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Atoltivimab, Maftivimab, and Odesivimab

Pronunciation

(A tol TIV i mab, maf TIV i mab, & OH de SIV i mab)

Index Terms

  • Atoltivimab, Odesivimab, and Maftivimab
  • Atoltivimab, Maftivimab, and Odesivimab-ebgn
  • Inmazeb
  • Maftivimab, Atoltivimab, and Odesivimab
  • Maftivimab, Odesivimab, and Atoltivimab
  • Odesivimab, Atoltivimab, and Maftivimab
  • Odesivimab, Maftivimab, and Atoltivimab

Pharmacologic Category

  • Antiviral Agent
  • Monoclonal Antibody

Pharmacology

Atoltivimab, maftivimab, and odesivimab is an antiviral drug combination of 3 recombinant human IgG1κ monoclonal antibodies, each targeting the 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 Zaire ebolavirus 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.

Use: Labeled Indications

Zaire ebolavirus infection: Treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection.

Limitations of use: Efficacy not established for other species of the Ebolavirus and Marburgvirus genera.

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

Zaire ebolavirus infection: IV: 50 mg/kg each of atoltivimab, maftivimab, and odesivimab as a single dose (Mulangu 2019).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Zaire ebolavirus infection: Infants, Children, and Adolescents: IV: 50 mg/kg each of atoltivimab, maftivimab, and odesivimab as a single dose.

Reconstitution

Do not shake the intact vial. Prior to IV infusion, dilute in an IV PVC infusion bag with NS, D5W, or LR. Withdraw and discard from a diluent solution infusion bag a volume of diluent solution equal to the calculated dose in volume; add the calculated volume of atoltivimab, maftivimab, and odesivimab to the bag. The total volume of the infusion is based on body weight; 250 mL for weight 16 to 38 kg, 500 mL for weight 39 to 70 kg, 1 L for weight 80 to 149 kg, or 2 L for weight ≥150 kg. Mix by gentle inversion; do not shake. Diluted solution should be used immediately after preparation when possible. When mixed with NS, may be stored for ≤8 hours at room temperature or ≤24 hours refrigerated; when mixed with D5W or LR, may be stored for ≤4 hours at room temperature or refrigerated.

Administration

IV: Allow diluted infusion solution to come to room temperature prior to administration. 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.

Storage

Prior to dilution: Store intact vials at 2°C to 8°C (36°F to 46°F). Protect from light; do not freeze or shake

After dilution:

Diluted with NS: Store at room temperature up to 25°C (77°F) for no more than 8 hours or at 2°C to 8°C (36°F to 46°F) for no more than 24 hours. Do not freeze.

Diluted with D5W or LR: Store at room temperature up to 25°C (77°F) or at 2°C to 8°C (36°F to 46°F) for no more than 4 hours. Do not freeze.

Drug Interactions

Vaccines (Live): Atoltivimab, Maftivimab, and Odesivimab may diminish the therapeutic effect of Vaccines (Live). Management: Wait several months (3 to 6 months, and even as long as 11 months) after use of atoltivimab, maftivimab, and odesivimab before administering live vaccines. Consider therapy modification

Adverse Reactions

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

Warnings/Precautions

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. Monitor for signs and symptoms such as fever, chills, and hypotension. 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.

Monitoring Parameters

Monitor for infusion-related reactions.

Pregnancy Considerations

Atoltivimab, maftivimab, and odesivimab are humanized IgG1κ monoclonal antibodies. 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).

A limited number of pregnant patients were included in a study which included treatment with atoltivimab, maftivimab, and odesivimab (Mulangu 2019). Zaire ebolavirus infection during pregnancy may result in maternal death, miscarriage, stillbirth, or neonatal death; treatment should not be withheld due to pregnancy.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.