Ansuvimab-zykl Monograph for Professionals - Drugs.com

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# Ansuvimab-zykl

Brand name: Ebanga
Drug class: Monoclonal Antibodies

Medically reviewed by Drugs.com on Jan 2, 2023. Written by ASHP.

## Introduction

Ansuvimab-zykl is a monoclonal antibody antiviral agent.

## Uses for Ansuvimab-zykl

### Ansuvimab-zykl has the following uses:

Ansuvimab-zykl is a Zaire ebolavirus glycoprotein (EBOV GP)-directed human monoclonal antibody indicated for the 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.

### Ansuvimab-zykl has the following limitations of use:

The efficacy of ansuvimab-zykl has not been established for other species of the Ebolavirus and Marburgvirus genera.

Zaire ebolavirus can change over time, and factors such as emergence of resistance or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating Zaire ebolavirus strains when deciding whether to use ansuvimab-zykl.

## Ansuvimab-zykl Dosage and Administration

### General

Ansuvimab-zykl is available in the following dosage form(s) and strength(s):

For injection: 400 mg lyophilized powder in a single-dose vial for reconstitution and further dilution.

### Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

#### Pediatric Patients

##### Dosage and Administration

The recommended dose of ansuvimab-zykl is 50 mg/kg reconstituted, further diluted, and administered as a single intravenous infusion over 60 minutes.

See the manufacturer's labeling for instructions on preparation, dilution and administration of ansuvimab-zykl injection.

#### Adults

##### Dosage and Administration

The recommended dose of ansuvimab-zykl is 50 mg/kg reconstituted, further diluted, and administered as a single intravenous infusion over 60 minutes.

See the manufacturer's labeling for instructions on preparation, dilution and administration of ansuvimab-zykl injection.

## Cautions for Ansuvimab-zykl

### Contraindications

None.

### Warnings/Precautions

#### Hypersensitivity Reactions Including Infusion-associated Events

Hypersensitivity reactions including infusion-associated events have been reported with ansuvimab-zykl. These may include acute, life-threatening reactions during and after the infusion. Monitor all patients for signs and symptoms including, but not limited to, hypotension, chills and elevation of fever during and following ansuvimab-zykl infusion. In the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of ansuvimab-zykl immediately and administer appropriate emergency care.

Infusion could not be completed in 1% of subjects who received ansuvimab-zykl due to infusion-associated adverse events. The rate of infusion of ansuvimab-zykl may be slowed or interrupted if the patient develops any signs of infusion-associated events or other adverse events.

#### Specific Populations

##### Pregnancy

Risk Summary: Zaire ebolavirus infection is life-threatening for both the mother and fetus and treatment should not be withheld due to pregnancy. Available data from the PALM trial in which pregnant women with Zaire ebolavirus infection were treated with ansuvimab-zykl demonstrate the high rate of maternal and fetal/neonatal morbidity consistent with published literature regarding the risk associated with underlying maternal Zaire ebolavirus infection. These data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal/fetal outcome.

Animal reproduction studies with ansuvimab-zykl have not been conducted. Monoclonal antibodies such as ansuvimab-zykl are transported across the placenta; therefore, ansuvimab-zykl has the potential to be transferred from the mother to the developing fetus.

Clinical Considerations: Maternal, fetal and neonatal outcomes are poor among pregnant women infected with Zaire ebolavirus. The majority of such pregnancies result in maternal death with miscarriage, stillbirth, or neonatal death. Treatment should not be withheld due to pregnancy.

##### Lactation

The Centers for Disease Control and Prevention (CDC) recommends that mothers with confirmed Zaire ebolavirus not breastfeed their infants to reduce the risk of postnatal transmission of Zaire ebolavirus infection.

There are no data on the presence of ansuvimab-zykl in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to ansuvimab-zykl are unknown.

##### Pediatric Use

The safety and effectiveness of ansuvimab-zykl for the treatment of infection caused by Zaire ebolavirus have been established in pediatric patients from birth to less than 18 years of age. Use of ansuvimab-zykl for this indication is supported by evidence from a multi-center, open-label, randomized controlled trial of ansuvimab-zykl in adults and pediatric subjects that included 54 pediatric subjects birth to less than 18 years of age, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection. Of the total number of subjects administered ansuvimab-zykl in the PALM trial, pediatric subjects (1 day to 17 years) accounted for 31% (n=54) of the study population in the PALM trial. The 28-day mortality and safety in adult and pediatric subjects treated with ansuvimab-zykl were similar. An additional 78 (31%) pediatric subjects from birth to less than 18 years of age received ansuvimab-zykl in an expanded-access program.

##### Geriatric Use

Clinical trials of ansuvimab-zykl did not include sufficient numbers of subjects aged 65 and over to determine whether the safety profile of ansuvimab-zykl is different in this population compared with younger subjects. Of the total number of subjects administered ansuvimab-zykl in the PALM trial, 6 subjects (3%) were 65 years or older. The limited clinical experience has not identified differences in responses between the elderly and younger subjects.

### Common Adverse Effects

The most frequently reported adverse events (≥5%) after administration of ansuvimab-zykl were pyrexia, tachycardia, diarrhea, vomiting, hypotension, tachypnea, and chills.

## Drug Interactions

### Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Interaction with live vaccine indicated for prevention of Zaire ebolavirus infection: No vaccine interaction studies have been performed. Ansuvimab-zykl may reduce the efficacy of the live vaccine. The interval between administration of ansuvimab-zykl therapy and live vaccination should be in accordance with current vaccination guidelines.

## Actions and Spectrum

### Mechanism Of Action

Ansuvimab-zykl is a recombinant human monoclonal antibody with antiviral activity against Zaire ebolavirus.

Ansuvimab-zykl is a recombinant, human IgG1κ monoclonal antibody that binds to the glycan cap and inner chalice of the EBOV GP1 subunit. The epitope to which it binds is located within the receptor binding domain of EBOV consisting of amino acids LEIKKPDGS (GP residues 111–119).

Ansuvimab-zykl binds EBOV GP without the mucin domain with a KD of 0.2 nM at pH 7.4 and 0.6 nM at pH 5.3 as measured by biolayer interferometry. Ansuvimab-zykl blocks binding of EBOV GP1 to the Neiman Pick cell receptor 1 in host cells (IC50 value of 0.09 μg/mL), inhibiting virus entry into the host cell. Ansuvimab-zykl exhibited Fc-mediated antibody-dependent cellular cytotoxicity (ADCC) activity against cells expressing EBOV GP when effector cells were added.

### Spectrum

In a live virus plaque-reduction neutralization assay performed in Vero E6 cells, ansuvimab-zykl neutralized Zaire ebolavirus Mayinga with an EC50 value of 0.06 µg/mL.

In an EBOV GP lentivirus infectivity assay using HEK293 cells, ansuvimab-zykl inhibited Zaire ebolavirus Mayinga with an EC50 value of 0.09 μg/mL and Zaire ebolavirus Makona with an EC50 value of 0.15 μg/mL.

The ADCC activity of ansuvimab-zykl was assessed in EBOV GP-transduced and non-transduced HEK293T target cells in the presence of antibody with effector cells added at an effector-to-target cell ratio of 1:50 and analyzed via flow cytometry. Ansuvimab-zykl mediated ADCC, with maximal activity observed at a monoclonal antibody concentration of 0.03 μg/mL.

Treatment of Zaire ebolavirus-infected rhesus macaques with a single IV dose of ansuvimab-zykl (50 mg per kg) generally protected infected animals from Zaire ebolavirus-mediated death when drug was administered 5 days post-infection.

Interaction studies with recombinant live EBOV vaccines and ansuvimab-zykl have not been conducted.

### Resistance

No nonclinical or clinical studies evaluating resistance to ansuvimab-zykl have been conducted. The possibility of resistance to ansuvimab-zykl should be considered in patients who either fail to respond to therapy or who develop relapse of disease after an initial period of responsiveness.

## Advice to Patients

### Hypersensitivity Reactions Including Infusion-Associated Events

Inform patients that hypersensitivity reactions including infusion-associated events have been reported during and post-infusion with ansuvimab-zykl and to immediately report if they experience any symptoms of systemic hypersensitivity reactions.

### Lactation

Instruct patients with Zaire ebolavirus not to breastfeed because of the risk of passing Zaire ebolavirus to the baby.

## Additional Information

AHFSfirstRelease™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

## Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Ansuvimab-zykl
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer
--- | --- | --- | --- | ---
Parenteral | For Injection, for IV Use | 400 mg | Ebanga | Ridgeback Biotherapeutics LP

AHFS Drug Information. © Copyright 2023, Selected Revisions January 11, 2021. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

Reload page with references included

## More about ansuvimab

- Breastfeeding

### Patient resources

- Advanced Reading

### Professional resources

#### Other brands

Ebanga

### Related treatment guides

- Zaire Ebolavirus Infection

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