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Pomalidomide 4 mg Capsule, 100-count — NDC 59651-0197-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pomalidomide 4 mg Capsule, 100-count — NDC 59651-197-01 (Billing 59651-0197-01)

by Aurobindo Pharma Limited · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Pomalidomide 4 mg Capsule from Aurobindo Pharma Limited, marketed since Oct 2020 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 59651-0197-01
🏷️ FDA NDC (as labeled) 59651-197-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also priced by: Part D plans $536.29/unit — full pricing hub ↓
Main listing for product 59651-197 · Also comes in: 21 capsules 59651-197-21
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

NDC database record

One package, one record: these facts belong to NDC 59651-197-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
59651 labeler · 197 product · 01 package
Package marketed since
Oct 30, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5965119701 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59651-197-01
Product NDC 59651-197
11-digit billing NDC 59651019701
RxCUI 1369718, 1369726, 1369730, 1369734
UNII D2UX06XLB5
Application # ANDA210249
SPL Set ID 1539fbf9-8281-4c7b-827b-9f53b50d9042
Established class (EPC) Thalidomide Analog
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-10-30
Route ORAL
Dosage form CAPSULE
Substance POMALIDOMIDE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 21450080000125
GCN Seq No 070572
GCN 34150
HICL code 039996
Ingredient (HICL) Pomalidomide
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 POMALIDOMIDE 4 MG CAPSULE
FDB brand name Pomalidomide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 070572
  • GCN: 34150
  • GPI-14 (Medi-Span): 21450080000125
  • HICL (First Databank): 039996
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 1369718
Why two NDCs? The FDA registers this code as 59651-197-01 — 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 → 59651-0197-01. 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 POMALIDOMIDE 4 MG CAPSULE Ingredient Pomalidomide
📖 What it is MedlinePlus · NLM

Pomalidomide is used in combination with dexamethasone to treat multiple myeloma (a type of cancer of the bone marrow) that has not improved during or within 60 days of treatment with at least two other medications, including lenalidomide (Revlimid) and a proteasome inhibitor such as bortezomib (Velcade) or carfilzomib (Kyprolis). It is also used to treat Kaposi's sarcoma (a type of cancer that causes abnormal tissue to grow on different parts of the body) related to acquired immunodeficiency syndrome (AIDS) after unsuccessful treatment with other medications or in people with Kaposi's sarcoma...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats multiple myeloma, taken with dexamethasone after at least two earlier treatments. It also treats Kaposi sarcoma, either AIDS-related after HIV therapy has failed or in pe...
  • You take one capsule by mouth once a day, with or without food, for Days 1 through 21 of each 28-day cycle. Follow your prescriber's schedule exactly. Your dose may change dependin...
  • It is never safe during pregnancy because it can cause severe birth defects. Women who can become pregnant need pregnancy tests and two forms of birth control. Men must use a condo...
  • Is it safe if I could become pregnant, or if my partner could?
📖 Read our full Pomalidomide 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 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 · Q2 2026 $536.29 $53,628.98 / 100 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
59651-0197-01 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE 2020-10-30 — Active
59651-0197-21 59651-197-21 21 CAPSULE in 1 BOTTLE 2020-10-30 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 capsule in 1 bottle.
How does this package differ from NDC 59651-0197-21?
Both are Pomalidomide 4 mg Capsule — the drug itself is identical. This page's package is the 100-count one, while NDC 59651-0197-21 is the 21 capsules package.
What NDC number is used to bill for this package of Pomalidomide 4 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
Pomalidomide 4 mg 00480-4035-21 Teva 21 capsules — AB FDA listed —
Pomalidomide 4 mg 31722-0773-01 Camber 100 capsules — AB FDA listed —
Pomalidomide 4 mg 51991-0346-21 Breckenridge 21 capsules — AB FDA listed —
Pomalyst 4 mg 59572-0504-00 Celgene 100 capsules — AB FDA listed —
Pomalidomide 4 mgthis 59651-0197-01 Aurobindo 100 capsules — AB FDA listed —
Pomalidomide 4 mg 60505-4500-02 Apotex 21 capsules — AB FDA listed —
Pomalidomide 4 mg 63850-0134-01 Natco 21 capsules — AB FDA listed —
pomalidomide 4 mg 43598-0517-01 Dr. 100 capsules — — FDA listed —
Pomalidomide 4 mg 70095-0060-01 Sun 21 capsules — — FDA listed —
Pomalidomide 4 mg 69097-0039-07 Cipla 100 capsules — — FDA listed —
Pomalidomide 4 mg 00781-2369-27 Sandoz 21 capsules — — FDA listed —
pomalidomide 4 mg 72205-0179-21 Novadoz 21 capsules — — 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

🏛️
2020
On the market since
Oct 2020
📍
2026
Currently FDA-listed
6 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 Red / White / Gray / Pink
ShapeCapsule
ImprintA04
Size18 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 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII PN2ZH5LOQY
    A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerAurobindo Pharma Limited
Application holderEUGIA PHARMA SPECIALITIES LTD
FDA applicationANDA210249 (ANDA)
Labeler code59651
First marketedOct 2020
Product typeHuman Prescription Drug
Portfolio1,456 products on file

More NDCs from Aurobindo Pharma Limited labeler code 59651

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 📋 Description 💬 Information for Patients 💬 Medication Guide 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Pomalidomide is contraindicated in pregnancy. Pomalidomide is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death.

In females of reproductive potential, obtain 2 negative pregnancy tests before starting pomalidomide treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping pomalidomide treatment [see Contraindications (4) , Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ]. Pomalidomide is only available through a restricted distribution program called PS-Pomalidomide REMS [see Warnings and Precautions (5.2) ].

Information about PS-Pomalidomide REMS is available at www.PS-PomalidomideREMS.com or by calling the REMS Call Center at 1-888-423-5436. Venous and Arterial Thromboembolism Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with pomalidomide. Prophylactic antithrombotic measures were employed in clinical trials.

Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient's underlying risk factors [see Warnings and Precautions (5.3) ] . WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning EMBRYO-FETAL TOXICITY Pomalidomide is contraindicated in pregnancy. Pomalidomide is a thalidomide analogue.

Thalidomide is a known human teratogen that causes severe life-threatening birth defects ( 4 , 5.1 , 8.1 ). For females of reproductive potential: Exclude pregnancy before start of treatment. Prevent pregnancy during treatment by the use of 2 reliable methods of contraception ( 5.1 , 8.3 ).

Pomalidomide is available only through a restricted program called PS- Pomalidomide REMS ( 5.2 ). VENOUS AND ARTERIAL THROMBOEMBOLISM Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with pomalidomide . Antithrombotic prophylaxis is recommended ( 5.3 ).

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy ( 1.1 ). with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative.

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) (1.2) .

1.1Multiple Myeloma Pomalidomide capsules, in combination with dexamethasone, is indicated for adult patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

1.2Kaposi Sarcoma Pomalidomide capsules are indicated for the treatment of: Adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART). Kaposi sarcoma (KS) in adult patients who are HIV-negative. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.2) ] .

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION MM: 4 mg per day taken orally on Days 1 through 21 of repeated 28-­day cycles until disease progression (2.2). Refer to section 14.1 for dexamethasone dosing (14.1) . KS: 5 mg per day taken orally on Days 1 through 21 of repeated 28-day cycles until disease progression or unacceptable toxicity (2.3) . Modify the dosage for certain patients with renal impairment (2.7, 8.6) or hepatic impairment (2.8, 8.7) .

2.1Pregnancy Testing Prior to Administration Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating pomalidomide capsules [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ].

2.2Recommended Dosage for Multiple Myeloma The recommended dosage of pomalidomide capsules is 4 mg once daily orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression. Give pomalidomide capsules in combination with dexamethasone [see Clinical Studies (14.1) ].

2.3Recommended Dosage for Kaposi Sarcoma The recommended dosage of pomalidomide capsules is 5 mg once daily taken orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression or unacceptable toxicity. Continue HAART as HIV treatment in patients with AIDS-related Kaposi sarcoma (KS) [see Clinical Studies (14.2) ] .

2.4Dosage Modifications for Hematologic Adverse Reactions Multiple Myeloma: Dosage Modifications for Hematologic Adverse Reactions Initiate a new cycle of pomalidomide capsules in patients with multiple myeloma (MM) when the neutrophil count is at least 500 per mcL and the platelet count is at least 50,000 per mcL. Dosage modification for pomalidomide capsules for hematologic adverse reactions in patients with MM are summarized in Table 1. Table 1: Dosage Modifications for Pomalidomide Capsules for Hematologic in MM * Permanently discontinue pomalidomide capsules if unable to tolerate 1 mg once daily.

ANC= absolute neutrophil count Adverse Reaction Severity Dosage Modification Neutropenia [see Warnings and Precautions (5.5)] ANC less than 500 per mcL or febrile neutropenia (fever greater than or equal to 38.5°C and ANC less than 1,000 per mcL) Withhold pomalidomide capsules until ANC is greater than or equal to 500 per mcL; follow CBC weekly. Resume pomalidomide capsules dose at 1 mg less than the previous dose.* For each subsequent drop of ANC less than 500 per mcL Withhold pomalidomide capsules until ANC is greater than or equal to 500 mcL.

Resume pomalidomide capsules dose at 1 mg less than the previous dose.* Thrombocytopenia [see Warnings and Precautions (5.5)] Platelets less than 25,000 per mcL Withhold pomalidomide capsules until platelets are greater than or equal to 50,000 per mcL; follow CBC weekly. Resume pomalidomide capsules dose at 1 mg less than the previous dose* For each subsequent drop of platelets less than 25,000 per mcL Withhold pomalidomide capsules until platelets are greater than or equal to 50,000 per mcL. Resume pomalidomide capsules at 1 mg less than the previous dose* Kaposi Sarcoma: Dosage Modifications for Hematologic Adverse Reactions Initiate a new cycle of pomalidomide capsules in patients with KS when the neutrophil count is at least 1000 per mcL and the platelet count is at least 75,000 per mcL.

Dose modifications for pomalidomide capsules for hematologic adverse reactions in patients with KS are summarized in Table 2. Table 2: Dosage Modifications for Pomalidomide Capsules for Hematologic Adverse Reactions in KS * Permanently discontinue pomalidomide capsules if unable to tolerate 1mg once daily. ANC= absolute neutrophil count Adverse Reaction Severity Dosage Modification Neutropenia [see Warnings and Precautions (5.5) ] ANC 500 to less than 1,000 per mcL Day 1 of cycle Withhold pomalidomide capsules until ANC is greater than or equal to 1,000 per mcL.

Resume pomalidomide capsules at the same dose. During cycle Continue pomalidomide capsules at the current… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 122 words ▾

3 DOSAGE FORMS AND STRENGTHS Pomalidomide is available in the following capsule strengths: 1 mg: Yellow powder filled in red opaque cap and red opaque body, imprinted “A01” on the cap in black ink and plain body. 2 mg: Yellow powder filled in red opaque cap and white opaque body, imprinted “A02” on the cap in black ink and plain body. 3 mg: Yellow powder filled in red opaque cap and grey opaque body, imprinted “A03” on the cap in black ink and plain body.

4 mg: Yellow powder filled in red opaque cap and pink opaque body, imprinted “A04” on the cap in black ink and plain body. Capsules: 1 mg, 2 mg, 3 mg, and 4 mg ( 3 )

⛔ Contraindications 116 words ▾

4 CONTRAINDICATIONS Pregnancy ( 4.1 ) Hypersensitivity ( 4.2 )

4.1Pregnancy Pomalidomide is contraindicated in females who are pregnant. Pomalidomide can cause fetal harm when administered to a pregnant female [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Pomalidomide is a thalidomide analogue and is teratogenic in both rats and rabbits when administered during the period of organogenesis.

If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus.

4.2Hypersensitivity Pomalidomide is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, anaphylaxis) to pomalidomide or any of the excipients [see Warnings and Precautions (5.7) , Description (11) ] .

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Increased Mortality: Observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue ( 5.4 ). Hematologic Toxicity: Neutropenia was the most frequently reported Grade 3/4 adverse event. Monitor patients for hematologic toxicities, especially neutropenia ( 5.5 ).

Hepatotoxicity: Hepatic failure including fatalities; monitor liver function tests monthly ( 5.6 ). Severe Cutaneous Reactions: Discontinue pomalidomide for severe reactions ( 5.7 ). Tumor Lysis Syndrome (TLS): Monitor patients at risk of TLS (i.e., those with high tumor burden) and take appropriate precautions ( 5.11 ).

Hypersensitivity: Monitor patients for potential hypersensitivity. Discontinue pomalidomide for angioedema and anaphylaxis ( 5.12 ).

5.1Embryo-Fetal Toxicity Pomalidomide is a thalidomide analogue and is contraindicated for use during pregnancy. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death [see Use in Specific Populations (8.1) ] . Pomalidomide is only available through PS-Pomalidomide REMS [see Warnings and Precautions (5.2) ].

Females of Reproductive Potential Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning pomalidomide 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 2 methods of reliable birth control, beginning 4 weeks prior to initiating treatment with pomalidomide, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of pomalidomide 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 pomalidomide 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 Pomalidomide 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 pomalidomide and for up to 4 weeks after discontinuing pomalidomide, even if they have undergone a successful vasectomy. Male patients taking pomalidomide must not donate sperm [see Use in Specific Populations (8.3) ] . Blood Donation Patients must not donate blood during treatment with pomalidomide 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 pomalidomide.

5.2PS-Pomalidomide REMS Because of the embryo-fetal risk [see Warnings and Precautions (5.1) ], Pomalidomide is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), “ PS - Pomalidomide REMS ”. Required components of PS-Pomalidomide REMS include the following: Prescribers must be certified with PS - Pomalidomide REMS by enrolling and complying with the REMS requirements. Patients must sign a Patient-Physician Agreement Form and comply with the REMS requirements.

In particular, female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements [see Use in Specific Populations (8.3) ] and males must comply with contraception requirements [see Use in Specific Populations (8.3) ] . Pharmacies must be certified with PS-Pomalidomide REMS, must only dispense to patients who are authorized to receive pomalidomide and comply with REMS requirements. Further information about PS-Pomalidomide REMS is available at www.PS-PomalidomideREMS.com or by telephone at 1-888-423-5436.

5.3Venous and Arterial Thromboembolism Venous thromboembolic events (deep venous thrombosis and pulmonary emboli… [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 labeling sections: Embryo-Fetal Toxicity [see Warnings and Precautions (5.1 , 5.2) ] Venous and Arterial Thromboembolism [see Warnings and Precautions (5.3) ] Increased Mortality in Patients with Multiple Myeloma When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone [see Warnings and Precautions (5.4) ] Hematologic Toxicity [see Warnings and Precautions (5.5) ] Hepatotoxicity [see Warnings and Precautions (5.6) ] Severe Cutaneous Reactions [see Warnings and Precautions (5.7) ] Dizziness and Confusional State [see Warnings and Precautions (5.8) ] Neuropathy [see Warnings and Precautions (5.9) ] Risk of Second Primary Malignancies [see Warnings and Precautions (5.10) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.11) ] Hypersensitivity [see Warnings and Precautions (5.12) ] MM: Most common adverse reactions (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia ( 6.1 ).

KS: Most common adverse reactions including laboratory abnormalities (≥30%) are decreased absolute neutrophil count or white blood cells, elevated creatinine or glucose, rash, constipation, fatigue, decreased hemoglobin, platelets, phosphate, albumin, or calcium, increased ALT, nausea, and diarrhea (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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. Multiple Myeloma (MM) In Trial 1, data were evaluated from 219 patients (safety population) who received treatment with pomalidomide + Low-dose Dex (112 patients) or pomalidomide alone (107 patients). Median number of treatment cycles was 5.

Sixty-seven percent of patients in the study had a dose interruption of either drug due to adverse reactions. Forty-two percent of patients in the study had a dose reduction of either drug due to adverse reactions. The discontinuation rate due to adverse reactions was 11%.

In Trial 2, data were evaluated from 450 patients (safety population) who received treatment with pomalidomide + Low-dose Dex (300 patients) or High-dose Dexamethasone (High-dose Dex) (150 patients). The median number of treatment cycles for the pomalidomide + Low-dose Dex arm was 5. In the pomalidomide + Low-dose Dex arm, 67% of patients had a dose interruption of pomalidomide, the median time to the first dose interruption of pomalidomide was 4.1 weeks.

Twenty-seven percent of patients had a dose reduction of pomalidomide, the median time to the first dose reduction of pomalidomide was 4.5 weeks. Eight percent of patients discontinued pomalidomide due to adverse reactions. Tables 3 and 4 summarize the adverse reactions reported in Trials 1 and 2, respectively.

Table 3: Adverse Reactions in Any Pomalidomide Treatment Arm in Trial 1 * * Regardless of attribution of relatedness to pomalidomide. a Pomalidomide alone arm includes all patients randomized to the pomalidomide alone arm who took study drug; 61 of the 107 patients had dexamethasone added during the treatment period. b Serious adverse reactions were reported in at least 2 patients in any pomalidomide treatment arm. Data cutoff: 01 March 2013 All Adverse Reactions ≥10% in Either Arm Grade 3 or 4 ≥5% in Either Arm Body System Adverse Reaction Pomalidomide a (N=107) Pomalidomide + Low-dose Dex (N=112) Pomalidomide (N=107) Pomalidomide + Low-dose Dex (N=112) Number (%) of patients with at least one adverse reaction 107 (100) 112 (100) 98 (92) 102 (91) Blood and lymphatic system disorders Neutropenia b 57 (53) 55 (49) 51 (48) 46 (41) Anemi… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 110 words ▾

7 DRUG INTERACTIONS Strong CYP1A2 Inhibitors: Avoid concomitant use of strong CYP1A2 inhibitors. If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce pomalidomide dose to 2 mg ( 2.6 , 7.1 , 12.3 ).

7.1Drugs That Affect Pomalidomide Plasma Concentrations CYP1A2 inhibitors : In healthy subjects, co-administration of fluvoxamine, a strong CYP1A2 inhibitor, increased C max and AUC of pomalidomide by 24% and 125% respectively [see Clinical Pharmacology (12.3) ] . Increased pomalidomide exposure may increase the risk of exposure related toxicities. Avoid co-administration of strong CYP1A2 inhibitors (e.g. ciprofloxacin and fluvoxamine).

If co-administration is unavoidable, reduce the pomalidomide dose [see Dosage and Administration (2.6) ] .

👥 Use in Specific Populations ~3 min read ▾

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

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to pomalidomide during pregnancy as well as female partners of male patients who are exposed to pomalidomide. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to pomalidomide to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423­5436.

Risk Summary Based on the mechanism of action [see Clinical Pharmacology (12.1) ] and findings from animal studies, pomalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy [see Contraindications (4) , and Warnings and Precautions (5.1) ] . Pomalidomide 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. Pomalidomide was teratogenic in both rats and rabbits when administered during the period of organogenesis. Pomalidomide crossed the placenta after administration to pregnant rabbits (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 pomalidomide to the FDA via the MedWatch program at 1­-800-FDA-1088 and also to the REMS Call Center at 1-888-423­5436. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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 Pomalidomide was teratogenic in both rats and rabbits in the embryo-fetal developmental studies when administered during the period of organogenesis. In rats, pomalidomide was administered orally to pregnant animals at doses of 25 to 1000 mg/kg/day. Malformations or absence of urinary bladder, absence of thyroid gland, and fusion and misalignment of lumbar and thoracic vertebral elements (vertebral, central, and/or neural arches) were observed at all dose levels.

There was no maternal toxicity observed in this study. The lowest dose in rats resulted in an exposure (AUC) approximately 85-fold of the human exposure at the recommended dose of 4 mg/day. Other embryo-fetal toxicities included increased resorptions leading to decreased number of viable fetuses.

In rabbits, pomalidomide was administered orally to pregnant animals at doses of 10 to 250 mg/kg/day. Increased cardiac malformations such as interventricular septal defect were seen at all doses with significant increases at 250 mg/kg/day. Additional malformations observed at 250 mg/kg/day included anomalies in limbs (flexed and/or rotated fore- and/or hindlimbs, unattached or absent digit) and associated skeletal malformations (not ossified metacarpal, misaligned phalanx and metacarpal, absent digit, not ossified phalanx, and short not ossified or bent tibia), moderate dilation of the lateral ventricle in the brain, abnormal placement of the right subclavian artery, absent intermediate lobe in the lungs, low-set… [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 pomalidomide during pregnancy as well as female partners of male patients who are exposed to pomalidomide. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to pomalidomide to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423­5436.

Risk Summary Based on the mechanism of action [see Clinical Pharmacology (12.1) ] and findings from animal studies, pomalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy [see Contraindications (4) , and Warnings and Precautions (5.1) ] . Pomalidomide 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. Pomalidomide was teratogenic in both rats and rabbits when administered during the period of organogenesis. Pomalidomide crossed the placenta after administration to pregnant rabbits (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 pomalidomide to the FDA via the MedWatch program at 1­-800-FDA-1088 and also to the REMS Call Center at 1-888-423­5436. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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 Pomalidomide was teratogenic in both rats and rabbits in the embryo-fetal developmental studies when administered during the period of organogenesis. In rats, pomalidomide was administered orally to pregnant animals at doses of 25 to 1000 mg/kg/day. Malformations or absence of urinary bladder, absence of thyroid gland, and fusion and misalignment of lumbar and thoracic vertebral elements (vertebral, central, and/or neural arches) were observed at all dose levels.

There was no maternal toxicity observed in this study. The lowest dose in rats resulted in an exposure (AUC) approximately 85-fold of the human exposure at the recommended dose of 4 mg/day. Other embryo-fetal toxicities included increased resorptions leading to decreased number of viable fetuses.

In rabbits, pomalidomide was administered orally to pregnant animals at doses of 10 to 250 mg/kg/day. Increased cardiac malformations such as interventricular septal defect were seen at all doses with significant increases at 250 mg/kg/day. Additional malformations observed at 250 mg/kg/day included anomalies in limbs (flexed and/or rotated fore- and/or hindlimbs, unattached or absent digit) and associated skeletal malformations (not ossified metacarpal, misaligned phalanx and metacarpal, absent digit, not ossified phalanx, and short not ossified or bent tibia), moderate dilation of the lateral ventricle in the brain, abnormal placement of the right subclavian artery, absent intermediate lobe in the lungs, low-set kidney, altered liver morphology, incompletely or not ossified pelvis, an increa… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 137 words ▾

8.4Pediatric Use The safety and effectiveness of pomalidomide have not been established in pediatric patients. The safety and effectiveness were assessed but not established in two open-label studies: a dose escalation study in 25 pediatric patients aged 5 to <17 with recurrent, progressive or refractory CNS tumors [NCT02415153] and a parallel-group study conducted in 47 pediatric patients aged 4 to <17 years with recurrent or progressive high-grade glioma, medulloblastoma, ependymoma, or diffuse intrinsic pontine glioma (DIPG) [NCT03257631].

No new safety signals were observed in pediatric patients across these studies. At the same dose by body surface area, pomalidomide exposure in 55 pediatric patients aged 4 to < 17 years old was within the range observed in adult patients with MM but higher than the exposure observed in adult patients with KS [see Clinical Pharmacology (12.3) ].

🧓 Geriatric Use 116 words ▾

8.5Geriatric Use Multiple Myeloma Of the total number of patients in clinical studies of pomalidomide, 44% were aged older than 65 years, while 10% were aged older than 75 years. No overall differences in effectiveness were observed between these patients and younger patients. In these studies, patients older than 65 years were more likely than patients less than or equal to 65 years of age to experience pneumonia.

Kaposi Sarcoma Of the 28 patients who received pomalidomide, 11% were 65 years or older, and 3.6% were 75 years of age or older. The clinical study did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

🆘 Overdosage 8 words ▾

10 OVERDOSAGE Hemodialysis can remove pomalidomide from circulation.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Pomalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of pomalidomide 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 and Ikaros) are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects.

In in vitro cellular assays, pomalidomide inhibited proliferation and induced apoptosis of hematopoietic tumor cells. Additionally, pomalidomide inhibited the proliferation of lenalidomide-resistant multiple myeloma (MM) cell lines and synergized with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumor cell apoptosis. Pomalidomide enhanced T cell- and natural killer (NK) cell-mediated immunity and inhibited production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes.

Pomalidomide demonstrated anti-angiogenic activity in a mouse tumor model and in the in vitro umbilical cord model.

12.2Pharmacodynamics Pomalidomide exposure-response analyses showed that there was no relationship between systemic pomalidomide exposure level and efficacy or safety following pomalidomide dose of 4 mg. Cardiac Electrophysiology The QTc prolongation potential of pomalidomide was evaluated in a single center, randomized, double-blind crossover study (N=72) using 4 mg pomalidomide, 20 mg pomalidomide, placebo, and 400 mg moxifloxacin (positive control). No significant QTc prolongation effect of pomalidomide was observed following pomalidomide doses of 4 and 20 mg.

12.3Pharmacokinetics In patients with MM who received pomalidomide 4 mg daily alone or in combination with dexamethasone, pomalidomide steady-state drug exposure was characterized by AUC (CV%) of 860 (37%) ng∙h/mL and C max (CV%) of 75 (32%) ng/mL. In patients with Kaposi sarcoma (KS) who received pomalidomide 5 mg daily, pomalidomide steady-state drug exposure was characterized by AUC of 462.3 ng∙h/mL (82%) and C max of 53.1 ng/mL (50%). Absorption Following administration of single oral doses of pomalidomide, the maximum plasma concentration (C max ) for pomalidomide occurs at 2 to 3 hours postdose in patients with MM or KS.

Effect of Food Co-administration of pomalidomide with a high-fat meal (approximately 50% of the total caloric content) and high-calorie meal (approximately 800 to 1000 calories) (the meal contained approximately 150, 250, and 500 to 600 calories from protein, carbohydrates, and fat, respectively) delays the T max by 2.5 hours, decreased mean plasma C max and AUC in healthy subjects by about 27% and 8%, respectively. Distribution Pomalidomide has a mean apparent volume of distribution (Vd/F) between 62 and 138 L at steady state in patients with MM or KS.

Pomalidomide is distributed in semen of healthy subjects at a concentration of approximately 67% of plasma level at 4 hours postdose (~T max ) after 4 days of 2 mg once-daily dosing. Human plasma protein binding of pomalidomide ranges from 12% to 44% and is not concentration dependent. Pomalidomide is a substrate for P-gp.

Elimination Pomalidomide has a mean total body clearance (CL/F) of 7 to 10 L/h in patients with MM or KS. Pomalidomide is eliminated with a median plasma half-life of 9.5 hours in healthy subjects and 7.5 hours in patients with MM or KS. Metabolism Pomalidomide is primarily metabolized in the liver by CYP1A2 and CYP3A4.

Minor contributions from CYP2C19 and CYP2D6 were also observed in vitro . Excretion Following a single oral administration of [ 14 C]-pomalidomide to healthy subjects, approximately 73% and 15% of the radioactive dose was eliminated in urine and feces, respectively, with approximately 2% and 8% of the radiolabeled dose eliminated unchanged as pomalidomide in urine and feces. Specific Populations Age (61 to 85 years old), s… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 147 words ▾

12.1Mechanism of Action Pomalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of pomalidomide 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 and Ikaros) are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects.

In in vitro cellular assays, pomalidomide inhibited proliferation and induced apoptosis of hematopoietic tumor cells. Additionally, pomalidomide inhibited the proliferation of lenalidomide-resistant multiple myeloma (MM) cell lines and synergized with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumor cell apoptosis. Pomalidomide enhanced T cell- and natural killer (NK) cell-mediated immunity and inhibited production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes.

Pomalidomide demonstrated anti-angiogenic activity in a mouse tumor model and in the in vitro umbilical cord model.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Pomalidomide Capsules 1 mg are yellow powder filled in red opaque cap and red opaque body, imprinted “A01” on the cap in black ink and plain body. Bottles of 21 NDC 59651-194-21 Bottles of 100 NDC 59651-194-01 Pomalidomide Capsules 2 mg are yellow powder filled in red opaque cap and white opaque body, imprinted “A02” on the cap in black ink and plain body. Bottles of 21 NDC 59651-195-21 Bottles of 100 NDC 59651-195-01 Pomalidomide Capsules 3 mg are yellow powder filled in red opaque cap and grey opaque body, imprinted “A03” on the cap in black ink and plain body.

Bottles of 21 NDC 59651-196-21 Bottles of 100 NDC 59651-196-01 Pomalidomide Capsules 4 mg are yellow powder filled in red opaque cap and pink opaque body, imprinted “A04” on the cap in black ink and plain body. Bottles of 21 NDC 59651-197-21 Bottles of 100 NDC 59651-197-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Care should be exercised in handling of pomalidomide capsules.

Do not open or crush pomalidomide capsules. If powder from pomalidomide capsules contacts the skin, wash the skin immediately and thoroughly with soap and water. If pomalidomide contacts the mucous membranes, flush thoroughly with water.

Follow procedures for proper handling and disposal of hazardous drugs. 1

📋 Description 176 words ▾

11 DESCRIPTION Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-­piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure: The empirical formula for pomalidomide is C 13 H 11 N 3 O 4 and the gram molecular weight is 273.24. Pomalidomide is yellow crystalline powder.

It is practically insoluble in water and chloroform, very slightly soluble in methanol and acetone. Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration.

Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: mannitol and pregelatinized starch (maize). The empty hard gelatin capsule shell contains gelatin, iron oxide red and titanium dioxide. In addition, 3 mg capsule shell contains iron oxide black and 4 mg capsule shell contains D&C yellow 10, FD&C blue 1 and FD&C red 3.

The capsule shells are printed with edible ink containing iron oxide black, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. 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 pomalidomide is contraindicated in pregnancy [see Contraindications (4) ] . Pomalidomide is a thalidomide analogue and may cause serious birth defects or death to a developing baby [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] .

Advise females of reproductive potential that they must avoid pregnancy while taking pomalidomide and for at least 4 weeks after completing therapy. Initiate pomalidomide 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 pomalidomide therapy, during dose interruptions, and for 4 weeks after she has completely finished taking pomalidomide.

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 pomalidomide 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 REMS Call the Center at 1-888-423-5436 [see Warnings and Precautions (5.1) and 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 pomalidomide and for up to 4 weeks after discontinuing pomalidomide, even if they have undergone a successful vasectomy. Advise male patients taking pomalidomide that they must not donate sperm [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] .

All patients must be instructed to not donate blood while taking pomalidomide and for 4 weeks following discontinuation of pomalidomide [see Warnings and Precautions (5.1) ] . PS-Pomalidomide REMS Because of the risk of embryo-fetal toxicity, pomalidomide is only available through a restricted program called PS-Pomalidomide REMS [see Warnings and Precautions (5.2) ] . Patients must sign a Patient-Physician Agreement Form and comply with the requirements to receive pomalidomide.

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) ] . Pomalidomide is available only from pharmacies that are certified in PS-Pomalidomide REMS.

Provide patients with the telephone number and website for information on how to obtain the product. Pregnancy Exposure Registry Inform females that there is a Pregnancy Exposure Registry that monitors pregnancy outcomes in females exposed to pomalidomide during pregnancy and that they can contact the Pregnancy Exposure Registry by calling 1-888-423-5436 [see Use in Specific Populations (8.1) ] . Venous and Arterial Thromboembolism Inform patients of the risk of developing 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) ] .

Hematologic Toxicities Inform patients on the risks of developing neutropenia, thrombocytopenia, and anemia and the need to report signs and symptoms associated with these events to their healthcare provider for further evaluation [see Warnings and Precautions (5.5) ] . Hepatotoxicity Inform patients on the risks of developing hepa… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Pomalidomide Capsules [(poeʺ ma lidʹ oh mide)] What is the most important information I should know about pomalidomide capsules? Before you begin taking pomalidomide capsules, you must read and agree to all of the instructions in PS-Pomalidomide REMS. For more information, call 1-888-423-5436 or go to www.PS-PomalidomideREMS.com.

Before prescribing pomalidomide capsules, your healthcare provider will explain PS-Pomalidomide REMS to you and have you sign the Patient-Physician Agreement Form. Pomalidomide capsules can 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 pomalidomide capsules.

Pomalidomide capsules are similar to the medicine thalidomide (THALOMID). We know thalidomide can cause severe life-threatening birth defects. Pomalidomide capsules have not been tested in pregnant females.

Pomalidomide capsules have harmed unborn animals in animal testing. Females must not get pregnant: o For at least 4 weeks before starting pomalidomide capsules o While taking pomalidomide capsules o During any breaks (interruptions) in your treatment with pomalidomide capsules o For at least 4 weeks after stopping pomalidomide capsules Females who can become pregnant : o 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. o 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 pomalidomide capsules. o 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 pomalidomide capsules.

If you become pregnant while taking pomalidomide 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: o FDA MedWatch at 1-800-FDA-1088, and o REMS Call Center at 1-888-423-5436 There is a pregnancy exposure registry that monitors the outcomes of females who take pomalidomide capsules during pregnancy, or if their male partner takes pomalidomide capsules and they are exposed during pregnancy.

You can enroll in this registry by calling the REMS Call Center at the phone number listed above. Pomalidomide can pass into human semen: o 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 pomalidomide capsules, during any breaks (interruptions) in your treatment with pomalidomide capsules, and for 4 weeks after stopping pomalidomide capsules. o 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. o Do not donate sperm while taking pomalidomide capsules, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping pomalidomide capsules. If a female becomes pregnant with your sperm, the baby may be exposed to pomalidomide capsules and may be born with birth defects. Men, if your female partner becomes pregnant, you should call your healthcare provider right away.

Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take pomalidomide capsules. Most people who take pomalidomide capsules will also take a blood thinner medicine to help prevent blood clots. Before taking pomalidomide capsules, tell your healthcare provid… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers ~2 min read ▾

8.3Females and Males of Reproductive Potential Pregnancy Testing Pomalidomide 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 pomalidomide therapy and during therapy. Advise females of reproductive potential that they must avoid pregnancy 4 weeks before therapy, while taking pomalidomide, during dose interruptions and for at least 4 weeks after completing therapy.

Females of reproductive potential must have 2 negative pregnancy tests before initiating pomalidomide. The first test should be performed within 10 to 14 days, and the second test within 24 hours prior to prescribing pomalidomide. 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. Pomalidomide 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 pomalidomide, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of pomalidomide 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 Pomalidomide is present in the semen of males who take pomalidomide.

Therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking pomalidomide and for up to 4 weeks after discontinuing pomalidomide, even if they have undergone a successful vasectomy. Male patients taking pomalidomide must not donate sperm. Infertility Based on findings in animals, female fertility may be compromised by treatment with pomalidomide [see Nonclinical Toxicology (13.1) ] .

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics In patients with MM who received pomalidomide 4 mg daily alone or in combination with dexamethasone, pomalidomide steady-state drug exposure was characterized by AUC (CV%) of 860 (37%) ng∙h/mL and C max (CV%) of 75 (32%) ng/mL. In patients with Kaposi sarcoma (KS) who received pomalidomide 5 mg daily, pomalidomide steady-state drug exposure was characterized by AUC of 462.3 ng∙h/mL (82%) and C max of 53.1 ng/mL (50%). Absorption Following administration of single oral doses of pomalidomide, the maximum plasma concentration (C max ) for pomalidomide occurs at 2 to 3 hours postdose in patients with MM or KS.

Effect of Food Co-administration of pomalidomide with a high-fat meal (approximately 50% of the total caloric content) and high-calorie meal (approximately 800 to 1000 calories) (the meal contained approximately 150, 250, and 500 to 600 calories from protein, carbohydrates, and fat, respectively) delays the T max by 2.5 hours, decreased mean plasma C max and AUC in healthy subjects by about 27% and 8%, respectively. Distribution Pomalidomide has a mean apparent volume of distribution (Vd/F) between 62 and 138 L at steady state in patients with MM or KS.

Pomalidomide is distributed in semen of healthy subjects at a concentration of approximately 67% of plasma level at 4 hours postdose (~T max ) after 4 days of 2 mg once-daily dosing. Human plasma protein binding of pomalidomide ranges from 12% to 44% and is not concentration dependent. Pomalidomide is a substrate for P-gp.

Elimination Pomalidomide has a mean total body clearance (CL/F) of 7 to 10 L/h in patients with MM or KS. Pomalidomide is eliminated with a median plasma half-life of 9.5 hours in healthy subjects and 7.5 hours in patients with MM or KS. Metabolism Pomalidomide is primarily metabolized in the liver by CYP1A2 and CYP3A4.

Minor contributions from CYP2C19 and CYP2D6 were also observed in vitro . Excretion Following a single oral administration of [ 14 C]-pomalidomide to healthy subjects, approximately 73% and 15% of the radioactive dose was eliminated in urine and feces, respectively, with approximately 2% and 8% of the radiolabeled dose eliminated unchanged as pomalidomide in urine and feces. Specific Populations Age (61 to 85 years old), sex and race have no clinically significant effect on the systemic exposure of pomalidomide.

Patients with Renal Impairment Pomalidomide pharmacokinetic parameters were not significantly affected in patients with moderate (30 mL/min ≤ CLcr< 60 mL/min) or severe (15 mL/min ≤ CLcr< 30 mL/min) renal impairment relative to patients with normal renal function (CLcr ≥ 60 mL/min). Mean exposure (AUC) to pomalidomide increased by 38% in patients with severe renal impairment requiring dialysis (CLcr< 30 mL/min requiring dialysis) and 40% in patients with end stage renal disease (CLcr< 15 mL/min) on non-dialysis days.

In patients with severe renal impairment requiring dialysis, the estimated dialysis clearance is approximately 12 L/h which is higher than pomalidomide total body clearance, indicating hemodialysis will remove pomalidomide from the blood circulation. Patients with Hepatic Impairment Mean exposure (AUC) of pomalidomide increased by 51%, 58% and 72% in subjects with mild, moderate or severe hepatic impairment as defined by Child-Pugh criteria, respectively. Drug Interaction Studies Clinical Studies Co-administration of pomalidomide with the following drugs did not increase pomalidomide exposure to a clinically significant extent: ketoconazole (a strong CYP3A4 and P-gp inhibitor), carbamazepine (a strong CYP3A4 inducer) and dexamethasone (a weak to moderate CYP3A4 inducer).

Co-administration of pomalidomide with drugs that are CYP1A2 inducers has not been studied. CYP1A2 Inhibitors: Co-administration of fluvoxamine (a strong CYP1A2 inhibitor) with pomalidomide increased mean [90% confidence interval] pomalidomide exposure by 125% [98% to 157%] compared to pomalidomide alone in healthy subjects. Co-admi… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 76 words ▾

12.2Pharmacodynamics Pomalidomide exposure-response analyses showed that there was no relationship between systemic pomalidomide exposure level and efficacy or safety following pomalidomide dose of 4 mg. Cardiac Electrophysiology The QTc prolongation potential of pomalidomide was evaluated in a single center, randomized, double-blind crossover study (N=72) using 4 mg pomalidomide, 20 mg pomalidomide, placebo, and 400 mg moxifloxacin (positive control). No significant QTc prolongation effect of pomalidomide was observed following pomalidomide doses of 4 and 20 mg.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Multiple Myeloma Trial 1 Trial 1 was a phase 2, multicenter, randomized open-label study in patients with relapsed multiple myeloma (MM) who were refractory to their last myeloma therapy and had received lenalidomide and bortezomib. Patients were considered relapsed if they had achieved at least stable disease for at least 1 cycle of treatment to at least 1 prior regimen and then developed progressive disease. Patients were considered refractory if they experienced disease progression on or within 60 days of their last therapy.

A total of 221 patients were randomized to receive pomalidomide alone or pomalidomide with Low-dose Dex. In Trial 1, the safety and efficacy of pomalidomide 4 mg, once daily for 21 of 28 days, until disease progression, were evaluated alone and in combination with Low-dose Dex (40 mg/day given only on Days 1, 8, 15, and 22 of each 28-day cycle for patients aged 75 years or younger, or 20 mg/day given only on Days 1, 8, 15, and 22 of each 28-day cycle for patients aged greater than 75 years). Patients in the pomalidomide alone arm were allowed to add Low-dose Dex upon disease progression.

Table 7 summarizes the baseline patient and disease characteristics in Trial 1. The baseline demographics and disease characteristics were balanced and comparable between the study arms. Table 7: Baseline Demographic and Disease-Related Characteristics – Trial 1 Data cutoff: 01 April 2011 Pomalidomide (n=108) Pomalidomide + Low-dose Dex (n=113) Patient Characteristics Median age, years (range) 61 (37 to 88) 64 (34 to 88) Age distribution, n (%) <65 years ≥65 years 65 (60.2) 43 (39.8) 60 (53.1) 53 (46.9) Sex, n (%) Male Female 57 (52.8) 51 (47.2) 62 (54.9) 51 (45.1) Race/ethnicity, n (%) White Black or African American All other race 86 (79.6) 16 (14.8) 6 (5.6) 92 (81.4) 17 (15) 4 (3.6) ECOG Performance, n (%) Status 0 to 1 95 (87.9) 100 (88.5) Disease Characteristics Number of prior therapies Median (min, max) 5 (2, 12) 5 (2, 13) Prior transplant, n (%) 82 (75.9) 84 (74.3) Refractory to bortezomib and lenalidomide, n (%) 64 (59.3) 69 (61.1) Table 8 summarizes the analysis results of overall response rate (ORR) and duration of response (DOR), based on assessments by the Independent Review Adjudication Committee for the treatment arms in Trial 1.

ORR did not differ based on type of prior antimyeloma therapy. Table 8: Trial 1 Results a Results are prior to the addition of dexamethasone. b ORR = PR + CR per EBMT criteria. CI, confidence interval; NE, not established (the median has not yet been reached).

Data cutoff: 01 April 2011 Pomalidomide a (n=108) Pomalidomide + Low-dose Dex (n=113) Response Overall Response Rate (ORR), b n (%) 8 (7.4) 33 (29.2) 95% CI for ORR (%) (3.3, 14.1) (21.0, 38.5) Complete Response (CR), n (%) 0 (0.0) 1 (0.9) Partial Response (PR), n (%) 8 (7.4) 32 (28.3) Duration of Response (DOR) Median, months NE 7.4 95% CI for DOR (months) NE (5.1, 9.2) Trial 2 Trial 2 was a Phase 3 multi-center, randomized, open-label study, where pomalidomide + Low-dose Dex therapy was compared to High-dose Dex in adult patients with relapsed and refractory MM, who had received at least two prior treatment regimens, including lenalidomide and bortezomib, and demonstrated disease progression on or within 60 days of the last therapy.

Patients with creatinine clearance ≥ 45mL/min qualified for the trial. A total of 455 patients were enrolled in the trial: 302 in the pomalidomide + Low-dose Dex arm and 153 in the High-dose Dex arm. Patients in the pomalidomide + Low-dose Dex arm were administered 4 mg pomalidomide orally on Days 1 to 21 of each 28-day cycle.

Dexamethasone (40 mg) was administered once per day on Days 1, 8, 15 and 22 of a 28-day cycle. Patients > 75 years of age started treatment with 20 mg dexamethasone using the same schedule. For the High-dose Dex arm, dexamethasone (40 mg) was administered once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle.

Patient… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies examining the carcinogenic potential of pomalidomide have not been conducted. One of 12 monkeys dosed with 1 mg/kg of pomalidomide (an exposure approximately 15-fold of the exposure in patients at the recommended dose of 4 mg/day) developed acute myeloid leukemia in a 9-month repeat-dose toxicology study. Pomalidomide was not mutagenic or clastogenic in a battery of tests, including the bacteria reverse mutation assay (Ames test), the in vitro assay using human peripheral blood lymphocytes, and the micronucleus test in orally treated rats administered doses up to 2000 mg/kg/day.

In a fertility and early embryonic development study in rats, drug-treated males were mated with untreated or treated females. Pomalidomide was administered to males and females at doses of 25 to 1000 mg/kg/day. When treated males were mated with treated females, there was an increase in post-implantation loss and a decrease in mean number of viable embryos at all dose levels.

There were no other effects on reproductive functions or the number of pregnancies. The lowest dose tested in animals resulted in an exposure (AUC) approximately 100-­fold of the exposure in patients at the recommended dose of 4 mg/day. When treated males in this study were mated with untreated females, all uterine parameters were comparable to the controls.

Based on these results, the observed effects were attributed to the treatment of females.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies examining the carcinogenic potential of pomalidomide have not been conducted. One of 12 monkeys dosed with 1 mg/kg of pomalidomide (an exposure approximately 15-fold of the exposure in patients at the recommended dose of 4 mg/day) developed acute myeloid leukemia in a 9-month repeat-dose toxicology study. Pomalidomide was not mutagenic or clastogenic in a battery of tests, including the bacteria reverse mutation assay (Ames test), the in vitro assay using human peripheral blood lymphocytes, and the micronucleus test in orally treated rats administered doses up to 2000 mg/kg/day.

In a fertility and early embryonic development study in rats, drug-treated males were mated with untreated or treated females. Pomalidomide was administered to males and females at doses of 25 to 1000 mg/kg/day. When treated males were mated with treated females, there was an increase in post-implantation loss and a decrease in mean number of viable embryos at all dose levels.

There were no other effects on reproductive functions or the number of pregnancies. The lowest dose tested in animals resulted in an exposure (AUC) approximately 100-­fold of the exposure in patients at the recommended dose of 4 mg/day. When treated males in this study were mated with untreated females, all uterine parameters were comparable to the controls.

Based on these results, the observed effects were attributed to the treatment of females.

📚 References 8 words ▾

15 REFERENCES 1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

📄 Recent Major Changes 9 words ▾

Boxed Warning 2/2025 Warnings and Precautions (5.1, 5.2) 2/2025

📄 Package Label / Principal Display Panel ~2 min read ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg (21 Capsules Bottle) NDC 59651-194-21 Pomalidomide Capsules 1 mg WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS. PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx only AUROBINDO 21 Capsules PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg (21 Capsules Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg (100 Capsules Bottle) NDC 59651-194-01 Pomalidomide Capsules 1 mg WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS . PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx only AUROBINDO 100 Capsules PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg (100 Capsules Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg (21 Capsules Bottle) NDC 59651-195-21 Pomalidomide Capsules 2 mg WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS. PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx only AUROBINDO 21 Capsules PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg (21 Capsules Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg (100 Capsules Bottle) NDC 59651-195-21 Pomalidomide Capsules 2 mg WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS. PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx only AUROBINDO 100 Capsules PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg (100 Capsules Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg (21 Capsules Bottle) NDC 59651-196-21 Pomalidomide Capsules 3 mg WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS. PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx only AUROBINDO 21 Capsules PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg (21 Capsules Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg (100 Capsules Bottle) NDC 59651-196-01 Pomalidomide Capsules 3 mg WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS. PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx only AUROBINDO 100 Capsules PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg (100 Capsules Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 mg (21 Capsules Bottle) NDC 59651-197-21 Pomalidomide Capsules 4 mg WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS. PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx only AUROBINDO 21 Capsules PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 mg (21 Capsules Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 mg (100 Capsules Bottle) NDC 59651-197-21 Pomalidomide Capsules 4 mg WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS. PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx only AUROBINDO 100 Capsules PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 mg (100 Capsules Bottle)

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

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

Medicare Part D (outpatient prescription) spending for Pomalidomide — the program that covers self-administered drugs. 5 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 Pomalidomide. 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.
Total Part D spend
$46.89M
Claims incl. refills
3.7K
Beneficiaries
3.6K
Spend / beneficiary
$12,970.58
Spend / claim
$12,672.60
💵 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 — PS-Pomalidomide 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
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NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — 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 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 Aurobindo Pharma Limited. 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 21 capsules (59651-0197-21). 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?
Aurobindo Pharma Limited 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.
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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.