Ansuvimab

Ansuvimab-zykl is a recombinant human monoclonal antibody with antiviral activity against Zaire ebolavirus [see Microbiology (12.4) ].

• EBANGA is 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 [see Dosage and Administration (2.2) and Clinical Studies (14) ] . EBANGA™ (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.

• None . None.contraindicated

The recommended dose of EBANGA for adult and pediatric patients is 50 mg/kg reconstituted, further diluted, and administered as a single intravenous infusion over 60 minutes. ( 2.1 , 2.2 ) See Full Prescribing Information for instructions on preparation, dilution and administration of EBANGA injection. ( 2.2 ) 2.1 Recommended Dosage for Adult and Pediatric Patients The recommended dosage of EBANGA is 50 mg/kg administered as a single intravenous (IV) infusion over 60 minutes. EBANGA must be reconstituted with Sterile Water for Injection, USP then further diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP prior to IV infusion [see Dosage and Administration (2.2) ] . 2.2. Preparation, Administration, and Storage Instructions EBANGA must be prepared and administered under the supervision of a health care professional. Reconstitution Instructions Aseptically reconstitute and further dilute EBANGA prior to IV infusion. Do not administer as an IV push or bolus. More than one vial may be needed for a full dose. Calculate the dose (mg) based on the patient's actual weight in kg and the number of EBANGA vials required [see Dosage and Administration (2.1) ] . Prior to reconstitution, allow EBANGA vial(s) to reach ambient temperature (15°C to 27°C [59°F to 81°F]) for approximately 20 minutes. If for any reason reconstitution cannot proceed immediately upon reaching ambient temperature, vials that have NOT been reconstituted may be kept at ambient temperature, protected from light, for no more than 24 hours.

Hypersensitivity Reactions Including Infusion-Associated Events: Hypersensitivity reactions including infusion-associated events have been reported with EBANGA. These may include acute, life-threatening reactions during and after the infusion. Monitor patients and in the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of EBANGA immediately and administer appropriate emergency care. ( 5.1 ) 5.1 Hypersensitivity Reactions Including Infusion-Associated Events Hypersensitivity reactions including infusion-associated events have been reported with EBANGA. 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 EBANGA infusion. In the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of EBANGA immediately and administer appropriate emergency care [see Adverse Reactions (6.1) ]. Infusion could not be completed in 1% of subjects who received EBANGA due to infusion-associated adverse events. The rate of infusion of EBANGA may be slowed or interrupted if the patient develops any signs of infusion-associated events or other adverse events [see Adverse Reactions (6.1) ].

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Infusion-Associated Events [see Warnings and Precautions (5.1) ] The most frequently reported adverse events (≥ 5%) after administration of EBANGA were pyrexia, tachycardia, diarrhea, vomiting, hypotension, tachypnea, and chills. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ridgeback Biotherapeutics, LP at 1-833-846-3789 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice. Overall, 424 adult and pediatric subjects with Zaire ebolavirus infection received EBANGA in one clinical trial and as part of an expanded access program during the 2018 Zaire ebolavirus outbreak in the Democratic Republic of Congo (DRC). In the PALM trial, the safety of EBANGA was evaluated in a multi-center, open-label, randomized controlled trial, in which 173 subjects (119 adults and 54 pediatric subjects) with confirmed Zaire ebolavirus infection received EBANGA as a single 50 mg/kg IV infusion and 168 subjects received an investigational control [see Clinical Studies (14) ] . All subjects received optimized standard of care treatment (oSOC). The median age of the study population that received EBANGA was 26 years (range: 1 day to 85 years). Fifty-five percent (55%) of enrolled subjects were female and 45% were male.

Lactation: Patients infected with Zaire ebolavirus should be instructed not to breastfed due to the potential for Zaire ebolavirus transmission. ( 8.2 ) 8.1 Pregnancy Risk Summary Zaire ebolavirus infection is life-threatening for both the mother and fetus and treatment should not be withheld due to pregnancy (see Clinical Considerations ) . Available data from the PALM trial in which pregnant women with Zaire ebolavirus infection were treated with EBANGA 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 EBANGA, are transported across the placenta; therefore, EBANGA has the potential to be transferred from the mother to the developing fetus. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk 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.

Metabolism

Limited data from 18 healthy subjects 22 to 56 years of age suggests that the pharmacokinetic profile of ansuvimab-zykl is consistent with the profile of other IgG1 monoclonal antibodies. Pharmacokinetic data are not available for Zaire ebolavirus infected patients.

• Dec 21, 2020BLABLA761172Ridgeback Biotherapeutics

1. 1Drug Ineffective For Unapproved Indication133%
2. 2Ebola Disease133%
3. 3Foetal Exposure During Pregnancy133%
4. 4Low Birth Weight Baby133%
5. 5Maternal Exposure During Pregnancy133%
6. 6Off Label Use133%
7. 7Postpartum Haemorrhage133%
8. 8Premature Baby133%
9. 9Premature Delivery133%

The 4 most recently updated of 4 ClinicalTrials.gov registrations naming Ansuvimab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Open-Label Expanded Access for Ebola-Infected Patients to Receive Human MAb Ansuvimab As Therapeutic or for HR PEP
  Available · Expanded access · Ridgeback Biotherapeutics, LP
  NCT05067166updated 2024-12-17
• Prophylaxis Vaccine Antibodies Ebola
  Unknown · Phase 2 · Interventional · 250 enrolled · ANRS, Emerging Infectious Diseases
  NCT04822376updated 2021-10-15
• Investigational Therapeutics for the Treatment of People With Ebola Virus Disease
  Completed · Phase 2 · Phase 3 · Interventional · 681 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT03719586updated 2021-09-08
• Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy Adults
  Completed · Phase 1 · Interventional · 19 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT03478891updated 2020-10-26

Frequently asked questions

How does Ansuvimab work?

Ansuvimab-zykl is a recombinant human monoclonal antibody with antiviral activity against Zaire ebolavirus [see Microbiology (12.4) ].

What is Ansuvimab used for?

According to FDA labeling, Ansuvimab carries indications including: EBANGA is 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 [see Dosage and Administration (2.2) and Clinical Studies (14) ] . EBANGA™ (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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ansuvimab?

Ansuvimab is classified as Antiviral monoclonal antibodies, Zaire Ebolavirus Glycoprotein-directed Antibody, Antibody Interactions, Zaire Ebolavirus Glycoprotein-directed Antibody Interactions.

What are the brand names for Ansuvimab?

Ansuvimab is marketed under brand names including Ebanga.

What are the contraindications for Ansuvimab?

Ansuvimab labeling lists contraindications including: None . None.. Always consult the full prescribing information and a clinician.