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Doxorubicin Hydrochloride 2 mg/mL Injection, Powder, Lyophilized, For Solution — NDC 70121-1219-01 package photo

Doxorubicin Hydrochloride 2 mg/mL Injection, Powder, Lyophilized, For Solution

by Amneal Pharmaceuticals LLC · 1 VIAL in 1 CARTON (70121-1219-1) / 25 mL in 1 VIAL
NDC 70121-1219-01
🏷️ FDA NDC (as labeled) 70121-1219-1 billing pads the package segment with a zero
Rx only Generic 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 ↗

🆔 Identity & classification

FDA NDC (as labeled) 70121-1219-1
Product NDC 70121-1219
11-digit billing NDC 70121121901
RxCUI 1790095, 1872062
UNII 82F2G7BL4E
Application # ANDA208888
SPL Set ID d928625e-c1ef-4f25-8d25-764c8c6aab67
Established class (EPC) Anthracycline Topoisomerase Inhibitor
Mechanism of action Topoisomerase Inhibitors
Chemical class Anthracyclines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-02-17
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance DOXORUBICIN HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 70121-1219-1 — a 5-4-1 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 package segment → 70121-1219-01. 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

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL EU LTD
FDA applicationANDA208888 (ANDA)
Labeler code70121
First marketedFeb 2017
Product typeHuman Prescription Drug
Portfolio472 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

📖 What it is MedlinePlus · NLM

Doxorubicin is used in combination with other medications to treat certain types of bladder, breast, lung, stomach, and ovarian cancer; Hodgkin's lymphoma (Hodgkin's disease) and non-Hodgkin's lymphoma (cancer that begins in the cells of the immune system); and certain types of leukemia (cancer of the white blood cells), including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML, ANLL). Doxorubicin is also used alone and in combination with other medications to treat certain types of thyroid cancer and certain types of soft tissue or bone sarcomas (cancer that forms in muscle...

Read the full MedlinePlus article ↗
📗 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.

  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.

1 inactive ingredient 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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Doxorubicin Hydrochloride 2 mg/mL 00143-9093-01 Hikma 1 vial — — FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 67457-0436-50 Mylan 1 vial — — FDA listed —
Doxorubicin Hydrochloride 2 mg/mLthis 70121-1219-01 Amneal 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 49315-0008-03 Zydus 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 68001-0345-26 BluePoint 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 16714-0742-01 NorthStar 1 vial — AB Discontinued —
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 68001-0492-36 BluePoint 1 vial — AB 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 —
Doxil 2 mg/mL 00338-0063-01 Baxter 1 vial — AB 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 62332-0810-10 Alembic 1 vial — AB 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 —
Doxorubicin Hydrochloride 2 mg/mL 47335-0049-40 Sun 1 vial — AB FDA listed —
Doxil 2 mg/mL 00338-9665-01 Baxter 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68001-0703-36 BluePoint 1 vial — AB FDA listed —
doxorubicin hydrochloride 2 mg/mL 75907-0363-01 Dr. 1 vial — AB 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 46708-0810-10 Alembic 1 vial — AB 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 68001-0629-26 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 72603-0103-01 NorthStar 1 vial — AB 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 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 Liposome 2 mg/mL 25021-0263-10 Sagent 1 vial — AB 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, Liposomal 2 mg/mL 00338-9581-02 Baxter 1 vial — — FDA listed —
Doxil 2 mg/mL 00338-9667-01 Baxter 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 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 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

🏛️
2017
On the market since
Feb 2017
📍
2026
Currently FDA-listed
9 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70121-1219-01 You're viewing this 1 VIAL in 1 CARTON (70121-1219-1) / 25 mL in 1 VIAL 2017-02-17 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70121-1219-1, 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: 70121-1219-01, written without dashes as 70121121901. 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 70121-1219-01, the first segment (70121) is the labeler code FDA assigned to Amneal Pharmaceuticals LLC; the middle segment (1219) 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 Amneal Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Amneal Pharmaceuticals LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning ~2 min read ▾

WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur with doxorubicin hydrochloride. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 1% to 20% for cumulative doses ranging from 300 mg/m 2 to 500 mg/m 2 when doxorubicin hydrochloride is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy.

Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with doxorubicin hydrochloride [see Warnings and Precautions (5.1) ] . Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin hydrochloride [see Warnings and Precautions (5.2) ] . Extravasation and Tissue Necrosis: Extravasation of doxorubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting.

Immediately terminate the drug and apply ice to the affected area [see Warnings and Precautions (5.3) ] . Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur [see Warnings and Precautions (5.4) ] . WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning.

Cardiomyopathy: Myocardial damage can occur with doxorubicin hydrochloride with incidences from 1% to 20% for cumulative doses from 300 mg/m 2 to 500 mg/m 2 when doxorubicin hydrochloride is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with doxorubicin hydrochloride.

( 5.1 ) Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin hydrochloride. ( 5.2 ) Extravasation and Tissue Necrosis: Extravasation of doxorubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision and skin grafting. Immediately terminate the drug, and apply ice to the affected area.

( 5.3 ) Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur. ( 5.4 )

🎯 Indications and Usage 176 words ▾

1 INDICATIONS AND USAGE Doxorubicin hydrochloride for injection is an anthracycline topoisomerase inhibitor indicated: as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer ( 1.1 ). for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms’ tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma ( 1.2 ).

1.1Adjuvant Breast Cancer Doxorubicin hydrochloride for injection is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer.

1.2Other Cancers Doxorubicin hydrochloride for injection is indicated for the treatment of acute lymphoblastic leukemia acute myeloblastic leukemia Hodgkin lymphoma non-Hodgkin lymphoma (NHL) metastatic breast cancer metastatic Wilms’ tumor metastatic neuroblastoma metastatic soft tissue sarcoma metastatic bone sarcoma metastatic ovarian carcinoma metastatic transitional cell bladder carcinoma metastatic thyroid carcinoma metastatic gastric carcinoma metastatic bronchogenic carcinoma

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Single agent : 60 to 75 mg/m 2 given intravenously every 21 days ( 2.1 ). In combination: 40 to 75 mg/m 2 given intravenously every 21 to 28 days ( 2.1 ). Discontinue doxorubicin hydrochloride for injection in patients who develop signs or symptoms of cardiomyopathy ( 2.2 ). Reduce dose in patients with hepatic impairment ( 2.3 ).

2.1Recommended Dosage for Adjuvant Breast Cancer The recommended dosage of doxorubicin hydrochloride for injection is 60 mg/m 2 administered as an intravenous bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of four cycles.

2.2Recommended Dosage for Other Cancers The recommended dosage of doxorubicin hydrochloride for injection when used as a single agent is 60 mg/m 2 to 75 mg/m 2 intravenously every 21 days. The recommended dosage of doxorubicin hydrochloride for injection, when administered in combination with other chemotherapy drugs, is 40 mg/m 2 to 75 mg/m 2 intravenously every 21 to 28 days. Consider use of the lower doxorubicin hydrochloride for injection dose in the recommended dosage range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.

Cumulative doses above 550 mg/m 2 are associated with an increased risk of cardiomyopathy [see Warnings and Precautions (5.1) ] .

2.3Dosage Modifications for Adverse Reactions Cardiomyopathy Discontinue doxorubicin hydrochloride for injection in patients who develop signs or symptoms of cardiomyopathy [see Warnings and Precautions (5.1) ] .

2.4Dosage Modifications for Hepatic Impairment Doxorubicin hydrochloride for injection is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C or serum bilirubin greater than 5 mg/dL) [see Contraindications (4) ]. Dosage modifications for doxorubicin hydrochloride for injection in patients with elevated serum total bilirubin concentrations [see Warnings and Precautions (5.5) , Use in Specific Populations (8.6) ] are provided in Table 1. Table 1.

Recommended Dosage Modification for Elevated Serum Total Bilirubin Serum total bilirubin concentration Dosage Modification 1.2 to 3 mg/dL 50% 3.1 to 5 mg/dL 75% greater than 5 mg/dL Do not initiate doxorubicin hydrochloride for injection; discontinue doxorubicin hydrochloride for injection

2.5Preparation and Administration Doxorubicin hydrochloride for injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Preparation Reconstitution of Doxorubicin Hydrochloride for Injection Reconstitute doxorubicin hydrochloride for injection with 0.9% Sodium Chloride Injection to obtain a final concentration of 2 mg per mL as follows: 10 mL 0.9% Sodium Chloride Injection, USP to reconstitute 20 mg vial 25 mL 0.9% Sodium Chloride Injection, USP to reconstitute 50 mg vial Gently shake vial until the contents have dissolved.

Protect reconstituted solution from light. Dilution of Reconstituted Doxorubicin Hydrochloride for Injection Dilute reconstituted doxorubicin hydrochloride for injection in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Protect from light following preparation until completion of infusion.

Use within 1 hour. If not used within 1 hour, discard the diluted product. Administration Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit.

Discard if the solution is discolored, cloudy, or contains particulate matter. Administration by Intravenous Injection Administer diluted reconstituted doxorubicin hydrochloride for injection as an intravenous injection through a central intravenous line or a secure and free-flowing peripheral venous line containing 0.9% Sodium Chloride Injection, USP, 0.45% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP. Administer intravenously over 3 to 10 minutes.

Decrease the rate of infusion if erythematous streaking along the vein proximal to the site of infusio…

💊 Dosage Forms and Strengths 54 words ▾

3 DOSAGE FORMS AND STRENGTHS Doxorubicin Hydrochloride for Injection, USP: Vials contain 20 mg/vial and 50 mg/vial of doxorubicin hydrochloride, USP as a red to orange-red lyophilized cake or powder in single-dose vials for reconstitution. For Injection: 20 mg/vial and 50 mg/vial as a lyophilized powder in single-dose vials for reconstitution ( 3 ).

⛔ Contraindications 116 words ▾

4 CONTRAINDICATIONS Doxorubicin hydrochloride for injection is contraindicated in patients with: Severe myocardial insufficiency [see Warnings and Precautions (5.1) ] Recent (occurring within the past 4 to 6 weeks) myocardial infarction [see Warnings and Precautions (5.1) ] Severe persistent drug-induced myelosuppression [see Warnings and Precautions (5.4) ] Severe hepatic impairment (defined as Child Pugh Class C or serum bilirubin level greater than 5 mg/dL) [see Warnings and Precautions (5.5) ] Severe hypersensitivity reaction to doxorubicin hydrochloride, including anaphylaxis [see Adverse Reactions (6.2) ] Severe myocardial insufficiency ( 4 ).

Recent myocardial infarction ( 4 ). Severe persistent drug-induced myelosuppression ( 4 ). Severe hepatic impairment ( 4 ).

Severe hypersensitivity to doxorubicin hydrochloride ( 4 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Radiation-Induced Toxicity: Can be increased by the administration of doxorubicin hydrochloride for injection. Radiation recall can occur in patients who receive doxorubicin hydrochloride for injection after prior radiation therapy ( 5.7 ). Embryo-Fetal Toxicity: Can cause fetal harm.

Advise females of reproductive potential of the potential risk to a fetus and on the use of effective contraception. Advise males with female partners of reproductive potential to use effective contraception. Advise males with pregnant partners to use condoms ( 5.8 , 8.1 , 8.3 ).

5.1Cardiomyopathy and Arrhythmias Cardiomyopathy Doxorubicin hydrochloride can result in myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy is generally proportional to the cumulative exposure. Include prior doses of other anthracyclines or anthracenediones in calculations of total cumulative dosage for doxorubicin hydrochloride.

Cardiomyopathy may develop during treatment or up to several years after completion of treatment and can include decrease in LVEF and signs and symptoms of congestive heart failure (CHF). The probability of developing cardiomyopathy is estimated to be 1% to 2% at a total cumulative dose of 300 mg/m 2 of doxorubicin hydrochloride, 3% to 5% at a dose of 400 mg/m 2 , 5% to 8% at a dose of 450 mg/m 2 , and 6% to 20% at a dose of 500 mg/m 2 , when doxorubicin hydrochloride is administered every 3 weeks. There is an additive or potentially synergistic increase in the risk of cardiomyopathy in patients who have received radiotherapy to the mediastinum or concomitant therapy with other known cardiotoxic agents, such as cyclophosphamide and trastuzumab.

Pericarditis and myocarditis have also been reported during or following doxorubicin hydrochloride treatment. Assess left ventricular cardiac function (e.g., MUGA or echocardiogram) prior to initiation of doxorubicin hydrochloride for injection, during treatment to detect acute changes, and after treatment to detect delayed cardiotoxicity. Increase the frequency of assessments as the cumulative dose exceeds 300 mg/m 2 .

Use the same method of assessment of LVEF at all time points [see Use in Specific Populations (8.4) ] . Discontinue doxorubicin hydrochloride for injection in patients who develop signs or symptoms of cardiomyopathy [see Dosage and Administration (2.3) ] . Consider the use of dexrazoxane to reduce the incidence and severity of cardiomyopathy due to doxorubicin hydrochloride administration in patients who have received a cumulative doxorubicin hydrochloride dose of 300 mg/m 2 and who will continue to receive doxorubicin hydrochloride.

Arrhythmias Doxorubicin hydrochloride can result in arrhythmias, including life-threatening arrhythmias, during or within a few hours after doxorubicin hydrochloride administration and at any time point during treatment. Tachyarrhythmias, including sinus tachycardia, premature ventricular contractions, and ventricular tachycardia, as well as bradycardia, can occur. Electrocardiographic changes, including non-specific ST-T wave changes, atrioventricular and bundle-branch block can also occur.

These electrocardiographic changes may be transient and self-limited and may not require a dosage modification of doxorubicin hydrochloride.

5.2Secondary Malignancies The risk of developing secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) is increased following treatment with doxorubicin hydrochloride. Cumulative incidences ranged from 0.2% at five years to 1.5% at 10 years in two separate trials involving the adjuvant treatment of women with breast cancer. These leukemias generally occur within 1 to 3 years of treatment.

5.3Extravasation and Tissue Necrosis Extravasation of doxorubicin hydrochloride can cause severe local tissue injury manifesting as blistering, ulceration, and necrosis requiring wide excision of the affected area and skin grafting. Extravasation should be cons…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling. Cardiomyopathy and Arrhythmias [see Warnings and Precautions (5.1) ] Secondary Malignancies [see Warnings and Precautions (5.2) ] Extravasation and Tissue Necrosis [see Warnings and Precautions (5.3) ] Severe Myelosuppression [see Warnings and Precautions (5.4) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.6) ] Radiation Sensitization and Radiation Recall [see Warnings and Precautions (5.7) ] The most common (> 10%) adverse reactions are alopecia, nausea and vomiting ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 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. Breast Cancer The safety data below were collected from 1,492 women who received doxorubicin hydrochloride at a dose of 60 mg/m 2 and cyclophosphamide at a dose of 600 mg/m 2 (AC) every 3 weeks for 4 cycles for the adjuvant treatment of axillary lymph node positive breast cancer.

The median number of cycles received was 4. Selected adverse reactions reported in this study are provided in Table 2. No treatment-related deaths were reported in patients on either arm of the study.

Table 2. Selected Adverse Reactions in Patients with Early Breast Cancer Involving Axillary Lymph Nodes Adverse Reactions AC* N=1,492 Conventional CMF N=739 % % Alopecia 92 71 Vomiting Vomiting ≤ 12 hours Vomiting > 12 hours Intractable 34 37 5 25 12 2 Leukopenia Grade 3 (1,000 to 1,999 /mm 3 ) Grade 4 (< 1,000 /mm 3 ) 3.4 0.3 9.4

0.3Shock, sepsis 2 1 Systemic infection 2 1 Cardiac dysfunction Asymptomatic Transient Symptomatic 0.2 0.1 0.1 0.1 0 0 Thrombocytopenia Grade 3 (25,000 to 49,999 /mm 3 ) Grade 4 (< 25,000 /mm 3 ) 0 0.1 0.3 0 AC = doxorubicin hydrochloride, cyclophosphamide; CMF = cyclophosphamide, methotrexate, fluorouracil * Includes pooled data from patients who received either AC for 4 cycles or AC for 4 cycles followed by CMF for 3 cycles

6.2Post-marketing Experience The following adverse reactions have been identified during post-approval use of doxorubicin hydrochloride for injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac – Cardiogenic shock Cutaneous – Skin and nail hyperpigmentation, oncolysis, rash, itching, photosensitivity, urticaria, acral erythema, palmar plantar erythrodysesthesia Gastrointestinal – Nausea, mucositis, stomatitis, necrotizing colitis, typhlitis, gastric erosions, gastrointestinal tract bleeding, hematochezia, esophagitis, anorexia, abdominal pain, dehydration, diarrhea, hyperpigmentation of the oral mucosa Hypersensitivity – Anaphylaxis Laboratory Abnormalities – Increased ALT, increased AST Neurological – Peripheral sensory and motor neuropathy, seizures, coma Ocular – Conjunctivitis, keratitis, lacrimation Vascular – Phlebosclerosis, phlebitis/thrombophlebitis, hot flashes, thromboembolism Other – Malaise/asthenia, fever, chills, weight gain

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Avoid concomitant use of doxorubicin hydrochloride with inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp ( 7.1 ). Do not administer doxorubicin hydrochloride in combination with trastuzumab due to increased risk of cardiac dysfunction ( 5.1 , 7.2 ).

7.1Effect of Other Drugs on Doxorubicin Hydrochloride for Injection Inhibitors of CYP3A4, CYP2D6, and P-gp Concomitant use of doxorubicin hydrochloride with inhibitors of CYP3A4, CYP2D6, or P-glycoprotein (P-gp), increased concentrations of doxorubicin, which may increase the incidence and severity of adverse reactions of doxorubicin hydrochloride. Avoid concomitant use of doxorubicin hydrochloride for injection with inhibitors of CYP3A4, CYP2D6, or P-gp. Inducers of CYP3A4, CYP2D6, or P-gp Concomitant use of doxorubicin hydrochloride with inducers of CYP3A4, CYP2D6, or P-gp may decrease the concentration of doxorubicin.

Avoid concomitant use of doxorubicin hydrochloride for injection with inducers of CYP3A4, CYP2D6, or P-gp. Paclitaxel Paclitaxel, when given prior to doxorubicin hydrochloride, increases the plasma-concentrations of doxorubicin and its metabolites. Administer doxorubicin hydrochloride for injection prior to paclitaxel if used concomitantly.

7.2Concomitant Use of Trastuzumab Concomitant use of trastuzumab and doxorubicin hydrochloride results in an increased risk of cardiac dysfunction. Avoid concomitant administration of doxorubicin hydrochloride for injection and trastuzumab [see Warnings and Precautions (5.1) ]. Patients receiving doxorubicin after stopping treatment with trastuzumab may also be at an increased risk of developing cardiotoxicity.

Trastuzumab may persist in the circulation for up to 7 months. Therefore, avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab when possible. If anthracyclines are used before this time, carefully monitor cardiac function.

7.3Concomitant Use of Dexrazoxane Do not administer dexrazoxane as a cardioprotectant at the initiation of doxorubicin hydrochloride-containing chemotherapy regimens. In a randomized trial in women with metastatic breast cancer, initiation of dexrazoxane with doxorubicin hydrochloride-based chemotherapy resulted in a significantly lower tumor response rate (48% vs. 63%; p = 0.007) and shorter time to progression compared to doxorubicin hydrochloride-based chemotherapy alone.

7.4Concomitant Use of 6-Mercaptopurine Doxorubicin hydrochloride may potentiate 6-mercaptopurine-induced hepatotoxicity. In 11 patients with refractory leukemia treated with 6-mercaptopurine (500 mg/m 2 intravenously daily for 5 days per cycle every 2 to 3 weeks) and doxorubicin hydrochloride (50 mg/m 2 intravenous once per cycle every 2 to 3 weeks) alone or with vincristine and prednisone, all developed hepatic dysfunction manifested by increased total serum bilirubin, alkaline phosphatase and aspartate aminotransferase.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed ( 8.2 ). Females and Males of Reproductive Potential: May impair fertility ( 8.3 ).

8.1Pregnancy Risk Summary Based on findings in animals and its mechanism of action, doxorubicin hydrochloride for injection can cause fetal harm when administered to a pregnant woman; avoid the use of doxorubicin hydrochloride for injection during the 1 st trimester. 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. Doxorubicin hydrochloride was teratogenic and embryotoxic in rats and embryotoxic in rabbits when administered during organogenesis at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m 2 (see Data) .

Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Doxorubicin hydrochloride was teratogenic and embryotoxic at doses of 0.8 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) when administered during the period of organogenesis in rats.

Teratogenicity and embryotoxicity were also seen using discrete periods of treatment. The most susceptible was the 6- to 9-day gestation period at doses of 1.25 mg/kg/day and greater. Characteristic malformations included esophageal and intestinal atresia, tracheo-esophageal fistula, hypoplasia of the urinary bladder, and cardiovascular anomalies.

Doxorubicin hydrochloride was embryotoxic (increase in embryofetal deaths) and abortifacient at 0.4 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) in rabbits when administered during the period of organogenesis.

8.2Lactation Risk Summary Doxorubicin was measured in the milk of one lactating patient after therapy with 70 mg/m 2 of doxorubicin hydrochloride given as a 15-minute intravenous infusion. The peak milk concentration at 24 hours after treatment was 4.4-fold greater than the corresponding plasma concentration. Doxorubicin was detectable in the milk up to 72 hours.

There are no data on the effects of doxorubicin hydrochloride on the breastfed child or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with doxorubicin hydrochloride for injection and for 10 days after the final dose.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating doxorubicin hydrochloride for injection. Contraception Females Doxorubicin hydrochloride for injection can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1) ] . Advise female patients of reproductive potential to use highly effective contraception during treatment with doxorubicin hydrochloride for injection and for 6 months after treatment [see Use in Specific Populations (8.1) ] .

Males Doxorubicin hydrochloride may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. Due to the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with doxorubicin hydrochloride for injection and for 3 months after treatment [see Nonclinical Toxicology (13.1) ] . Males with pregnant partners should use condoms during treatment and for at least 10 days after the final dose [see Nonclinical Toxicology (13.1) , Use in Specific Populations (8.1) ] .

Infertility Females In females of reproductive potential, doxorubicin hydrochloride may cause infertility and result in amenorrhea. Premature menopause can occur. Recovery of menses and ovulation is related to age at treat…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on findings in animals and its mechanism of action, doxorubicin hydrochloride for injection can cause fetal harm when administered to a pregnant woman; avoid the use of doxorubicin hydrochloride for injection during the 1 st trimester. 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. Doxorubicin hydrochloride was teratogenic and embryotoxic in rats and embryotoxic in rabbits when administered during organogenesis at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m 2 (see Data) .

Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Doxorubicin hydrochloride was teratogenic and embryotoxic at doses of 0.8 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) when administered during the period of organogenesis in rats.

Teratogenicity and embryotoxicity were also seen using discrete periods of treatment. The most susceptible was the 6- to 9-day gestation period at doses of 1.25 mg/kg/day and greater. Characteristic malformations included esophageal and intestinal atresia, tracheo-esophageal fistula, hypoplasia of the urinary bladder, and cardiovascular anomalies.

Doxorubicin hydrochloride was embryotoxic (increase in embryofetal deaths) and abortifacient at 0.4 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) in rabbits when administered during the period of organogenesis.

🧒 Pediatric Use 132 words ▾

8.4Pediatric Use Based on post-marketing reports, pediatric patients treated with doxorubicin hydrochloride are at risk for developing late cardiovascular dysfunction. Risk factors include young age at treatment (especially < 5 years), high cumulative doses and receipt of combined modality therapy. Long-term periodic cardiovascular monitoring is recommended for all pediatric patients who have received doxorubicin hydrochloride.

Doxorubicin hydrochloride, as a component of intensive chemotherapy regimens administered to pediatric patients, may contribute to prepubertal growth failure and may also contribute to gonadal impairment, which is usually temporary. There are no recommended dose adjustments based on age. Doxorubicin clearance was increased in patients aged 2 years to 20 years as compared to adults, while doxorubicin clearance was similar in infants less than 2 years as compared to adults [see Clinical Pharmacology (12.3) ] .

🧓 Geriatric Use 37 words ▾

8.5Geriatric Use Clinical experience in patients who were 65 years of age and older who received doxorubicin hydrochloride-based chemotherapy regimens for metastatic breast cancer showed no overall differences in safety and effectiveness compared with younger patients.

🆘 Overdosage 131 words ▾

10 OVERDOSAGE Few cases of overdose have been described. A 58-year-old man with acute lymphoblastic leukemia received 10-fold overdose of doxorubicin hydrochloride (300 mg/m 2 ) in one day. He was treated with charcoal filtration, hemopoietic growth factor (G-CSF), proton pump inhibitor and antimicrobial prophylaxis.

The patient suffered sinus tachycardia, grade 4 neutropenia and thrombocytopenia for 11 days, severe mucositis and sepsis. The patient recovered completely 26 days after the overdose. A 17-year-old girl with osteogenic sarcoma received 150 mg of doxorubicin hydrochloride daily for 2 days (intended dose was 50 mg per day for 3 days).

The patient developed severe mucositis on days 4 to 7 after the overdose and chills and pyrexia on day 7. The patient was treated with antibiotics and platelets and recovered 18 days after overdose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The cytotoxic effect of doxorubicin hydrochloride on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding activities of doxorubicin. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases. The interaction of doxorubicin with topoisomerase II to form DNA-cleavable complexes appears to be an important mechanism of doxorubicin hydrochloride cytocidal activity.

12.3Pharmacokinetics Pharmacokinetic studies conducted in patients with various types of tumors have shown that doxorubicin follows multiphasic disposition after intravenous injection. In four patients, doxorubicin demonstrated dose-independent pharmacokinetics across a dose range of 30 mg/m 2 to 70 mg/m 2 . Distribution The distribution half-life is approximately 5 minutes.

Steady-state distribution volume ranges from 809 L/m 2 to 1214 L/m 2 . Binding of doxorubicin and its major metabolite, doxorubicinol, to plasma proteins is 75% and is independent of plasma concentration of doxorubicin up to 1.1 mcg/mL. Doxorubicin does not cross the blood brain barrier.

Elimination Plasma clearance is ranges from 324 mL/min/m 2 to 809 mL/min/m 2 . The terminal half-life is 20 hours to 48 hours. Metabolism Doxorubicin is a substrate of CYP3A4, CYP2D6, and P-gp.

Enzymatic reduction at the 7 position and cleavage of the daunosamine sugar yields aglycones which are accompanied by free radical formation, the local production of which may contribute to the cardiotoxic activity of doxorubicin hydrochloride. Disposition of doxorubicinol in patients is formation rate limited, with the terminal half-life of doxorubicinol being similar to doxorubicin. The relative exposure of doxorubicinol, i.e. the ratio between the AUC of doxorubicinol and the AUC of doxorubicin is approximately 0.5.

Excretion Plasma clearance is predominately by metabolism and biliary excretion. Approximately 40% of the dose appears in the bile in 5 days, while only 5% to 12% of the drug and its metabolites appear in the urine during the same time period. In urine, < 3% of the dose was recovered as doxorubicinol over 7 days.

Specific Populations Weight Systemic clearance of doxorubicin is significantly reduced in obese women with ideal body weight greater than 130%. There was a significant reduction in clearance without any change in volume of distribution in obese patients when compared with normal patients with less than 115% ideal body weight. Pediatric Patients Following administration of doses ranging from 10 mg/m 2 to 75 mg/m 2 of doxorubicin hydrochloride to 60 patients ranging from 2 months to 20 years, doxorubicin clearance averaged 1,443 ± 114 mL/min/m 2 .

Further analysis demonstrated that clearance in 52 patients ranging from 2 to 20 years (1540 mL/min/m 2 ) was increased compared with adults. However, clearance in infants younger than 2 years of age (813 mL/min/m 2 ) was decreased compared with older patients (ranging from 2 to 20 years) and approached the range of clearance values determined in adults [see Use in Specific Populations (8.4) ] . Sex A published clinical study involving 6 men and 21 women with no prior anthracycline therapy reported a significantly higher median doxorubicin clearance in men compared to women (1,088 mL/min/m 2 versus 433 mL/min/m 2 ).

However, the terminal half-life of doxorubicin was longer in men compared to women (54 versus 35 hours). Patients with Hepatic Impairment The clearance of doxorubicin and doxorubicinol was reduced in patients with elevated serum total bilirubin concentrations [see Dosage and Administration (2.4) , Warnings and Precautions (5.5) ] .

🧬 Mechanism of Action 70 words ▾

12.1Mechanism of Action The cytotoxic effect of doxorubicin hydrochloride on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding activities of doxorubicin. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases. The interaction of doxorubicin with topoisomerase II to form DNA-cleavable complexes appears to be an important mechanism of doxorubicin hydrochloride cytocidal activity.

📦 How Supplied / Storage and Handling 118 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Doxorubicin Hydrochloride for Injection, USP is a sterile red to orange-red lyophilized cake or powder, available in Type 1 glass vials in single vial packs or 10 vial packs as: 20 mg/vial : Single-Dose Vial in mono-carton NDC 70121-1218-1 10 mono-cartons in Outer Carton NDC 70121-1218-7 50 mg/vial: Single-Dose Vial in a Carton NDC 70121-1219-1 Storage Store all vials at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Protect from light. Retain in carton until time of use. Discard unused portion.

Handling and Disposal Doxorubicin Hydrochloride for Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

📋 Description 110 words ▾

11 DESCRIPTION Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor isolated from cultures of Streptomyces peucetius var. caesius. The chemical name of doxorubicin hydrochloride is 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-α-L- lyx o-hexopyranosyl)oxy]-7,8,9,10tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, hydrochloride (8S- ci s)-. The chemical structure of doxorubicin hydrochloride is: Doxorubicin Hydrochloride for Injection, USP, for intravenous use is a sterile red to orange-red lyophilized cake or powder, provided in single-dose vials.

Each 20 mg/vial contains 20 mg of doxorubicin hydrochloride, USP (equivalent to 18.74 mg of doxorubicin free base) and 100 mg of lactose monohydrate. Each 50 mg/vial contains 50 mg of doxorubicin hydrochloride, USP (equivalent to 46.86 mg of doxorubicin free base) and 250 mg of lactose monohydrate. formula_

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Cardiomyopathy Advise patients that doxorubicin hydrochloride for injection can cause irreversible myocardial damage and to contact a healthcare provider for symptoms of heart failure during or after treatment [see Warnings and Precautions (5.1) ] . Secondary Malignancy Advise patients of the increased risk of treatment-related leukemia [see Warnings and Precautions (5.2) ] .

Myelosuppression Advise patients that doxorubicin hydrochloride for injection can reduce the absolute neutrophil count resulting in an increased risk of infection and to contact a healthcare provider for new onset fever or symptoms of infection [see Warnings and Precautions (5.4) ] . Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus, and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.8) , Use in Specific Populations (8.1) ] .

Advise females of reproductive potential to use effective contraception during treatment with doxorubicin hydrochloride for injection and for 6 months after treatment [see Warnings and Precautions (5.8) , Use in Specific Populations (8.3) ] . Advise patients that doxorubicin hydrochloride for injection may induce chromosomal damage in sperm, which may lead to loss of fertility and offspring with birth defects. Advise males with female partners of reproductive potential to use effective contraception during treatment with doxorubicin hydrochloride for injection and for 3 months after treatment [see Warnings and Precautions (5.8) , Use in Specific Populations (8.3) , Nonclinical Toxicology (13.1) ] .

Advise males with pregnant partners to use condoms during treatment with doxorubicin hydrochloride for injection and for at least 10 days after the final dose [see Use in Specific Populations (8.3) ] . Lactation Advise females not to breastfeed during treatment with doxorubicin hydrochloride for injection and for 10 days after the final dose [see Use in Specific Populations (8.2) ] . Infertility Advise females and males of the potential loss of fertility from doxorubicin hydrochloride for injection [see Use in Specific Populations (8.3) ] .

Gastrointestinal and Dermatologic Adverse Reactions Advise patients that doxorubicin hydrochloride for injection can cause nausea, vomiting, diarrhea, mouth/oral pain and sores and to contact a healthcare provider should they develop any severe symptoms that prevent them from eating and drinking [see Adverse Reactions (6) ] . Advise patients that doxorubicin hydrochloride for Injection can cause alopecia [see Adverse Reactions (6.1) ] . Administration Advise patients that doxorubicin hydrochloride for injection can cause their urine to appear red for 1 to 2 days after administration.

This product’s label may have been updated. For full prescribing information, please visit www.amneal.com. Manufactured by: Amneal Oncology Pvt.

Ltd. Telangana 509301, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 05-2024-03

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