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DOXIL doxorubicin hydrochloride 2 mg/mL Injection, Suspension, Liposomal — NDC 00338-0063-01 package photo

DOXIL doxorubicin hydrochloride 2 mg/mL Injection, Suspension, Liposomal

by Baxter Healthcare Company · 1 VIAL, SINGLE-USE in 1 CARTON (0338-0063-01) / 10 mL in 1 VIAL, SINGLE-USE
NDC 00338-0063-01
🏷️ FDA NDC (as labeled) 0338-0063-01 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced 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

⚠️
Other active recalls for Doxorubicin Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · May 12, 2026 — Presence of Particulate matter: Particulate matter identified as glass. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0580-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (1)
Class II · Aug 24, 2023 · Terminated — CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake. (Baxter Healthcare Corporation) · FDA recall D-0048-2024

🆔 Identity & classification

FDA NDC (as labeled) 0338-0063-01
Product NDC 0338-0063
11-digit billing NDC 00338006301
NCPDP billing unit ML — per mL (volume)
RxCUI 1790115, 1790127, 1790128, 1790131
UNII 82F2G7BL4E
Application # NDA050718
SPL Set ID 1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dce
Established class (EPC) Anthracycline Topoisomerase Inhibitor
Mechanism of action Topoisomerase Inhibitors
Chemical class Anthracyclines
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-08-13
Route INTRAVENOUS
Dosage form INJECTION, SUSPENSION, LIPOSOMAL
Substance DOXORUBICIN HYDROCHLORIDE
GPI-14 21200040401820
GPI class Doxil
GCN Seq No 024447
GCN 47343
HICL code 010222
Ingredient (HICL) Doxorubicin Hcl Peg-Liposomal
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1D
Therapeutic class — specific (HIC3) Antibiotic Antineoplastics
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name DOXIL 20 MG/10 ML VIAL
FDB brand name Doxil
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0338-0063-01 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00338-0063-01. 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 Anthracycline Topoisomerase Inhibitor class.

Pharmacologic class Anthracycline Topoisomerase Inhibitor
Drug family (ATC) Anthracyclines and related substances
How it works Topoisomerase Inhibitors
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.

🏭 Manufacturer & labeler

LabelerBaxter Healthcare Company
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA050718 (NDA)
Labeler code00338
First marketedAug 2019
Product typeHuman Prescription Drug
Portfolio121 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.

🩺 Clinical

Label name DOXIL 20 MG/10 ML VIAL Ingredient Doxorubicin Hcl Peg-Liposomal
📗 Our plain-language guide HelloPharmacist
  • Doxorubicin is well-known for its potential to damage the heart muscle over time — a condition called cardiomyopathy. The higher the total amount you receive over your lifetime, th...
  • Why is my doctor monitoring my heart so closely while I'm on this drug?
  • It's a real but uncommon risk. A small number of people who receive doxorubicin — especially when combined with other DNA-damaging chemotherapy drugs or radiation — have gone on to...
  • I've heard this drug can cause leukemia later. Should I be worried?
📖 Read our full Doxorubicin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Doxorubicin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Doxorubicin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

🧪 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.

  • 0.6 mg / 1 mL UNII SU46BAM238
    Ammonium sulfate is a mineral salt used in medications as a buffering agent and pH regulator. It helps maintain the chemical stability and balance of the drug formulation.
  • 3.19 mg / 1 mL UNII 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • 1.55 mg / 1 mL UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 9.58 mg / 1 mL UNII H1109Z9J4N
    A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 3.19 mg / 1 mL UNII 3L6NN8ZZKU
    A synthetic lipid compound derived from polyethylene glycol and phospholipids. It functions as an emulsifier and solubilizer in medications, helping to stabilize and distribute oil and water-based ingredients evenly throughout the formulation.
  • 94 mg / 1 mL UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $53.36 $533.63 / 10 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · Q2050 $116.605 / Q2050 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)0338-0063-01
11-digit billing NDC00338-0063-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeQ2050
DescriptorINJECTION, DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL, NOT OTHERWISE SPECIFIED, 10 MG
Billing units / pkg0.2 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Doxil 2 mg/mLthis 00338-0063-01 Baxter 1 vial — AB FDA listed —
Doxorubicin Hydrochloride Liposome 2 mg/mL 00338-0080-01 Baxter 1 vial — AB FDA listed —
Doxil 2 mg/mL 00338-9667-01 Baxter 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 16714-0742-01 NorthStar 1 vial — AB Discontinued —
Doxorubicin Hydrochloride Liposome 2 mg/mL 25021-0263-10 Sagent 1 vial — AB FDA listed —
doxorubicin hydrochloride 2 mg/mL 46708-0810-10 Alembic 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 47335-0049-40 Sun 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 49315-0008-03 Zydus 1 vial — AB FDA listed —
doxorubicin hydrochloride 2 mg/mL 62332-0810-10 Alembic 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68001-0345-26 BluePoint 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68001-0492-36 BluePoint 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68001-0629-26 BluePoint 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68001-0703-36 BluePoint 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 70710-1530-01 Zydus 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 70748-0339-01 Lupin 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 72603-0103-01 NorthStar 1 vial — AB FDA listed —
doxorubicin hydrochloride 2 mg/mL 75907-0363-01 Dr. 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 49315-0009-07 Zydus 1 vial — AB FDA listed —
DOXOrubicin Hydrochloride 2 mg/mL 62756-0826-40 Sun 1 vial — AP FDA listed —
DOXOrubicin Hydrochloride 2 mg/mL 62756-0827-40 Sun 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 16714-0856-01 NorthStar 1 vial — AB Discontinued —
Doxorubicin Hydrochloride 2 mg/mL 00069-0343-02 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9085-01 Hikma 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 63323-0883-05 Fresenius 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68001-0704-26 BluePoint 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-0277-02 Pfizer 1 vial — AP FDA listed —
Doxorubicin hydrochloride 2 mg/mL 45963-0733-55 Actavis 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68083-0248-01 Gland 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-1442-04 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-3358-25 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-4031-12 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9084-01 Hikma 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9090-01 Hikma 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68083-0249-01 Gland 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-1542-20 Pfizer 1 vial — AP FDA listed —
Doxil 2 mg/mL 00338-9665-01 Baxter 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 70121-1219-01 Amneal 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-0358-20 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-4205-05 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9092-01 Hikma 1 vial — — FDA listed —
doxorubicin hydrochloride 2 mg/mL 62332-0525-25 Alembic 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68001-0493-26 BluePoint 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 70748-0340-01 Lupin 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-0255-10 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9086-01 Hikma 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9087-01 Hikma 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 72603-0200-01 NorthStar 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9091-01 Hikma 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 67457-0436-50 Mylan 1 vial — — FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 70710-1531-01 Zydus 1 vial — AB FDA listed —
doxorubicin hydrochloride 2 mg/mL 75907-0364-01 Dr. 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-5629-05 Pfizer 1 vial — AP FDA listed —
doxorubicin hydrochloride 2 mg/mL 46708-0525-25 Alembic 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68083-0250-01 Gland 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 47335-0050-40 Sun 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 63323-0101-61 Fresenius 1 vial — AP FDA listed —
doxorubicin hydrochloride 2 mg/mL 25021-0207-25 Sagent 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9088-01 Hikma 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9089-01 Hikma 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9093-01 Hikma 1 vial — — FDA listed —
doxorubicin hydrochloride, Liposomal 2 mg/mL 00338-9581-02 Baxter 1 vial — — FDA listed —
doxorubicin hydrochloride 2 mg/mL 68001-0706-36 BluePoint 1 vial — AB FDA listed —
doxorubicin hydrochloride 2 mg/mL 68001-0707-26 BluePoint 1 vial — AB FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2019
On the market since
Aug 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

🗺️ 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 00338-0063-01, 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
24
Units reimbursed last 4 qtrs
256
Gross reimbursed last 4 qtrs
$13.7K
Avg / prescription
$569.21
Avg / unit
$53.3631
Latest quarter Q4 2025
11Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 24 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: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 51 units · 0.1 per 100k residents 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: 205 units · 0.7 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.10.7
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 Texas 0.7 /100k
2 California 0.1 /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.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Febrile Neutropenia3,499
Neutropenia2,196
Pyrexia1,805
Disease Progression1,794
Nausea1,623
Alopecia1,533
Anaemia1,522

Reporter sex

32,345 reports
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,507 1,209
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00338-0063-01 You're viewing this 1 VIAL, SINGLE-USE in 1 CARTON (0338-0063-01) / 10 mL in 1 VIAL, SINGLE-USE 2019-08-13 Active

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0338-0063-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00338-0063-01, written without dashes as 00338006301. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00338-0063-01, the first segment (00338) is the labeler code FDA assigned to Baxter Healthcare Company; the middle segment (0063) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Baxter Healthcare Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Baxter Healthcare Company is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code Q2050 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning ~1 min read ▾

WARNING: CARDIOMYOPATHY and INFUSION-RELATED REACTIONS • DOXIL liposomal infusion can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 mg/m 2 to 550 mg/m 2 . Assess left ventricular cardiac function prior to initiation of DOXIL liposomal infusion and during and after treatment [see Warnings and Precautions (5.1) ] . • Serious, life-threatening, and fatal infusion-related reactions can occur with DOXIL liposomal infusion Acute infusion-related reactions occurred in 11% of patients with solid tumors.

Withhold DOXIL liposomal infusion for infusion-related reactions and resume at a reduced rate. Discontinue DOXIL liposomal infusion for serious or life-threatening infusion-related reactions [see Warnings and Precautions (5.2) ] . WARNING: CARDIOMYOPATHY and INFUSION- RELATED REACTIONS See full prescribing information for complete boxed warning. • DOXIL liposomal infusion can cause myocardial damage, including acute left ventricular failure.

The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 mg/m 2 to 550 mg/m 2 . Assess left ventricular cardiac function prior to initiation of DOXIL liposomal infusion, during treatment, and after treatment ( 5.1 ). • Serious, life-threatening, and fatal infusion‑related reactions can occur. Acute infusion-related reactions occurred in 11% of patients with solid tumors.

Withhold DOXIL liposomal infusion for infusion-related reactions and resume at a reduced rate. Discontinue DOXIL liposomal infusion for serious or life-threatening infusion-related reactions ( 5.2 ).

🎯 Indications and Usage 157 words ▾

1 INDICATIONS AND USAGE Doxil liposomal infusion is an anthracycline topoisomerase inhibitor indicated for: • Ovarian cancer: After failure of platinum-based chemotherapy ( 1.1 ) • AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy ( 1.2 ) • Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy ( 1.3 )

1.1Ovarian Cancer DOXIL liposomal infusion is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

1.2AIDS-Related Kaposi’s Sarcoma DOXIL liposomal infusion is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.

1.3Multiple Myeloma DOXIL liposomal infusion, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer DOXIL liposomal infusion at an initial rate of 1 mg/min to minimize the risk of infusion reactions. If no infusion-related reactions occur, increase rate of infusion to complete administration over 1 hour. Do not administer as bolus injection or undiluted solution ( 2 ). • Ovarian cancer: 50 mg/m 2 intravenously every 4 weeks ( 2.2 ) • AIDS-related Kaposi’s Sarcoma: 20 mg/m 2 intravenously every 3 weeks ( 2.3 ) • Multiple Myeloma: 30 mg/m 2 intravenously on day 4 following bortezomib ( 2.4 )

2.1Important Use Information Do not substitute DOXIL liposomal infusion for other doxorubicin hydrochloride products. Do not administer as an undiluted suspension or as an intravenous bolus [see Warnings and Precautions (5.2) ] .

2.2Ovarian Cancer The recommended dose of DOXIL liposomal infusion is 50 mg/m 2 intravenously over 60 minutes every 28 days until disease progression or unacceptable toxicity.

2.3AIDS-Related Kaposi’s Sarcoma The recommended dose of DOXIL liposomal infusion is 20 mg/m 2 intravenously over 60 minutes every 21 days until disease progression or unacceptable toxicity.

2.4Multiple Myeloma The recommended dose of DOXIL liposomal infusion is 30 mg/m 2 intravenously over 60 minutes on day 4 of each 21-day cycle for eight cycles or until disease progression or unacceptable toxicity. Administer DOXIL liposomal infusion after bortezomib on day 4 of each cycle [see Clinical Studies (14.3) ] .

2.5Dose Modifications for Adverse Reactions Do not increase DOXIL liposomal infusion after a dose reduction for toxicity. Table 1: Recommended Dose Modifications for Hand-Foot Syndrome, Stomatitis, or Hematologic Adverse Reactions Toxicity Dose Adjustment Hand-Foot Syndrome (HFS) Grade 1: Mild erythema, swelling, or desquamation not interfering with daily activities • If no previous Grade 3 or 4 HFS: no dose adjustment. • If previous Grade 3 or 4 HFS: delay dose up to 2 weeks, then decrease dose by 25%. Grade 2: Erythema, desquamation, or swelling interfering with, but not precluding normal physical activities; small blisters or ulcerations less than 2 cm in diameter • Delay dosing up to 2 weeks or until resolved to Grade 0–1. • Discontinue DOXIL liposomal infusion if no resolution after 2 weeks. • If resolved to Grade 0–1 within 2 weeks: • And no previous Grade 3 or 4 HFS: continue treatment at previous dose. • And previous Grade 3 or 4 toxicity: decrease dose by 25%.

Grade 3: Blistering, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing • Delay dosing up to 2 weeks or until resolved to Grade 0–1, then decrease dose by 25%. • Discontinue DOXIL liposomal infusion if no resolution after 2 weeks. Grade 4: Diffuse or local process causing infectious complications, or a bed ridden state or hospitalization • Delay dosing up to 2 weeks or until resolved to Grade 0–1, then decrease dose by 25%. • Discontinue DOXIL liposomal infusion if no resolution after 2 weeks.

Stomatitis Grade 1: Painless ulcers, erythema, or mild soreness • If no previous Grade 3 or 4 toxicity: no dose adjustment. • If previous Grade 3 or 4 toxicity: delay up to 2 weeks then decrease dose by 25%. Grade 2: Painful erythema, edema, or ulcers, but can eat • Delay dosing up to 2 weeks or until resolved to Grade 0–1. • Discontinue DOXIL liposomal infusion if there is no resolution after 2 weeks. • If resolved to Grade 0–1 within 2 weeks: • And no previous Grade 3 or 4 stomatitis: resume treatment at previous dose. • And previous Grade 3 or 4 toxicity: decrease dose by 25%.

Grade 3: Painful erythema, edema, or ulcers, and cannot eat • Delay dosing up to 2 weeks or until resolved to Grade 0–1. Decrease dose by 25% and return to original dose interval. • If after 2 weeks there is no resolution, discontinue DOXIL liposomal infusion. Grade 4: Requires parenteral or enteral support • Delay dosing up to 2 weeks or until resolved to Grade 0–1.

Decrease dose by 25% and return to original…

💊 Dosage Forms and Strengths 51 words ▾

3 DOSAGE FORMS AND STRENGTHS DOXIL (doxorubicin hydrochloride liposome injection): 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) translucent, red liposomal dispersion in single dose vials. Doxorubicin hydrochloride liposomal injection: 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) in single dose vials ( 3 )

⛔ Contraindications 46 words ▾

4 CONTRAINDICATIONS DOXIL liposomal infusion is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see Warnings and Precautions (5.2) ]. • Hypersensitivity reactions to doxorubicin hydrochloride or the components of DOXIL liposomal infusion ( 4 , 5.2 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Hand-Foot Syndrome may occur. Dose modification or discontinuation may be required ( 5.3 ) • Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus. Use effective contraception ( 5.5 , 8.1 , 8.3 )

5.1Cardiomyopathy Doxorubicin hydrochloride can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy with doxorubicin hydrochloride is generally proportional to the cumulative exposure. Include prior use of other anthracyclines or anthracenediones in calculations of cumulative dose.

The risk of cardiomyopathy may be increased at lower cumulative doses in patients with prior mediastinal irradiation. In a clinical study in 250 patients with advanced cancer who were treated with DOXIL liposomal infusion, the risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 mg/m 2 to 550 mg/m 2 . Cardiomyopathy was defined as >20% decrease in resting left ventricular ejection fraction (LVEF) from baseline where LVEF remained in the normal range or a >10% decrease in LVEF from baseline where LVEF was less than the institutional lower limit of normal.

Two percent of patients developed signs and symptoms of congestive heart failure without documented evidence of cardiomyopathy. Assess left ventricular cardiac function (e.g. MUGA or echocardiogram) prior to initiation of DOXIL liposomal infusion, during treatment to detect acute changes, and after treatment to detect delayed cardiomyopathy.

Administer DOXIL liposomal infusion to patients with a history of cardiovascular disease only when the potential benefit of treatment outweighs the risk.

5.2Infusion-Related Reactions Serious, life-threatening, and fatal infusion-related reactions characterized by one or more of the following symptoms can occur with DOXIL liposomal infusion: flushing, shortness of breath, facial swelling, headache, chills, chest pain, back pain, tightness in the chest and throat, fever, tachycardia, pruritus, rash, cyanosis, syncope, bronchospasm, asthma, apnea, and hypotension. Of 239 patients with ovarian cancer treated with DOXIL liposomal infusion in Trial 4, 7% of patients experienced acute infusion-related reactions resulting in dose interruption.

All occurred during cycle 1 and none during subsequent cycles. Across multiple studies of DOXIL liposomal infusion monotherapy including this and other studies enrolling 760 patients with various solid tumors, 11% of patients had infusion-related reactions. The majority of infusion-related events occurred during the first infusion.

Ensure that medications to treat infusion-related reactions and cardiopulmonary resuscitative equipment are available for immediate use prior to initiation of DOXIL liposomal infusion. Initiate DOXIL liposomal infusions at a rate of 1 mg/min and increase rate as tolerated [see Dosage and Administration (2.6) ] . Withhold DOXIL liposomal infusion for Grade 1, 2, or 3 infusion-related reactions and resume at a reduced infusion rate.

Discontinue DOXIL liposomal infusion for serious or life-threatening infusion-related reactions.

5.3Hand-Foot Syndrome (HFS) In Trial 4, the incidence of HFS was 51% of patients in the DOXIL liposomal infusion arm and 0.9% of patients in the topotecan arm, including 24% Grade 3 or 4 cases of HFS in DOXIL liposomal infusion-treated patients and no Grade 3 or 4 cases in topotecan-treated patients. HFS or other skin toxicity required discontinuation of DOXIL liposomal infusion in 4.2% of patients. HFS was generally observed after 2 or 3 cycles of treatment but may occur earlier.

Delay DOXIL liposomal infusion for the first episode of Grade 2 or greater HFS [see Dosage and Administration (2.5) ] . Discontinue DOXIL liposomal infusion if HFS is severe and debilitating.

5.4Secondary Oral Neoplasms Secondary oral cancers, primarily squamous cell carcinoma, have been reported from post-marketing experience in patients with long-term (more than one year) expos…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling. • Cardiomyopathy [see Warnings and Precautions (5.1) ] • Infusion-Related Reactions [see Warnings and Precautions (5.2) ] • Hand-Foot Syndrome [see Warnings and Precautions (5.3) ] • Secondary Oral Neoplasms [see Warnings and Precautions (5.4) ] Most common adverse reactions (>20%) are asthenia, fatigue, fever, anorexia, nausea, vomiting, stomatitis, diarrhea, constipation, hand-foot syndrome, rash, neutropenia, thrombocytopenia, and anemia ( 6 ).

To report SUSPECTED ADVERSE REACTIONS contact Baxter Healthcare at 1-866-888-2472 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, the adverse reaction rates observed cannot be directly compared to rates on other clinical trials and may not reflect the rates observed in clinical practice. The safety data reflect exposure to DOXIL liposomal infusion in 1310 patients including: 239 patients with ovarian cancer, 753 patients with AIDS-related Kaposi’s sarcoma, and 318 patients with multiple myeloma. The most common adverse reactions (>20%) observed with DOXIL liposomal infusion are asthenia, fatigue, fever, nausea, stomatitis, vomiting, diarrhea, constipation, anorexia, hand-foot syndrome, rash and neutropenia, thrombocytopenia and anemia.

The following tables present adverse reactions from clinical trials of single-agent DOXIL liposomal infusion in ovarian cancer and AIDS-Related Kaposi’s sarcoma. Patients With Ovarian Cancer The safety data described below are from Trial 4, which included 239 patients with ovarian cancer treated with DOXIL liposomal infusion 50 mg/m 2 once every 4 weeks for a minimum of four courses in a randomized, multicenter, open-label study. In this trial, patients received DOXIL liposomal infusion for a median number of 3.2 months (range 1 day to 25.8 months).

The median age of the patients is 60 years (range 27 to 87), with 91% Caucasian, 6% Black, and 3% Hispanic or Other. Table 3 presents the hematologic adverse reactions from Trial 4. Table 3: Hematologic Adverse Reactions in Trial 4 DOXIL Liposomal Infusion Patients (n=239) Topotecan Patients (n=235) Neutropenia 500 – <1000/mm 3 8% 14% <500/mm 3 4.2% 62% Anemia 6.5 – <8 g/dL 5% 25% < 6.5 g/dL 0.4% 4.3% Thrombocytopenia 10,000 – <50,000/mm 3 1.3% 17% <10,000/mm 3 0.0% 17% Table 4 presents the non-hematologic adverse reactions from Trial 4.

Table 4: Non-Hematologic Adverse Reactions in Trial 4 Non-Hematologic Adverse Reaction 10% or Greater DOXIL Liposomal Infusion (%) treated (n=239) Topotecan (%) treated (n=235) All grades Grades 3–4 All grades Grades 3–4 Body as a Whole Asthenia 40 7 52 8 Fever 21 0.8 31 6 Mucous Membrane Disorder 14 3.8 3.4 0 Back Pain 12 1.7 10

0.9Infection 12 2.1 6

0.9Headache 11 0.8 15 0 Digestive Nausea 46 5 63 8 Stomatitis 41 8 15

0.4Vomiting 33 8 44 10 Diarrhea 21 2.5 35

4.2Anorexia 20 2.5 22

1.3Dyspepsia 12 0.8 14 0 Nervous Dizziness 4.2 0 10 0 Respiratory Pharyngitis 16 0 18

0.4Dyspnea 15 4.1 23

4.3Cough increased 10 0 12 0 Skin and Appendages Hand-foot syndrome 51 24 0.9 0 Rash 29 4.2 12

0.4Alopecia 19 N/A 52 N/A The following additional adverse reactions were observed in patients with ovarian cancer with doses administered every four weeks (Trial 4). Incidence 1% to 10% Cardiovascular: vasodilation, tachycardia, deep vein thrombosis, hypotension, cardiac arrest. Digestive: oral moniliasis, mouth ulceration, esophagitis, dysphagia, rectal bleeding, ileus.

Hematologic and Lymphatic: ecchymosis. Metabolic and Nutritional: dehydration, weight loss, hyperbilirubinemia, hypokalemia, hypercalcemia, hyponatremia. Nervous: somnolence, dizziness, depression.

Respiratory: rhinitis, pneumonia, sinusitis, epistaxis. Skin and Appendages: pruritus, skin discoloration, vesiculobullous rash, maculopapular rash, exfoliative dermatitis, herpes zoster, dry skin, herpes simple…

🔄 Drug Interactions 15 words ▾

7 DRUG INTERACTIONS No formal drug interaction studies have been conducted with DOXIL liposomal infusion.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Lactation: Discontinue breastfeeding ( 8.2 ).

8.1Pregnancy Risk Summary Based on findings in animals and its mechanism of action, DOXIL liposomal infusion can cause fetal harm when administered to a pregnant woman; avoid the use of DOXIL liposomal infusion during the 1 st trimester. In animal reproduction studies, DOXIL liposomal infusion was embryotoxic in rats and abortifacient in rabbits following intravenous administration during organogenesis at doses approximately 0.12 times the recommended clinical dose (see Data ) . Available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of doxorubicin hydrochloride during the 2 nd and 3 rd trimesters.

Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2–4% and of miscarriage is 15–20% of clinically recognized pregnancies.

Data Animal Data DOXIL liposomal infusion was embryotoxic at doses of 1 mg/kg/day in rats and was embryotoxic and abortifacient at 0.5 mg/kg/day in rabbits (both doses are about 0.12 times the recommended dose of 50 mg/m 2 human dose on a mg/m 2 basis). Embryotoxicity was characterized by increased embryo-fetal deaths and reduced live litter sizes.

8.2Lactation Risk Summary It is not known whether DOXIL liposomal infusion is present in human milk. Because many drugs, including anthracyclines, are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants from DOXIL liposomal infusion, discontinue breastfeeding during treatment with DOXIL liposomal infusion.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating DOXIL liposomal infusion. Contraception Females DOXIL liposomal infusion can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during and for 6 months after treatment with DOXIL liposomal infusion.

Males DOXIL liposomal infusion may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. Males with female sexual partners of reproductive potential should use effective contraception during and for 6 months after treatment with DOXIL liposomal infusion [see Non-clinical Toxicology (13.1) ]. Infertility Females In females of reproductive potential, DOXIL liposomal infusion may cause infertility and result in amenorrhea.

Premature menopause can occur with doxorubicin hydrochloride. Recovery of menses and ovulation is related to age at treatment . Males DOXIL liposomal infusion may result in oligospermia, azoospermia, and permanent loss of fertility.

Sperm counts have been reported to return to normal levels in some men. This may occur several years after the end of therapy [see Non-clinical Toxicology (13.1) ] .

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

8.5Geriatric Use Clinical studies of DOXIL liposomal infusion conducted in patients with either epithelial ovarian cancer (Trial 4) or with AIDS-related Kaposi’s sarcoma (Trial 5) did not contain sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. In Trial 6, of 318 patients treated with DOXIL liposomal infusion in combination with bortezomib for multiple myeloma, 37% were 65 years of age or older and 8% were 75 years of age or older. No overall differences in safety or efficacy were observed between these patients and younger patients.

8.6Hepatic Impairment The pharmacokinetics of DOXIL liposomal infusion has not been adequately evaluated in patients with hepatic impairment. Doxorubicin is el…

🤰 Pregnancy 209 words ▾

8.1Pregnancy Risk Summary Based on findings in animals and its mechanism of action, DOXIL liposomal infusion can cause fetal harm when administered to a pregnant woman; avoid the use of DOXIL liposomal infusion during the 1 st trimester. In animal reproduction studies, DOXIL liposomal infusion was embryotoxic in rats and abortifacient in rabbits following intravenous administration during organogenesis at doses approximately 0.12 times the recommended clinical dose (see Data ) . Available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of doxorubicin hydrochloride during the 2 nd and 3 rd trimesters.

Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2–4% and of miscarriage is 15–20% of clinically recognized pregnancies.

Data Animal Data DOXIL liposomal infusion was embryotoxic at doses of 1 mg/kg/day in rats and was embryotoxic and abortifacient at 0.5 mg/kg/day in rabbits (both doses are about 0.12 times the recommended dose of 50 mg/m 2 human dose on a mg/m 2 basis). Embryotoxicity was characterized by increased embryo-fetal deaths and reduced live litter sizes.

🧒 Pediatric Use 18 words ▾

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

🧓 Geriatric Use 96 words ▾

8.5Geriatric Use Clinical studies of DOXIL liposomal infusion conducted in patients with either epithelial ovarian cancer (Trial 4) or with AIDS-related Kaposi’s sarcoma (Trial 5) did not contain sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. In Trial 6, of 318 patients treated with DOXIL liposomal infusion in combination with bortezomib for multiple myeloma, 37% were 65 years of age or older and 8% were 75 years of age or older. No overall differences in safety or efficacy were observed between these patients and younger patients.

🆘 Overdosage 16 words ▾

10 OVERDOSAGE Acute overdosage with doxorubicin hydrochloride causes increased risk of severe mucositis, leukopenia, and thrombocytopenia.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The active ingredient of DOXIL liposomal infusion is doxorubicin hydrochloride. The mechanism of action of doxorubicin hydrochloride is thought to be related to its ability to bind DNA and inhibit nucleic acid synthesis. Cell structure studies have demonstrated rapid cell penetration and perinuclear chromatin binding, rapid inhibition of mitotic activity and nucleic acid synthesis, and induction of mutagenesis and chromosomal aberrations.

12.3Pharmacokinetics The pharmacokinetic parameters for total doxorubicin following a single dose of DOXIL infused over 30 minutes are presented in Table 8 . Table 8: Pharmacokinetic Parameters of Total Doxorubicin from DOXIL Liposomal Infusion in Patients With AIDS-Related Kaposi’s Sarcoma Dose Parameter (units) 10 mg/m 2 20 mg/m 2 N=23 Mean ± Standard Error Peak Plasma Concentration (µg/mL) 4.12 ± 0.215 8.34 ±

0.49Plasma Clearance (L/h/m 2 ) 0.056 ± 0.01 0.041 ± 0.004 Steady State Volume of Distribution (L/m 2 ) 2.83 ± 0.145 2.72 ± 0.120 AUC (µg/mL∙h) 277 ± 32.9 590 ±

58.7First Phase (λ 1 ) Half-Life (h) 4.7 ± 1.1 5.2 ±

1.4Second Phase (λ 1 ) Half-Life (h) 52.3 ± 5.6 55.0 ±

4.8DOXIL liposomal infusion displayed linear pharmacokinetics over the range of 10 to 20 mg/m 2 . Relative to DOXIL liposomal infusion doses at or below 20 mg/m 2 , the pharmacokinetics of total doxorubicin following a 50 mg/m 2 DOXIL liposomal infusion dose are nonlinear. At this dose, the elimination half-life of DOXIL liposomal infusion is longer and the clearance lower compared to a 20 mg/m 2 dose.

Distribution Direct measurement of liposomal doxorubicin shows that at least 90% of the drug (the assay used cannot quantify less than 5–10% free doxorubicin) remains liposome-encapsulated during circulation. In contrast to doxorubicin, which displays a large volume of distribution (range 700 to 1100 L/m 2 ), the small steady state volume of distribution of liposomal doxorubicin suggests that DOXIL liposomal infusion is largely confined to vascular fluid. Doxorubicin becomes available after the liposomes are extravasated.

Plasma protein binding of DOXIL liposomal infusion has not been determined; the plasma protein binding of doxorubicin is approximately 70%. Metabolism Doxorubicinol, the major metabolite of doxorubicin, was detected at concentrations of 0.8 to 26.2 ng/mL in the plasma of patients who received 10 or 20 mg/m 2 DOXIL liposomal infusion. Elimination The plasma clearance of total doxorubicin from DOXIL liposomal infusion was 0.041 L/h/m 2 at a dose of 20 mg/m 2 .

Following administration of doxorubicin hydrochloride, the plasma clearance of doxorubicin is 24 to 35 L/h/m 2 .

🧬 Mechanism of Action 65 words ▾

12.1Mechanism of Action The active ingredient of DOXIL liposomal infusion is doxorubicin hydrochloride. The mechanism of action of doxorubicin hydrochloride is thought to be related to its ability to bind DNA and inhibit nucleic acid synthesis. Cell structure studies have demonstrated rapid cell penetration and perinuclear chromatin binding, rapid inhibition of mitotic activity and nucleic acid synthesis, and induction of mutagenesis and chromosomal aberrations.

📦 How Supplied / Storage and Handling 89 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING DOXIL (doxorubicin hydrochloride liposome injection) is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. The following individually cartoned vials are available: Table 14 vial concentration vial size NDC #s 20 mg/10 mL (2 mg/ mL) 10-mL 0338-0063-01 50 mg/25 mL (2 mg/mL) 30-mL 0338-0067-01 Refrigerate unopened vials of DOXIL (doxorubicin hydrochloride liposome injection) at 2°C- 8°C (36°F- 46°F). Do not freeze.

Discard unused portion. DOXIL liposomal infusion is a cytotoxic drug. Follow applicable special handling and disposal procedures.

1

📦 Storage and Handling 35 words ▾

Refrigerate unopened vials of DOXIL (doxorubicin hydrochloride liposome injection) at 2°C- 8°C (36°F- 46°F). Do not freeze. Discard unused portion. DOXIL liposomal infusion is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

📋 Description 189 words ▾

11 DESCRIPTION The active ingredient in DOXIL liposomal infusion is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in STEALTH liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6‑trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11‑trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C27-H29 -NO11•HCl and the molecular weight is 579.99.

The structural formula is: DOXIL liposomal infusion is a sterile, translucent, red liposomal dispersion. Each single- dose vial contains 20 mg or 50 mg doxorubicin hydrochloride at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin). The STEALTH liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL.

Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine, 1.55 mg as a buffer; hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (6.0 to 7.0); and sucrose, 94 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the STEALTH liposomes. MPEG-DSPE has the following structural formula: HSPC has the following structural formula: Representation of a STEALTH liposome: Structural Formula MPEG-DSPE Structural Formula HSPC Structural Formula Representation of a STEALTH liposome

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Cardiomyopathy Advise patients to contact their healthcare provider if they develop symptoms of heart failure [see Warnings and Precautions (5.1) ] . Infusion-Related Reactions Advise patients about the symptoms of infusion related reactions and to seek immediate medical attention if they develop any of these symptoms [see Warnings and Precautions (5.2) ] . Myelosuppression Advise patients to contact their healthcare provider for a new onset fever or symptoms of infection.

Hand-Foot Syndrome Advise patients to notify their healthcare provider if they experience tingling or burning, redness, flaking, bothersome swelling, small blisters, or small sores on the palms of their hands or soles of their feet (symptoms of Hand-Foot Syndrome) [see Warnings and Precautions (5.3) ] . Stomatitis Advise patients to notify their healthcare provider if they develop painful redness, swelling, or sores in the mouth (symptoms of stomatitis). Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider with a known or suspected pregnancy [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1) ].

Advise females and males of reproductive potential to use effective contraception during and for 6 months following treatment with DOXIL liposomal infusion [see Use in Specific Populations (8.3) ] . Lactation Advise females not to breastfeed during treatment with DOXIL liposomal infusion [see Use in Specific Populations (8.2) ]. Infertility Advise females and males of reproductive potential that DOXIL liposomal infusion may cause temporary or permanent infertility [see Use in Specific Populations (8.3) ].

Discoloration of Urine and Body Fluids Inform patients that following DOXIL liposomal infusion administration, a reddish-orange color to the urine and other body fluids may be observed. This nontoxic reaction is due to the color of the product and will dissipate as the drug is eliminated from the body.

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