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Lenalidomide 5 mg Capsule, 28-count — NDC 47781-0484-28 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lenalidomide 5 mg Capsule, 28-count — NDC 47781-484-28 (Billing 47781-0484-28)

by Alvogen, Inc. · 28 CAPSULE in 1 BOTTLE

This is a package of 28 capsules of Lenalidomide 5 mg Capsule from Alvogen, Inc., marketed since Sep 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 47781-0484-28
🏷️ FDA NDC (as labeled) 47781-484-28 billing pads the product segment with a zero
This package
Contains28-count Medicaid pays$592.52 / unit · 12 mo Per package$16,590.61 / 28 capsules · Medicaid Pack sizes2 compare ↓
Also priced by: Part D plans $427.44/unit — full pricing hub ↓
Main listing for product 47781-484 · Also comes in: 100 capsules 47781-484-01
Rx only Generic On market Non-controlled 🛡 REMS ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 47781-484-28
Product NDC 47781-484
11-digit billing NDC 47781048428
NCPDP billing unit EA — each (per item)
RxCUI 602910, 602912, 643712, 643720, 1242231, 1428947
UNII F0P408N6V4
UPC 0347781488772, 0347781483289, 0347781485283, 0347781487775 +2 more
Application # ANDA210480
SPL Set ID adee5af1-c9ab-c0c7-e400-dea7d2a0d4be
Established class (EPC) Thalidomide Analog
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-09-03
Route ORAL
Dosage form CAPSULE
Substance LENALIDOMIDE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 99394050000120
GCN Seq No 060230
GCN 26314
HICL code 033412
Ingredient (HICL) Lenalidomide
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1M
Therapeutic class — specific (HIC3) Antineoplastic Immunomodulator Agents
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name LENALIDOMIDE 5 MG CAPSULE
FDB brand name Lenalidomide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 060230
  • GCN: 26314
  • GPI-14 (Medi-Span): 99394050000120
  • HICL (First Databank): 033412
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 602910
Why two NDCs? The FDA registers this code as 47781-484-28 — a 5-3-2 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 product segment → 47781-0484-28. 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 Thalidomide Analog class.

Pharmacologic class Thalidomide Analog
Drug family (ATC) Other immunosuppressants
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 LENALIDOMIDE 5 MG CAPSULE Ingredient Lenalidomide
📗 Our plain-language guide HelloPharmacist
  • Lenalidomide is the active ingredient in both Revlimid and the generic version called Lenalidomide — they are the same medicine. Depending on your diagnosis, your doctor may prescr...
  • What exactly is lenalidomide used for — and do I need both Revlimid and the generic?
  • Because lenalidomide can cause severe birth defects or kill an unborn baby, it's only available through a strictly controlled program called the Lenalidomide REMS program. Everyone...
  • I heard this drug is really hard to get — why do I have to jump through so many hoops just to fill my prescription?
📖 Read our full Lenalidomide 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $592.52 $16,590.61 / 28 capsules
Medicare drug plans payPart D · Q2 2026 $427.44 $11,968.44 / 28 capsules
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
47781-0484-01 47781-484-01 100 CAPSULE in 1 BOTTLE 2022-09-03 — Active
47781-0484-28 You're viewing this Main listing 28 CAPSULE in 1 BOTTLE 2022-09-03 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 28-count package — 28 capsule in 1 bottle.
How does this package differ from NDC 47781-0484-01?
Both are Lenalidomide 5 mg Capsule — the drug itself is identical. This page's package is the 28-count one, while NDC 47781-0484-01 is the 100 capsules package.
What NDC number is used to bill for this package of Lenalidomide 5 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lenalidomide 5 mg 00378-1936-01 Mylan 100 capsules — AB FDA listed —
Lenalidomide 5 mg 00480-1242-28 Teva 28 capsules — AB FDA listed —
Lenalidomide 5 mg 00574-1405-28 Padagis 28 capsules — AB FDA listed —
Lenalidomide 5 mg 16729-0693-09 Accord 28 capsules — AB FDA listed —
Lenalidomide 5 mg 31722-0258-01 Camber 100 capsules — AB FDA listed —
Lenalidomide 5 mg 43598-0511-01 Dr. 100 capsules — AB FDA listed —
Lenalidomide 5 mgthis 47781-0484-28 Alvogen, 28 capsules — AB FDA listed —
Revlimid 5 mg 59572-0405-00 Celgene 100 capsules — AB FDA listed —
Lenalidomide 5 mg 59651-0343-01 Aurobindo 100 capsules — AB FDA listed —
Lenalidomide 5 mg 60219-1715-01 Amneal 28 capsules — AB FDA listed —
Lenalidomide 5 mg 60505-4533-01 Apotex 100 capsules — AB Discontinued —
Lenalidomide 5 mg 63304-0042-01 Sun 100 capsules — AB FDA listed —
lenalidomide 5 mg 69097-0381-73 Cipla 28 capsules — AB FDA listed —
Lenalidomide 5 mg 70377-0050-12 BIOCON 100 capsules — AB FDA listed —
Lenalidomide 5 mg 70710-1031-01 Zydus 100 capsules — AB FDA listed —
Lenalidomide 5 mg 70771-1677-01 Zydus 100 capsules — AB FDA listed —
Lenalidomide 5 mg 73043-0039-01 Devatis 100 capsules — AB FDA listed —
lenalidomide 5 mg 76282-0697-48 EXELAN 28 capsules — AB FDA listed —
Lenalidomide 5 mg 82293-0007-10 Novugen 28 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2022
On the market since
Sep 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

What it looks like

Color Blue / Orange / Green / Yellow / Gray / Brown / Red / White
ShapeCapsule
ImprintLP;642
Size22 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerAlvogen, Inc.
Application holderALVOGEN INC
FDA applicationANDA210480 (ANDA)
Labeler code47781
First marketedSep 2022
Product typeHuman Prescription Drug
Portfolio32 products on file
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.
🚨 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use lenalidomide capsules during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects.

If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting lenalidomide capsules treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after lenalidomide capsules treatment [see Warnings and Precautions ( 5.1 ), Medication Guide ( 17 )] .

To avoid embryo-fetal exposure to lenalidomide, lenalidomide capsules are only available through a restricted distribution program, the Lenalidomide REMS program ( 5.2 ). Information about the Lenalidomide REMS program is available at www.lenalidomiderems.com or by calling the toll-free number 1-888-423-5436. Hematologic Toxicity (Neutropenia and Thrombocytopenia) Lenalidomide capsules can cause significant neutropenia and thrombocytopenia.

Eighty percent of patients with del 5q myelodysplastic syndromes had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study.

Patients on therapy for del 5q myelodysplastic syndromes should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors [see Dosage and Administration ( 2.2 )].

Venous and Arterial Thromboembolism Lenalidomide capsules have demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma who were treated with lenalidomide capsules and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling.

Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient’s underlying risks [see Warnings and Precautions ( 5.4 )]. WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning. EMBRYO-FETAL TOXICITY Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans.

If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. Pregnancy must be excluded before start of treatment. Prevent pregnancy during treatment by the use of two reliable methods of contraception ( 5.1 ).

Lenalidomide capsules are available only through a restricted distribution program, called the Lenalidomide REMS program ( 5.2 , 17 ). HEMATOLOGIC TOXICITY. Lenalidomide capsules can cause significant neutropenia and thrombocytopenia ( 5.3 ).

VENOUS AND ARTERIAL THROMBOEMBOLISM Significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma receiving lenalidomide capsules with dexamethasone. Anti-thrombotic prophylaxis is recommended ( 5.4 ).

🎯 Indications and Usage 173 words ▾

1 INDICATIONS AND USAGE Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with: Multiple myeloma (MM), in combination with dexamethasone ( 1.1 ). Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2 ). Limitations of Use: Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials ( 1.6 ).

1.1Multiple Myeloma Lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (MM).

1.2Myelodysplastic Syndromes Lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

1.6Limitations of Use Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with CLL outside of controlled clinical trials [see Warnings and Precautions ( 5.5 )].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION MM combination therapy: 25 mg once daily orally on Days 1 to 21 of repeated 28-day cycles. ( 2.1 ). MDS: 10 mg once daily ( 2.2 ). Renal impairment: Adjust starting dose based on the creatinine clearance value ( 2.6 ). For concomitant therapy doses, see Full Prescribing Information ( 2.1 , 14.1 ).

2.1Recommended Dosage for Multiple Myeloma Lenalidomide Capsules Combination Therapy The recommended starting dose of lenalidomide capsules is 25 mg orally once daily on Days 1 to 21 of repeated 28-day cycles in combination with dexamethasone. Refer to Section 14.1 for specific dexamethasone dosing. For patients greater than 75 years old, the starting dose of dexamethasone may be reduced [see Clinical Studies ( 14.1 )] .

Treatment should be continued until disease progression or unacceptable toxicity. In patients who are not eligible for auto-HSCT, treatment should continue until disease progression orunacceptable toxicity. For patients who are auto-HSCT-eligible, hematopoietic stem cell mobilization shouldoccur within 4 cycles of a lenalidomide-containing therapy [see Warnings and Precautions ( 5.12 )] .

Dose Adjustments for Hematologic Toxicities During MM Treatment Dose modification guidelines, as summarized in Table 1 below, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to lenalidomide capsules. Table 1: Dose Adjustments for Hematologic Toxicities for MM Platelet counts Thrombocytopenia in MM When Platelets Recommended Course Days 1 to 21 of repeated 28-day cycle Fall below 30,000/mcL Interrupt lenalidomide capsules treatment, follow CBC weekly Return to at least 30,000/mcL Resume lenalidomide capsules at next lower dose.

Do not dose below 2.5 mg daily For each subsequent drop below 30,000/mcL Interrupt lenalidomide capsules treatment Return to at least 30,000/mcL Resume lenalidomide capsules at next lower dose. Do not dose below 2.5 mg daily Absolute Neutrophil counts (ANC) Neutropenia in MM When Neutrophils Recommended Course Days 1 to 21 of repeated 28-day cycle Fall below 1,000/mcL Interrupt lenalidomide capsules treatment, follow CBC weekly Return to at least 1,000/mcL and neutropenia is the only toxicity Resume lenalidomide capsules at 25 mg daily or initial starting dose Return to at least 1,000/mcL and if other toxicity Resume lenalidomide capsules at next lower dose.

Do not dose below 2.5 mg daily For each subsequent drop below 1,000/mcL Interrupt lenalidomide capsules treatment Return to at least 1,000/mcL Resume lenalidomide capsules at next lower dose. Do not dose below 2.5 mg daily

2.2Recommended Dosage for Myelodysplastic Syndromes The recommended starting dose of lenalidomide capsules is 10 mg daily. Treatment is continued or modified based upon clinical and laboratory findings. Continue treatment until disease progression or unacceptable toxicity.

Dose Adjustments for Hematologic Toxicities During MDS Treatment Patients who are dosed initially at 10 mg and who experience thrombocytopenia should have their dosage adjusted as follows: Platelet counts If thrombocytopenia develops WITHIN 4 weeks of starting treatment at 10 mg daily in MDS If baseline is at least 100,000/mcL When Platelets Recommended Course Fall below 50,000/mcL Interrupt lenalidomide capsules treatment Return to at least 50,000/mcL Resume lenalidomide capsules at 5 mg daily If baseline is below 100,000/mcL When Platelets Recommended Course Fall to 50% of the baseline value Interrupt lenalidomide capsules treatment If baseline is at least 60,000/mcL and returns to at least 50,000/mcL Resume lenalidomide capsules at 5 mg daily If baseline is below 60,000/mcL and returns to at least 30,000/mcL Resume lenalidomide capsules at 5 mg daily If thrombocytopenia develops AFTER 4 weeks of starting treatment at 10 mg daily in MDS When Platelets Recommended Course Fall below 30,000/mcL or below 50,000/mcL with platelet transfusions Interrupt lenalidomide cap… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: 2.5 mg: A dark blue opaque cap/ light orange opaque body, capsule shell size No. 4 imprinted in black ink with “LP” on the cap and “637” on the body and filled with white powder. 5 mg: A green opaque cap/ light caramel opaque body, capsule shell size No.

2 imprinted in black ink with “LP” on the cap and “638” on the body and filled with white powder. 10 mg: A gold opaque cap/ gray opaque body, capsule shell size No. 0 imprinted in black ink with “LP” on the cap and “639” on the body and filled with white powder.

15 mg: A caramel opaque cap/ grey opaque body, capsule shell size No. 2 imprinted in black ink with “LP” on the cap and “640” on the body and filled with white powder. 20 mg: A warm brick red opaque cap/ light gray opaque body, capsule shell size No.

1 imprinted in black ink with “LP” on the cap and “641” on the body and filled with white powder. 25 mg: A white opaque cap/ white opaque body, capsule shell size No. 0 imprinted in black ink with “LP” on the cap and “642” on the body and filled with white powder.

Capsules: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg ( 3 ).­

⛔ Contraindications 175 words ▾

4 CONTRAINDICATIONS Pregnancy ( Boxed Warning , 4.1 , 5.1 , 8.1 ). Demonstrated severe hypersensitivity to lenalidomide ( 4.2 , 5.9 , 5.15 ).

4.1Pregnancy Lenalidomide can cause fetal harm when administered to a pregnant female. Limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. This effect was seen at all doses tested.

Due to the results of this developmental monkey study, and lenalidomide's structural similarities to thalidomide, a known human teratogen, lenalidomide is contraindicated in females who are pregnant [see Boxed Warning] . If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus [see Warnings and Precautions ( 5.1 , 5.2 ), Use in Special Populations ( 8.1 , 8.3 )] .

4.2Severe Hypersensitivity Reactions Lenalidomide capsules are contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide [see Warnings and Precautions ( 5.9 , 5.15 )] .

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Increased Mortality: serious and fatal cardiac adverse reactions occurred in patients with CLL treated with lenalidomide capsules ( 5.5 ). Second Primary Malignancies (SPM): Higher incidences of SPM were observed in controlled trials of patients with MM receiving lenalidomide capsules ( 5.6 ). Increased Mortality: Observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue ( 5.7 ).

Hepatotoxicity: Hepatic failure including fatalities; monitor liver function. Stop lenalidomide capsules and evaluate if hepatotoxicity is suspected ( 5.8 ). Severe Cutaneous Reactions: Discontinue lenalidomide capsules for severe reactions ( 5.9 ).

Tumor lysis syndrome (TLS) including fatalities: Monitor patients at risk of TLS (i.e., those with high tumor burden) and take appropriate precautions ( 5.10 ). Tumor flare reaction: Serious tumor flare reactions, including fatal reactions, have occurred during investigational use of lenalidomide capsules for chronic lymphocytic leukemia and lymphoma ( 5.11 ). Impaired Stem Cell mobilization: A decrease in the number of CD34+ cells collected after treatment (> 4 cycles) with lenalidomide capsules has been reported.

Consider early referral to transplant center ( 5.12 ). Hypersensitivity: Monitor patients for potential hypersensitivity. Discontinue lenalidomide capsules for angioedema and anaphylaxis ( 5.15 ).

5.1Embryo-Fetal Toxicity Lenalidomide capsules are a thalidomide analogue and are contraindicated for use during pregnancy. Thalidomide is a known human teratogen that causes life-threatening human birth defects or embryo-fetal death [see Use in Specific Populations ( 8.1 )] . An embryo-fetal development study in monkeys indicates that lenalidomide produced malformations in the offspring of female monkeys who received the drug during pregnancy, similar to birth defects observed in humans following exposure to thalidomide during pregnancy.

Lenalidomide capsules are only available through the Lenalidomide REMS program [see Warnings and Precautions ( 5.2 )]. Females of Reproductive Potential Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning lenalidomide capsules therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy. Females must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control, beginning 4 weeks prior to initiating treatment with lenalidomide capsules, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide capsules therapy.

Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10 to 14 days and the second test within 24 hours prior to prescribing lenalidomide capsules therapy and then weekly during the first month, then monthly thereafter in females with regular menstrual cycles or every 2 weeks in females with irregular menstrual cycles [see Use in Specific Populations ( 8.3 )]. Males Lenalidomide is present in the semen of patients receiving the drug.

Therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking lenalidomide capsules and for up to 4 weeks after discontinuing lenalidomide capsules, even if they have undergone a successful vasectomy. Male patients taking lenalidomide capsules must not donate sperm and for up to 4 weeks after discontinuing lenalidomide capsules [see Use in Specific Populations ( 8.3 )]. Blood Donation Patients must not donate blood during treatment with lenalidomide capsules and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to lenalidomide capsules.

5.2Lenalidomide REMS Program Because of the embryo-fetal risk [see Warnings and Precautions ( 5.1 )] , l… [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 prescribing information: Embryo-Fetal Toxicity [see Boxed Warning , Warnings and Precautions ( 5.1 , 5.2 )] Hematologic Toxicity [see Boxed Warning, Warnings and Precautions ( 5.3 )] Venous and Arterial Thromboembolism [see Boxed Warning, Warnings and Precautions ( 5.4 )] Increased Mortality in Patients with CLL [see Warnings and Precautions ( 5.5 )] Second Primary Malignancies [see Warnings and Precautions ( 5.6 )] Increased Mortality in Patients with MM When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone [see Warnings and Precautions ( 5.7 )] Hepatotoxicity [see Warnings and Precautions ( 5.8 )] Severe Cutaneous Reactions [see Warnings and Precautions ( 5.9 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.10 )] Tumor Flare Reactions [see Warnings and Precautions ( 5.11 )] Impaired Stem Cell Mobilization [see Warnings and Precautions ( 5.12 )] Thyroid Disorders [see Warnings and Precautions ( 5.13 )] Hypersensitivity [see Warnings and Precautions ( 5.15 )] MM: Most common adverse reactions (≥20%) include diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, upper respiratory tract infection, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, and tremor ( 6.1 ).

MDS: Most common adverse reactions (>15%) include thrombocytopenia, neutropenia, diarrhea, pruritus, rash, fatigue, constipation, nausea, nasopharyngitis, arthralgia, pyrexia, back pain, peripheral edema, cough, dizziness, headache, muscle cramp, dyspnea, pharyngitis, and epistaxis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS contact Alvogen, Inc. at 1-866-770-3024 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. Newly Diagnosed MM – Lenalidomide Capsules Combination Therapy: Data were evaluated from 1613 patients in a large phase 3 study who received at least one dose of lenalidomide capsules with low dose dexamethasone (Rd) given for 2 different durations of time (i.e., until progressive disease [Arm Rd Continuous; N=532] or for up to eighteen 28-day cycles [72 weeks, Arm Rd18; N=540] or who received melphalan, prednisone and thalidomide (Arm MPT; N=541) for a maximum of twelve 42-day cycles (72 weeks).

The median treatment duration in the Rd Continuous arm was 80.2 weeks (range 0.7 to 246.7) or 18.4 months (range 0.16 to 56.7). In general, the most frequently reported adverse reactions were comparable in Arm Rd Continuous and Arm Rd18, and included diarrhea, anemia, constipation, peripheral edema, neutropenia, fatigue, back pain, nausea, asthenia, and insomnia. The most frequently reported Grade 3 or 4 reactions included neutropenia, anemia, thrombocytopenia, pneumonia, asthenia, fatigue, back pain, hypokalemia, rash, cataract, lymphopenia, dyspnea, DVT, hyperglycemia, and leukopenia.

The highest frequency of infections occurred in Arm Rd Continuous (75%) compared to Arm MPT (56%). There were more grade 3 and 4 and serious adverse reactions of infection in Arm Rd Continuous than either Arm MPT or Rd18. In the Rd Continuous arm, the most common adverse reactions leading to dose interruption of lenalidomide capsules were infection events (28.8%); overall, the median time to the first dose interruption of lenalidomide capsules was 7 weeks.

The most common adverse reactions leading to dose reduction of lenalidomide capsules in the Rd Continuous arm were hematologic events (10.7%); overall, the median time to the first dose reduction of lenalidomide c… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Digoxin: Monitor digoxin plasma levels periodically due to increased C max and AUC with concomitant lenalidomide capsules therapy ( 7.1 ). Concomitant use of erythropoietin stimulating agents or estrogen containing therapies with lenalidomide capsules may increase the risk of thrombosis ( 7.2 ).

7.1Digoxin When digoxin was co-administered with multiple doses of lenalidomide capsules (10 mg/day) the digoxin C max and AUC inf were increased by 14%. Periodically monitor digoxin plasma levels, in accordance with clinical judgment and based on standard clinical practice in patients receiving this medication, during administration of lenalidomide capsules.

7.2Concomitant Therapies That May Increase the Risk of Thrombosis Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as estrogen containing therapies, should be used with caution after making a benefit-risk assessment in patients receiving lenalidomide capsules [see Warnings and Precautions ( 5.4 )] .

7.3Warfarin Co-administration of multiple doses of lenalidomide capsules (10 mg/day) with a single dose of warfarin (25 mg) had no effect on the pharmacokinetics of lenalidomide or R- and S-warfarin. Expected changes in laboratory assessments of PT and INR were observed after warfarin administration, but these changes were not affected by concomitant lenalidomide capsules administration. It is not known whether there is an interaction between dexamethasone and warfarin.

Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed ( 8.2 ).

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to lenalidomide capsules during pregnancy as well as female partners of male patients who are exposed to lenalidomide capsules. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to lenalidomide capsules to the FDA via the MedWatch program at 1-800-FDA-1088 and also 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 [see Data] , Lenalidomide capsules can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy [see Boxed Warning , Contraindications ( 4.1 ), Use in Specific Populations ( 5.1 )] . Lenalidomide capsules is a thalidomide analogue. 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. Lenalidomide caused thalidomide-type limb defects in monkey offspring. Lenalidomide crossed the placenta after administration to pregnant rabbits and pregnant rats [see Data].

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised 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 lenalidomide capsules to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423-5436. The estimated 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.

The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal data In an embryo-fetal developmental toxicity study in monkeys, teratogenicity, including thalidomide-like limb defects, occurred in offspring when pregnant monkeys received oral lenalidomide during organogenesis. Exposure (AUC) in monkeys at the lowest dose was 0.17 times the human exposure at the maximum recommended human dose (MRHD) of 25 mg.

Similar studies in pregnant rabbits and rats at 20 times and 200 times the MRHD respectively, produced embryo lethality in rabbits and no adverse reproductive effects in rats. In a pre- and post-natal development study in rats, animals received lenalidomide from organogenesis through lactation. The study revealed a few adverse effects on the offspring of female rats treated with lenalidomide at doses up to 500 mg/kg (approximately 200 times the human dose of 25 mg based on body surface area).

The male offspring exhibited slightly delayed sexual maturation and the female offspring had slightly lower body weight gains during gestation when bred to male offspring. As with thalidomide, the rat model may not adequately address the full spectrum of potential human embryo-fetal developmental effects for lenalidomide. Following daily oral administration of lenalidomide from Gestation Day 7 through Gestation Day 20 in pregnant rabbits, fetal plasma lenalidomide concentrations were approximat… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to lenalidomide capsules during pregnancy as well as female partners of male patients who are exposed to lenalidomide capsules. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to lenalidomide capsules to the FDA via the MedWatch program at 1-800-FDA-1088 and also 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 [see Data] , Lenalidomide capsules can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy [see Boxed Warning , Contraindications ( 4.1 ), Use in Specific Populations ( 5.1 )] . Lenalidomide capsules is a thalidomide analogue. 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. Lenalidomide caused thalidomide-type limb defects in monkey offspring. Lenalidomide crossed the placenta after administration to pregnant rabbits and pregnant rats [see Data].

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised 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 lenalidomide capsules to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423-5436. The estimated 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.

The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal data In an embryo-fetal developmental toxicity study in monkeys, teratogenicity, including thalidomide-like limb defects, occurred in offspring when pregnant monkeys received oral lenalidomide during organogenesis. Exposure (AUC) in monkeys at the lowest dose was 0.17 times the human exposure at the maximum recommended human dose (MRHD) of 25 mg.

Similar studies in pregnant rabbits and rats at 20 times and 200 times the MRHD respectively, produced embryo lethality in rabbits and no adverse reproductive effects in rats. In a pre- and post-natal development study in rats, animals received lenalidomide from organogenesis through lactation. The study revealed a few adverse effects on the offspring of female rats treated with lenalidomide at doses up to 500 mg/kg (approximately 200 times the human dose of 25 mg based on body surface area).

The male offspring exhibited slightly delayed sexual maturation and the female offspring had slightly lower body weight gains during gestation when bred to male offspring. As with thalidomide, the rat model may not adequately address the full spectrum of potential human embryo-fetal developmental effects for lenalidomide. Following daily oral administration of lenalidomide from Gestation Day 7 through Gestation Day 20 in pregnant rabbits, fetal plasma lenalidomide concentrations were approximately 20% to 40% of the maternal C max .

Following a single oral dose to preg… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 13 words ▾

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

🧓 Geriatric Use ~2 min read ▾

8.5Geriatric Use MM In Combination : Overall, of the 1613 patients in the NDMM study who received study treatment, 94% (1521/1613) were 65 years of age or older, while 35% (561/1613) were over 75 years of age. The percentage of patients over age 75 was similar between study arms (Rd Continuous: 33%; Rd18: 34%; MPT: 33%). Overall, across all treatment arms, the frequency in most of the adverse reaction categories (e.g., all adverse reactions, grade 3/4 adverse reactions, serious adverse reactions) was higher in older (> 75 years of age) than in younger (≤75 years of age) subjects.

Grade 3 or 4 adverse reactions in the General Disorders and Administration Site Conditions body system were consistently reported at a higher frequency (with a difference of at least 5%) in older subjects than in younger subjects across all treatment arms. Grade 3 or 4 adverse reactions in the Infections and Infestations, Cardiac Disorders (including cardiac failure and congestive cardiac failure), Skin and Subcutaneous Tissue Disorders, and Renal and Urinary Disorders (including renal failure) body systems were also reported slightly, but consistently, more frequently (<5% difference), in older subjects than in younger subjects across all treatment arms.

For other body systems (e.g., Blood and Lymphatic System Disorders, Infections and Infestations, Cardiac Disorders, Vascular Disorders), there was a less consistent trend for increased frequency of grade 3/4 adverse reactions in older vs younger subjects across all treatment arms. Serious adverse reactions were generally reported at a higher frequency in the older subjects than in the younger subjects across all treatment arms. MM After At Least One Prior Therapy : Of the 703 MM patients who received study treatment in Studies 1 and 2, 45% were age 65 or over while 12% of patients were age 75 and over.

The percentage of patients age 65 or over was not significantly different between the lenalidomide/dexamethasone and placebo/dexamethasone groups. Of the 353 patients who received lenalidomide/dexamethasone, 46% were age 65 and over. In both studies, patients > 65 years of age were more likely than patients ≤ 65 years of age to experience DVT, pulmonary embolism, atrial fibrillation, and renal failure following use of lenalidomide capsules.

No differences in efficacy were observed between patients over 65 years of age and younger patients. Of the 148 patients with del 5q MDS enrolled in the major study, 38% were age 65 and over, while 33% were age 75 and over. Although the overall frequency of adverse reactions (100%) was the same in patients over 65 years of age as in younger patients, the frequency of serious adverse reactions was higher in patients over 65 years of age than in younger patients (54% vs.

33%). A greater proportion of patients over 65 years of age discontinued from the clinical studies because of adverse reactions than the proportion of younger patients (27% vs. 16%).

No differences in efficacy were observed between patients over 65 years of age and younger patients. Since elderly patients are more likely to have decreased renal function, care should be taken in dose selection. Monitor renal function.

🆘 Overdosage 72 words ▾

10 OVERDOSAGE There is no specific experience in the management of lenalidomide overdose in patients with MM or MDS. In dose-ranging studies in healthy subjects, some were exposed to up to 200 mg (administered 100 mg BID) and in single-dose studies, some subjects were exposed to up to 400 mg. Pruritus, urticaria, rash, and elevated liver transaminases were the primary reported AEs.

In clinical trials, the dose-limiting toxicity was neutropenia and thrombocytopenia.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Lenalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of lenalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. In vitro, in the presence of drug, substrate proteins (including Aiolos, Ikaros, and CK1α) are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects.

Lenalidomide inhibits proliferation and induces apoptosis of certain hematopoietic tumor cells including MM and del (5q) myelodysplastic syndromes in vitro . Lenalidomide causes a delay in tumor growth in some in vivo nonclinical hematopoietic tumor models including MM. Immunomodulatory properties of lenalidomide include increased number and activation of T cells and natural killer (NK) cells leading to direct and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) via increased secretion of interleukin-2 and interferon-gamma, increased numbers of NKT cells, and inhibition of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes.

In MM cells, the combination of lenalidomide and dexamethasone synergizes the inhibition of cell proliferation and the induction of apoptosis.

12.2Pharmacodynamics Cardiac Electrophysiology The effect of lenalidomide on the QTc interval was evaluated in 60 healthy male subjects in a thorough QT study. At a dose two times the maximum recommended dose, lenalidomide did not prolong the QTc interval. The largest upper bound of the two-sided 90% CI for the mean differences between lenalidomide and placebo was below 10 ms.

12.3Pharmacokinetics Absorption Following single and multiple doses of lenalidomide capsules in patients with MM or MDS, the maximum plasma concentrations occurred between 0.5 and 6 hours post-dose. The single and multiple dose pharmacokinetic disposition of lenalidomide is linear with AUC and C max values increasing proportionally with dose. Multiple doses of lenalidomide capsules at the recommended dosage does not result in drug accumulation.

Administration of a single 25 mg dose of lenalidomide capsules with a high-fat meal in healthy subjects reduces the extent of absorption, with an approximate 20% decrease in AUC and 50% decrease in C max . In the trials where the efficacy and safety were established for lenalidomide capsules, the drug was administered without regard to food intake. Lenalidomide capsules can be administered with or without food.

Distribution In vitro [ 14 C]-lenalidomide binding to plasma proteins is approximately 30%. Lenalidomide is present in semen at 2 hours (1379 ng/ejaculate) and 24 hours (35 ng/ejaculate) after the administration of lenalidomide capsule 25 mg daily. Elimination The mean half-life of lenalidomide is 3 hours in healthy subjects and 3 to 5 hours in patients with MM or MDS.

Metabolism Lenalidomide undergoes limited metabolism. Unchanged lenalidomide is the predominant circulating component in humans. Two identified metabolites are 5-hydroxy-lenalidomide and N-acetyl-lenalidomide; each constitutes less than 5% of parent levels in circulation.

Excretion Elimination is primarily renal. Following a single oral administration of [ 14 C]-lenalidomide 25 mg to healthy subjects, approximately 90% and 4% of the radioactive dose was eliminated within ten days in urine and feces, respectively. Approximately 82% of the radioactive dose was excreted as lenalidomide in the urine within 24 hours.

Hydroxy-lenalidomide and N-acetyl-lenalidomide represented 4.6% and 1.8% of the excreted dose, respectively. The renal clearance of lenalidomide exceeds the glomerular filtration rate. Specific Populations Renal Impairment: Eight subjects with mild renal impairment (creatinine clearance (CLcr) 50 to 79 mL/min calculated using Cockcroft-Gault), 9 subjects with moderate renal impairment (CLcr 30 to 49 mL/min), 4 subjects with severe renal impairm… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 172 words ▾

12.1Mechanism of Action Lenalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of lenalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. In vitro, in the presence of drug, substrate proteins (including Aiolos, Ikaros, and CK1α) are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects.

Lenalidomide inhibits proliferation and induces apoptosis of certain hematopoietic tumor cells including MM and del (5q) myelodysplastic syndromes in vitro . Lenalidomide causes a delay in tumor growth in some in vivo nonclinical hematopoietic tumor models including MM. Immunomodulatory properties of lenalidomide include increased number and activation of T cells and natural killer (NK) cells leading to direct and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) via increased secretion of interleukin-2 and interferon-gamma, increased numbers of NKT cells, and inhibition of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes.

In MM cells, the combination of lenalidomide and dexamethasone synergizes the inhibition of cell proliferation and the induction of apoptosis.

📦 How Supplied / Storage and Handling ~3 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied A dark blue opaque cap/ light orange opaque body, capsule shell size No. 4 imprinted in black ink with “LP” on the cap and “637” on the body and filled with white powder. 2.5 mg bottles of 28 (NDC 47781-483-28) 2.5 mg bottles of 100 (NDC 47781-483-01) A green opaque cap/ light caramel opaque body, capsule shell size No.

2 imprinted in black ink with “LP” on the cap and “638” on the body and filled with white powder. 5 mg bottles of 28 (NDC 47781-484-28) 5 mg bottles of 100 (NDC 47781-484-01) A gold opaque cap/ gray opaque body, capsule shell size No. 0 imprinted in black ink with “LP” on the cap and “639” on the body and filled with white powder.

10 mg bottles of 28 (NDC 47781-485-28) 10 mg bottles of 100 (NDC 47781-485-01) A caramel opaque cap/ grey opaque body, capsule shell size No. 2 imprinted in black ink with “LP” on the cap and “640” on the body and filled with white powder. 15 mg bottles of 21 (NDC 47781-486-77) 15 mg bottles of 100 (NDC 47781-486-01) A warm brick red opaque cap/ light gray opaque body, capsule shell size No.

1 imprinted in black ink with “LP” on the cap and “641” on the body and filled with white powder. 20 mg bottles of 21 (NDC 47781-487-77) 20 mg bottles of 100 (NDC 47781-487-01) A white opaque cap/ white opaque body, capsule shell size No. 0 imprinted in black ink with “LP” on the cap and “642” on the body and filled with white powder.

25 mg bottles of 21 (NDC 47781-488-77) 25 mg bottles of 100 (NDC 47781-488-01)

16.2Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

16.3Handling and Disposal Care should be exercised in the handling of lenalidomide capsules. Lenalidomide capsules should not be opened or broken. If powder from lenalidomide capsules contacts the skin, wash the skin immediately and thoroughly with soap and water.

If lenalidomide capsules contacts the mucous membranes, flush thoroughly with water. Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.

1 Dispense no more than a 28-day supply.

16.1How Supplied A dark blue opaque cap/ light orange opaque body, capsule shell size No. 4 imprinted in black ink with “LP” on the cap and “637” on the body and filled with white powder. 2.5 mg bottles of 28 (NDC 47781-483-28) 2.5 mg bottles of 100 (NDC 47781-483-01) A green opaque cap/ light caramel opaque body, capsule shell size No.

2 imprinted in black ink with “LP” on the cap and “638” on the body and filled with white powder. 5 mg bottles of 28 (NDC 47781-484-28) 5 mg bottles of 100 (NDC 47781-484-01) A gold opaque cap/ gray opaque body, capsule shell size No. 0 imprinted in black ink with “LP” on the cap and “639” on the body and filled with white powder.

10 mg bottles of 28 (NDC 47781-485-28) 10 mg bottles of 100 (NDC 47781-485-01) A caramel opaque cap/ grey opaque body, capsule shell size No. 2 imprinted in black ink with “LP” on the cap and “640” on the body and filled with white powder. 15 mg bottles of 21 (NDC 47781-486-77) 15 mg bottles of 100 (NDC 47781-486-01) A warm brick red opaque cap/ light gray opaque body, capsule shell size No.

1 imprinted in black ink with “LP” on the cap and “641” on the body and filled with white powder. 20 mg bottles of 21 (NDC 47781-487-77) 20 mg bottles of 100 (NDC 47781-487-01) A white opaque cap/ white opaque body, capsule shell size No. 0 imprinted in black ink with “LP” on the cap and “642” on the body and filled with white powder.

25 mg bottles of 21 (NDC 47781-488-77) 25 mg bottles of 100 (NDC 47781-488-01)

📦 Storage and Handling 104 words ▾

16.2Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

16.3Handling and Disposal Care should be exercised in the handling of lenalidomide capsules. Lenalidomide capsules should not be opened or broken. If powder from lenalidomide capsules contacts the skin, wash the skin immediately and thoroughly with soap and water.

If lenalidomide capsules contacts the mucous membranes, flush thoroughly with water. Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.

1 Dispense no more than a 28-day supply.

📋 Description ~2 min read ▾

11 DESCRIPTION Lenalidomide capsules, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H -isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure: 3-(4-amino-1-oxo 1,3-dihydro-2 H -isoindol-2-yl) piperidine-2,6-dione The empirical formula for lenalidomide is C 13 H 13 N 3 O 3 , and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder.

It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml.

Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide capsules are available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose anhydrous, magnesium stearate and microcrystalline cellulose.

The 2.5 mg capsule shell contains gelatin, red iron oxide, yellow iron oxide, titanium dioxide, FD&C blue #1, FD&C red #3, FD&C red #40 and black ink. The 5 mg capsule shell contains gelatin, titanium dioxide, black iron oxide, red iron oxide, yellow iron oxide, FD&C blue #1, FD&C yellow #6 and black ink. The 10 mg capsule shell contains gelatin, titanium dioxide, FD&C blue #1, FD&C red #40, FD&C yellow #6, FD&C yellow #5 and black ink.

The 15 mg capsule shell contains gelatin, titanium dioxide, FD&C blue #1, FD&C red #40, FD&C yellow #5, black iron oxide, red iron oxide, yellow iron oxide and black ink. The 20 mg capsule shell contains gelatin, titanium dioxide, FD&C blue #1, FD&C red #40, red iron oxide, yellow iron oxide and black ink. The 25 mg capsule shell contains gelatin, titanium dioxide and black ink.

The black imprinting ink contains shellac, strong ammonia solution, black iron oxide. 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 lenalidomide capsules are contraindicated in pregnancy [see Boxed Warning , Contraindications ( 4.1 )] . Lenalidomide capsules are a thalidomide analogue and can cause serious birth defects or death to a developing baby [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential that they must avoid pregnancy while taking lenalidomide capsules and for at least 4 weeks after completing therapy.

Initiate lenalidomide capsules treatment in females of reproductive potential only following a negative pregnancy test. 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 lenalidomide capsules therapy, during dose interruption and for 4 weeks after she has completely finished taking lenalidomide capsules. 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 lenalidomide capsules and contact her healthcare provider if she becomes pregnant while taking this drug, if she misses her menstrual period, or experiences unusual menstrual bleeding, if she stops taking birth control, or if she thinks FOR ANY REASON that she 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 ), Use in Specific Populations ( 8.3 )] .

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

Lenalidomide REMS program Because of the risk of embryo-fetal toxicity, lenalidomide capsules are only available through a restricted program called the Lenalidomide REMS program [see Warnings and Precautions ( 5.2 )]. Patients must sign a Patient-Physician agreement form and comply with the requirements to receive lenalidomide capsules. In particular, females of reproductive potential must comply with the pregnancy testing, contraception requirements and participate in monthly telephone surveys.

Males must comply with the contraception requirements [see Use in Specific Populations ( 8.3 )] . Lenalidomide capsules are available only from pharmacies that are certified in Lenalidomide REMS program. Provide patients with the telephone number and website for information on how to obtain the product.

Pregnancy Exposure Registry Inform females there is a Pregnancy Exposure Registry that monitors pregnancy outcomes in females exposedto lenalidomide capsules during pregnancy and that they can contact the Pregnancy Exposure Registry bycalling 1-888-423-5436 [see Use in Specific Populations ( 8.1 )] . Hematologic Toxicity Inform patients that lenalidomide capsules are associated with significant neutropenia and thrombocytopenia [see Boxed Warning , Warnings and Precautions ( 5.3 )] . Venous and Arterial Thromboembolism Inform patients of the risk of thrombosis including DVT, PE, MI, and str… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: November 2023 PL483-00 MEDICATION GUIDE Lenalidomide (len" a lid' oh mide) Capsules What is the most important information I should know about lenalidomide capsules?

Before you begin taking lenalidomide capsules, you must read and agree to all of the instructions in the Lenalidomide REMS program. Before prescribing lenalidomide capsules, your healthcare provider will explain the Lenalidomide REMS program to you and have you sign the Patient-Physician Agreement Form. Lenalidomide capsules may cause serious side effects including: Possible birth defects (deformed babies) or death of an unborn baby.

Females who are pregnant or who plan to become pregnant must not take lenalidomide capsules. Lenalidomide capsules are similar to the medicine thalidomide. We know thalidomide can cause severe life-threatening birth defects.

Lenalidomide capsules have not been tested in pregnant females. Lenalidomide capsules have harmed unborn animals in animal testing. Females must not get pregnan t : For at least 4 weeks before starting lenalidomide capsules While taking lenalidomide capsules During any breaks (interruptions) in your treatment with lenalidomide capsules For at least 4 weeks after stopping lenalidomide capsules Females who can become pregnant: Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular.

If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling. Must agree to use two acceptable forms of birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping lenalidomide capsules. Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy before, during, and after treatment with lenalidomide capsules.

If you had unprotected sex or if you think your birth control has failed, stop taking lenalidomide capsules immediately and call your healthcare provider right away. If you become pregnant while taking lenalidomide capsules, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call the REMS Call Center at 1-888-423-5436.

Healthcare providers and patients should report all cases of pregnancy to: FDA MedWatch at 1-800-FDA-1088, and The Lenalidomide REMS program at 1-888-423-5436 There is a pregnancy exposure registry that monitors the outcomes of females who take lenalidomide capsules during pregnancy, or if their male partner takes lenalidomide capsules and they are exposed during pregnancy. You can enroll in this registry by calling the Lenalidomide REMS program at the phone number listed above. Lenalidomide can pass into human semen: Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking lenalidomide capsules, during any breaks (interruptions) in your treatment with lenalidomide capsules, and for up to 4 weeks after stopping lenalidomide capsules.

Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant. Do not donate sperm while taking lenalidomide capsules, during any breaks (interruptions) in your treatment, and for up to 4 weeks after stopping lenalidomide capsules.

If a female becomes pregnant with your sperm, the baby may be exposed to lenalidomide capsules and may be born with birth defects. Men, if your female partner becomes pregnant, you should call your healthcare provider right away. Low white blood cells (neutropenia) and low platelets (thromboc… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers ~2 min read ▾

8.3Females and Males of Reproductive Potential Pregnancy Testing Lenalidomide capsules can cause fetal harm when administered during pregnancy [see Use in Specific Populations ( 8.1 )] . Verify the pregnancy status of females of reproductive potential prior to initiating lenalidomide capsules therapy and during therapy. Advise females of reproductive potential that they must avoid pregnancy 4 weeks before therapy, while taking lenalidomide capsules, during dose interruptions and for at least 4 weeks after completing therapy.

Females of reproductive potential must have 2 negative pregnancy tests before initiating lenalidomide capsules. The first test should be performed within 10 to 14 days, and the second test within 24 hours prior to prescribing lenalidomide capsules. Once treatment has started and during dose interruptions, pregnancy testing for females of reproductive potential should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated every 4 weeks in females with regular menstrual cycles.

If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in her menstrual bleeding. Lenalidomide capsules treatment must be discontinued during this evaluation.

Contraception Females Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously: one highly effective form of contraception - tubal ligation, IUD, hormonal (birth control pills, injections, hormonal patches, vaginal rings, or implants), or partner's vasectomy, and 1 additional effective contraceptive method - male latex or synthetic condom, diaphragm, or cervical cap. Contraception must begin 4 weeks prior to initiating treatment with lenalidomide capsules, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of lenalidomide capsules therapy.

Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy. Females of reproductive potential should be referred to a qualified provider of contraceptive methods, if needed. Males Lenalidomide is present in the semen of males who take lenalidomide capsules.

Therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking lenalidomide capsules and for up to 4 weeks after discontinuing lenalidomide capsules, even if they have undergone a successful vasectomy. Male patients taking lenalidomide capsules must not donate sperm and for up to 4 weeks after discontinuing lenalidomide capsules.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Following single and multiple doses of lenalidomide capsules in patients with MM or MDS, the maximum plasma concentrations occurred between 0.5 and 6 hours post-dose. The single and multiple dose pharmacokinetic disposition of lenalidomide is linear with AUC and C max values increasing proportionally with dose. Multiple doses of lenalidomide capsules at the recommended dosage does not result in drug accumulation.

Administration of a single 25 mg dose of lenalidomide capsules with a high-fat meal in healthy subjects reduces the extent of absorption, with an approximate 20% decrease in AUC and 50% decrease in C max . In the trials where the efficacy and safety were established for lenalidomide capsules, the drug was administered without regard to food intake. Lenalidomide capsules can be administered with or without food.

Distribution In vitro [ 14 C]-lenalidomide binding to plasma proteins is approximately 30%. Lenalidomide is present in semen at 2 hours (1379 ng/ejaculate) and 24 hours (35 ng/ejaculate) after the administration of lenalidomide capsule 25 mg daily. Elimination The mean half-life of lenalidomide is 3 hours in healthy subjects and 3 to 5 hours in patients with MM or MDS.

Metabolism Lenalidomide undergoes limited metabolism. Unchanged lenalidomide is the predominant circulating component in humans. Two identified metabolites are 5-hydroxy-lenalidomide and N-acetyl-lenalidomide; each constitutes less than 5% of parent levels in circulation.

Excretion Elimination is primarily renal. Following a single oral administration of [ 14 C]-lenalidomide 25 mg to healthy subjects, approximately 90% and 4% of the radioactive dose was eliminated within ten days in urine and feces, respectively. Approximately 82% of the radioactive dose was excreted as lenalidomide in the urine within 24 hours.

Hydroxy-lenalidomide and N-acetyl-lenalidomide represented 4.6% and 1.8% of the excreted dose, respectively. The renal clearance of lenalidomide exceeds the glomerular filtration rate. Specific Populations Renal Impairment: Eight subjects with mild renal impairment (creatinine clearance (CLcr) 50 to 79 mL/min calculated using Cockcroft-Gault), 9 subjects with moderate renal impairment (CLcr 30 to 49 mL/min), 4 subjects with severe renal impairment (CLcr < 30 mL/min), and 6 patients with end stage renal disease (ESRD) requiring dialysis were administered a single 25 mg dose of lenalidomide capsules.

Three healthy subjects of similar age with normal renal function (CLcr > 80 mL/min) were also administered a single 25 mg dose of lenalidomide capsules. As CLcr decreased, half-life increased and drug clearance decreased linearly. Patients with moderate and severe impairment had a 3-fold increase in half-life and a 66% to 75% decrease in drug clearance compared to healthy subjects.

Patients on hemodialysis (n=6) had an approximate 4.5-fold increase in half-life and an 80% decrease in drug clearance compared to healthy subjects. Approximately 30% of the drug in body was removed during a 4-hour hemodialysis session. Adjust the starting dose of lenalidomide capsules in patients with renal impairment based on the CLcr value [see Dosage and Administration ( 2.6 )].

Hepatic Impairment: Mild hepatic impairment (defined as total bilirubin > 1 to 1.5 times upper limit normal (ULN) or any aspartate transaminase greater than ULN) did not influence the disposition of lenalidomide. No pharmacokinetic data is available for patients with moderate to severe hepatic impairment. Other Intrinsic Factors: Age (39 to 85 years), body weight (33 to 135 kg), sex, race, and type of hematological malignancies (MM or MDS) did not have a clinically relevant effect on lenalidomide clearance in adult patients.

Drug Interactions Co-administration of a single dose or multiple doses of dexamethasone (40 mg) had no clinically relevant effect on the multiple dose pharmacokinetics of lenalidomide capsules (25 mg). Co-administration of lenalidomide… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 61 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology The effect of lenalidomide on the QTc interval was evaluated in 60 healthy male subjects in a thorough QT study. At a dose two times the maximum recommended dose, lenalidomide did not prolong the QTc interval. The largest upper bound of the two-sided 90% CI for the mean differences between lenalidomide and placebo was below 10 ms.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Multiple Myeloma Randomized, Open-Label Clinical Trial in Patients with Newly Diagnosed MM: A randomized multicenter, open-label, 3-arm trial of 1,623 patients, was conducted to compare the efficacy and safety of lenalidomide capsules and low-dose dexamethasone (Rd) given for 2 different durations of time to that of melphalan, prednisone and thalidomide (MPT) in newly diagnosed MM patients who were not a candidate for stem cell transplant. In the first arm of the study, Rd was given continuously until progressive disease [Arm Rd Continuous].

In the second arm, Rd was given for up to eighteen 28-day cycles [72 weeks, Arm Rd18]). In the third arm, melphalan, prednisone and thalidomide (MPT) was given for a maximum of twelve 42-day cycles (72 weeks). For the purposes of this study, a patient who was < 65 years of age was not a candidate for SCT if the patient refused to undergo SCT therapy or the patient did not have access to SCT due to cost or other reasons.

Patients were stratified at randomization by age (≤75 versus >75 years), stage (ISS Stages I and II versus Stage III), and country. Patients in the Rd Continuous and Rd18 arms received lenalidomide capsules 25 mg once daily on Days 1 to 21 of 28-day cycles. Dexamethasone was dosed 40 mg once daily on Days 1, 8, 15, and 22 of each 28-day cycle.

For patients over > 75 years old, the starting dose of dexamethasone was 20 mg orally once daily on days 1,8,15, and 22 of repeated 28-day cycles. Initial dose and regimens for Rd Continuous and Rd18 were adjusted according to age and renal function. All patients received prophylactic anticoagulation with the most commonly used being aspirin.

The demographics and disease-related baseline characteristics of the patients were balanced among the 3 arms. In general, study subjects had advanced-stage disease. Of the total study population, the median age was 73 in the 3 arms with 35% of total patients > 75 years of age; 59% had ISS Stage I/II; 41% had ISS stage III; 9% had severe renal impairment (creatinine clearance [CLcr] < 30 mL/min); 23% had moderate renal impairment (CLcr > 30 to 50 mL/min; 44% had mild renal impairment (CLcr >50 to 80 mL/min).

For ECOG Performance Status, 29% were Grade 0, 49% Grade 1, 21% Grade 2, 0.4% ≥ Grade 3. The primary efficacy endpoint, progression-free survival (PFS), was defined as the time from randomization to the first documentation of disease progression as determined by Independent Response Adjudication Committee (IRAC), based on International Myeloma Working Group [IMWG] criteria or death due to any cause, whichever occurred first during the study until the end of the PFS follow-up phase. For the efficacy analysis of all endpoints, the primary comparison was between Rd Continuous and MPT arms.

The efficacy results are summarized in the table below. PFS was significantly longer with Rd Continuous than MPT: HR 0.72 (95% CI: 0.61-0.85 p <0.0001). A lower percentage of subjects in the Rd Continuous arm compared with the MPT arm had PFS events (52% versus 61%, respectively).

The improvement in median PFS time in the Rd Continuous arm compared with the MPT arm was 4.3 months. The myeloma response rate was higher with Rd Continuous compared with MPT (75.1% versus 62.3%); with a complete response in 15.1% of Rd Continuous arm patients versus 9.3% in the MPT arm. The median time to first response was 1.8 months in the Rd Continuous arm versus 2.8 months in the MPT arm.

For the interim OS analysis with 03 March 2014 data cutoff, the median follow-up time for all surviving patients is 45.5 months, with 697 death events, representing 78% of prespecified events required for the planned final OS analysis (697/896 of the final OS events). The observed OS HR was 0.75 for Rd Continuous versus MPT (95% CI = 0.62, 0.90). Table 13: Overview of Efficacy Results – Study MM-020 (Intent-to-treat Population) Rd Continuous (N = 535) Rd18 (N = 541) MPT (N = 547) PFS – IRAC (months) g Number of PFS even… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 120 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies with lenalidomide have not been conducted. Lenalidomide was not mutagenic in the bacterial reverse mutation assay (Ames test) and did not induce chromosome aberrations in cultured human peripheral blood lymphocytes, or mutations at the thymidine kinase (tk) locus of mouse lymphoma L5178Y cells. Lenalidomide did not increase morphological transformation in Syrian Hamster Embryo assay or induce micronuclei in the polychromatic erythrocytes of the bone marrow of male rats.

A fertility and early embryonic development study in rats, with administration of lenalidomide up to 500 mg/kg (approximately 200 times the human dose of 25 mg, based on body surface area) produced no parental toxicity and no adverse effects on fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 117 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies with lenalidomide have not been conducted. Lenalidomide was not mutagenic in the bacterial reverse mutation assay (Ames test) and did not induce chromosome aberrations in cultured human peripheral blood lymphocytes, or mutations at the thymidine kinase (tk) locus of mouse lymphoma L5178Y cells. Lenalidomide did not increase morphological transformation in Syrian Hamster Embryo assay or induce micronuclei in the polychromatic erythrocytes of the bone marrow of male rats.

A fertility and early embryonic development study in rats, with administration of lenalidomide up to 500 mg/kg (approximately 200 times the human dose of 25 mg, based on body surface area) produced no parental toxicity and no adverse effects on fertility.

📚 References 14 words ▾

15 REFERENCES 1. OSHA Hazardous Drugs. OSHA [Accessed on 29 January 2013, from http://www.osha.gov/SLTC/hazardousdrugs/index.html]

📄 Package Label / Principal Display Panel 204 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION NDC 47781-483-28 Lenalidomide Capsules 2.5 mg ATTENTION PHARMACIST: Dispense the accompanying Medication Guide to each patient. WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS Rx only 28 Capsules

PACKAGE LABEL PRINCIPAL DISPLAY PANEL NDC 47781-484-28 Lenalidomide Capsules 5 mg ATTENTION PHARMACIST: Dispense the accompanying Medication Guide to each patient. WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS Rx only 28 Capsules Container Label 5mg Capsules

PACKAGE LABEL PRINCIPAL DISPLAY PANEL NDC 47781-485-28 Lenalidomide Capsules 10 mg ATTENTION PHARMACIST: Dispense the accompanying Medication Guide to each patient. WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS Rx only 28 Capsules Container Label 10mg Capsules

PACKAGE LABEL PRINCIPAL DISPLAY PANEL NDC 47781-486-77 Lenalidomide Capsules 15 mg ATTENTION PHARMACIST: Dispense the accompanying Medication Guide to each patient. WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS Rx only 21 Capsules Container Label 15mg Capsules

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION NDC 47781-487-77 Lenalidomide Capsules 20 mg ATTENTION PHARMACIST: Dispense the accompanying Medication Guide to each patient. WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS Rx only 21 Capsules

PACKAGE LABEL PRINCIPAL DISPLAY PANEL NDC 47781-488-77 Lenalidomide Capsules 25 mg ATTENTION PHARMACIST: Dispense the accompanying Medication Guide to each patient. WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS Rx only 21 Capsules Container Label 25mg Capsules

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 – Q4 2025 · 4 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
76
Units reimbursed last 4 qtrs
1.6K
Gross reimbursed last 4 qtrs
$954K
Avg / prescription
$12,552.10
Avg / unit
$592.52
Latest quarter Q4 2025
19Rx
Fee-for-service vs managed care ⓘ
84% FFS 16% MCO
Fee-for-service · 64 Rx Managed care · 12 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: 1,379 units · 7.0 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: 231 units · 2.5 per 100k residents 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
2.57.0
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 7.0 /100k
2 New Jersey 2.5 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
28 capsules this page47781-0484-28 76 Rx · $953,960
100 capsules47781-0484-01 No Medicaid data
Drug total (last 4 qtrs): 76 Rx · 1,610 units · $953,960 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Lenalidomide — the program that covers self-administered drugs. 14 manufacturers.
⚠️ 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 Lenalidomide. 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
$950.15M
Claims incl. refills
100.1K
Beneficiaries
38.7K
Spend / beneficiary
$24,529.42
Spend / claim
$9,495.96
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 — Lenalidomide 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 ↗.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 Alvogen, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 capsules (47781-0484-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Alvogen, Inc. 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.
← 47781-0483-01 · Alvogen, 47781-0485-01 · Alvogen, →
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.