Odesivimab: 56 mL/kg
Elimination
Half-life
- Atoltivimab: 21.2 days
- Maftivimab: 22.3 days
- Odesivimab: 25.3 days
Clearance
- Atoltivimab: 3.08 mL/day/kg
- Maftivimab: 2.78 mL/day/kg
- Odesivimab: 2.02 mL/day/kg
Administration
IV Compatibilities
0.9% NaCl (do not use for neonates)
D5W
Lactated Ringers (do not use for neonates)
IV Incompatibilities
Do not mix or infuse through same IV line with other medication; compatibility studies have not been performed
IV Preparation
Inspect visually for particulate matter and discoloration before administering
Solution should appear clear to slightly opalescent, colorless to pale yellow
Discard vial if solution is cloudy, discolored, or contains particulate matter
Calculate number of vials needed based on calculated dosage volume (mL)
Do not shake vial
Further dilution required
- Adults: Dilute in IV PVC infusion bag containing 0.9% NaCl, D5W, or Lactated Ringers
- Neonates: Dilute in D5W
- Mix diluted solution by gentle inversion; do not shake
-
Dilution example
- Antibody dosage volume per kg: 3 mL/kg or 1.5 mL/kg depending on drug solution concentration
- 50-kg patient: atoltivimab 2,500 mg/maftivimab 2,500 mg/ odesivimab 2,500 mg = 150 mL (11 vials) if using the 16.67 mg/16.67 mg/16.67 mg/mL solution, OR 75 mL (6 vials) if using the 33.33 mg/33.33 mg/33.33 mg/mL solution
- Depending on drug solution concentration, withdraw and discard 150 mL or 75 mL from 500-mL infusion bag, then add 150 or 75 mL of monoclonal antibody mixture to obtain total infusion volume of 500 mL
- Total infusion volumes after dilution by body weight: See detailed chart in prescribing information
- Does not contain preservatives; recommend administering immediately after preparation
IV Administration
Allow diluted solution to come to room temperature before administration
Administer IV infusion in a IV-line containing a sterile, in-line or add-on 0.2-micron filter
Slow or interrupt infusion rate if signs of infusion-associated events or other adverse events occur
Weight-based infusion rate
- Also see prescribing information for preparing total volume by weight
- 0.5-1.9 kg: Infuse over 4 hr
- 2-15 kg: Infuse over 3 hr
- 16-149 kg: Infuse over 2 hr
- ≥150 kg: Infuse over 4 hr
Storage
Unopened vials
- Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light
- Do not freeze or shake
Diluted solution
- Diluted in 0.9% NaCl: Store at room temperature up to 25ºC (77ºF) for up to 8 hr OR refrigerate at 2-8ºC (36-46ºF) for up to 24 hr
- Diluted in D5W: Store at room temperature up to 25ºC (77ºF) for up to 4 hr OR refrigerate at 2-8ºC (36-46ºF) for up to 24 hr
- Diluted in Lactated Ringers: Store at room temperature up to 25ºC (77ºF) for up to 4 hr OR refrigerate at 2-8ºC (36-46ºF) for up to 4 hr
- Do not freeze or shake
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Formulary
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