Ansuvimab
Ansuvimab is a human monoclonal antibody used to treat Ebola virus disease caused by Orthoebolavirus zairense (Zaire ebolavirus) in adults, children, and newborns.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Ansuvimab (Ebanga) is a lab-made antibody that treats Ebola caused by the Zaire species in patients of any age, newborns included, by blocking the virus from entering cells and flagging infected cells for the immune system to destroy; on the market since about 2020, it is a specialist hospital treatment and one of two approved Ebola antibody medicines. The single IV infusion is usually well tolerated, though fever, chills, a fast heartbeat, vomiting and diarrhea are common and overlap with Ebola itself. Watch most closely for a serious allergic or infusion reaction, such as a sudden blood pressure drop or trouble breathing, during or right after the drip.
Clinical pearls
- It is proven only against the Zaire species, not Sudan ebolavirus or Marburg virus, so the exact strain matters.
- Pregnancy is no reason to withhold it; Ebola threatens mother and baby, though the antibody may cross the placenta.
- Tell the team about any recent Ebola vaccine, because ansuvimab can blunt a live Ebola vaccine given around the same time.
- Avoid breastfeeding with confirmed Ebola, mainly to keep the virus from passing to the baby, not because of the drug itself.
Patient information guide A plain-language walkthrough of Ansuvimab, written from its FDA label.
What Ansuvimab is used for
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Ansuvimab (brand name Ebanga) is approved to treat one specific type of Ebola virus infection.
- Ebanga treats infection caused by Orthoebolavirus zairense (also called Zaire ebolavirus) in adults and children of all ages, including newborns born to a mother who tests positive for the virus.
- Ebanga is not proven to work against other Ebola virus species or against Marburg virus.
- Because the virus can change over time, resistance or changes in how dangerous the virus is could reduce how well Ebanga works; healthcare providers check available information on local virus strains before using it.
How Ansuvimab works
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Ansuvimab is a human IgG1 monoclonal antibody — a precision-engineered protein that works like a targeted immune weapon. It attaches tightly to a specific region on the Ebola virus surface called the glycoprotein (GP), right at the spot the virus uses to grab onto and enter your cells. By blocking that handshake between the virus and your cells, it prevents the virus from getting inside and spreading. It also flags infected cells so the immune system can destroy them through a process called ADCC (antibody-dependent cellular cytotoxicity).
Resistance is possible. If the Ebola virus mutates in the region where ansuvimab binds, the antibody may not work as well. Clinicians consider local viral strain information before deciding to use it, and watch for signs that a patient is not responding to treatment.
Ansuvimab dosage
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Ebanga is given as a single intravenous (IV) infusion — once, directly into a vein — by a healthcare professional in a clinical setting. The infusion takes approximately 60 minutes. It is not taken by mouth and is never given as a rapid injection. The dose is weight-based, calculated by the care team.
- The powder must be dissolved and diluted by clinical staff before administration — patients do not prepare it themselves.
- There is no at-home dosing; this is a one-time, in-facility treatment.
- Because it is a single dose, there is no missed-dose scenario for patients to manage.
Dosing details from the FDA-approved label
From the Ansuvimab prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adult and pediatric patients
- 50 mg/kg administered as a single intravenous infusion over 60 minutes, after reconstitution with Sterile Water for Injection, USP and further dilution in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP
- Dose is calculated from the patient's actual weight in kg; total infusion volume is based on body weight (Table 1); more than one vial may be needed for a full dose
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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. Immediately upon reaching ambient temperature, use a sterile 10 mL syringe and an 18-gauge needle to withdraw 7.7 mL of Sterile Water for Injection, USP. Insert the needle tip into the EBANGA vial. Holding horizontally, angle the needle down at an approximate 45° angle, above the lyophilized powder, which has a cake-like appearance. Slowly inject the diluent along the wall of the vial and without any air to avoid foaming and bubbles. Gently swirl (do NOT shake) for approximately 10 seconds; then set the vial down to rest for at least 10 seconds. Repeat until the cake is dissolved. This may take up to 20 minutes. Upon reconstitution, one vial delivers 8 mL of solution that is clear to slightly opalescent and colorless to slightly yellow containing 50 mg/mL of ansuvimab-zykl.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Ansuvimab side effects
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Most side effects reported with Ebanga occurred during or right after the infusion. Common ones include:
Common side effects
- Fever (pyrexia)
- Fast heart rate (tachycardia)
- Diarrhea
- Vomiting
- Low blood pressure (hypotension)
- Fast breathing (tachypnea)
- Chills, rigors, or tremors
When to get medical help
- Signs of a severe allergic or infusion reaction — sudden drop in blood pressure, severe chills, high fever, or trouble breathing — seek emergency care immediately
- Any reaction during or shortly after the infusion that feels life-threatening — tell your care team right away so the infusion can be stopped
Some of these symptoms overlap with Ebola infection itself, making it hard to separate drug effects from disease effects. Serious infusion reactions — including severe drops in blood pressure or life-threatening allergic responses — can happen and require immediate medical attention; healthcare staff monitor for these throughout the infusion.
Ansuvimab warnings and precautions
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- Serious infusion and allergic reactions: Hypersensitivity reactions — including acute, life-threatening ones — have been reported during and after Ebanga infusion. Staff monitor all patients for low blood pressure, chills, rising fever, and other symptoms. The infusion is slowed or stopped immediately if a severe reaction occurs, and emergency care is provided.
- Infusion completion: About 1% of patients in trials could not complete their full infusion due to reactions; in 5% of cases, the infusion rate was reduced.
- Virus resistance: The Ebola virus can mutate in ways that reduce how well ansuvimab works. Providers consider current viral strain data when deciding to use it, and watch for patients who don't respond or who relapse.
Ansuvimab interactions
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Ebanga has one known interaction category to be aware of:
- Live Ebola vaccines: Ebanga may interfere with how a live Ebola vaccine replicates, potentially making the vaccine less effective. Do not receive a live Ebola vaccine at the same time as Ebanga treatment. The exact waiting period should follow current vaccination guidelines as advised by your care team.
Interactions listed in the FDA-approved label
From the Ansuvimab prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Live vaccine indicated for prevention of Orthoebolavirus zairense infection: No vaccine interaction studies have been performed, but EBANGA may inhibit replication of the live vaccine virus and possibly reduce the efficacy of the vaccine. Avoid concurrent administration of a live vaccine during treatment with EBANGA; the interval between EBANGA therapy and live vaccination should be in accordance with current vaccination guidelines.
Read the label’s full interactions text
7 DRUG INTERACTIONS Interaction with live vaccine indicated for prevention of Orthoebolavirus zairense infection: No vaccine interaction studies have been performed. EBANGA may reduce the efficacy of the live vaccine. The interval between administration of EBANGA therapy and live vaccination should be in accordance with current vaccination guidelines. ( 7.1 ) 7.1 Vaccine Interactions No vaccine-therapeutic interaction studies have been performed in human participants using EBANGA. However, because of the potential for EBANGA to inhibit replication of a live vaccine virus indicated for prevention of Orthoebolavirus zairense infection and possibly reduce the efficacy of the vaccine, avoid the concurrent administration of a live vaccine during treatment with EBANGA. The interval between administration of EBANGA therapy and live vaccination should be in accordance with current vaccination guidelines. The efficacy of EBANGA among participants who reported receipt of a recombinant live vaccine prior to their enrollment in the PALM trial was similar to participants who did not report receiving a vaccine prior to enrollment.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Ansuvimab
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- Pregnancy: Ebola infection itself is life-threatening for both mother and fetus — treatment with Ebanga should not be withheld because of pregnancy. Ebanga may cross the placenta to the baby. There are no animal reproduction studies available.
- Breastfeeding: Mothers with confirmed Ebola infection are advised not to breastfeed in order to prevent passing the virus to the infant — this recommendation comes from the CDC and applies regardless of Ebanga use.
- Children and newborns: Ebanga is established as safe and effective for pediatric patients from birth through 17 years of age, including newborns of Ebola-positive mothers.
- Older adults (65+): Only a small number of older adults were included in clinical trials; no clear differences in safety were found, but data are limited.
- Kidney or liver problems: The effect of kidney or liver impairment on how the body handles ansuvimab is currently unknown.
- Live Ebola vaccination: Tell your care team if you have recently received or are planning to receive a live Ebola vaccine.
What Ansuvimab does in the body
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The precise relationship between how much ansuvimab is in the body and how strongly it works — and how quickly that effect unfolds — is not yet fully understood from clinical data.
How your body processes Ansuvimab
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Based on limited data from 18 healthy adults, ansuvimab behaves like other antibodies in its class (IgG1 monoclonal antibodies) once in the body. However, formal pharmacokinetic data from people actually infected with Ebola virus are not available. How age, kidney problems, or liver problems affect the way the body processes ansuvimab has not been established.
How to store Ansuvimab
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Store refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light. Do not freeze. is needed, the entire storage time for the reconstituted solution in the vial and the diluted solution in the IV bag should be protected from light and limited to 4 hours…
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Ansuvimab: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Ansuvimab — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Ebanga and what is it used for?
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How is Ebanga given — do I take a pill or get a shot?
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What side effects should I expect during or after the infusion?
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What should I tell the team before getting Ebanga?
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Can I breastfeed while being treated with Ebanga?
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Is Ebanga safe for babies and young children?
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Is Ansuvimab available over the counter?
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When was Ansuvimab first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Ansuvimab on HelloPharmacist
Ansuvimab forms and strengths (how it comes)
Ansuvimab is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Ansuvimab inactive ingredients by manufacturer.
Injection
How this form is used
- Ebanga is used to treat Orthoebolavirus zairense (Zaire ebolavirus) infection in adults and pediatric patients of all ages
- Ebanga is used to treat newborns whose mother tests positive for Orthoebolavirus zairense infection by RT-PCR
- Ebanga is given as a single intravenous infusion over approximately 60 minutes by a trained healthcare professional
- Ebanga must be reconstituted from a powder with Sterile Water for Injection, then further diluted in saline or dextrose solution before it is given
- Ebanga must not be given as a rapid IV push or bolus injection — only as a slow infusion
- Ebanga infusion rate may be slowed or stopped if a reaction occurs during administration
Ansuvimab on the U.S. market: products, makers and brands
How Ansuvimab appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Ansuvimab product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2020. Brand names on the directory include Ebanga; the rest are generics.
Compare Ansuvimab products
A representative set of FDA-listed product records for Ansuvimab — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 400 mg/8 mL | Intravenous | Emergent BioDefense Operations Lansing LLC | BLA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Ansuvimab NDCs →
Ansuvimab side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ansuvimab — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Ansuvimab are drug ineffective for unapproved indication, ebola disease, foetal exposure during pregnancy; about 100% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ansuvimab in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Ansuvimab FDA approval history
How Ansuvimab went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Ansuvimab was first approved by the FDA in 2020 (Brand: EBANGA · Ridgeback Biotherapeutics). It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Ansuvimab recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Ansuvimab recalls since July 2021.
✅No Ansuvimab recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2472152 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 2472155In current FDA listingsClinical drug / strength (SCD) zykl 400 MGRxCUI 2472156
Look up RxCUI 2472152 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Ansuvimab supply and shortage status
Whether Ansuvimab is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Ansuvimab brand names
Ansuvimab is sold under one brand name in the FDA directory — Ebanga. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Ansuvimab: manufacturers and labelers
One company lists Ansuvimab products with the FDA. By number of product records, the largest are Emergent Manufacturing Operations Baltimore, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Ansuvimab drug class (RxNorm)
Ansuvimab belongs to the Zaire Ebolavirus Glycoprotein-directed Antibody class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Ansuvimab page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Emergent Manufacturing Operations Baltimore, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →