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Empliciti elotuzumab 400 mg Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 00003-4522-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Empliciti elotuzumab 400 mg Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 0003-4522-11 (Billing 00003-4522-11)

by E.R. Squibb & Sons, L.L.C. · 1 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

This is a package of 1 vial of Empliciti elotuzumab 400 mg Injection, Powder, Lyophilized, For Solution from E.R. Squibb & Sons, L.L.C., marketed since Nov 2015 and currently FDA-listed. It is this product's only package size.

NDC 00003-4522-11
🏷️ FDA NDC (as labeled) 0003-4522-11 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled 🛡 REMS ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0003-4522-11 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0003 labeler · 4522 product · 11 package
Package marketed since
Nov 30, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
1 EA per package
Barcode (UPC)
0300032291118
Medicaid fills, this package
26 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0003-4522-11
Product NDC 0003-4522
11-digit billing NDC 00003452211
NCPDP billing unit EA — each (per item)
RxCUI 1726110, 1726115, 1726117, 1726119
UNII 1351PE5UGS
UPC 0300032291118
Application # BLA761035
SPL Set ID 80686b7e-f6f4-4154-b5c0-c846425e2d91
Established class (EPC) SLAMF7-directed Immunostimulatory Antibody
Mechanism of action SLAMF7-directed Antibody Interactions
Chemical class Antibodies, Monoclonal
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-11-30
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance ELOTUZUMAB
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21359030002130
GPI class Empliciti
GCN Seq No 075216
GCN 40228
HICL code 042842
Ingredient (HICL) Elotuzumab
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V3
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs (Continued 1)
HIC3 code V3W
Therapeutic class — specific (HIC3) Antineoplastic - Anti-Slamf7 Monoclonal Antibody
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name EMPLICITI 400 MG VIAL
FDB brand name Empliciti
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 075216
  • GCN: 40228
  • GPI-14 (Medi-Span): 21359030002130
  • HICL (First Databank): 042842
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 1726110
Why two NDCs? The FDA registers this code as 0003-4522-11 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00003-4522-11. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine 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
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name EMPLICITI 400 MG VIAL Ingredient Elotuzumab
📗 Our plain-language guide HelloPharmacist
  • It treats multiple myeloma in adults who have already had earlier treatment. You get it along with lenalidomide or pomalidomide, plus dexamethasone. It is not used alone.
  • It is given as a slow IV infusion by your care team. Before each dose you get premedicines, such as dexamethasone, an antihistamine and acetaminophen, to lower the risk of a reacti...
  • Fatigue, diarrhea, fever, constipation, cough and colds are common. Some people get numbness or tingling in the hands or feet. Tell your team about anything that bothers you.
  • Call for fever or any sign of infection, since infections can be serious. Tell your team right away about chills, chest discomfort or dizziness during or after an infusion. Report...
📖 Read our full Elotuzumab Injection guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $1,938.45 —
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9176 $8.189 / J9176 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)0003-4522-11
11-digit billing NDC00003-4522-11
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ9176
DescriptorInjection, elotuzumab, 1 mg
Billing units / pkg400 units
How the units are derivedThis package is 1; the HCPCS unit is 1 MG, so one package = 400 billing units.
Medicare Part B spend (2026 (Q1))$17,914,205 · 1,951 claims · $9,182.06 per claim (all NDCs under J9176)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00003-4522-11 You're viewing this Main listing 1 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE 2015-11-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Empliciti 400 mgthis 00003-4522-11 E.R. 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2015
First FDA approval
Nov 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2027
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2027. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 30, 2015 ⏳ ~1.1 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Emplicitielotuzumab
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2015 2017 2019 2021 2023 2025 2027
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateNov 30, 2027
Common questions
Is there a biosimilar for EMPLICITI 400 MG VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Elotuzumab Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 3.17 mg UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 4.4 mg UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 21.5 mg UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 660 mg UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerE.R. Squibb & Sons, L.L.C.
FDA applicationBLA761035 (BLA)
Labeler code00003
First marketedNov 2015
Product typeHuman Prescription Drug
Portfolio51 products on file

More NDCs from E.R. Squibb & Sons, L.L.C. labeler code 00003

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 126 words ▾

1 INDICATIONS AND USAGE • EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. • EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in • combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies.

(1) • combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • With lenalidomide and dexamethasone: 10 mg/kg administered intravenously every week for the first two cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity. (2.1) • With pomalidomide and dexamethasone: 10 mg/kg administered intravenously every week for the first two cycles and 20 mg/kg every 4 weeks thereafter until disease progression or unacceptable toxicity. (2.2) • Premedicate with dexamethasone, diphenhydramine, ranitidine and acetaminophen.

(2.3)

2.1Recommended Dosing when EMPLICITI Is Used in Combination with Lenalidomide and Dexamethasone The recommended dosage of EMPLICITI is 10 mg/kg administered intravenously every week for the first two cycles (28-day cycle) and every 2 weeks thereafter in conjunction with the recommended dosing of lenalidomide and low-dose dexamethasone as described below. Continue treatment until disease progression or unacceptable toxicity. Refer to the dexamethasone and lenalidomide prescribing information for additional information.

Administer premedications before each dose of EMPLICITI [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ] . Administer dexamethasone as follows: • On days that EMPLICITI is administered, give dexamethasone 28 mg orally between 3 and 24 hours before EMPLICITI plus 8 mg intravenously between 45 and 90 minutes before EMPLICITI. • On days that EMPLICITI is not administered but a dose of dexamethasone is scheduled (Days 8 and 22 of cycle 3 and all subsequent cycles), give 40 mg orally. The recommended dosing is presented in Table 1.

Table 1: Recommended Dosing Schedule of EMPLICITI in Combination with Lenalidomide and Dexamethasone Cycle 28-Day Cycles 1 and 2 28-Day Cycles 3+ * Premedicate with the following 45 to 90 minutes prior to EMPLICITI infusion: 8 mg intravenous dexamethasone, H1 blocker: diphenhydramine (25 to 50 mg orally or intravenously) or equivalent; H2 blocker: ranitidine (50 mg intravenously) or equivalent; acetaminophen (650 to 1000 mg orally). † Oral dexamethasone (28 mg) taken between 3 and 24 hours before EMPLICITI infusion. ** Intravenous dexamethasone 45-90 minutes before EMPLICITI infusion.

Day of Cycle 1 8 15 22 1 8 15 22 Premedication* ✓ ✓ ✓ ✓ ✓ ✓ EMPLICITI (mg/kg) intravenously 10 10 10 10 10 10 Lenalidomide (25 mg) orally Days 1-21 Days 1-21 Dexamethasone † (mg) orally 28 28 28 28 28 40 28 40 Dexamethasone** (mg) intravenously 8 8 8 8 8 8 Day of Cycle 1 8 15 22 1 8 15 22

2.2Recommended Dosing when EMPLICITI Is Used in Combination with Pomalidomide and Dexamethasone The recommended dosage of EMPLICITI is 10 mg/kg administered intravenously every week for the first two cycles (28-day cycle). Starting at cycle 3 (28-day cycle), administer EMPLICITI 20 mg/kg intravenously every 4 weeks. Administer EMPLICITI in conjunction with pomalidomide and low-dose dexamethasone as described below (Table 2).

Continue treatment until disease progression or unacceptable toxicity. Refer to the dexamethasone and pomalidomide prescribing information for additional information. Administer premedications before each dose of EMPLICITI [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ] .

Administer dexamethasone as follows: • On days that EMPLICITI is administered, for patients 75 years or younger give dexamethasone 28 mg orally between 3 and 24 hours before EMPLICITI plus 8 mg intravenously between 45 and 90 minutes before EMPLICITI and for patients older than 75 years give dexamethasone 8 mg orally between 3 and 24 hours before EMPLICITI plus 8 mg intravenously between 45 and 90 minutes before EMPLICITI. • On days that EMPLICITI is not administered but a dose of dexamethasone is scheduled (Days 8, 15 and 22 of cycle 3 and all subsequent cycles), give 40 mg orally to patients 75 years or younger and 20 mg orally to patients older than 75 years.

The recommended dosing is presented in Table 2. Table 2: Recommended Dosing Schedule of EMPLICITI in Combination wi… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 43 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 300 mg or 400 mg of elotuzumab as a white to off-white lyophilized powder in a single-dose vial for reconstitution. For Injection: 300 mg or 400 mg lyophilized powder in a single-dose vial for reconstitution. (3)

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None. None (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Infusion reactions: Premedication is required. Interrupt EMPLICITI for Grade 2 or higher and permanently discontinue for severe infusion reaction. ( 2.3 , 2.4 , 5.1) • Infections: Monitor for fever and other signs of infection and treat promptly.

(5.2) • Second Primary Malignancies (SPM): Higher incidences of SPM were observed in a controlled clinical trial of patients with multiple myeloma receiving EMPLICITI. (5.3) • Hepatotoxicity: Monitor liver function and stop EMPLICITI if hepatotoxicity is suspected. (5.4) • Interference with determination of complete response: EMPLICITI can interfere with assays used to monitor M-protein.

This interference can impact the determination of complete response. (5.5)

5.1Infusion Reactions EMPLICITI can cause infusion reactions. Infusion reactions were reported in 10% of patients treated with EMPLICITI in the ELOQUENT-2 trial and 3.3% in the ELOQUENT-3 trial. In the ELOQUENT-2 trial, all reports of infusion reaction were Grade 3 or lower.

In the ELOQUENT-2 trial, Grade 3 infusion reactions occurred in 1% of patients. The most common symptoms of an infusion reaction included fever, chills, and hypertension. Bradycardia and hypotension also developed during infusions.

In the ELOQUENT-2 trial, 5% of patients required interruption of the administration of EMPLICITI for a median of 25 minutes due to infusion reactions, and 1% of patients discontinued due to infusion reactions. Of the patients who experienced an infusion reaction, 70% (23/33) had them during the first dose. In the ELOQUENT-3 trial, the only infusion reaction symptom was chest discomfort (2%), which was Grade 1.

All patients in the ELOQUENT-3 trial who experienced an infusion reaction had them during the first treatment cycle. Administer premedication consisting of dexamethasone, antihistamines (H1 and H2 blockers) and acetaminophen prior to EMPLICITI infusion [see Dosage and Administration (2.3) ]. Interrupt EMPLICITI infusion for Grade 2 or higher infusion reactions and institute appropriate medical management [see Dosage and Administration (2.4) ].

5.2Infections In the ELOQUENT-2 trial (N=635), infections were reported in 81% of patients in EMPLICITI combined with lenalidomide and dexamethasone (E-Ld) arm and 74% in lenalidomide and dexamethasone (Ld). In the ELOQUENT-3 trial (N=115), infections were reported in 65% of patients in both EMPLICITI combined with pomalidomide and dexamethasone (E-Pd) arm and in pomalidomide and dexamethasone (Pd) arm. In the ELOQUENT-2 trial, Grade 3 to 4 infections were noted in 28% and 24% of E-Ld- and Ld-treated patients and in the ELOQUENT-3 trial, 13% and 22% of E-Pd- and Pd-treated patients, respectively.

Discontinuations due to infections occurred in 3.5% of E-Ld-treated and 4.1% of Ld-treated patients in the ELOQUENT-2 trial and 7% of E-Pd-treated and 5% of Pd-treated patients in the ELOQUENT-3 trial. Fatal infections were reported in 2.5% and 2.2% of E-Ld- and Ld-treated patients in the ELOQUENT-2 trial and 5% and 3.6% of E-Pd- and Pd-treated patients in the ELOQUENT-3 trial. Opportunistic infections were reported in 22% of patients in the E-Ld arm and 13% of patients in the Ld arm in the ELOQUENT-2 trial and 10% of patients in the E-Pd arm and 9% of patients in the Pd arm in the ELOQUENT-3 trial.

In the ELOQUENT-2 trial, fungal infections occurred in 10% of patients in the E-Ld arm and 5% of patients in the Ld arm. Herpes zoster was reported in 14% of patients treated with E-Ld and 7% of patients treated with Ld in the ELOQUENT-2 trial and 5% of patients treated with E-Pd and 1.8% of patients treated with Pd in the ELOQUENT-3 trial. Monitor patients for development of infections and treat promptly.

5.3Second Primary Malignancies In the ELOQUENT-2 trial (N=635), invasive second primary malignancies (SPM) have been observed in 9% of patients treated with E-Ld and 6% of patients treated with Ld and in the ELOQUENT-3 trial (N=115) in 1.8% of patients treated wit… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in detail in other sections of the label: • Infusion reaction [see Warnings and Precautions (5.1) ] . • Infections [see Warnings and Precautions (5.2) ] . • Second Primary Malignancies [ see Warnings and Precautions (5.3) ] . • Hepatotoxicity [see Warnings and Precautions (5.4) ] . • Interference with determination of complete response [see Warnings and Precautions (5.5) ] . Most common adverse reactions (20% or higher) • with lenalidomide and dexamethasone are fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, pneumonia.

(6.1) • with pomalidomide and dexamethasone are constipation and hyperglycemia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. EMPLICITI in Combination with Lenalidomide and Dexamethasone [ELOQUENT-2] The safety data described in this section are based on the ELOQUENT-2 study, a randomized, open-label clinical trial in patients with previously treated multiple myeloma.

In ELOQUENT-2, EMPLICITI 10 mg/kg was administered with lenalidomide and dexamethasone [see Clinical Studies (14) ] . For adverse reaction evaluation, EMPLICITI combined with lenalidomide and dexamethasone was compared with lenalidomide and dexamethasone alone. The mean age of the population was 66 years and 57% of patients were 65 years of age or older.

Sixty percent (60%) of the population were male, 84% were white, 10% were Asian, and 4% were black. The Eastern Cooperative Oncology Group (ECOG) performance status was 0 in 47%, 1 in 44%, and 2 in 9% of patients. These data reflect exposure of 318 patients to EMPLICITI and 317 to control with a median number of cycles of 19 for EMPLICITI and 14 for control.

Serious adverse reactions were reported in 65% of patients treated on the EMPLICITI arm and 57% for patients treated on the control arm. The most frequent serious adverse reactions in the EMPLICITI arm compared to the control arm were: pneumonia (15% vs. 11%), pyrexia (7% vs.

5%), respiratory tract infection (3.1% vs. 1.3%), anemia (2.8% vs. 1.9%), pulmonary embolism (3.1% vs.

2.5%), and acute renal failure (2.5% vs. 1.9%). The proportion of patients who discontinued any component of the treatment regimen due to adverse reactions as listed below was similar for both treatment arms; 6.0% for patients treated on the EMPLICITI arm and 6.3% for patients treated on the control.

Adverse reactions occurring at a frequency of 10% or higher in the EMPLICITI arm and 5% or higher than the lenalidomide and dexamethasone arm for the randomized trial in multiple myeloma are presented in Table 6. Table 6: ELOQUENT-2: Adverse Reactions with a 10% or Higher Incidence for EMPLICITI-Treated Patients and a 5% or Higher Incidence than Lenalidomide and Dexamethasone-Treated Patients [All Grades] EMPLICITI + Lenalidomide and Dexamethasone N=318 Lenalidomide and Dexamethasone N=317 Primary Term All Grades Grade 3/4 All Grades Grade 3/4 * The term fatigue is a grouping of the following terms: fatigue and asthenia. † The term cough is a grouping of the following terms: cough, productive cough, and upper airway cough. ‡ The term peripheral neuropathy is a grouping of the following terms: peripheral neuropathy, axonal neuropathy, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy. § The term pneumonia is a grouping of the following terms: pneumonia, atypical pneumonia, bronchopneumonia, lobar pneumonia, bacterial pneumonia, fungal pneumonia, pneumonia influenza, and pneumococcal… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 112 words ▾

7 DRUG INTERACTIONS

7.1Drug Interactions For important drug interactions involving lenalidomide, pomalidomide and dexamethasone, refer to their respective prescribing information.

7.2Laboratory Test Interference EMPLICITI may be detected in the SPEP and serum immunofixation assays of myeloma patients and could interfere with correct response classification. A small peak in the early gamma region on SPEP that is IgGƙ on serum immunofixation may potentially be attributed to EMPLICITI, particularly in patients whose endogenous myeloma protein is IgA, IgM, IgD, or lambda light chain restricted. This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein [see Warnings and Precautions (5.5) ].

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Embryo-fetal toxicity in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone. (8.1)

8.1Pregnancy Risk Summary There are no available data on EMPLICITI use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. Animal reproduction studies have not been conducted with elotuzumab. EMPLICITI is administered in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone.

Lenalidomide and pomalidomide can cause embryo-fetal harm and are contraindicated for use in pregnancy. Refer to the lenalidomide, pomalidomide and dexamethasone prescribing information for additional information. Lenalidomide and pomalidomide are only available through a REMS program.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

8.2Lactation Risk Summary There are no data on the presence of EMPLICITI in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child from elotuzumab administered in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone, advise lactating women not to breastfeed during treatment with EMPLICITI. Refer to the lenalidomide, pomalidomide and dexamethasone prescribing information for additional information.

8.3Females and Males of Reproductive Potential Pregnancy Testing Refer to the lenalidomide and pomalidomide labeling for pregnancy testing requirements prior to initiating treatment in females of reproductive potential. When EMPLICITI is used with lenalidomide or pomalidomide, there is a risk of fetal harm, including severe life-threatening human birth defects associated with lenalidomide and pomalidomide, and the need to follow requirements regarding pregnancy avoidance, including testing. Contraception Females Refer to the lenalidomide and pomalidomide labeling for contraception requirements prior to initiating treatment in females of reproductive potential.

Males Lenalidomide and pomalidomide are present in the blood and semen of patients receiving the drug. Refer to the lenalidomide and pomalidomide full prescribing information for requirements regarding contraception and the prohibitions against blood and/or sperm donation due to presence and transmission in blood and/or semen and for additional information.

8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients.

8.5Geriatric Use Of the 646 patients across treatment groups in the ELOQUENT-2 randomized trial designed to evaluate the use of EMPLICITI in combination with lenalidomide and low-dose dexamethasone in multiple myeloma, 57% were 65 years of age or older; the number of patients 65 years or older was similar between treatment groups. No overall differences in efficacy or safety were observed between patients 65 years or older and younger patients (less than 65 years of age). Of the 117 patients across treatment groups in the ELOQUENT-3 randomized trial designed to evaluate the use of EMPLICITI in combination with pomalidomide and low-dose dexamethasone in multiple myeloma, 62% were 65 years of age or older; the number of patients 65 years or older was similar between treatment groups.

This study did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🤰 Pregnancy 138 words ▾

8.1Pregnancy Risk Summary There are no available data on EMPLICITI use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. Animal reproduction studies have not been conducted with elotuzumab. EMPLICITI is administered in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone.

Lenalidomide and pomalidomide can cause embryo-fetal harm and are contraindicated for use in pregnancy. Refer to the lenalidomide, pomalidomide and dexamethasone prescribing information for additional information. Lenalidomide and pomalidomide are only available through a REMS program.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients.

🧓 Geriatric Use 149 words ▾

8.5Geriatric Use Of the 646 patients across treatment groups in the ELOQUENT-2 randomized trial designed to evaluate the use of EMPLICITI in combination with lenalidomide and low-dose dexamethasone in multiple myeloma, 57% were 65 years of age or older; the number of patients 65 years or older was similar between treatment groups. No overall differences in efficacy or safety were observed between patients 65 years or older and younger patients (less than 65 years of age). Of the 117 patients across treatment groups in the ELOQUENT-3 randomized trial designed to evaluate the use of EMPLICITI in combination with pomalidomide and low-dose dexamethasone in multiple myeloma, 62% were 65 years of age or older; the number of patients 65 years or older was similar between treatment groups.

This study did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🆘 Overdosage 52 words ▾

10 OVERDOSAGE The dose of EMPLICITI at which severe toxicity occurs is not known. EMPLICITI does not appear to be removed by dialysis as determined in a study of patients with renal impairment. In case of overdosage, monitor patients closely for signs or symptoms of adverse reactions and institute appropriate symptomatic treatment.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Elotuzumab is a humanized IgG1 monoclonal antibody that specifically targets the SLAMF7 (Signaling Lymphocytic Activation Molecule Family member 7) protein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 is also expressed on Natural Killer (NK) cells, plasma cells, and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.

Elotuzumab directly activates NK cells through the SLAMF7 pathway. Elotuzumab also targets SLAMF7 on myeloma cells and interacts with Fc receptors on effector cells to mediate the killing of myeloma cells through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). In nonclinical models, the combination of elotuzumab and lenalidomide resulted in enhanced activation of NK cells that was greater than the effects of either agent alone and increased anti-tumor activity in vitro and in vivo.

Elotuzumab has also demonstrated increased anti-tumor activity when combined with pomalidomide in vivo.

12.2Pharmacodynamics Cardiac Electrophysiology EMPLICITI does not prolong the QT interval to any clinically relevant extent when administered with lenalidomide and dexamethasone at the recommended dose or as monotherapy (at a dose 2 times the recommended dose).

12.3Pharmacokinetics Elotuzumab exhibits nonlinear pharmacokinetics (PK) resulting in greater than proportional increases in area under the concentration-time curve (AUC) indicative of target-mediated clearance. The administration of the recommended 10 mg/kg EMPLICITI regimen with lenalidomide and dexamethasone is predicted to result in geometric mean (CV%) steady-state trough concentrations of 194 μg/mL (52%). The administration of the recommended EMPLICITI regimen with pomalidomide and dexamethasone is predicted to result in geometric mean (CV%) steady-state trough concentrations of 124 μg/mL (59%).

Elimination The clearance of elotuzumab in combination with lenalidomide and dexamethasone decreased from a geometric mean (CV%) of 17.5 (21.2%) to 5.8 (31%) mL/day/kg with an increase in dose from 0.5 (i.e., 0.05 times the recommended dosage) to 20 mg/kg (i.e., 2 times the recommended dosage). When elotuzumab is administered with lenalidomide and dexamethasone, approximately 97% of the maximum steady-state concentration is predicted to be eliminated with a geometric mean (CV%) of 82.4 (48%) days. When elotuzumab is administered with pomalidomide and dexamethasone, approximately 97% of the maximum steady-state concentration is predicted to be eliminated with a geometric mean (CV%) of 78 (42%) days.

Specific Populations Clinically significant differences were not observed in the PK of elotuzumab based on age (37 to 88 years), sex, race, baseline lactate dehydrogenase, albumin, renal impairment (creatinine clearance (CLcr) 15 to 89 mL/min), end-stage renal disease (CLcr <15 mL/min) with or without hemodialysis, mild hepatic impairment (total bilirubin ≤ upper limit of normal (ULN) and aspartate transaminase (AST) > ULN OR total bilirubin 1 to 1.5 times the ULN and AST any value), and coadministration with lenalidomide/dexamethasone or pomalidomide/dexamethasone.

The PK of elotuzumab in patients with moderate (total bilirubin > 1.5 to 3 times the ULN and AST any value) to severe (total bilirubin > 3 times the ULN and AST any value) hepatic impairment is unknown. The clearance of elotuzumab increased with increasing body weight supporting a weight-based dose.

🧬 Mechanism of Action 150 words ▾

12.1Mechanism of Action Elotuzumab is a humanized IgG1 monoclonal antibody that specifically targets the SLAMF7 (Signaling Lymphocytic Activation Molecule Family member 7) protein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 is also expressed on Natural Killer (NK) cells, plasma cells, and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.

Elotuzumab directly activates NK cells through the SLAMF7 pathway. Elotuzumab also targets SLAMF7 on myeloma cells and interacts with Fc receptors on effector cells to mediate the killing of myeloma cells through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). In nonclinical models, the combination of elotuzumab and lenalidomide resulted in enhanced activation of NK cells that was greater than the effects of either agent alone and increased anti-tumor activity in vitro and in vivo.

Elotuzumab has also demonstrated increased anti-tumor activity when combined with pomalidomide in vivo.

📦 How Supplied / Storage and Handling 59 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING EMPLICITI (elotuzumab) is white to off-white lyophilized powder available as follows: Carton Content NDC One 300 mg single-dose vial 0003-2291-11 One 400 mg single-dose vial 0003-4522-11 Store EMPLICITI under refrigeration at 2°C to 8°C (36°F-46°F). Protect EMPLICITI from light by storing in the original package until time of use. Do not freeze or shake.

📋 Description ~1 min read ▾

11 DESCRIPTION Elotuzumab is a humanized recombinant monoclonal antibody directed to SLAMF7, a cell surface glycoprotein. Elotuzumab consists of the complementary determining regions (CDR) of the mouse antibody, MuLuc63, grafted onto human IgG1 heavy and kappa light chain frameworks. Elotuzumab is produced in NS0 cells by recombinant DNA technology.

Elotuzumab has a theoretical mass of 148.1 kDa for the intact antibody. EMPLICITI (elotuzumab) is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake in single-dose vials. EMPLICITI for Injection is supplied as 300 mg per vial and 400 mg per vial and requires reconstitution with Sterile Water for Injection, USP (13 mL and 17 mL, respectively) to obtain a solution with a concentration of 25 mg/mL.

After reconstitution, each vial contains overfill to allow for withdrawal of 12 mL (300 mg) and 16 mL (400 mg). The reconstituted solution is colorless to slightly yellow, clear to slightly opalescent. Prior to intravenous infusion, the reconstituted solution is diluted with either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP [see Dosage and Administration (2.6) ] .

Each 300 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (2.44 mg), polysorbate 80 (3.4 mg), sodium citrate (16.6 mg), and sucrose (510 mg). Each 400 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (3.17 mg), polysorbate 80 (4.4 mg), sodium citrate (21.5 mg), and sucrose (660 mg).

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) . Infusion Reactions • EMPLICITI may cause infusion reactions. Advise patients to contact their healthcare provider if they experience signs and symptoms of infusion reactions, including fever, chills, rash, or breathing problems within 24 hours of infusion [see Warnings and Precautions (5.1) ] . • Advise patients that they will be required to take the following oral medications prior to EMPLICITI dosing to reduce the risk of infusion reaction [see Dosage and Administration (2.3) ] : • Dexamethasone orally as prescribed • H1 blocker: diphenhydramine or equivalent (if oral) • H2 blocker: ranitidine or equivalent (if oral) • Acetaminophen (650 to 1000 mg orally) Pregnancy • Advise patients that lenalidomide and pomalidomide have the potential to cause fetal harm and has specific requirements regarding contraception, pregnancy testing, blood and sperm donation, and transmission in sperm.

Lenalidomide and pomalidomide are only available through a REMS program [see Use in Specific Populations (8.1) ] . Infections • Inform patients of the risk of developing infections during treatment with EMPLICITI, and to report any symptoms of infection [see Warnings and Precautions (5.2) ] . Second Primary Malignancies • Inform patients of the risk of developing SPM during treatment with EMPLICITI [see Warnings and Precautions (5.3) ] .

Hepatotoxicity • Inform patients of the risk of hepatotoxicity during treatment with EMPLICITI and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions (5.4) ] . Manufactured by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA U.S. License No.

1713

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Elotuzumab exhibits nonlinear pharmacokinetics (PK) resulting in greater than proportional increases in area under the concentration-time curve (AUC) indicative of target-mediated clearance. The administration of the recommended 10 mg/kg EMPLICITI regimen with lenalidomide and dexamethasone is predicted to result in geometric mean (CV%) steady-state trough concentrations of 194 μg/mL (52%). The administration of the recommended EMPLICITI regimen with pomalidomide and dexamethasone is predicted to result in geometric mean (CV%) steady-state trough concentrations of 124 μg/mL (59%).

Elimination The clearance of elotuzumab in combination with lenalidomide and dexamethasone decreased from a geometric mean (CV%) of 17.5 (21.2%) to 5.8 (31%) mL/day/kg with an increase in dose from 0.5 (i.e., 0.05 times the recommended dosage) to 20 mg/kg (i.e., 2 times the recommended dosage). When elotuzumab is administered with lenalidomide and dexamethasone, approximately 97% of the maximum steady-state concentration is predicted to be eliminated with a geometric mean (CV%) of 82.4 (48%) days. When elotuzumab is administered with pomalidomide and dexamethasone, approximately 97% of the maximum steady-state concentration is predicted to be eliminated with a geometric mean (CV%) of 78 (42%) days.

Specific Populations Clinically significant differences were not observed in the PK of elotuzumab based on age (37 to 88 years), sex, race, baseline lactate dehydrogenase, albumin, renal impairment (creatinine clearance (CLcr) 15 to 89 mL/min), end-stage renal disease (CLcr <15 mL/min) with or without hemodialysis, mild hepatic impairment (total bilirubin ≤ upper limit of normal (ULN) and aspartate transaminase (AST) > ULN OR total bilirubin 1 to 1.5 times the ULN and AST any value), and coadministration with lenalidomide/dexamethasone or pomalidomide/dexamethasone.

The PK of elotuzumab in patients with moderate (total bilirubin > 1.5 to 3 times the ULN and AST any value) to severe (total bilirubin > 3 times the ULN and AST any value) hepatic impairment is unknown. The clearance of elotuzumab increased with increasing body weight supporting a weight-based dose.

🧬 Pharmacodynamics 37 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology EMPLICITI does not prolong the QT interval to any clinically relevant extent when administered with lenalidomide and dexamethasone at the recommended dose or as monotherapy (at a dose 2 times the recommended dose).

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES ELOQUENT-2 (NCT01239797) The efficacy and safety of EMPLICITI in combination with lenalidomide and dexamethasone were evaluated in ELOQUENT-2, a randomized, open-label trial in patients with multiple myeloma who had received one to three prior therapies and had documented progression following their most recent therapy. Eligible patients were randomized in a 1:1 ratio to receive either EMPLICITI in combination with lenalidomide and low-dose dexamethasone or lenalidomide and low-dose dexamethasone.

Treatment was administered in 4-week cycles until disease progression or unacceptable toxicity. EMPLICITI 10 mg/kg was administered intravenously each week for the first 2 cycles and every 2 weeks thereafter. Prior to EMPLICITI infusion, dexamethasone was administered as a divided dose: an oral dose of 28 mg and an intravenous dose of 8 mg.

In the control group and on weeks without EMPLICITI, dexamethasone 40 mg was administered as a single oral dose weekly. Lenalidomide 25 mg was taken orally once daily for the first 3 weeks of each cycle. Assessment of tumor response was conducted every 4 weeks.

A total of 646 patients were randomized to receive treatment: 321 to EMPLICITI in combination with lenalidomide and low-dose dexamethasone and 325 to lenalidomide and low-dose dexamethasone. Demographics and baseline disease characteristics were balanced between treatment arms. The median age was 66 years (range, 37-91); 57% of patients were 65 years or older; 60% of patients were male; whites comprised 84% of the study population, Asians 10%, and blacks 4%.

The ECOG performance status was 0 in 47%, 1 in 44%, and 2 in 9% of patients, and ISS Stage was I in 43%, II in 32%, and III in 21% of patients. The cytogenetic categories of del 17p and t(4;14) were present in 32% and 9% of patients, respectively. The median number of prior therapies was 2.

Thirty-five percent (35%) of patients were refractory (progression during or within 60 days of last therapy) and 65% were relapsed (progression after 60 days of last therapy). Prior therapies included stem cell transplant (55%), bortezomib (70%), melphalan (65%), thalidomide (48%), and lenalidomide (6%). The efficacy of EMPLICITI was evaluated by progression-free survival (PFS) as assessed by hazard ratio, and overall response rate (ORR) as determined by a blinded Independent Review Committee using the European Group for Blood and Marrow Transplantation (EBMT) response criteria.

Efficacy results are shown in Table 12 and Figure 1. The median number of treatment cycles was 19 for the EMPLICITI group and 14 for the comparator arm with a minimum follow-up of two years. A pre-planned final overall survival (OS) analysis was performed after at least 427 deaths occurred.

The minimum follow-up was 70.6 months. The OS results at final analysis reached statistical significance. A significantly longer OS was observed in patients in the E-Ld arm compared to patients in Ld arm, representing an 18% reduction in the risk of death.

Efficacy results are presented in Table 12 and Figure 2. Table 12: ELOQUENT-2 Efficacy Results EMPLICITI + Lenalidomide/ Dexamethasone N=321 Lenalidomide/ Dexamethasone N=325 PFS * p-value based on the log-rank test stratified by ß2 microglobulins (<3.5 mg/L vs ≥3.5 mg/L), number of prior lines of therapy (1 vs 2 or 3), and prior immunomodulatory therapy (no vs prior thalidomide only vs other). † European Group for Blood and Marrow Transplantation (EBMT) criteria. ‡ p-value based on the Cochran-Mantel-Haenszel chi-square test stratified by ß2 microglobulins (<3.5 mg/L vs ≥3.5 mg/L), number of prior lines of therapy (1 vs 2 or 3), and prior immunomodulatory therapy (no vs prior thalidomide only vs other). § Complete response (CR) + stringent complete response (sCR). ¶ EMPLICITI’s interference with the assessment of myeloma protein with immunofixation and serum protein electrophoresis assay may interfere with correct response classification [see Drug Interactions (7) ].… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 30 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or mutagenicity data are available for elotuzumab in animals or humans. Fertility studies have not been performed for elotuzumab.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 27 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or mutagenicity data are available for elotuzumab in animals or humans. Fertility studies have not been performed for elotuzumab.

📄 Patient Package Insert ~3 min read ▾

Patient Information EMPLICITI ® (em-plis-city) (elotuzumab) for injection EMPLICITI is used with other prescription medicines called REVLIMID ® (lenalidomide) and dexamethasone or POMALYST ® (pomalidomide) and dexamethasone. Read the Medication Guide that comes with REVLIMID if used with REVLIMID and POMALYST if used with POMALYST. You can ask your healthcare provider or pharmacist for information about dexamethasone.

What is EMPLICITI? EMPLICITI is a prescription medicine used to treat: • multiple myeloma in combination with the medicines REVLIMID (lenalidomide) and dexamethasone in adults who have received one to three prior treatments for their multiple myeloma. • multiple myeloma in combination with the medicines POMALYST (pomalidomide) and dexamethasone in adults who have received at least two prior treatments including REVLIMID (lenalidomide) and a proteasome inhibitor. It is not known if EMPLICITI is safe and effective in children.

Before you receive EMPLICITI, tell your healthcare provider about all of your medical conditions, including if you: • have an infection • are pregnant or plan to become pregnant. It is not known if EMPLICITI may harm your unborn baby. However, REVLIMID and POMALYST may cause birth defects or death of an unborn baby. o Before receiving EMPLICITI with REVLIMID and dexamethasone, or EMPLICITI with POMALYST and dexamethasone, females and males must agree to the instructions in the REVLIMID REMS ® program for the use of EMPLICITI in combination with REVLIMID and dexamethasone and the POMALYST REMS ® program for the use of EMPLICITI in combination with POMALYST and dexamethasone. o The REVLIMID REMS and POMALYST REMS programs have specific requirements about birth control (contraception), pregnancy testing, blood donation, and sperm donation that you need to know.

Talk to your healthcare provider to learn more about REVLIMID or POMALYST. • are breastfeeding or plan to breastfeed. It is not known if EMPLICITI passes into breast milk. You should not breastfeed during treatment with EMPLICITI and REVLIMID and dexamethasone or EMPLICITI and POMALYST and dexamethasone. • Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive EMPLICITI? • EMPLICITI will be given to you by intravenous (IV) infusion into your vein. • Your EMPLICITI treatment schedule is divided into cycles that are 28 days (4 weeks) long. A cycle includes the number of days you are on treatment and also the time you spend resting in between treatments. • EMPLICITI with REVLIMID and dexamethasone is usually given as follows: o Cycles 1 and 2 (28 days per cycle), you will receive EMPLICITI one time every week. o Cycles 3 and up (28 days per cycle), you will receive EMPLICITI one time every 2 weeks. • EMPLICITI with POMALYST and dexamethasone is usually given as follows: o Cycle 1 and 2 (28 days per cycle), you will receive EMPLICITI one time every week. o Cycle 3 and up (28 days per cycle), you will receive EMPLICITI one time every 4 weeks. • Your healthcare provider will decide how many treatments you will receive. • Before every EMPLICITI infusion, you will receive medicines to help reduce the risk of infusion reactions. • If you miss any appointments call your healthcare provider as soon as possible.

What are the possible side effects of EMPLICITI? EMPLICITI may cause serious side effects, including: • Infusion reactions. Infusion reactions can happen during your infusion or within 24 hours after your infusion of EMPLICITI.

Your healthcare provider will give you medicines before each infusion of EMPLICITI to help reduce the risk of an infusion reaction. If you have an infusion reaction while receiving EMPLICITI, your healthcare provider will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your healthcare provider may stop your treatment completely.

Tell your healthcare provider o… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 74 words ▾

EMPLICITI 300 mg Representative Packaging NDC 0003-2291-11 Rx only Empliciti ® (elotuzumab) for Injection 300 mg per vial For intravenous Infusion Only Reconstitute and Further Dilute Prior to Use Single-Dose Vial. Discard Unused Portion. Bristol-Myers Squibb empliciti-300mg.JPG

EMPLICITI 400 mg Representative Packaging NDC 0003-4522-11 Rx only Empliciti ® (elotuzumab) for Injection 400 mg per vial For intravenous Infusion Only Reconstitute and Further Dilute Prior to Use Single-Dose Vial. Discard Unused Portion. Bristol-Myers Squibb empliciti-400mg-carton.JPG

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
26
Units reimbursed last 4 qtrs
34
Gross reimbursed last 4 qtrs
$65.9K
Avg / prescription
$2,534.90
Avg / unit
$1,927.45
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 26 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 34 units · 0.2 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.20.2
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 0.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Empliciti — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Empliciti. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$743.3K
Claims incl. refills
72
Beneficiaries
22
Spend / beneficiary
$33,787.88
Spend / claim
$10,324.07
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🛡
This drug has a REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It may require enrollment, counseling, or monitoring to manage a serious risk. See the boxed warning & full label below, and REMS@FDA ↗.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for EMPLICITI (this brand).

Top reported reactions

Plasma Cell Myeloma564
Pneumonia304
Death298
Malignant Neoplasm Progression254
Fatigue236
Diarrhoea231
Pyrexia221

Reporter sex

5,137 reports
Male · 55%
Female · 45%
Unknown · 0%

Serious outcomes

Hospitalization2,010
Life-threatening261
Disabling55
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 566 81
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by E.R. Squibb & Sons, L.L.C.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
E.R. Squibb & Sons, L.L.C. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9176 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00003-4160-14 · E.R. 00003-5150-14 · E.R. →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.