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ZENBEXUS iberdomide 1 mg Capsule, 21-count

by E.R. Squibb & Sons, L.L.C. · 21 CAPSULE in 1 BOTTLE (0003-5710-21)

NDC 00003-5710-21

🏷️ FDA NDC (as labeled) 0003-5710-21 billing pads the labeler segment with a zero

Rx only Brand On market Non-controlled 🛡 REMS

🗂️ Data synced Sep 3, 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 Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 0003-5710-21

Product NDC 0003-5710

11-digit billing NDC 00003571021

RxCUI 2749737, 2749743, 2749745, 2749747

UNII 79L3645KFI

Application # NDA221075

SPL Set ID 3663d9cb-3f66-48ae-bf0a-6958bc0888de

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2026-08-13

Route ORAL

Dosage form CAPSULE

Substance IBERDOMIDE HYDROCHLORIDE

Why two NDCs? The FDA registers this code as 0003-5710-21 — 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 → 00003-5710-21. 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.

🏭 Manufacturer & labeler

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

FDA applicationNDA221075 (NDA)

Labeler code00003

First marketedAug 2026

Product typeHuman Prescription Drug

Portfolio51 products on file

🔎 All NDCs from E.R. Squibb & Sons, L.L.C.

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.

🩺 Clinical

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

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.

💊 What it looks like

Color Gray / Brown / White

ShapeCapsule

ImprintBMS;1;mg

Size16 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

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

UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

3 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.

💲 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 system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Zenbexus 1 mgthis 00003-5710-21	E.R.	21 capsules	—	—	FDA listed	—

About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.

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 & generic status

🏛️

2026

On the market since

Aug 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔒

No generic listed yet

brand only

ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🛡

This drug has a REMS — ZENBEXUS REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It is available only through a restricted program (certified prescribers/pharmacies, enrollment, or required monitoring). See the boxed warning & full label below, and REMS@FDA ↗.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
00003-5710-21 You're viewing this	21 CAPSULE in 1 BOTTLE (0003-5710-21)	2026-08-13	Active

🧭 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	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“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 FDA registers it as 0003-5710-21, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00003-5710-21, written without dashes as 00003571021. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 00003-5710-21, the first segment (00003) is the labeler code FDA assigned to E.R. Squibb & Sons, L.L.C.; the middle segment (5710) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (21) identifies this exact package size and type. Together they name one specific package of one specific product.

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.

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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 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 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning ~2 min read ▾

WARNING: EMBRYO-FETAL TOXICITY and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM EMBRYO-FETAL TOXICITY ZENBEXUS is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. In females of reproductive potential, obtain 2 negative pregnancy tests before starting ZENBEXUS treatment [ Contraindications (4) , see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ] .

Females of reproductive potential must use 2 effective forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after last dose of ZENBEXUS treatment [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3) ] . Because of the risk of embryo-fetal toxicity, ZENBEXUS is only available through a restricted distribution program called ZENBEXUS REMS [see Warnings and Precautions (5.2) ] . Information about ZENBEXUS REMS is available at www.ZENBEXUSREMS.com or by calling the REMS Call Center at 1-888-423-5436.

SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM Increased risk of deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS with daratumumab and hyaluronidase-fihj and dexamethasone. Anti-thrombotic prophylaxis is recommended [see Warnings and Precautions (5.3) ] . WARNING: EMBRYO-FETAL TOXICITY and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning.

EMBRYO-FETAL TOXICITY • ZENBEXUS is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. In females of reproductive potential, obtain 2 negative pregnancy tests before starting ZENBEXUS treatment.

(4 , 5.1 , 8.1 , 8.3) • Females of reproductive potential must use 2 effective forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after last dose of ZENBEXUS. (4 , 5.1 , 8.1 , 8.3) • Because of the risk of embryo-fetal toxicity, ZENBEXUS is only available through a restricted distribution program called ZENBEXUS Risk Evaluation and Mitigation Strategy (REMS). (5.2) Information about ZENBEXUS REMS is available at www.ZENBEXUSREMS.com or by calling the REMS Call Center at 1-888-423-5436.

SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM • Increased risk of deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS. Anti-thrombotic prophylaxis is recommended. Monitor patients for signs and symptoms of thromboembolic event during treatment with ZENBEXUS.

Interrupt ZENBEXUS and initiate anticoagulant therapy as appropriate. (2.3 , 5.3)

🎯 Indications and Usage 166 words ▾

1 INDICATIONS AND USAGE ZENBEXUS is indicated, in combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

ZENBEXUS is a cereblon-modulating protein degrader indicated in combination with daratumumab and hyaluronidase-fihj and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. (1) This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Recommended dosage: 1 mg orally once daily with or without food on Days 1 to 21 of repeated 28-day cycles until disease progression or unacceptable toxicity. (2.2) • See Full Prescribing Information for recommended ZENBEXUS dosage modifications. (2.3 , 2.4 , 2.5)

2.1Pregnancy Testing Prior to Administration Females of reproductive potential must have negative pregnancy testing and use effective contraception methods before initiating ZENBEXUS [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] .

2.2Recommended Dosage The recommended dosage of ZENBEXUS is 1 mg orally once daily with or without food [see Clinical Pharmacology (12.3) ] on Days 1 to 21 of a 28-day cycle, until disease progression or unacceptable toxicity, in combination with daratumumab and hyaluronidase-fihj and dexamethasone.

2.3Dosage Modifications The recommended dosage modifications for adverse reactions are provided in Table 1. Table 1: Recommended Dosage Modifications for Adverse Reactions Adverse Reaction Severity Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0. Dosage Modification Refer to daratumumab and hyaluronidase-fihj and dexamethasone Prescribing Information for information about dosage modifications for daratumumab and hyaluronidase-fihj and dexamethasone.

Neutropenia (Absolute neutrophil count [ANC] <500 cells/mcL) [see Warnings and Precautions (5.4) ] Grade 4 • Interrupt ZENBEXUS. • Consider initiating granulocyte colony-stimulating factor (GCSF), as appropriate. • Follow complete blood count (CBC) at least weekly. • ANC must return to ≥1,000 cells/mcL before restarting. • The dose of ZENBEXUS may be maintained if neutropenia was the only ZENBEXUS-related toxicity requiring a dose modification and GCSF treatments are continued. • If a dose reduction is clinically appropriate, decrease ZENBEXUS to 0.75 mg once daily when restarting treatment.

Febrile Neutropenia (ANC <1,000 cells/mcL with a single temperature of >38.3°C [101°F] or with a sustained temperature of ≥38°C [100.4°F] for more than 1 hour) Grade 3 Thrombocytopenia (platelet count <25,000/mcL) Grade 4 • Withhold ZENBEXUS for the remainder of the cycle. • Platelet count must return to ≥50,000/mcL before restarting. • Decrease ZENBEXUS to 0.75 mg once daily when restarting treatment. Thrombocytopenia with bleeding or any requirement for a platelet transfusion Grade 3 Thromboembolism [see Warnings and Precautions (5.3) ] ≥ Grade 3 • Interrupt ZENBEXUS. • Initiate anticoagulant therapy. • Restart treatment at a decreased ZENBEXUS dose to 0.75 mg once daily when acute symptoms of thrombosis/embolism have been resolved, at the discretion of the treating physician.

Other ZENBEXUS related adverse reactions [see Adverse Reactions (6.1) ] ≥ Grade 3 • Interrupt ZENBEXUS. • Restart ZENBEXUS when adverse event has resolved or improved to ≤ Grade 2. • If a dose reduction is clinically appropriate, decrease ZENBEXUS to 0.75 mg once daily when restarting treatment.

2.4Dosage Modifications for CYP3A Inhibitors Avoid concomitant use of ZENBEXUS with strong or moderate CYP3A inhibitors. If concomitant use with strong CYP3A inhibitors is unavoidable, reduce ZENBEXUS dose to 1 mg every other day on Days 1 to 21 of a 28-day cycle [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ] . If concomitant use with moderate CYP3A inhibitors is unavoidable, reduce ZENBEXUS dose to 0.75 mg once daily on Days 1 to 21 of a 28-day cycle [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ] .

If dose modification is needed due to adverse events, reduce ZENBEXUS dose to 1 mg every other day on Days 1 to 21 of a 28-day cycle.

2.5Recommended Dosage in Patients with Renal Impairment In patients with eGFR less than 30 mL/min/1.73 m 2 not receiving dialysis, reduce ZENBEXUS dose to 0.75 mg once daily on Days 1 to 21 of a 28-day cycle. If dose modification is needed due to adverse events, redu…

💊 Dosage Forms and Strengths 71 words ▾

3 DOSAGE FORMS AND STRENGTHS ZENBEXUS capsules are available as follows: • 0.75 mg of iberdomide: light gray opaque cap imprinted with “BMS” in white ink and dark brown opaque body imprinted with “0.75 mg” in white ink. • 1 mg of iberdomide: light gray opaque cap imprinted with “BMS” in white ink and ivory opaque body imprinted with “1 mg” in black ink. • Capsules: 0.75 and 1 mg. (3)

⛔ Contraindications 109 words ▾

4 CONTRAINDICATIONS Based on the mechanism of action [see Clinical Pharmacology (12.1) ] and findings in animal studies, ZENBEXUS can cause birth defects or embryo-fetal death in humans [see Boxed Warning , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1) ] . ZENBEXUS is contraindicated in females who are pregnant. Iberdomide causes adverse developmental outcomes in both rats and rabbits when administered during the period of organogenesis.

If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus. • Pregnancy (Boxed Warning , 4 , 5.1 , 8.1)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Neutropenia : Monitor complete blood counts at baseline and throughout treatment. Interrupt, reduce, or discontinue ZENBEXUS and initiate growth factor support as appropriate. (2.3 , 5.4) • Infections : Can cause severe, life-threatening, or fatal infections.

Monitor patients for signs and symptoms of infection, including opportunistic infections, and treat appropriately. (5.5) • Second Primary Malignancies : Monitor patients for the development of second primary malignancies. (5.6)

5.1Embryo-Fetal Toxicity Based on the mechanism of action [see Clinical Pharmacology (12.1) ] and findings in animal studies, ZENBEXUS can cause birth defects or embryo-fetal death in humans and is contraindicated for use during pregnancy. Oral administration of iberdomide in pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes including embryo-fetal mortality, alterations to growth, and structural abnormalities [see Use in Specific Populations (8.1) ] . ZENBEXUS is only available through ZENBEXUS REMS [see Warnings and Precautions (5.2) ] .

Females of Reproductive Potential Females of reproductive potential must avoid pregnancy while taking ZENBEXUS and for at least 4 weeks after completing therapy. Advise females of reproductive potential of the potential risk to a fetus and to use 2 methods of effective contraception for at least 4 weeks before beginning ZENBEXUS therapy, during therapy, during dose interruptions and for at least 4 weeks after last dose of ZENBEXUS therapy [see Contraindications (4) and Use in Specific Populations (8.1) ] . Two negative pregnancy tests with a sensitivity of at least 25 mIU/mL must be obtained prior to initiating therapy.

Pregnancy testing should be performed weekly during the first 4 weeks of treatment. Thereafter, testing should occur every 4 weeks in patients with regular menstrual cycles, or every 2 weeks in patients with irregular menstrual cycles [see Use in Specific Populations (8.3) ] . Females of reproductive potential taking ZENBEXUS must not donate eggs during treatment and for 4 weeks after completion [see Use in Specific Populations (8.3) ] .

Males ZENBEXUS may pass into human semen. Advise patients who can impregnate partners to use effective contraception during treatment and for 4 weeks following the discontinuation of ZENBEXUS therapy [see Use in Specific Populations (8.1 , 8.3) ] . Male patients taking ZENBEXUS must not donate sperm during treatment and for 4 weeks after completion [see Use in Specific Populations (8.3) ] .

Blood Donation Patients must not donate blood during treatment with ZENBEXUS and for 4 weeks following discontinuation of ZENBEXUS therapy.

5.2ZENBEXUS REMS ZENBEXUS is available only through a restricted program called ZENBEXUS REMS, because of the risk of embryo-fetal toxicity [see Warnings and Precautions (5.1) ] . Notable requirements of the ZENBEXUS REMS Program include the following: • Prescribers must be certified by enrolling in the ZENBEXUS REMS Program. • Patients must enroll in the ZENBEXUS REMS Program and comply with ongoing monitoring and contraception requirements [see Boxed Warning , Warnings and Precautions (5.1) , and Use in Specific Populations (8.3) ] . • Pharmacies must be certified by enrolling in the ZENBEXUS REMS Program and must only dispense to patients who are authorized to receive ZENBEXUS. • Wholesalers and distributors must only distribute to certified pharmacies.

Further information about ZENBEXUS REMS is available at www.ZENBEXUSREMS.com or by telephone at 1-888-423-5436.

5.3Serious Venous and Arterial Thromboembolism ZENBEXUS can cause serious and life-threatening venous thromboembolic events (deep venous thrombosis and pulmonary embolism) and arterial thromboembolic events (myocardial infarction and stroke). In the EXCALIBER-RRMM study evaluating ZENBEXUS in combination with daratumumab and hyaluronidase-fihj and dexamethasone (IberDd), venous thromboembolic ev…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling. • Serious Venous and Arterial Thromboembolism [see Warnings and Precautions (5.3) ] • Neutropenia [see Warnings and Precautions (5.4) ] • Infections [see Warnings and Precautions (5.5) ] • Second Primary Malignancies [see Warnings and Precautions (5.6) ] Most common (≥20%) adverse reactions with ZENBEXUS in combination with daratumumab and hyaluronidase-fihj and dexamethasone are upper respiratory tract infection, fatigue, musculoskeletal pain, pneumonia, diarrhea, motor dysfunction, rash, sleep disorder, hypogammaglobulinemia, COVID-19, and constipation.

The most common Grade 3 or 4 (≥30%) laboratory abnormalities are neutrophil count decreased, white blood cell count decreased, and lymphocyte count decreased. (6) 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 clinical practice. The safety of ZENBEXUS in combination with daratumumab and hyaluronidase-fihj and dexamethasone was evaluated in EXCALIBER-RRMM, a two-stage, phase 3, randomized, multicenter open-label study in patients with relapsed or refractory multiple myeloma (RRMM) after 1 or 2 prior lines of therapy [see Clinical Studies (14) ] .

Patients were randomized to receive ZENBEXUS (at 1 of 3 dose levels) in combination with daratumumab and hyaluronidase-fihj and dexamethasone or daratumumab and hyaluronidase-fihj, bortezomib and dexamethasone (DVd) in stage 1, and ZENBEXUS 1 mg in combination with daratumumab and hyaluronidase-fihj and dexamethasone (IberDd) or DVd in stage 2. The MRD Primary Analysis Group included the first 420 patients randomized to ZENBEXUS 1 mg in combination with Dd (N=207) or DVd (N=213) in stage 1 and stage 2. Safety was assessed in patients in the MRD Primary Analysis Group who received at least one dose of the study drug (IberDd: N=204; DVd: N=204).

Among patients who received ZENBEXUS, 86% were exposed for 6 months or longer and 73% were exposed for greater than one year. Serious adverse reactions occurred in 58.3% of patients who received ZENBEXUS. Serious adverse reactions in ≥2% of patients included pneumonia (26%), upper respiratory tract infection (6.4%), second primary malignancy (5.9%), neutropenia (4.9%), febrile neutropenia (3.9%), COVID-19 (4.4%), and sepsis (2.9%).

Fatal adverse reactions occurred in 10 patients (4.9%) who received ZENBEXUS. Sepsis (1.5%) was the only fatal drug reaction that occurred in more than 1 patient. The following fatal adverse reactions occurred in one patient each: listeria encephalitis, influenza, lung adenocarcinoma, cardiac arrest, large intestine perforation, metabolic acidosis, and respiratory failure.

Permanent discontinuation of ZENBEXUS due to an adverse reaction occurred in 7.8% of patients. The most frequent adverse reaction which resulted in permanent ZENBEXUS discontinuation was neutropenia (1%). Dosage interruption of ZENBEXUS due to an adverse reaction occurred in 84% of patients.

Adverse reactions which required dosage interruption in >10% of patients included neutropenia, upper respiratory tract infection, pneumonia and COVID-19. Dosage reductions of ZENBEXUS due to an adverse reaction occurred in 29% of patients. Adverse reactions which required dose reductions in >2% of patients included neutropenia, fatigue, pneumonia, and sensory neuropathy.

The most common adverse reactions (≥20%) were upper respiratory tract infection, fatigue, musculoskeletal pain, pneumonia, diarrhea, motor dysfunction, rash, sleep disorder, hypogammaglobulinemia, COVID-19, and constipation. The most common Grade 3 to 4 laboratory…

🔄 Drug Interactions 151 words ▾

7 DRUG INTERACTIONS • Strong or moderate CYP3A inhibitors: Avoid concomitant use with ZENBEXUS or, if concomitant use is unavoidable, reduce dose. (2.3 , 7.1) • Strong or moderate CYP3A inducers: Avoid concomitant use with ZENBEXUS. (7.1)

7.1Effects of Other Drugs on ZENBEXUS Strong or Moderate CYP3A Inhibitors Avoid concomitant use of strong or moderate CYP3A inhibitors with ZENBEXUS. If concomitant use cannot be avoided, reduce ZENBEXUS dose [see Dosage and Administration (2.4) ] . Iberdomide is primarily metabolized by CYP3A.

Concomitant use with strong or moderate CYP3A inhibitors increases iberdomide exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions. Strong or Moderate CYP3A Inducers Avoid concomitant use of strong or moderate CYP3A inducers with ZENBEXUS. Iberdomide is primarily metabolized by CYP3A.

Concomitant use with a strong or moderate CYP3A inducer decreases iberdomide exposure [see Clinical Pharmacology (12.3) ] , which may decrease efficacy.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Lactation: Advise not to breastfeed. (8.2) • Renal impairment: Reduce dose in patients with eGFR less than 30 mL/min/1.73 m 2 not on dialysis. (2.5)

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in patients exposed to ZENBEXUS during pregnancy. Report any suspected fetal exposure to ZENBEXUS to the FDA via the MedWatch program at 1-800-FDA-1088 and to the REMS Call Center at 1-888-423-5436. Risk Summary Based on the mechanism of action [see Clinical Pharmacology (12.1) ] and findings from animal studies, ZENBEXUS can cause birth defects or embryo-fetal death in humans when administered to a pregnant female and is contraindicated during pregnancy [see Boxed Warning , Contraindications (4) , and Warnings and Precautions (5.1) ] .

ZENBEXUS has a shared mechanism of action with thalidomide. Thalidomide is a human teratogen, inducing a high frequency of severe and life-threatening birth defects such as amelia (absence of limbs), phocomelia (short limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities (including anotia, micropinna, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects. Alimentary tract, urinary tract, and genital malformations have also been documented, and mortality at or shortly after birth has been reported in about 40% of infants.

There are no available data on the use of ZENBEXUS in pregnant women to evaluate for drug associated risk. Oral administration of iberdomide in pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes including embryo-fetal mortality, alterations to growth, and structural abnormalities. Iberdomide crossed the placenta after administration to pregnant rats and rabbits (see Data) .

Advise patients of the potential risk to a fetus. If pregnancy does occur during treatment, immediately discontinue the drug. Under these conditions, refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Report any suspected fetal exposure to ZENBEXUS to the REMS Call Center at 1-888-423-5436. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Iberdomide caused adverse developmental outcomes in both rats and rabbits in the embryo-fetal developmental studies when administered during the period of organogenesis.

Pregnant rats were administered oral doses of 0.6, 50, or 300 mg/kg/day. At 300 mg/kg/day, adverse effects included increased post-implantation loss, fetal resorptions, reduced numbers of viable fetuses, lower fetal body weights, and the occurrence of external and skeletal malformations in the head (acephaly, dome shaped, meningoencephalocele), eyes (malpositioned, microphthalmia), mouth (cleft lip, small tongue, misshapen palate), ear(s) (misshapen or small), cervical vertebrae (fused or misshapen neural arches), pectoral girdle (bent scapula), skull (fused or misshapen bones), and sternum (sternoschisis).

Pregnant rabbits were administered oral doses of 0.3, 50 or 300 mg/kg/day. At doses of 300 mg/kg/day, increased abortions were observed. At doses of ≥50 mg/kg/day developmental effects included increased post-implantation loss, fetal resorptions, reduced numbers of viable fetuses, decreased fetal body weights, and external, skeletal, and visceral malformations in the entire body and hindlimbs (edema), tail (short), gallbladder and thyroid (absent), aortic arch (small), interventricular septum (discontinuous), cervical vertebrae (fused, misshapen neural arches), skull (fused or misshapen bones), and sternum (fused).

In rats, fetal plasma concentration levels on gestation day (GD) 17 were 17 to 22% of the maternal concentration at 2 hours post-dosing,…

🤰 Pregnancy ~3 min read ▾

In rats, fetal plasma concentration levels on gestation day (GD) 17 were 17 to 22% of the maternal concentration at 2 hours post-dosing, and in rabbits, fetal plasma concentration levels on GD 17 were 2 to 4% of the maternal concentration at 2 hours post-dosing. This indicates that iberdomide crossed the placenta.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of ZENBEXUS have not been established in pediatric patients.

🧓 Geriatric Use 125 words ▾

8.5Geriatric Use Of the 207 patients who were randomized to IberDd and included in the minimal residual disease (MRD) analysis group in EXCALIBER-RRMM study, 39% of adult patients were younger than 65 years of age, 43% were 65 years of age to younger than 75 years of age, and 19% were 75 years and over [see Clinical Studies (14) ] . No overall differences in effectiveness were observed between elderly patients and younger patients. In patients treated with IberDd, the incidence of serious adverse reactions was 53%, 56%, and 74% in adult patients younger than 65 years of age, 65 years of age to younger than 75 years of age, and 75 years of age and older, respectively [see Adverse Reactions (6.1) ] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Iberdomide is a cereblon-modulating protein degrader that binds to cereblon, a substrate recognition component of an E3 ubiquitin ligase complex. Iberdomide engages cereblon and facilitates recruitment, ubiquitination, and proteasomal degradation of the transcription factors, Aiolos and Ikaros, resulting in anti‑tumor and immunomodulatory activity. In vitro and in vivo, iberdomide treatment showed anti-tumor activity in multiple myeloma (MM) cells and xenografts including in lenalidomide- and pomalidomide-resistant MM cell lines.

Immunomodulatory properties of iberdomide include increased secretion of the immune stimulatory cytokines (interleukin-2 and interferon-gamma), inhibition of proinflammatory cytokine release (interleukin-6), enhanced immune mediated killing of MM cells, and prevention of T-cell exhaustion. In vitro, the combination of iberdomide and daratumumab produced an increase in complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC) activity of daratumumab against multiple myeloma cells. In vivo, iberdomide showed increased anti-tumor activity in combination with dexamethasone or daratumumab compared to iberdomide, dexamethasone or daratumumab alone.

12.2Pharmacodynamics In patients with relapsed or refractory multiple myeloma, at a dose of 1 mg, iberdomide in combination with daratumumab and dexamethasone decreases B cells, natural killer (NK) cells, and naïve CD8⁺ T cells, and increases effector memory CD8⁺ T cells, HLA-DR expression on CD8⁺ T cells, and Ki-67–positive CD4+ and CD8+ T cells and NK cells. Iberdomide exposure-response analyses demonstrated no clinically relevant relationship between systemic iberdomide exposure level and efficacy following iberdomide dose of 1 to 1.6 mg (1 to 1.6 times the recommended dosage).

Increasing iberdomide exposure was associated with higher risk of Grade 3+ neutropenia and at least 1 dose modification due to treatment-emergent adverse events (TEAE). Cardiac Electrophysiology At 2.6-times the mean maximum concentration produced by the recommended ZENBEXUS dosage, a clinically relevant QT interval prolongation was not observed.

12.3Pharmacokinetics Iberdomide pharmacokinetic parameters for patients with multiple myeloma receiving the recommended approved dosage at steady state are presented as mean (% CV), unless otherwise specified. Iberdomide maximum plasma concentration (C max ) is 6.35 ng/mL (30%) and area under the concentration-time curve (AUC) is 82.6 ng*h/mL (32%). Drug accumulation is approximately two-fold.

Iberdomide C max and AUC are approximately dose-proportional over the dose range of 0.1 mg to 6 mg (0.1 to 6 times the recommended dosage) following a single oral dose in healthy subjects. Absorption Iberdomide median (min, max) time to C max (T max ) at steady state is 2 (2, 10) hours. Effect of Food No clinically significant difference in iberdomide PK is expected following administration of ZENBEXUS with food.

Distribution Iberdomide volume of distribution (V ss /F) is 415 L (40%). In vitro plasma protein binding is 75% and is not concentration-dependent. In vitro blood-to-plasma ratio is 0.78.

Elimination Iberdomide terminal elimination half-life (t 1/2 ) is 37 hours (51%) and apparent oral clearance (CL/F) is

12.3L/h (38%). Metabolism Iberdomide is metabolized primarily by CYP3A. Excretion Following a single oral administration of [ 14 C] iberdomide to healthy subjects, approximately 46% of the dose was eliminated in urine (16% as unchanged drug) and 43% of the dose was eliminated in feces (11% as unchanged drug).

Specific Populations No clinically significant differences in the pharmacokinetics of iberdomide were observed based on age (36 to 90 years), sex (45% female), race (65% White, 27% Asian, and 4% African American), body weight (37.6 kg to 137 kg), body mass index (16.7 to 49.7 kg/m 2 ), body surface area (1.27 to 2.60 m 2 ), or hepatic impairment (Child-Pu…

🧬 Mechanism of Action 152 words ▾

📦 How Supplied / Storage and Handling 143 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ZENBEXUS™ (iberdomide) capsules, 0.75 mg, light gray opaque cap imprinted with “BMS” in white ink and dark brown opaque body imprinted with “0.75 mg” in white ink, are supplied as follows: • Bottle of 21 capsules (NDC 0003-5700-21). ZENBEXUS™ (iberdomide) capsules, 1 mg, light gray opaque cap imprinted with “BMS” in white ink and ivory opaque body imprinted with “1 mg” in black ink, are supplied as follows: • Bottle of 21 capsules (NDC 0003-5710-21). Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Store and dispense in the original bottle with desiccant. Replace the cap securely each time after opening. Do not discard the desiccant.

The capsules should not be removed until just prior to dosing. ZENBEXUS is a hazardous drug. Follow applicable special handling and disposal procedures.

📋 Description 168 words ▾

11 DESCRIPTION ZENBEXUS capsules contain iberdomide hydrochloride, iberdomide is a cereblon-modulating protein degrader. The chemical name of iberdomide hydrochloride is (3 S )-3-[4-({4-[(morpholin-4-yl)methyl]phenyl}methoxy)-1-oxo-2,3-dihydro-1 H -isoindol-2-yl]piperidine-2,6-dione hydrochloride and the chemical structure is as follows: The molecular formula for iberdomide hydrochloride is C 25 H 27 N 3 O 5 HCl and the molecular weight is 485.97. ZENBEXUS capsules contain 0.75 mg or 1 mg of iberdomide (equivalent to 0.81 mg or 1.08 mg respectively of iberdomide hydrochloride) in HPMC capsules and the following inactive ingredients: anhydrous lactose, pregelatinized starch, and stearic acid.

The HPMC capsule shell contain hypromellose, iron oxide black, iron oxide yellow, and titanium dioxide. The 0.75 mg capsule shell also contains iron oxide red. The 0.75 mg capsule is imprinted with white ink that contains povidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide.

The 1 mg capsule is imprinted with white and black ink that contains iron oxide black, potassium hydroxide, povidone, propylene glycol, shellac, sodium hydroxide, strong ammonia solution, and titanium dioxide. chemical structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Embryo-Fetal Toxicity Advise patients that ZENBEXUS is contraindicated in pregnancy and can cause birth defects or embryo-fetal death in humans [see Boxed Warning and Contraindications (4) ] . • Advise females of reproductive potential that they must avoid pregnancy while taking ZENBEXUS and for at least 4 weeks after completing therapy. • Initiate ZENBEXUS treatment in females of reproductive potential only following two negative pregnancy tests. • Advise females of reproductive potential of the importance of monthly pregnancy tests and the need to use 2 different forms of contraception, including at least 1 highly effective form, simultaneously during ZENBEXUS therapy, during dose interruption and for 4 weeks after she has completely finished taking ZENBEXUS.

Highly effective forms of contraception other than tubal ligation include IUD and hormonal (birth control pills, injections, patch, or implants) and a partner's vasectomy. Additional effective contraceptive methods include latex or synthetic condom, diaphragm, and cervical cap. • Instruct patient to immediately stop taking ZENBEXUS and contact her healthcare provider if patient becomes pregnant while taking this drug, if patient misses her menstrual period, or experiences unusual menstrual bleeding, stops taking birth control, or thinks FOR ANY REASON that the patient may be pregnant. • Advise patient that if her healthcare provider is not available, she should call the REMS Call Center at 1-888-423-5436 [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] . • ZENBEXUS may pass into human semen.

Advise males to always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking ZENBEXUS and for at least 4 weeks after discontinuing ZENBEXUS, even if they have undergone a successful vasectomy. • Advise male patients taking ZENBEXUS that they must not donate sperm while taking ZENBEXUS and for 4 weeks after discontinuing ZENBEXUS [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] . • Advise females of reproductive potential taking ZENBEXUS that they must not donate eggs [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] . • All patients must be instructed to not donate blood while taking ZENBEXUS and for 4 weeks following discontinuation of ZENBEXUS [see Warnings and Precautions (5.1) ] .

ZENBEXUS REMS Program Because of the risk of embryo-fetal toxicity, ZENBEXUS is only available through a restricted program called the ZENBEXUS REMS Program [see Warnings and Precautions (5.2) ] . Patients must sign a Patient Enrollment Form and comply with the requirements to receive ZENBEXUS. In particular, females of reproductive potential must comply with the pregnancy testing and contraception requirements [see Warnings and Precautions (5.2) and Use in Specific Populations (8.3) ] .

ZENBEXUS is available only from pharmacies that are certified in the ZENBEXUS REMS program. Pregnancy Exposure Registry Inform females that there is a Pregnancy Exposure Registry that monitors pregnancy outcomes in females exposed to ZENBEXUS during pregnancy and advise them to contact the REMS Call Center by calling 1-888-423-5436 [see Use in Specific Populations (8.1) ] . Serious Thromboembolic Events Inform patients of the risk of venous and arterial thromboembolic events including DVT, PE, MI and stroke and to report immediately any signs and symptoms suggestive of these events for evaluation [see Warnings and Precautions (5.3) ] .

Neutropenia Advise patients to contact their healthcare provider if they have a fever [see Warnings and Precautions (5.4) ] . Infections Instruct patients to tell their healthcare provider if they develop any signs or symptoms of an infection [see Warnings and Precautions (5.5) ] . Second Primary Malignancies Inform patients of the risk of d…

💬 Medication Guide ~3 min read ▾

Medication Guide MEDICATION GUIDE ZENBEXUS™ (zen-BEX-us) (iberdomide) capsules, for oral use What is the most important information I should know about ZENBEXUS? ZENBEXUS can cause serious side effects, including: ZENBEXUS can harm your unborn baby, causing birth defects or death of an unborn baby. Females who can become pregnant: • Do not become pregnant during treatment with ZENBEXUS and for at least 4 weeks after your last dose of ZENBEXUS. • You must agree to stop sexual activity with a male or use two different forms of birth control (contraception) for at least 4 weeks before starting treatment with ZENBEXUS, during treatment, during any breaks (interruptions) in treatment, and for 4 weeks after your last dose of ZENBEXUS.

You must use birth control even if you have a history of infertility, unless you have had a hysterectomy. • Talk to your healthcare provider about birth control methods that you can use before, during and after treatment with ZENBEXUS. • Your healthcare provider will do 2 pregnancy tests before you start treatment with ZENBEXUS. After starting treatment with ZENBEXUS, your healthcare provider will do a pregnancy test every week for the first 4 weeks, then every 4 weeks if your menstrual cycle is regular or every 2 weeks if your menstrual cycle is not regular. • If you miss your period or have unusual bleeding, your healthcare provider will do a pregnancy test and you will receive counseling. • Do not donate eggs during treatment and for 4 weeks after your last dose of ZENBEXUS.

Stop taking ZENBEXUS right away and tell your healthcare provider if you: • become pregnant • miss your period or have unusual bleeding • stop using birth control • think for any reason that you may be pregnant If your healthcare provider is not available, you can call the REMS Call Center at 1-888-423-5436. Pregnancy Registry. There is a pregnancy exposure registry that monitors the outcomes of females exposed to ZENBEXUS during pregnancy.

You should report all cases of pregnancy to FDA MedWatch at 1-800-FDA-1088 and the REMS Call Center at 1-888-423-5436. Males with female partners who can become pregnant: • ZENBEXUS may pass into human semen: Use a latex or synthetic condom during any sexual contact during your treatment, and for at least 4 weeks after your last dose of ZENBEXUS, even if you had a successful vasectomy. • Do not donate sperm during treatment with ZENBEXUS and for 4 weeks after your last dose of ZENBEXUS. Tell your healthcare provider right away if your female partner becomes pregnant.

ZENBEXUS REMS Program Because of the risk of harm to an unborn baby, ZENBEXUS is available only through a restricted program called the ZENBEXUS Risk Evaluation and Mitigation Strategy (REMS). Before you can take ZENBEXUS, you and your healthcare provider must be enrolled in the ZENBEXUS REMS. Your healthcare provider will explain the ZENBEXUS REMS to you.

You must: • read and agree to all the instructions in the ZENBEXUS REMS. • sign the Patient Enrollment Form. ZENBEXUS is only available through pharmacies that participate in the ZENBEXUS REMS. Your healthcare provider will give you information about how to find a participating pharmacy.

For more information, go to www.ZENBEXUSREMS.com or call 1-888-423-5436. Increased risk of blood clots. ZENBEXUS can cause serious and life-threatening blood clots in the veins of your legs (deep vein thrombosis), lungs (pulmonary embolism), and in your heart or brain that can cause heart attack or stroke (arterial thromboembolic events).

Your healthcare provider may start you on medicine to help prevent blood clots if you have certain risk factors. Tell your healthcare provider right away if you get any of the following signs and symptoms of blood clots during treatment with ZENBEXUS: ∘ swelling, pain or tenderness in your legs ∘ red or discolored skin on your leg ∘ chest pain that may spread to the arms, neck, jaw, back, or stomach area ∘ sudden shortness of breath ∘ dizziness or lightheadedn…

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

absolute neutrophil count: A blood test number showing how many infection-fighting neutrophil white blood cells you have.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

ANC: A blood test number showing how many infection-fighting neutrophil white blood cells you have.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

CBC: A common blood test that measures red blood cells, white blood cells, and platelets.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

complete blood count: A common blood test that measures red blood cells, white blood cells, and platelets.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

deep vein thrombosis: A blood clot that forms in a deep vein, usually in the leg, causing swelling and pain.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

DVT: A blood clot that forms in a deep vein, usually in the leg, causing swelling and pain.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

eGFR: Estimated glomerular filtration rate, a blood-test-based estimate of how well the kidneys filter; lower numbers mean weaker function.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embolism: A blockage of a blood vessel by a clot or other material that has traveled from elsewhere in the body.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

febrile: Having a fever, or relating to a fever.

febrile neutropenia: A fever that happens when infection-fighting white blood cells are very low, which can be a sign of serious infection.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inducer: A substance that speeds up an enzyme, which can lower the levels of drugs that enzyme breaks down.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

metabolic acidosis: A condition where too much acid builds up in the body's blood and fluids.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

neutrophil: A type of white blood cell that is one of the body's main defenders against infection.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

perforation: A hole that forms all the way through the wall of the stomach or intestine.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

pulmonary embolism: A blood clot that has traveled to the lungs and blocks blood flow there, which can make breathing hard.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

refractory: Describing a disease that does not respond to, or improve with, treatment.

REMS: A special FDA-required safety program that manages a serious risk, sometimes adding extra steps for patients, pharmacists, or prescribers.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

respiratory failure: A serious condition in which the lungs cannot get enough oxygen into the blood or remove enough carbon dioxide.

sepsis: A serious, body-wide reaction to an infection in which the body's own response can start to injure its tissues and organs.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

thromboembolism: A blood clot that forms in one place and travels through the bloodstream to block a vessel somewhere else.

thrombosis: The forming of a blood clot inside a blood vessel, which can block normal blood flow.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

upper respiratory tract infection: An infection of the nose, sinuses, or throat, such as the common cold.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 00003-5700-21 · E.R. 00003-6120-01 · 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.

ZENBEXUS iberdomide 1 mg Capsule, 21-count

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