ansuvimab (Rx)

Brand and Other Names:Ebanga, ansuvimab-zykl
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 400mg/vial

Ebolavirus Infection

Indicated for treatment of infection caused by Zaire ebolavirus in adults

50 mg/kg IV single infusion

Dosage Modifications

Renal or hepatic impairment

  • Effect of renal or hepatic impairment on pharmacokinetics 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

injection, lyophilized powder for reconstitution

  • 400mg/vial

Ebolavirus Infection

Indicated for treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to mothers who are reverse-transcriptase polymerase chain reaction-positive for Zaire ebolavirus infection

50 mg/kg IV single infusion

Dosage Modifications

Renal or hepatic impairment

  • Effect of renal or hepatic impairment on pharmacokinetics 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

Clinical trials did not include sufficient numbers of participants aged 65 and over

However, limited clinical experience has not identified differences in responses compared with younger individuals

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Interactions

Interaction Checker

and ansuvimab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (6)

              • axicabtagene ciloleucel

                ansuvimab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • brexucabtagene autoleucel

                ansuvimab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • ciltacabtagene autoleucel

                ansuvimab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • idecabtagene vicleucel

                ansuvimab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • lisocabtagene maraleucel

                ansuvimab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • tisagenlecleucel

                ansuvimab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              Monitor Closely (2)

              • efgartigimod alfa

                efgartigimod alfa will decrease the level or effect of ansuvimab 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

                ansuvimab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

              Minor (0)

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                Adverse Effects

                >10%

                During admission for treatment

                • Diarrhea (≥40%)
                • Pyrexia (≥40%)
                • Abdominal pain (≥40%)
                • Vomiting (≥40%)

                During infusion

                • Creatinine >1.8x ULN or ≥1.5x baseline (27%)
                • Pyrexia (17%)
                • Potassium, high ≥6.5 mmol/L (15%)
                • AST ≥5x ULN (13%)
                • ALT ≥5x ULN (12%)

                1-10%

                During infusion

                • Tachycardia (9%)
                • Diarrhea (9%)
                • Vomiting (8%)
                • Hypotension (8%)
                • Sodium, low <125 mmol/L (7%)
                • Tachypnea (6%)
                • Potassium, low <2.5 mmol/L (6%)
                • Sodium, high ≥154 mmol/L (5%)
                • Chills (5%)
                • Hypoxia (3%)
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                Warnings

                Contraindications

                None

                Cautions

                Hypersensitivity reactions

                • Hypersensitivity reactions, including infusion-associated events, have been reported
                • These may include acute, life-threatening reactions during and after infusion
                • Monitor for signs and symptoms (eg, hypotension, chills, elevation of fever) during and following infusion
                • Infusion rate may be slowed or interrupted if any signs of infusion-associated events or other adverse events develop
                • Discontinue infusion immediately if severe or life-threatening reaction occurs 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
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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 because of pregnancy; majority of such pregnancies result in maternal death with miscarriage, stillbirth, or neonatal death

                Data from clinical trial demonstrate a high rate maternal and fetal/neonatal morbidity in treated pregnant females with Zaire ebolavirus infection 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 are potentially transferred from mother to fetus

                Lactation H3

                CDC recommends patients with confirmed Zaire ebolavirus not breastfeed their infants to reduce the risk of postnatal transmission

                No data are 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

                Recombinant human IgG1 monoclonal antibody binds to glycoprotein on the Ebola virus surface and blocks attachment and entry of the virus on the host cell membranes

                Ansuvimab exhibited Fc-mediated antibody-dependent cellular cytotoxicity activity against cells expressing Zaire ebolavirus glycoprotein 1 when effector cells were added

                Pharmacokinetics

                Limited data from 18 healthy subjects (aged 22-56 years) suggest that the pharmacokinetic profile is consistent with the profile of other IgG1 monoclonal antibodies

                Pharmacokinetic data are not available for Zaire ebolavirus-infected patients

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                Administration

                IV Incompatibilities

                Do not mix with or administer as an infusion with other medicinal products

                IV Compatibilities

                0.9% NaCl

                Lactated Ringers (LR)

                IV Preparation

                Reconstitution

                • Calculate dose and number of vials required
                • Remove vials from refrigerator and allow vials to reach room temperature (15-27ºC [59-81ºF]) for ~20 min
                • Vials that cannot immediately be reconstituted can be kept at room temperature, protected from light, for no more than 24 hr
                • Reconstitute each vial with 7.7 mL of sterile water for injection diluent
                • Slowly inject diluent along vial wall by angling needle down at a ~45º angle above powder cake and without any air to avoid foaming and bubbles
                • Gently swirl (do NOT shake) for ~10 seconds; then set vial down to rest for at least 10 seconds; repeat until cake is dissolved; may take up to 20 minutes
                • Upon reconstitution, 1 vial yields 8 mL (final concentration: 50 mg/mL); solution appears clear to slightly opalescent and colorless to slightly yellow; discard if reconstituted solution is discolored or contains visible particles

                Dilution

                Refer to prescribing information for exact diluent and drug volumes

                Following reconstitution, ansuvimab must be further diluted with 0.9% NaCl or LR before administering

                Weight 0.5 to <2 kg
                • Use a 10-mL syringe compatible with IV infusion pump
                • Fill 10-mL syringe with appropriate amount of diluent
                • Add calculated drug volume to 10-mL syringe
                • Gently invert diluted solution 3-5x until admixed; do NOT shake
                • Final concentration of diluted solution is ~8-30 mg/mL
                Weight >2 kg
                • Use either a PVC 0.9% NaCl infusion bag or a non-PVC or non-DEHP LR IV infusion bag
                • Based on body weight, select an infusion bag with the appropriate volume
                • Withdraw and discard from bag a volume that accounts for drug and final infusion volume according to patient’s weight
                • Add calculated drug volume to bag based on patient’s weight
                • For example, for a 55-kg patient, withdraw and discard 150 mL of diluent from a 250-mL infusion bag, then add 55 mL of drug to obtain a final volume of 155 mL
                • Gently invert IV bag 5-10x until diluted solution is mixed; do NOT shake
                • Final concentration of diluted solution is ~8-30 mg/mL
                • Discard vial(s) and all unused contents

                IV Administration

                Administer as IV infusion; do NOT administer as IV push or bolus

                Do not coadminister other drugs simultaneously through same infusion line

                Prepare IV infusion line with 1.2-micron in-line filter extension set

                Infuse over 60 minutes; can be infused via a central line or peripheral catheter

                Infusions may be slowed or stopped if necessary, to alleviate any effects

                At end of infusion

                • Syringe pump:Remove syringe and flush line with 2-5 mL of diluent, but not to exceed the total infusion volume
                • Infusion bag: Replace empty bag and flush line by infusing at least 25 mL of diluent, to ensure complete product administration

                Storage

                Unopened vials

                • Refrigerate at 2-8ºC (36-46ºF) in the original carton to protect from light
                • Do not freeze
                • Do not shake
                • Vials that cannot immediately be reconstituted upon reaching room temperature may be kept at room temperature, protected from light, for no more than 24 hr

                Reconstituted vials

                • Store at room temperature (15-27ºC [59-81ºF]) or refrigerate at 2-8ºC (36-46ºF) for up to 4 hr; includes time required for further dilution and infusion
                • Protect from light

                Diluted solutions

                • If not used immediately, store at room temperature (15-27ºC [59-81ºF]) or refrigerate at 2-8ºC (36-46ºF) for up to 4 hr; time limits include reconstitution time
                • Do not freeze
                • If refrigerated, allow diluted solution to come to room temperature before use
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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

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                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                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.
                OR Other Restrictions
                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.