Elranatamab-Bcmm
Elranatamab-bcmm is a targeted cancer therapy used to treat relapsed or refractory multiple myeloma in adults who have already tried multiple other treatments.
🧬 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 2 clinical label sets 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Elrexfio carries a serious FDA boxed warning for two life-threatening risks: cytokine release syndrome (CRS) and neurologic toxicity, including ICANS. CRS is a powerful immune overreaction that can be life-threatening or fatal — symptoms include fever, chills, low blood pressure, rapid heartbeat, and trouble breathing. Neurologic toxicity, including ICANS (a type of brain dysfunction), can also be serious or life-threatening, with symptoms like confusion, altered consciousness, and difficulty thinking clearly. To reduce these risks, treatment starts with a step-up dosing schedule, and patients must be hospitalized and monitored after the first two doses. Because of these risks, Elrexfio is only available through a restricted safety program called the ELREXFIO REMS — prescribers, pharmacies, and healthcare settings must all be specially certified to prescribe or dispense it.
📖 Elranatamab-Bcmm: Patient Information Guide
A plain-language walkthrough of Elranatamab-Bcmm — 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▾
Elranatamab-bcmm is an injectable cancer treatment for adults with multiple myeloma that has returned or stopped responding to prior therapy.
- Elrexfio (subcutaneous injection) is approved for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy — including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
- This approval is under the FDA's accelerated approval pathway, based on how many patients responded and how long responses lasted — continued approval depends on confirmatory trial results.
⚙️How it works▾
Elranatamab-bcmm is a bispecific antibody engineered to bridge two different cells together. It simultaneously binds to BCMA — a protein found on the surface of multiple myeloma cells and certain other plasma cells — and to CD3, a protein on your immune T-cells. This connection activates the T-cells and directs them to destroy the BCMA-carrying cancer cells. In lab studies, this process caused myeloma cell death and triggered the release of inflammatory signaling proteins called cytokines.
💊How it's taken▾
Elrexfio is given as a subcutaneous (under-the-skin) injection by a healthcare professional — always in a medical setting, never self-administered at home. Treatment follows a careful step-up schedule: a smaller first dose, then a slightly larger second dose a few days later, then the full treatment dose — all designed to reduce the risk of a serious immune reaction.
- After the step-up phase, Elrexfio is given weekly through week 24.
- Patients who respond well may transition to every-two-week dosing, and later to every-four-week dosing if the response is maintained.
- Pre-treatment medications are required before the first three doses to lower the risk of cytokine release syndrome.
- If a dose is missed or delayed, your care team will follow specific guidelines for how and when to restart — do not adjust the schedule on your own.
🤒Side effects — in detail▾
Many patients experience side effects with Elrexfio, especially during the early step-up doses. Common reactions include:
- Cytokine release syndrome (CRS) — fever, chills, low blood pressure, rapid heartbeat
- Fatigue
- Injection site reactions
- Diarrhea
- Upper respiratory tract infections
- Musculoskeletal pain
- Decreased appetite
- Rash
- Nausea and cough
- Headache and encephalopathy (confusion or altered mental state)
Serious reactions — including life-threatening infections (pneumonia, sepsis), severe low white blood cell counts, and liver enzyme elevations — have occurred. Seek medical attention immediately if you develop high fever, trouble breathing, confusion, or signs of serious infection.
⚠️Warnings & precautions▾
- Cytokine Release Syndrome (CRS): Occurred in 58% of patients in clinical trials. Can be life-threatening. Most common after the first step-up dose. Symptoms include fever, chills, low blood pressure, and rapid heartbeat. Hospitalization is required after the first two doses.
- Neurologic toxicity / ICANS: Serious brain-related reactions occurred in 59% of patients; ICANS specifically in 3.3%. Symptoms include confusion, memory problems, and depressed consciousness. Patients must not drive or operate heavy machinery for 48 hours after the first three doses or if new neurologic symptoms arise.
- Serious infections: Occurred in 42% of patients; some were fatal. Pneumonia and sepsis were most common. Do not start Elrexfio if you have an active infection.
- Neutropenia (low white blood cells): Occurred in 62% of patients; severe in over half. Raises infection risk. Blood counts monitored regularly.
- Hepatotoxicity (liver damage): Liver enzyme elevations were common; monitor liver tests throughout treatment.
- ELREXFIO REMS: Only available through a restricted safety program. Prescribers, pharmacies, and healthcare settings must all be certified.
🔀What it interacts with▾
Elranatamab-bcmm affects how the body processes certain other drugs, particularly in the early weeks of treatment.
- CYP enzyme substrates: Elrexfio causes cytokine release that can suppress liver enzymes (CYP enzymes) responsible for breaking down many medications. This raises the blood levels of those drugs and may cause toxicity. The risk is highest in the first two weeks and during or after CRS episodes.
- If you take any medication where even small changes in blood levels can be dangerous (such as certain blood thinners, immunosuppressants, or seizure medications), your doctor should monitor drug levels or watch for side effects closely.
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▾
- Active infections: Do not start Elrexfio if you currently have an active infection — treatment should only begin once the infection is treated.
- Pregnancy: Elrexfio may harm a developing fetus. Women who could become pregnant must use effective contraception during treatment and for 4 months after the last dose. A pregnancy test is required before starting.
- Breastfeeding: Do not breastfeed during treatment or for 4 months after the last dose.
- Children: Safety and effectiveness in patients under 18 have not been established.
- Older adults: Most patients studied were 65 or older; no significant safety differences were seen in those aged 65–74. Data on patients 75 and older are limited.
- Kidney impairment: Mild-to-moderate kidney impairment did not significantly affect drug levels, but the effects of severe kidney disease or end-stage renal disease are not known.
- Liver impairment: Mild liver impairment did not significantly affect drug levels; effects of moderate-to-severe liver disease are unknown.
📡Pharmacodynamics — effects in the body▾
After Elrexfio is given, it triggers the release of immune signaling proteins called cytokines — including IL-2, IL-6, IL-8, IL-10, TNF-α, and IFN-γ. These cytokines rise most sharply within 72 hours after the first dose, then generally return to baseline before the first full treatment dose is given. This cytokine surge is what drives the risk of cytokine release syndrome, and is why the step-up dosing schedule and close monitoring are so important in early treatment.
🔬Pharmacokinetics — how your body processes it▾
Elrexfio is absorbed under the skin with about 56% bioavailability, reaching peak blood levels in roughly 7 days after each subcutaneous dose. The drug has a half-life of about 22 days, meaning it stays in the body for an extended period between doses. It is broken down into small peptides through normal protein breakdown pathways in the body — not through the liver's standard drug-processing enzymes. Drug levels build up over the weekly dosing phase and then stabilize at lower levels as dosing is spread out to every two weeks or every four weeks.
📦How to store it▾
Store refrigerated at 2 °C to 8 °C (36 °F to 46 °F) in the original carton until time of use to protect from light. Do not freeze or shake the vial or carton.
📄 Written from Elranatamab-Bcmm’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 Elranatamab-Bcmm — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Elrexfio and why has my doctor recommended it? ▾
How will I actually receive this medication — do I take a pill or inject it myself? ▾
What side effects should I expect, and which ones mean I need to call for help right away? ▾
I've heard this drug has a special safety program — what does that mean for me? ▾
Can I drive or go about my normal life while on this treatment? ▾
Is this medication safe if I'm pregnant or thinking about getting pregnant? ▾
Is Elranatamab-Bcmm available over the counter? ▾
When was Elranatamab-Bcmm first available? ▾
Who makes Elranatamab-Bcmm? ▾
💬 Answers drafted from Elranatamab-Bcmm’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 Elranatamab-Bcmm comes
Elranatamab-Bcmm 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
- Elrexfio subcutaneous injection is used to treat adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy
- Elrexfio is approved under accelerated approval based on response rate and durability of response in clinical trials
- Elrexfio is given only as a subcutaneous (under-the-skin) injection by a qualified healthcare professional
- Elrexfio treatment begins with a step-up dosing schedule — two smaller starter doses days apart, then a full treatment dose — to reduce the risk of cytokine release syndrome
- Elrexfio requires hospitalization for 48 hours after the first step-up dose and 24 hours after the second step-up dose
- Elrexfio pre-treatment medications (including acetaminophen, dexamethasone, and diphenhydramine) are given about one hour before each of the first three doses
📊 Elranatamab-Bcmm across the U.S. market
How Elranatamab-Bcmm 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.
🔍 Compare Elranatamab-Bcmm products
A representative set of FDA-listed product records for Elranatamab-Bcmm — 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 | ||||
| 44 mg/1.1 mL | Subcutaneous | Pfizer Laboratories Div Pfizer Inc × 3 listings | BLA | View NDC → |
| 76 mg/1.9 mL | Subcutaneous | Pfizer Laboratories Div Pfizer Inc × 3 listings | BLA | View NDC → |
| 44 mg/1.1 mL | Subcutaneous | U.S. Pharmaceuticals × 2 listings | BLA | View NDC → |
Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Elranatamab-Bcmm 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 Elranatamab-Bcmm — 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 Elranatamab-Bcmm 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 Elranatamab-Bcmm 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 2644880 1 dose form · 2 strengths
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Dose form (SCDF) Injection RxCUI 2644884In current FDA listingsClinical drug / strength (SCD) 1.1 ML elranatamab-bcmm 40 MG/MLRxCUI 26448851.9 ML elranatamab-bcmm 40 MG/MLRxCUI 2644893
Look up RxCUI 2644880 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 Elranatamab-Bcmm 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
Elranatamab-Bcmm belongs to the Other monoclonal antibodies and antibody drug conjugates 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 2 FDA-filed SPL label sets 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.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. 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. Pfizer Laboratories Div Pfizer Inc 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.