FDA-filed SPL labeling · retrieved through openFDA

Elotuzumab Injection

Elotuzumab injection (Empliciti) is an immunostimulatory antibody used in combination regimens to treat multiple myeloma in adults who have already received prior therapy.

Brand name Empliciti
Drug class Slamf7-directed Immunostimulatory Antibody
Rx Form 1 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 →

At a glance
Linked label effectiveMar 22, 2022
AvailabilityRx
Earliest approval/marketing year 2015
FDA-listed product records 10
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Elotuzumab Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Empliciti (elotuzumab) is an IV immunotherapy used alongside lenalidomide or pomalidomide and dexamethasone to treat relapsed or refractory multiple myeloma in adults. It works by harnessing your immune system's natural killer cells to attack myeloma cells. It requires careful monitoring for infusion reactions, infections, liver changes, and new cancers throughout treatment.

📖 Elotuzumab Injection: Patient Information Guide

A plain-language walkthrough of Elotuzumab 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

Elotuzumab (Empliciti) injection is approved for the treatment of multiple myeloma in adults who have already received prior therapy. It is always used as part of a combination regimen.

  • Empliciti + lenalidomide + dexamethasone: for adults with multiple myeloma who have received one to three prior therapies
  • Empliciti + pomalidomide + dexamethasone: for adults with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor
⚙️How it works

Elotuzumab is a humanized monoclonal antibody — a lab-made protein designed to seek out a specific target. It locks onto a protein called SLAMF7, which is found on the surface of myeloma cells as well as on natural killer (NK) cells (a key part of the immune system's cancer defense). By binding SLAMF7, elotuzumab does two things: it directly activates NK cells to go on the attack, and it tags myeloma cells so other immune cells can destroy them through processes called antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP — essentially, engulfing and clearing the tagged cells).

When combined with lenalidomide or pomalidomide, the immune response against myeloma cells is stronger than what either drug produces alone.

💊How it's taken

Empliciti is given as an intravenous (IV) infusion in a clinic or infusion center — it cannot be taken by mouth or self-administered. The infusion rate starts slowly and is increased in steps to minimize the risk of reactions.

  • During cycles 1 and 2, Empliciti is infused once weekly (every 28-day cycle)
  • With the lenalidomide + dexamethasone regimen, from cycle 3 onward it shifts to every 2 weeks
  • With the pomalidomide + dexamethasone regimen, from cycle 3 onward it shifts to once every 4 weeks (at a higher per-infusion amount)
  • Required pre-medications must be taken 45–90 minutes before every infusion; follow your care team's instructions exactly
🤒Side effects — in detail

The most commonly reported side effects with Empliciti include:

  • Fatigue or weakness
  • Diarrhea
  • Fever (pyrexia)
  • Constipation
  • Cough
  • Peripheral neuropathy (numbness, tingling, or pain in hands and feet)
  • Nasopharyngitis and upper respiratory tract infections
  • Decreased appetite
  • Pneumonia
  • Elevated blood sugar (hyperglycemia) — particularly noted with the pomalidomide and dexamethasone combination

Serious reactions to watch for include infusion reactions (fever, chills, chest discomfort, blood pressure changes), severe infections, signs of liver damage (jaundice, dark urine), and any new or unusual growths that could indicate a second cancer — report any of these to your care team promptly.

⚠️Warnings & precautions
  • Infusion reactions: Can occur during the drip — symptoms include fever, chills, high or low blood pressure, and chest discomfort. Pre-medications are required. The infusion will be paused and managed if a reaction occurs. Severe reactions may require permanently stopping Empliciti.
  • Infections: Serious infections — including pneumonia, fungal infections, and shingles — were common in clinical trials. Monitor for fever or signs of infection and get treatment quickly.
  • Second primary malignancies: A slightly higher rate of new cancers (including skin cancers) was observed in patients receiving Empliciti with lenalidomide and dexamethasone. Your care team will monitor for this.
  • Hepatotoxicity (liver damage): Elevated liver enzymes were reported. Liver function is checked periodically; Empliciti may be stopped if liver enzyme levels become significantly elevated.
  • Interference with myeloma monitoring tests: Empliciti can appear on blood protein tests (SPEP and immunofixation) used to track myeloma, which may affect how well your response to treatment is assessed.
🔀What it interacts with

Because Empliciti is always given with other medications, interactions from those partner drugs are also important to consider.

  • Lenalidomide and pomalidomide — always co-administered with Empliciti; review their own interaction profiles with your prescriber, including restrictions on blood and sperm donation
  • Dexamethasone — part of every Empliciti regimen; if dexamethasone is delayed or stopped, your doctor will decide whether Empliciti should still be given based on your risk of infusion reaction
  • Blood protein monitoring tests (SPEP and immunofixation assays) — Empliciti can show up on these lab tests and interfere with accurate assessment of your myeloma response, particularly if your myeloma is IgG kappa type

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
  • Pregnancy: Do not use if pregnant. Empliciti is given with lenalidomide or pomalidomide, which can cause severe, life-threatening birth defects. Pregnancy testing and strict contraception are required — follow the REMS program requirements for those drugs.
  • Breastfeeding: Do not breastfeed during treatment. The potential for serious harm to a nursing infant exists.
  • People who could become pregnant or father a child: Both females and males must follow contraception requirements due to the lenalidomide and pomalidomide components; sperm and blood donation are also restricted during treatment.
  • Children: Safety and effectiveness in pediatric patients have not been established.
  • Older adults (65+): Represented in clinical trials with no overall difference in safety or effectiveness versus younger adults.
  • Kidney impairment: Empliciti's behavior is similar across a range of kidney function levels, including patients on dialysis; no dose adjustment is specifically required based on kidney function alone.
  • Liver impairment: How Empliciti behaves in patients with moderate to severe liver problems is not fully known — discuss with your doctor.
🚑If you take too much

The dose at which Empliciti causes severe toxicity is not known. Empliciti does not appear to be removed by dialysis. If an overdose is suspected, patients should be monitored closely for any signs of side effects and treated with supportive care as needed.

📡Pharmacodynamics — effects in the body

Empliciti does not meaningfully prolong the QT interval — the heart's electrical recovery time — when given at the recommended dose with lenalidomide and dexamethasone, or at higher doses as a single agent. This means Empliciti is not expected to cause the type of irregular heart rhythm (arrhythmia) sometimes associated with QT prolongation.

🔬Pharmacokinetics — how your body processes it

Elotuzumab is cleared from the body in a nonlinear way — meaning that as the dose increases, clearance slows down more than proportionally, a pattern driven by the drug binding to its SLAMF7 target (called target-mediated clearance). It takes roughly 78–82 days for the body to eliminate most of the drug after reaching steady-state levels. Body weight affects how quickly elotuzumab is cleared, which is why dosing is calculated based on body weight. Age, sex, race, and mild-to-moderate kidney problems do not significantly change how the drug behaves in the body; the effects of significant liver impairment are not fully known.

📦How to store it

Store EMPLICITI under refrigeration at 2°C to 8°C (36°F-46°F). storing in the original package until time of use. Do not freeze or shake.

📄 Written from Elotuzumab 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 →

38

Supplements & herbs that interact with Elotuzumab Injection

38 supplements and herbal products have documented interactions with Elotuzumab Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 35
Every supplement checked against Elotuzumab Injection — ranked by severity The full interaction hub: 3 major · 35 moderate · every one linked to its full report. Check Elotuzumab Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Elotuzumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Empliciti treating, and how is it different from chemotherapy?
Empliciti targets a protein called SLAMF7 that sits on the surface of myeloma cells. Instead of directly poisoning cancer cells the way chemotherapy does, it wakes up your own immune system's natural killer cells and directs them to attack the myeloma. It's always used alongside other medications — lenalidomide or pomalidomide, plus dexamethasone — to give the best effect.
What should I expect during the infusion itself?
Before your infusion starts, you'll be given pre-medications — including a steroid, an antihistamine, and acetaminophen — to help prevent reactions. The infusion itself goes slowly at first and the rate is increased gradually. The whole process can take several hours, especially during the first few treatments. Most infusion reactions that do happen occur during the very first dose, so your care team will watch you closely.
What side effects are most likely to affect me day-to-day?
The most common ones people notice are fatigue, diarrhea, fever, constipation, and a nagging cough. Infections — including respiratory infections and shingles — are also fairly common, so it's important to let your doctor know right away if you develop a fever or feel like you're coming down with something. Your care team will keep an eye on your blood counts and liver function throughout treatment.
Are there any signs I should call my doctor about right away?
Yes — call immediately if you develop fever, chills, chest discomfort, or changes in blood pressure during or shortly after an infusion, as these can be signs of an infusion reaction. Also reach out quickly for any signs of infection, yellowing of the skin or eyes (which could signal liver problems), or any new or unusual lumps. Don't wait to see if things get better on their own with these.
Can I get pregnant or father a child while on this treatment?
This is really important: the medications used alongside Empliciti — lenalidomide and pomalidomide — can cause very serious birth defects and are strictly contraindicated in pregnancy. Both women and men need to follow the contraception requirements set out in the REMS programs for those drugs before and throughout treatment. Talk with your doctor about what specific steps you need to take before you start.
Will Empliciti affect my myeloma monitoring blood tests?
It can, yes. Empliciti is a protein that can show up on the same blood protein tests — called SPEP and immunofixation — used to track your myeloma. This can make it harder to tell whether the myeloma has responded completely to treatment. Your care team is aware of this and will factor it into how they interpret your results.
Is Elotuzumab Injection available over the counter?
Elotuzumab Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Elotuzumab Injection first available?
Elotuzumab Injection has been available in the United States since at least 2015, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Elotuzumab Injection?
Elotuzumab Injection is supplied by 4 manufacturers listed in the FDA NDC Directory, including E.R. Squibb & Sons, L.L.C., Patheon Italia S.p.A., Bristol-Myers Squibb Company.

💬 Answers drafted from Elotuzumab 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 Elotuzumab Injection comes

Elotuzumab 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

By injection · Into a vein
Brands Empliciti
How this form is used
What it may be used for
  • Empliciti is used intravenously in combination with lenalidomide and dexamethasone to treat multiple myeloma in adults who have received one to three prior therapies
  • Empliciti is used intravenously in combination with pomalidomide and dexamethasone to treat multiple myeloma in adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor
Important instructions
  • Empliciti is administered as a slow intravenous infusion in a clinical setting — never self-injected at home
  • Pre-medications (dexamethasone, an antihistamine, an H2 blocker, and acetaminophen) must be given 45 to 90 minutes before every Empliciti infusion
  • Empliciti must not be mixed with or infused at the same time as other medications in the same IV line
  • Empliciti is given weekly during the first two treatment cycles, then less frequently — the schedule depends on which combination regimen you are receiving
Available strengths 3 strengths
10 FDA-listed product records

📊 Elotuzumab Injection across the U.S. market

How Elotuzumab 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.

1
Dose forms
4
Manufacturers
1
Brand names
10
FDA-listed product records
2015
First marketed
E.R. Squibb & Sons, L.L.C.60%
Patheon Italia S.p.A.20%
Bristol-Myers Squibb Company10%
Lotte Biologics USA, LLC10%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Elotuzumab Injection is used

A general measure of how commonly Elotuzumab 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 Elotuzumab 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.

269
Medicaid prescriptions filled (Q1–Q4 2025)
$828,865 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Elotuzumab Injection prescribed? Of the 1,596 medications we measure, Elotuzumab Injection ranks #1,431 by Medicaid prescriptions — more than 10% of them.

Where Elotuzumab Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Elotuzumab 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.

The 300 mg injection is the most-dispensed Elotuzumab Injection product — about 86% of these Medicaid prescriptions.

elotuzumab 300 MG Injection Most dispensed

230 Medicaid prescriptions (Q1–Q4 2025) 86% of Elotuzumab Injection prescriptions shown $693,458 gross reimbursement (before rebates) ≈ $3,015 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1726110

elotuzumab 400 MG Injection

39 Medicaid prescriptions (Q1–Q4 2025) 14% of Elotuzumab Injection prescriptions shown $135,407 gross reimbursement (before rebates) ≈ $3,472 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1726117

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 Elotuzumab 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 2 of 4 listed Elotuzumab Injection NDCs with Medicaid activity.

🔍 Compare Elotuzumab Injection products

A representative set of FDA-listed product records for Elotuzumab 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
1 kg/kg Bristol-Myers Squibb Company BULK INGREDIENT View NDC →
300 mg Intravenous E.R. Squibb & Sons, L.L.C. × 3 listings BLA View NDC →
400 mg Intravenous E.R. Squibb & Sons, L.L.C. × 3 listings BLA View NDC →
1 kg/kg Lotte Biologics USA, LLC BULK INGREDIENT View NDC →
300 mg Patheon Italia S.p.A. DRUG FOR FURTHER PROCESSING View NDC →
400 mg Patheon Italia S.p.A. DRUG FOR FURTHER PROCESSING View NDC →

Showing 10 of 10 products — FDA National Drug Code Directory. See every product, package size and price: browse all 10 Elotuzumab Injection NDCs →

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.

Ingredient (IN) Elotuzumab Injection RxCUI 1726104 1 dose form · 2 strengths
  1. Dose form (SCDF) Injection RxCUI 1726109 In current FDA listings
    Clinical drug / strength (SCD) 300 MG RxCUI 1726110 400 MG RxCUI 1726117

Look up RxCUI 1726104 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.

🏷️ Sold under these brand names

Empliciti

🏭 Manufacturers & labelers

E.R. Squibb & Sons, L.L.C. 6 Patheon Italia S.p.A. 2 Bristol-Myers Squibb Company 1 Lotte Biologics USA, LLC 1

RxNorm drug class

Elotuzumab Injection belongs to the SLAMF7-directed Immunostimulatory Antibody class.

Pharmacologic class SLAMF7-directed Immunostimulatory Antibody
Drug family (ATC) Other monoclonal antibodies and antibody drug conjugates
How it works SLAMF7-directed Antibody Interactions

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 22, 2022
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Elotuzumab Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Elotuzumab Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
10
Distinct labelers/manufacturers represented
4
Linked representative label
E.R. Squibb & Sons, L.L.C.
Linked label effective
Mar 22, 2022
Composite sections available
21
Linked SPL Set ID
80686b7e-f6f4-4154-b5c0-c846425e2d91
Linked SPL Document ID
8441efc2-338a-4d1d-8fa1-9b9863a49ffd
Open the linked representative label on DailyMed ↗

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. E.R. Squibb & Sons, L.L.C. 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.