Benralizumab Injection
Benralizumab is a targeted injectable antibody used to treat severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES).
🧬 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 →
📖 Benralizumab Injection: Patient Information Guide
A plain-language walkthrough of Benralizumab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Benralizumab (sold as Fasenra) is a prescription injection approved for several conditions caused by excess eosinophils (inflammatory white blood cells):
- Severe eosinophilic asthma: Fasenra is an add-on maintenance treatment for adults and children aged 6 and older whose asthma has an eosinophilic pattern and is not adequately controlled on their current regimen.
- Eosinophilic granulomatosis with polyangiitis (EGPA): Fasenra is approved for adult patients with this rare inflammatory condition affecting blood vessels.
- Hypereosinophilic syndrome (HES): Fasenra is approved for adults and children aged 12 and older with HES that does not have an identifiable non-blood-related cause.
- Fasenra is not used to relieve acute asthma symptoms, acute bronchospasm, or status asthmaticus (a severe, prolonged asthma attack).
⚙️How it works▾
Benralizumab targets a specific protein called the IL-5 receptor alpha (IL-5Rα), found on the surface of eosinophils and basophils — two types of immune cells that fuel inflammation in conditions like severe asthma, EGPA, and HES. By binding tightly to this receptor, benralizumab signals natural killer (NK) cells in the immune system to destroy eosinophils directly through a process called antibody-dependent cell-mediated cytotoxicity (ADCC). This leads to a rapid and dramatic reduction in eosinophil levels — often down to near zero in the blood within the first few weeks of treatment.
The reduction in eosinophils is measurable as early as 24 hours after the first dose and is maintained throughout treatment. While the precise mechanism by which this translates into clinical benefit in asthma, EGPA, and HES has not been fully established, controlling eosinophilic inflammation is a central goal in managing all three conditions.
💊How it's taken▾
Fasenra is given as a subcutaneous injection (under the skin) — not by mouth or intravenously. It is injected into the thigh, abdomen, or upper arm. The frequency of injections depends on the condition being treated:
- Severe asthma: First three injections are given every 4 weeks, then every 8 weeks after that. (Dosing for children aged 6–11 varies by body weight.)
- EGPA and HES: One injection every 4 weeks on an ongoing basis.
There are no food restrictions with this medication. Follow your prescriber's schedule closely, and do not adjust or stop your corticosteroid medications without talking to your doctor first.
🤒Side effects — in detail▾
The most commonly reported side effects with Fasenra include:
- Headache (most common overall)
- Sore throat (pharyngitis)
- Fever (pyrexia)
- Flu-like illness (particularly noted in HES patients)
- Skin rash or hives
- Injection site reactions such as pain, redness, itching, or a small raised bump
Serious allergic reactions — including anaphylaxis (a severe, life-threatening reaction) and angioedema (deep tissue swelling) — have been reported after injection. Seek emergency care immediately if you develop trouble breathing, swelling of the face or throat, rapid heartbeat, or dizziness.
⚠️Warnings & precautions▾
- Serious allergic reactions: Hypersensitivity reactions including anaphylaxis, angioedema, hives, and rash have occurred — sometimes hours after injection, sometimes days later. Monitoring after each dose is recommended. If a serious reaction happens, Fasenra must be stopped permanently.
- Not a rescue treatment: Fasenra cannot treat a sudden asthma attack. Always keep a quick-relief (rescue) inhaler available, and seek medical help if your asthma suddenly worsens.
- Steroid tapering: Do not stop oral or inhaled corticosteroids suddenly when starting Fasenra. Stopping too fast can cause withdrawal effects or uncover hidden conditions. Your doctor must supervise any dose reduction.
- Parasitic infections: Eosinophils help fight certain parasitic worm (helminth) infections. Because Fasenra reduces eosinophil levels dramatically, existing helminth infections should be treated before starting the drug. If you develop such an infection during treatment and it doesn't respond to anti-parasite medicine, Fasenra may need to be paused.
🔀What it interacts with▾
The Fasenra label does not identify specific drug-drug interactions. However, there are important medication management points to be aware of:
- Corticosteroids (oral or inhaled steroids): Do not stop these suddenly after starting Fasenra — reductions must be gradual and supervised by your doctor to avoid withdrawal symptoms or flare-ups of underlying conditions.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Known allergy to benralizumab: Do not take Fasenra if you have had a hypersensitivity reaction to benralizumab or any of its inactive ingredients — this is a contraindication.
- Parasitic (helminth/worm) infections: These should be fully treated before starting Fasenra.
- Pregnancy: There is limited data on use during pregnancy. Like other monoclonal antibodies, benralizumab can cross the placenta, especially in the third trimester. Discuss risks and benefits with your doctor if you are pregnant or planning to become pregnant. Women with poorly controlled asthma face their own pregnancy risks, so treatment decisions should be individualized.
- Breastfeeding: It is not known if benralizumab passes into breast milk. Discuss with your doctor to weigh the benefits of breastfeeding against any potential risk.
- Children: Fasenra is approved for severe eosinophilic asthma in children aged 6 and older, and for HES in children aged 12 and older. It is not approved for EGPA in children. Dosing in younger children with asthma is based on body weight.
- Kidney or liver disease: Based on how the drug is processed by the body (broken down by enzymes rather than cleared through the kidneys or liver), dose adjustments are not expected to be necessary — but always disclose your full medical history to your prescriber.
🚑If you take too much▾
There is no specific antidote for a benralizumab overdose. If an overdose is suspected, supportive care and close monitoring are recommended. You can contact the Poison Help line at 1-800-222-1222 for guidance, or seek emergency medical care.
📡Pharmacodynamics — effects in the body▾
Benralizumab dramatically reduces the number of eosinophils circulating in the blood — often to near-zero levels — starting as early as 24 hours after the first dose. This reduction is sustained throughout the entire treatment period. The drug also lowers levels of basophils, another type of immune cell, which has been consistently observed across clinical studies. In children aged 6 to 11 years with severe eosinophilic asthma, the degree of eosinophil reduction was similar to that seen in adults and older adolescents.
🔬Pharmacokinetics — how your body processes it▾
After a subcutaneous injection, benralizumab is absorbed with a half-life of about 3.5 days, meaning it takes that long for half of the absorbed dose to enter the bloodstream; about 59% of the injected dose reaches systemic circulation. There is no meaningful difference in absorption whether the injection is given in the abdomen, thigh, or arm. Once in the body, benralizumab is broken down by protein-digesting enzymes distributed throughout the body — not specifically by the liver or kidneys — and has an elimination half-life of approximately 15.5 days, meaning it takes several weeks to fully clear after a dose. Age, sex, and race do not significantly affect how the drug is processed.
📦How to store it▾
Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. stored at room temperature up to 77°F (25°C) for a maximum of 14 days in the original carton to protect from light.
📄 Written from Benralizumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Benralizumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Fasenra treating — is it just for asthma? ▾
Can I use Fasenra if I'm having an asthma attack? ▾
Do I have to keep taking my inhaler or steroid medication after starting Fasenra? ▾
What side effects should I actually watch out for? ▾
Can I give myself the injection at home, or does it have to be done at a clinic? ▾
Is Fasenra safe to use during pregnancy? ▾
Is Benralizumab Injection available over the counter? ▾
When was Benralizumab Injection first available? ▾
Who makes Benralizumab Injection? ▾
💬 Answers drafted from Benralizumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Benralizumab Injection comes
Benralizumab Injection 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.
Injection
How this form is used
- Fasenra is used as add-on maintenance treatment for severe eosinophilic asthma in adults and children aged 6 and older
- Fasenra is used to treat eosinophilic granulomatosis with polyangiitis (EGPA) in adults
- Fasenra is used to treat hypereosinophilic syndrome (HES) in adults and children aged 12 and older
- Fasenra is not for relieving sudden asthma attacks or acute bronchospasm
- Fasenra is injected subcutaneously (under the skin) into the thigh, abdomen, or upper arm; the upper arm site should only be used by a healthcare provider or caregiver
- Fasenra prefilled syringe is intended for administration by a healthcare provider; the Fasenra Pen autoinjector may be used by a trained patient or caregiver at home if the doctor approves
- In children aged 6 to 11 years weighing 35 kg or more, the Fasenra Pen should only be administered by a caregiver or healthcare provider — not by the child
- Before injecting, allow Fasenra to warm to room temperature (up to 77°F / 25°C) for about 30 minutes; do not use if the liquid is cloudy, discolored, or contains large particles
📊 Benralizumab Injection across the U.S. market
How Benralizumab Injection 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Benralizumab Injection is used
A general measure of how commonly Benralizumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Benralizumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Benralizumab Injection prescribed? Of the 1,596 medications we measure, Benralizumab Injection ranks #715 by Medicaid prescriptions — more than 55% of them.
Utilization by Benralizumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
1 ML benralizumab 30 MG/ML Auto-Injector Most dispensed
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2205632
1 ML benralizumab 30 MG/ML Prefilled Syringe
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1989104
0.5 ML benralizumab 20 MG/ML Prefilled Syringe
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2679499
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Benralizumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 6 listed Benralizumab Injection NDCs with Medicaid activity.
🔍 Compare Benralizumab Injection products
A representative set of FDA-listed product records for Benralizumab Injection — 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 | ||||
| 30 mg/mL | — | AstraZeneca AB | DRUG FOR FURTHER PROCESSING | View NDC → |
| 10 mg/0.5 mL | Subcutaneous | AstraZeneca Pharmaceuticals LP | BLA | View NDC → |
| 30 mg/mL | Subcutaneous | AstraZeneca Pharmaceuticals LP × 6 listings | BLA | View NDC → |
| 10 mg/0.5 mL | — | Catalent Indiana, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 9 of 9 products — FDA National Drug Code Directory. See every product, package size and price: browse all 9 Benralizumab Injection NDCs →
📈 What people report — real-world data (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 Benralizumab Injection — a signal of what to watch for, not proof the drug caused it.
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 Benralizumab Injection 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.
🏛️ The road to your pharmacy
How Benralizumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
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 1989100 2 dose forms · 3 strengths
-
Dose form (SCDF) Auto-Injector RxCUI 2205631In current FDA listingsClinical drug / strength (SCD) 1 ML benralizumab 30 MG/MLRxCUI 2205632 -
Dose form (SCDF) Prefilled Syringe RxCUI 1989103No current FDA listingClinical drug / strength (SCD) 0.5 ML benralizumab 20 MG/MLRxCUI 26794991 ML benralizumab 30 MG/MLRxCUI 1989104
Look up RxCUI 1989100 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.
📦 Supply & shortage status
Whether Benralizumab Injection 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.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Benralizumab Injection belongs to the Interleukin-5 Receptor alpha-directed Cytolytic 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.
🔬 Where this comes from
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 we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. AstraZeneca Pharmaceuticals LP is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.