atoltivimab/maftivimab/odesivimab (Rx)

Brand and Other Names:Inmazeb, Ebola monoclonal antibodies
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Dosing & Uses

AdultPediatric

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)

Ebola Virus Infection

Indicated for treatment of Zaire ebolavirus (Ebola virus) infection

50 mg atoltivimab/50 mg maftivimab/50 mg odesivimab per kg (ie, 3 mL/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)

Ebola Virus Infection

Indicated for treatment of 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 (ie, 3 mL/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
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Interactions

Interaction Checker

and atoltivimab/maftivimab/odesivimab

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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%)*

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            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 antiboides and administering live vaccine
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            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.

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            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
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            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 invertion; do not shake
            • Dilution example
              • Antibody dosage volume per kg: 3 mL/kg
              • 50-kg patient: atoltivimab 2,500 mg/maftivimab 2,500 mg/ odesivimab 2,500 mg = eleven 14.5-mL vials (total 150 mL)
              • Withdraw and discard 150 mL of diluent from 500-mL infusion bag, then add 150 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 IV over 4 hr
            • 2-15 kg: Infuse IV over 3 hr
            • 16-149 kg: Infuse IV over 2 hr
            • ≥150 kg: Infuse IV 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 or 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

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.