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BEIZRAY Docetaxel 20 mg/mL Injection, Solution, 4 mL — NDC 83513-0009-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

BEIZRAY Docetaxel 20 mg/mL Injection, Solution, 4 mL — NDC 83513-009-01 (Billing 83513-0009-01)

by Zhuhai Beihai Biotech Co., Ltd. · 4 mL in 1 VIAL, GLASS

This is a package of 4 mL of BEIZRAY Docetaxel 20 mg/mL Injection, Solution from Zhuhai Beihai Biotech Co., Ltd., marketed since Oct 2024 and currently FDA-listed. It is this product's only package size.

NDC 83513-0009-01
🏷️ FDA NDC (as labeled) 83513-009-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 83513-009-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
83513 labeler · 009 product · 01 package
Package marketed since
Oct 23, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0383513009013
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83513-009-01
Product NDC 83513-009
11-digit billing NDC 83513000901
RxCUI 1860480, 1860485, 2697044, 2728902
UNII 699121PHCA
UPC 0383513009013
Application # NDA218711
SPL Set ID 3538b979-8cac-49ed-b8dc-50f73ce38c72
Established class (EPC) Microtubule Inhibitor
Physiologic effect Microtubule Inhibition
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-23
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DOCETAXEL ANHYDROUS
Quick answers
  • RxCUI (RxNorm): 1860480
Why two NDCs? The FDA registers this code as 83513-009-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 83513-0009-01. 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 Microtubule Inhibitor class.

Pharmacologic class Microtubule Inhibitor
Drug family (ATC) Taxanes
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It’s a chemotherapy medicine used for several cancers. Beizray is used for breast cancer, non-small cell lung cancer, metastatic castration-resistant prostate cancer, stomach cance...
  • It’s given as an IV infusion at a medical facility, generally over about 1 hour every 3 weeks. You’ll take a steroid by mouth beforehand to help prevent fluid retention and allergi...
  • Common ones include low blood counts, infections, tiredness, nausea, diarrhea, mouth sores, hair loss, nail changes, numbness or tingling, and swelling. Your team will check your b...
  • Call for fever or signs of infection, trouble breathing or swelling during or after the infusion, severe diarrhea, severe skin reactions, worsening numbness or tingling, vision cha...
📖 Read our full Docetaxel Injection guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
83513-0009-01 You're viewing this Main listing 4 mL in 1 VIAL, GLASS 2024-10-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Docetaxel 20 mg/mL 00143-9205-01 Hikma 1 vial — AP FDA listed —
Docetaxel 80 mg/4mL 00955-1021-04 Sanofi-Aventis 1 vial — — FDA listed —
Docetaxel 80 mg/4mL 23155-0904-31 Heritage 1 vial — AP FDA listed —
Docetaxel 20 mg/mL 25021-0245-01 Sagent 1 vial — AP FDA listed —
Docetaxel 80 mg/4mL 43598-0259-40 Dr. 4 ml — AP FDA listed —
Docetaxel 80 mg/4mL 43598-0610-40 Dr. 4 ml — AP FDA listed —
Docetaxel 20 mg/mL 45963-0765-52 Actavis 1 vial — AP FDA listed —
Docetaxel 80 mg/4mL 47335-0895-40 Sun 1 vial — — FDA listed —
Docetaxel 80 mg/4mL 57884-3042-01 Jiangsu 1 vial — AP FDA listed —
Docetaxel 80 mg/4mL 70121-1222-01 Amneal 1 vial — AP FDA listed —
Beizray 20 mg/mL 70710-2152-01 Zydus 1 vial — — FDA listed —
Docetaxel 20 mg/mL 71288-0152-04 Meitheal 1 vial — — FDA listed —
Beizray 20 mg/mLthis 83513-0009-01 Zhuhai 4 ml — — FDA listed —
Docetaxel 20 mg/mL 47335-0323-40 Sun 1 vial — — FDA listed —
Beizray 20 mg/mL 70710-2092-08 Zydus 1 vial — — FDA listed —
Beizray 20 mg/mL 83513-0008-01 Zhuhai 1 vial — — FDA listed —
Docetaxel 20 mg/mL 16729-0267-63 Accord 1 vial — AP FDA listed —
Docetaxel 20 mg/mL 70121-1221-01 Amneal 1 vial — AP 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

🏛️
2025
First FDA approval
Dec 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2036
Latest patent/protection listed
not a guaranteed launch date
🔒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.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2036. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 10, 2025 RLD RS ⏳ ~9.6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11419842 — method of use (U-881)
US 11419842 — method of use (U-937)
US 11419842 — method of use (U-946)
US 11419842 — method of use (U-4027)
US 11419842 — method of use (U-4028)
US 12090134 — method of use (U-881)
US 12090134 — method of use (U-937)
US 12090134 — method of use (U-946)
US 12090134 — method of use (U-4027)
US 12090134 — method of use (U-4028)
US 12090135 — drug product
2025 2027 2029 2031 2033 2035
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (11)
PatentTypeUse codeExpires
US 11419842 ↗ Method of use U-881 May 16, 2036
US 11419842 ↗ Method of use U-937 May 16, 2036
US 11419842 ↗ Method of use U-946 May 16, 2036
US 11419842 ↗ Method of use U-4027 May 16, 2036
US 11419842 ↗ Method of use U-4028 May 16, 2036
US 12090134 ↗ Method of use U-881 May 16, 2036
US 12090134 ↗ Method of use U-937 May 16, 2036
US 12090134 ↗ Method of use U-946 May 16, 2036
US 12090134 ↗ Method of use U-4027 May 16, 2036
US 12090134 ↗ Method of use U-4028 May 16, 2036
US 12090135 ↗ Drug product — May 16, 2036
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

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.

🧪 Avoiding an ingredient? See Docetaxel Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • 0.04 mg / 1 mL UNII DSO12WL7AU
    A salt derived from citric acid, this ingredient acts as a buffer and pH regulator in medicines. It helps maintain stable acidity levels and may improve taste or aid preservation.
  • 0.77 g / 1 mL UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerZhuhai Beihai Biotech Co., Ltd.
Application holderZHUHAI BEIHAI BIOTECH CO LTD
FDA applicationNDA218711 (NDA)
Labeler code83513
First marketedOct 2024
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Zhuhai Beihai Biotech Co., Ltd. labeler code 83513

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📚 References 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with BEIZRAY is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non- small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive BEIZRAY as a single agent at a dose of 100 mg/m 2 [ see Warnings and Precautions ( 5.1 ) ] . Avoid the use of BEIZRAY in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN.

Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 × ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of BEIZRAY [ see Warnings and Precautions ( 5.2 ) ] .

Do not administer BEIZRAY to patients with neutrophil counts of <1500 cells/mm 3 . Monitor blood counts frequently as neutropenia may be severe and result in infection. [ see Warnings and Precautions ( 5.3 ) ] . Do not administer BEIZRAY to patients who have a history of severe hypersensitivity reactions to docetaxel [see Contraindications (4) ] .

Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the BEIZRAY infusion and administration of appropriate therapy [see Warnings and Precautions ( 5.5 )] . Severe fluid retention occurred in 6.5% (6/92) of patients despite use of dexamethasone premedication.

It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites) [ see Warnings and Precautions ( 5.6 ) ] . WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION See full prescribing information for complete boxed warning. Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving BEIZRAY at 100 mg/m 2 ( 5.1 ) Avoid use of BEIZRAY if bilirubin > ULN, or if AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN.

LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle ( 5.2 ) Do not administer BEIZRAY to patients with neutrophil counts <1500 cells/mm 3 . Obtain frequent blood counts to monitor for neutropenia ( 4 , 5.3 ) Severe hypersensitivity, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication.

Severe reactions require immediate discontinuation of BEIZRAY and administration of appropriate therapy ( 5.5 ) Contraindicated if history of severe hypersensitivity reactions to docetaxel ( 4 ) Severe fluid retention may occur despite dexamethasone ( 5.6 )

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE BEIZRAY is a microtubule inhibitor indicated for: Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1 ) Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2 ) Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer ( 1.3 ) Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction ( 1.4 ) Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN ( 1.5 )

1.1Breast Cancer BEIZRAY is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. BEIZRAY in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.

1.2Non-small Cell Lung Cancer BEIZRAY as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. BEIZRAY in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.

1.3Prostate Cancer BEIZRAY in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.

1.4Gastric Adenocarcinoma BEIZRAY in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.

1.5Head and Neck Cancer BEIZRAY in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).

1.1Breast Cancer BEIZRAY is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. BEIZRAY in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.

1.2Non-small Cell Lung Cancer BEIZRAY as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. BEIZRAY in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.

1.3Prostate Cancer BEIZRAY in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.

1.4Gastric Adenocarcinoma BEIZRAY in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.

1.5Head and Neck Cancer BEIZRAY in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Do not substitute BEIZRAY for other docetaxel products . ( 2.1 ) Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hr every 3 weeks.

BC locally advanced or metastatic: 60 mg/m 2 to 100 mg/m 2 single agent ( 2.2 ) BC adjuvant: 75 mg/m 2 administered 1 hour after doxorubicin 50 mg/m 2 and cyclophosphamide 500 mg/m 2 every 3 weeks for 6 cycles ( 2.2 ) NSCLC: after platinum therapy failure: 75 mg/m 2 single agent ( 2.3 ) NSCLC: chemotherapy naive: 75 mg/m 2 followed by cisplatin 75 mg/m 2 ( 2.3 ) CRPC: 75 mg/m 2 with 5 mg prednisone twice a day continuously ( 2.4 ) GC: 75 mg/m 2 followed by cisplatin 75 mg/m 2 (both on day 1 only) followed by fluorouracil 750 mg/m 2 per day as a 24-hr IV (days 1-5), starting at end of cisplatin infusion ( 2.5 ) SCCHN: 75 mg/m 2 followed by cisplatin 75 mg/m 2 IV (day 1), followed by fluorouracil 750 mg/m 2 per day as a 24-hr IV (days 1-5), starting at end of cisplatin infusion; for 4 cycles ( 2.6 ) SCCHN: 75 mg/m 2 followed by cisplatin 100 mg/m 2 IV (day 1), followed by fluorouracil 1000 mg/m 2 per day as a 24-hr IV (days 1-4); for 3 cycles ( 2.6 ) For all patients: Premedicate with oral corticosteroids ( 2.7 ) Adjust dose as needed ( 2.8 )

2.1Important Dosage and Administration Instructions Do not substitute BEIZRAY for or with other docetaxel products because BEIZRAY has different administration instructions from other docetaxel products. For all indications, toxicities may warrant dosage adjustments [see Dosage and Administration ( 2.8 )] . Administer in a facility equipped to manage possible complications (e.g. anaphylaxis).

See additional premedication recommendations for the indicated populations [see Dosage and Administration ( 2.7 )]

2.2Recommended Dosage for Breast Cancer For locally advanced or metastatic breast cancer after failure of prior chemotherapy, the recommended dose of BEIZRAY is 60 mg/m 2 to 100 mg/m 2 administered intravenously over 1 hour every 3 weeks. For the adjuvant treatment of operable node-positive breast cancer, the recommended BEIZRAY dose is 75 mg/m 2 administered 1 hour after doxorubicin 50 mg/m 2 and cyclophosphamide 500 mg/m 2 every 3 weeks for 6 courses. Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities [see Dosage and Administration ( 2.7 )] .

2.3Recommended Dosage for Non-small Cell Lung Cancer For treatment after failure of prior platinum-based chemotherapy, BEIZRAY was evaluated as monotherapy, and the recommended dose is 75 mg/m 2 administered intravenously over 1 hour every 3 weeks. In patients previously treated with chemotherapy, a dosage of 100 mg/m 2 is not recommended because this dosage was associated with increased hematologic toxicity, infection, and treatment-related mortality in randomized controlled trials [see Boxed Warning, Dosage and Administration (2.7), Warnings and Precautions (5), Clinical Studies (14)] .

For chemotherapy-naive patients, the recommended dosage of BEIZRAY is 75 mg/m 2 administered intravenously over 1 hour immediately followed by cisplatin 75 mg/m 2 over 30-60 minutes every 3 weeks [see Dosage and Administration (2.7)] .

2.4Recommended Dosage for Prostate Cancer For metastatic castration-resistant prostate cancer, the recommended dose of BEIZRAY is 75 mg/m 2 every 3 weeks as a 1 hour intravenous infusion. Recommend concomitant use of 5 mg of prednisone orally twice daily continuously [see Dosage and Administration ( 2.7 )] .

2.5Recommended Dosage for Gastric Adenocarcinoma For gastric adenocarcinoma, the recommended dose of BEIZRAY is 75 mg/m 2 as a 1 hour intravenous infusion, followed by cisplatin 75 mg/m 2 , as a 1 to 3 hour intravenous infusion (both on day 1 only), followed by fluorouracil 750 mg/m 2 per day given as a 24-hour continuous intravenous infusion for 5 days, starting at the end of the cisplatin infusion. Repeat treatment every three weeks. Must receive premedication wi… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 197 words ▾

3 DOSAGE FORMS AND STRENGTHS BEIZRAY (docetaxel) injection is a clear, colorless liquid supplied as follows: BEIZRAY 80 mg kit consisting of the following: One single-dose vial of BEIZRAY: 80 mg/4 mL One single-dose vial of IV Solution Stabilizer: 50 mL of 25% Albumin Human USP solution for infusion; a clear and slightly viscous solution BEIZRAY 160 mg kit consisting of the following: Two single-dose vials of BEIZRAY: 80 mg/4 mL each One single-dose vial of IV Solution Stabilizer: 50 mL of 25% Albumin Human USP solution for infusion; a clear and slightly viscous solution BEIZRAY carton containing one single-dose vial: 80 mg/4 mL 20 mg/mL BEIZRAY (docetaxel) injection is supplied as follows: BEIZRAY 80 mg kit contains: One single-dose vial of BEIZRAY: 80 mg/4 mL ( 3 ) One single-dose vial of IV Solution Stabilizer (50 mL, 25% Albumin Human USP solution) ( 3 ) BEIZRAY 160 mg kit contains: Two single-dose vials of BEIZRAY: 80 mg/4 mL each ( 3 ) One single-dose vial of IV Solution Stabilizer (50 mL, 25% Albumin Human USP solution) ( 3 ) BEIZRAY carton containing one single-dose vial: 80 mg/4 mL ( 3 ) 20 mg/mL ( 3 )

⛔ Contraindications 61 words ▾

4 CONTRAINDICATIONS BEIZRAY is contraindicated in patients with: • neutrophil counts of <1500 cells/mm 3 [see Warnings and Precautions ( 5.3 )] . • a history of severe hypersensitivity reactions to docetaxel. Severe reactions, including anaphylaxis, have occurred [see Warnings and Precautions ( 5.5 )] . Hypersensitivity to docetaxel ( 4 ) Neutrophil counts of <1500 cells/mm 3 ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Second primary malignancies: In patients treated with BEIZRAY- containing regimens, monitor for delayed AML, MDS, NHL, and renal cancer. ( 5.7 ) Cutaneous reactions: Reactions including erythema of the extremities with edema followed by desquamation may occur. Severe cutaneous adverse reactions have been reported.

Severe skin toxicity may require dose adjustment or permanent treatment discontinuation. ( 5.8 ) Neurologic reactions: Reactions including paresthesia, dysesthesia, and pain may occur. Severe neurosensory symptoms require dose adjustment or discontinuation if persistent.

( 5.9 ) Eye disorders: Cystoid macular edema (CME) has been reported and requires treatment discontinuation. ( 5.10 ) Asthenia: Severe asthenia may occur and may require treatment discontinuation. ( 5.11 ) Embryo-fetal toxicity: Can cause fetal harm.

Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.12 , 8.1 , 8.3 ) Alcohol content: The alcohol content in a dose of BEIZRAY Injection may affect the central nervous system. This may include impairment of a patient’s ability to drive or use machines immediately after infusion.

( 5.13 ) Tumor lysis syndrome: Tumor lysis syndrome has been reported. Patients at risk should be well hydrated and closely monitored during treatment. ( 5.14 ) BEIZRAY final infusion solution contains albumin derived from human blood, which has a theoretical risk of viral transmission.

( 5.15 )

5.1Toxic Deaths Breast Cancer BEIZRAY administered at 100 mg/m 2 was associated with deaths considered possibly or probably related to treatment in 2.0% (19/965) of metastatic breast cancer patients, both previously treated and untreated, with normal baseline liver function and in 11.5% (7/61) of patients with various tumor types who had abnormal baseline liver function (AST and/or ALT >1.5 times ULN together with AP >2.5 times ULN). Among patients dosed at 60 mg/m 2 , mortality related to treatment occurred in 0.6% (3/481) of patients with normal liver function, and in 3 of 7 patients with abnormal liver function.

Approximately half of these deaths occurred during the first cycle. Sepsis accounted for the majority of the deaths. Non-small Cell Lung Cancer BEIZRAY administered at a dose of 100 mg/m 2 in patients with locally advanced or metastatic non-small cell lung cancer who had a history of prior platinum-based chemotherapy was associated with increased treatment-related mortality (14% and 5% in two randomized, controlled studies).

There were 2.8% treatment-related deaths among the 176 patients treated at the 75 mg/m 2 dose in the randomized trials. Among patients who experienced treatment-related mortality at the 75 mg/m 2 dose level, 3 of 5 patients had an ECOG PS of 2 at study entry [see Dosage and Administration ( 2.2 ), Clinical Studies ( 14 )] .

5.2Hepatic Impairment Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Avoid BEIZRAY in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN [see Warnings and Precautions ( 5.1 )] . For patients with isolated elevations of transaminase >1.5 × ULN, consider BEIZRAY dose modifications [see Dosage and Administration ( 2.7 )] .

Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of BEIZRAY therapy.

5.3Hematologic Effects Perform frequent peripheral blood cell counts on all patients receiving BEIZRAY. Do not retreat patients with subsequent cycles of BEIZRAY until neutrophils recover to a level >1500 cells/mm 3 [see Contraindications ( 4 )] . Avoid retreating patients until platelets recover to a level >100,000 cells/mm 3 . A 25% reduction in the dose of BEIZRAY is recomme… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most serious adverse reactions from BEIZRAY are: Toxic Deaths [see Boxed Warning, Warnings and Precautions ( 5.1 )] Hepatic Impairment [see Boxed Warning, Warnings and Precautions ( 5.2 )] Hematologic Effects [see Boxed Warning, Warnings and Precautions ( 5.3 )] Enterocolitis and Neutropenic Colitis [see Warnings and Precautions ( 5.4 )] Hypersensitivity Reactions [see Boxed Warning, Warnings and Precautions ( 5.5 )] Fluid Retention [see Boxed Warning, Warnings and Precautions ( 5.6 )] Second Primary Malignancies [see Warnings and Precautions ( 5.7 )] Cutaneous Reactions [see Warnings and Precautions ( 5.8 )] Neurologic Reactions [see Warnings and Precautions ( 5.9 )] Eye Disorders [see Warnings and Precautions ( 5.10 )] Asthenia [see Warnings and Precautions ( 5.11 )] Alcohol Content [see Warnings and Precautions ( 5.13 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.14 )] The most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia.

Incidence varies depending on the indication. Adverse reactions are described according to indication. 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.

Responding patients may not experience an improvement in performance status on therapy and may experience worsening. The relationship between changes in performance status, response to therapy, and treatment-related side effects has not been established. Most common adverse reactions across all BEIZRAY indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Zhuhai Beihai Biotech Co.,Ltd. at 1-856-390-0826 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Breast Cancer Monotherapy with docetaxel for locally advanced or metastatic breast cancer after failure of prior chemotherapy Docetaxel 100 mg/m 2 : Adverse drug reactions occurring in at least 5% of patients are compared for three populations who received docetaxel administered at 100 mg/m 2 as a 1-hour infusion every 3 weeks: 2045 patients with various tumor types and normal baseline liver function tests; the subset of 965 patients with locally advanced or metastatic breast cancer, both previously treated and untreated with chemotherapy, who had normal baseline liver function tests; and an additional 61 patients with various tumor types who had abnormal liver function tests at baseline.

These reactions were described using COSTART terms and were considered possibly or probably related to docetaxel. At least 95% of these patients did not receive hematopoietic support. The safety profile is generally similar in patients receiving docetaxel for the treatment of breast cancer and in patients with other tumor types.

(See Table 4 .) Table 4: Summary of Adverse Reactions in Patients Receiving Docetaxel at 100 mg/m 2 * Normal Baseline LFTs: Transaminases ≤1.5 times ULN or alkaline phosphatase ≤2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN. ** Elevated Baseline LFTs: AST and/or ALT >1.5 times ULN concurrent with alkaline phosphatase >2.5 times ULN. *** Febrile Neutropenia: ANC grade 4 with fever >38°C with intravenous antibiotics and/or hospitalization. Adverse Reaction All Tumor Types Normal LFTs * n=2045 % All Tumor Types… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 141 words ▾

7 DRUG INTERACTIONS Docetaxel is a CYP3A4 substrate. In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4. In vivo studies showed that the exposure of docetaxel increased 2.2-fold when it was coadministered with ketoconazole, a potent inhibitor of CYP3A4.

Protease inhibitors, particularly ritonavir, may increase the exposure of docetaxel. Concomitant use of BEIZRAY and drugs that inhibit CYP3A4 may increase exposure to docetaxel and should be avoided. In patients receiving treatment with BEIZRAY, close monitoring for toxicity and a BEIZRAY dose reduction could be considered if systemic administration of a potent CYP3A4 inhibitor cannot be avoided [see Dosage and Administration ( 2.7 ), Clinical Pharmacology ( 12.3 )] . • Cytochrome P450 3A4 inducers, inhibitors, or substrates: May alter docetaxel metabolism.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed. ( 8.2 ) Females and Males of Reproductive Potential: Verify pregnancy status of females prior to initiation of BEIZRAY. ( 8.3 )

8.1Pregnancy Risk Summary Based on findings in animal reproduction studies and its mechanism of action, BEIZRAY can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . Available data from case reports in the literature and pharmacovigilance with docetaxel use in pregnant women are not sufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. BEIZRAY contains alcohol which can interfere with neurobehavioral development [see Clinical Considerations].

In animal reproductive studies, administration of docetaxel to pregnant rats and rabbits during the period of organogenesis caused an increased incidence of embryo-fetal toxicities, including intrauterine mortality, at doses as low as 0.02 and 0.003 times the recommended human dose based on body surface area, respectively [see Data]. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

All pregnancies have a background risk of birth defect, miscarriage, or other adverse outcomes. 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. Clinical Considerations BEIZRAY contains alcohol [see Warnings and Precautions ( 5.13 )] .

Published studies have demonstrated that alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development. Data Animal data Intravenous administration of ≥ 0.3 and 0.03 mg/kg/day docetaxel to pregnant rats and rabbits, respectively, during the period of organogenesis caused an increased incidence of intrauterine mortality, resorptions, reduced fetal weights, and fetal ossification delays. Maternal toxicity was also observed at these doses, which were approximately 0.02 and 0.003 times the daily maximum recommended human dose based on body surface area, respectively.

8.2Lactation Risk Summary There is no information regarding the presence of docetaxel in human milk, or on its effects on milk production or the breastfed child. No lactation studies in animals have been conducted. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with BEIZRAY and for 1 week after the last dose.

8.3Females and Males of Reproductive Potential Based on findings in animals, BEIZRAY can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating BEIZRAY. Contraception Females Based on genetic toxicity findings, advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose of BEIZRAY.

Males Based on genetic toxicity findings, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of BEIZRAY. Infertility Based on findings in animal studies, BEIZRAY may impair fertility in males of reproductive potential [see Nonclinical Toxicology ( 13.1 )] .

8.4Pediatric Use The alcohol content of BEIZRAY Injection should be taken into account when given to pediatric patients [see Warnings and Precautions ( 5.13 )] . The efficacy of BEIZRAY in pediatric patients as monotherapy or in combination has not been established. The overall safety profile of BEIZRAY in pediatric patients receiving monotherapy or TCF was consistent with the known safety profile in adults.

Docetaxel has been st… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 197 words ▾

10 OVERDOSAGE There is no known antidote for BEIZRAY overdosage. In case of overdosage, the patient should be kept in a specialized unit where vital functions can be closely monitored. Anticipated complications of overdosage include: bone marrow suppression, peripheral neurotoxicity, and mucositis.

Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed. In two reports of overdose, one patient received 150 mg/m 2 and the other received 200 mg/m 2 as 1-hour infusions.

Both patients experienced severe neutropenia, mild asthenia, cutaneous reactions, and mild paresthesia, and recovered without incident. In mice, lethality was observed following single intravenous doses that were ≥154 mg/kg (about 4.5 times the human dose of 100 mg/m 2 on a mg/m 2 basis); neurotoxicity associated with paralysis, non-extension of hind limbs, and myelin degeneration was observed in mice at 48 mg/kg (about 1.5 times the human dose of 100 mg/m 2 basis). In male and female rats, lethality was observed at a dose of 20 mg/kg (comparable to the human dose of 100 mg/m 2 on a mg/m 2 basis) and was associated with abnormal mitosis and necrosis of multiple organs.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. This leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, which results in the inhibition of mitosis in cells.

Docetaxel’s binding to microtubules does not alter the number of protofilaments in the bound microtubules, a feature which differs from most spindle poisons currently in clinical use.

12.2Pharmacodynamics Docetaxel exposure-response relationships and the time course of pharmacodynamic response are unknown.

12.3Pharmacokinetics Absorption The pharmacokinetics of docetaxel has been evaluated in cancer patients after administration of 20 mg/m 2 to 115 mg/m 2 in phase 1 studies. The area under the curve (AUC) was dose proportional following doses of 70 mg/m 2 to 115 mg/m 2 with infusion times of 1 to 2 hours. Docetaxel’s pharmacokinetic profile is consistent with a three-compartment pharmacokinetic model, with initial rapid distribution phase and the late (terminal) phase.

Distribution Mean steady state volume of distribution was 113 L. Docetaxel is approximately 94% protein bound in vitro, mainly to α1-acid glycoprotein, albumin, and lipoproteins. In three cancer patients, the in vitro binding to plasma proteins was approximately 97%.

Dexamethasone does not affect the protein binding of docetaxel. Elimination With extended plasma sampling up to 8 to 22 days post infusion, the estimated mean total body clearance was 18 L/h/m 2 (range of means: 14 to 23) and mean terminal elimination half-life was 116 hours (range of means: 92 to 135). Metabolism Docetaxel is metabolized by the CYP3A4 isoenzyme in vitro [see Drug Interactions ( 7 )] .

Excretion In three cancer patients urinary and fecal excretion accounted for approximately 6% and 75% of the administered radioactivity, respectively, within 7 days. About 80% of the radioactivity recovered in feces was excreted during the first 48 hours as 1 major and 3 minor metabolites with less than 8% as unchanged drug. Specific Populations Effect of Age: A population pharmacokinetic analysis was carried out after docetaxel treatment of 535 patients dosed at 100 mg/m 2 .

Pharmacokinetic parameters estimated by this analysis were very close to those estimated from phase 1 studies. The pharmacokinetics of docetaxel was not influenced by age. Effect of Gender: The population pharmacokinetics analysis described above also indicated that gender did not influence the pharmacokinetics of docetaxel.

Hepatic Impairment: The population pharmacokinetic analysis described above indicated that in patients with clinical chemistry data suggestive of mild to moderate liver impairment (AST and/or ALT >1.5 times ULN concomitant with alkaline phosphatase >2.5 times ULN), total body clearance was lowered by an average of 27%, resulting in a 38% increase in systemic exposure (AUC). This average, however, includes a substantial range and there is, at present, no measurement that would allow recommendation for dose adjustment in such patients.

Patients with combined abnormalities of transaminase and alkaline phosphatase should not be treated with docetaxel. Patients with severe hepatic impairment have not been studied [see Warnings and Precautions (5.2), Use in Specific Populations (8.6)] . Effect of Race: Mean total body clearance for Japanese patients dosed at the range of 10 mg/m 2 to 90 mg/m 2 was similar to that of European/American populations dosed at 100 mg/m 2 , suggesting no significant difference in the elimination of docetaxel in the two populations.

Drug Interaction Studies Effect of Ketoconazole: The effect of ketoconazole (a strong CYP3A4 inhibitor) on the pharmacokinetics of docetaxel… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied BEIZRAY injection is a clear, colorless liquid supplied as follows: Co-packaged kit containing BEIZRAY vial(s) and IV Solution Stabilizer (25% Albumin Human USP), a clear and slightly viscous solution Carton containing one BEIZRAY vial only Package Configuration BEIZRAY Strength Carton Contents NDC Number 80 mg kit 80 mg/4 mL one single-dose vial of 80 mg/4 mL BEIZRAY injection (NDC 83513-009-01). one single-dose vial of 50 mL of 25% Albumin Human USP solution (NDC 64208-2512-4). NDC 83513-010-01 160 mg kit 80 mg/4 mL two single-dose vials of 80 mg/4 mL BEIZRAY injection (NDC 83513-009-01). one single-dose vial of 50 mL of 25% Albumin Human USP solution (NDC 64208-2512-4).

NDC 83513-010-02 20 mg/mL vial 20 mg/mL one single-dose vial of 20 mg/mL BEIZRAY injection. NDC 83513-008-01 80 mg/4 mL vial 80 mg/4 mL one single-dose vial of 80 mg/4 mL BEIZRAY injection. NDC 83513-009-01

16.2Storage BEIZRAY Injection and 25% Albumin Human USP (IV Solution Stabilizer): Store at 20°C to 25°C (68°F to 77°F). Excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Retain in the original package to protect from light. Protect from freezing.

16.3Handling and Disposal BEIZRAY is a hazardous drug. Follow applicable special handling and disposal procedures.

16.1How Supplied BEIZRAY injection is a clear, colorless liquid supplied as follows: Co-packaged kit containing BEIZRAY vial(s) and IV Solution Stabilizer (25% Albumin Human USP), a clear and slightly viscous solution Carton containing one BEIZRAY vial only Package Configuration BEIZRAY Strength Carton Contents NDC Number 80 mg kit 80 mg/4 mL one single-dose vial of 80 mg/4 mL BEIZRAY injection (NDC 83513-009-01). one single-dose vial of 50 mL of 25% Albumin Human USP solution (NDC 64208-2512-4). NDC 83513-010-01 160 mg kit 80 mg/4 mL two single-dose vials of 80 mg/4 mL BEIZRAY injection (NDC 83513-009-01). one single-dose vial of 50 mL of 25% Albumin Human USP solution (NDC 64208-2512-4).

NDC 83513-010-02 20 mg/mL vial 20 mg/mL one single-dose vial of 20 mg/mL BEIZRAY injection. NDC 83513-008-01 80 mg/4 mL vial 80 mg/4 mL one single-dose vial of 80 mg/4 mL BEIZRAY injection. NDC 83513-009-01

16.2Storage BEIZRAY Injection and 25% Albumin Human USP (IV Solution Stabilizer): Store at 20°C to 25°C (68°F to 77°F). Excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Retain in the original package to protect from light. Protect from freezing.

16.3Handling and Disposal BEIZRAY is a hazardous drug. Follow applicable special handling and disposal procedures.

📋 Description 170 words ▾

11 DESCRIPTION Docetaxel is an antineoplastic agent belonging to the taxoid family. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β, 20-epoxy-1,2α,4,7β,10β,13α-hex-ahydroxytax-11-en-9-one4-acetate 2-benzoate. Docetaxel has the following structural formula: Docetaxel is a white to almost-white powder with an empirical formula of C 43 H 53 NO 14 , and a molecular weight of 807.89.

It is highly lipophilic and practically insoluble in water. BEIZRAY Injection for intravenous use is a sterile, non-pyrogenic, clear colorless liquid at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) in 0.770 grams dehydrated alcohol (100% v/v) solution, with citric acid for pH adjustment.

The BEIZRAY kit also contains a single dose vial of IV Solution Stabilizer, 50 mL of 25% Albumin Human USP solution. 25% Albumin Human USP is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The product contains 0.25 g Albumin Human USP per mL and is stabilized with 0.08 mmol sodium acetyltryptophanate and 0.08 mmol sodium caprylate per gram of albumin. structure.jpg

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Locally Advanced or Metastatic Breast Cancer The efficacy and safety of docetaxel have been evaluated in locally advanced or metastatic breast cancer after failure of previous chemotherapy (alkylating agent–containing regimens or anthracycline-containing regimens). Randomized Trials In one randomized trial, patients with a history of prior treatment with an anthracyclinecontaining regimen were assigned to treatment with docetaxel (100 mg/m 2 every 3 weeks) or the combination of mitomycin (12 mg/m 2 every 6 weeks) and vinblastine (6 mg/m 2 every 3 weeks).

Two hundred three patients were randomized to docetaxel and 189 to the comparator arm. Most patients had received prior chemotherapy for metastatic disease; only 27 patients on the docetaxel arm and 33 patients on the comparator arm entered the study following relapse after adjuvant therapy. Three-quarters of patients had measurable, visceral metastases.

The primary endpoint was time to progression. The following table summarizes the study results. (See Table 13 .) Table 13: Efficacy of Docetaxel in the Treatment of Breast Cancer Patients Previously Treated with an Anthracycline-Containing Regimen (Intent-to-Treat Analysis) Efficacy Parameter Docetaxel (n=203) Mitomycin/Vinblastine (n=189) p-value * For the risk ratio, a value less than 1.00 favors docetaxel.

Median Survival 11.4 months 8.7 months p=0.01 Log Rank Risk Ratio*, Mortality (Docetaxel: Control) 95% CI (Risk Ratio) 0.73 0.58 to

0.93Median Time to Progression 4.3 months 2.5 months p=0.01 Log Rank Risk Ratio*, Progression (Docetaxel: Control) 95% CI (Risk Ratio) 0.75 0.61 to

0.94Overall Response Rate Complete Response Rate 28.1% 3.4% 9.5% 1.6% p<0.0001 Chi Square In a second randomized trial, patients previously treated with an alkylating-containing regimen were assigned to treatment with docetaxel (100 mg/m 2 ) or doxorubicin (75 mg/m 2 ) every 3 weeks. One hundred sixty-one patients were randomized to docetaxel and 165 patients to doxorubicin. Approximately one-half of patients had received prior chemotherapy for metastatic disease, and one-half entered the study following relapse after adjuvant therapy.

Three-quarters of patients had measurable, visceral metastases. The primary endpoint was time to progression. The study results are summarized below.

(See Table 14 .) Table 14: Efficacy of Docetaxel in the Treatment of Breast Cancer Patients Previously Treated with an Alkylating-Containing Regimen (Intent-to-Treat Analysis) Efficacy Parameter Docetaxel (n=161) Doxorubicin (n=165) p-value * For the risk ratio, a value less than 1.00 favors docetaxel. Median Survival 14.7 months 14.3 months p=0.39 Log Rank Risk Ratio*, Mortality (Docetaxel: Control) 95% CI (Risk Ratio) 0.89 0.68 to

1.16Median Time to Progression 6.5 months 5.3 months p=0.45 Log Rank Risk Ratio*, Progression (Docetaxel: Control) 95% CI (Risk Ratio) 0.93 0.71 to

1.16Overall Response Rate Complete Response Rate 45.3% 6.8% 29.7% 4.2% p=0.004 Chi Square In another multicenter open-label, randomized trial (TAX313), in the treatment of patients with advanced breast cancer who progressed or relapsed after one prior chemotherapy regimen, 527 patients were randomized to receive docetaxel monotherapy 60 mg/m 2 (n=151), 75 mg/m 2 (n=188) or 100 mg/m 2 (n=188). In this trial, 94% of patients had metastatic disease and 79% had received prior anthracycline therapy. Response rate was the primary endpoint.

Response rates increased with docetaxel dose: 19.9% for the 60 mg/m 2 group compared to 22.3% for the 75 mg/m 2 and 29.8% for the 100 mg/m 2 group; pair-wise comparison between the 60 mg/m 2 and 100 mg/m 2 groups was statistically significant (p=0.037). Single Arm Studies Docetaxel at a dose of 100 mg/m 2 was studied in six single arm studies involving a total of 309 patients with metastatic breast cancer in whom previous chemotherapy had failed. Among these, 190 patients had anthracycline-resistant breast cancer, defined as progression… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 185 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies with docetaxel have not been performed. Docetaxel was genotoxic by an aneugenic mechanism in the in vitro chromosome aberration test in CHO-K 1 cells and in the in vivo micronucleus test in mice administered doses of 0.39 to 1.56 mg/kg (about 1/60th to 1/15th the recommended human dose on a mg/m 2 basis). Docetaxel was not mutagenic in the Ames test or the CHO/HGPRT gene mutation assays.

Docetaxel did not reduce fertility in rats when administered in multiple intravenous doses of up to 0.3 mg/kg (about 1/50th the recommended human dose on a mg/m 2 basis), but decreased testicular weights were reported. This correlates with findings of a 10-cycle toxicity study (dosing once every 21 days for 6 months) in rats and dogs in which testicular atrophy or degeneration was observed at intravenous doses of 5 mg/kg in rats and 0.375 mg/kg in dogs (about 1/3 rd and 1/15 th the recommended human dose on a mg/m 2 basis, respectively).

An increased frequency of dosing in rats produced similar effects at lower dose levels.

📚 References 7 words ▾

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

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 12/2025 PATIENT INFORMATION BEIZRAY (BAY-zer-ray) (docetaxel) injection for intravenous use What is the most important information I should know about BEIZRAY ?

BEIZRAY can cause serious side effects, including death. • The chance of death in people who receive BEIZRAY is higher if you: o have liver problems o receive high doses of BEIZRAY o have non-small cell lung cancer and have been treated with chemotherapy medicines that contain BEIZRAY can affect your blood cells. Your healthcare provider should do routine blood tests during treatment with BEIZRAY. This will include regular checks of your white blood cell counts.

If your white blood cells are too low, your healthcare provider may not treat you with BEIZRAY until you have enough white blood cells. People with low white blood cell counts can develop life- threatening infections. The earliest sign of infection may be fever.

Follow your healthcare provider’s instructions for how often to take your temperature during treatment with BEIZRAY. Call your healthcare provider right away if you have a fever. Swelling (inflammation) of the small intestine and colon.

This can happen at any time during treatment and could lead to death as early as the first day you get symptoms. Tell your healthcare provider right away if you develop new or worse symptoms of intestinal problems, including stomach (abdominal) pain or tenderness or diarrhea, with or without fever. Severe allergic reactions are medical emergencies that can happen in people who receive BEIZRAY and can lead to death.

You may be at higher risk of developing a severe allergic reaction to BEIZRAY if you are allergic to paclitaxel. Your healthcare provider will monitor you closely for allergic reactions during your BEIZRAY infusion. Tell your healthcare provider right away if you have any of these signs of a severe allergic reaction: o trouble breathing o sudden swelling of your face, lips, tongue, throat, or trouble swallowing o hives (raised bumps), rash, or redness all over your body Your body may hold too much fluid (severe fluid retention) during treatment with BEIZRAY.

This can be life threatening. To decrease the chance of this happening, you must take another medicine, a corticosteroid, before each BEIZRAY treatment. You must take the corticosteroid exactly as your healthcare provider tells you.

Tell your healthcare provider or nurse before your BEIZRAY treatment if you forgot to take your corticosteroid dose or do not take it as your healthcare provider tells you. Tell your healthcare provider right away if you have swelling in your legs or feet, weight gain or shortness of breath. Risk of new cancers.

An increase in new (second) cancers has happened in people treated with BEIZRAY together with certain other anticancer treatments. This includes certain blood cancers, such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), non-Hodgkin’s Lymphoma (NHL), and kidney cancer. o Changes in blood counts due to leukemia and other blood disorders may occur years after treatment with BEIZRAY. Your healthcare provider will check you for new cancers during and after your treatment with BEIZRAY.

Severe skin problems. Tell your healthcare provider right away if you have any of these signs of a severe skin reaction: o redness and swelling of your arms and legs. o blistering, peeling, or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. You may also have flu-like symptoms such as fever, chills, or muscle aches. o red, scaly rash all over your body with blisters, small red or white bumps under the skin that contain pus (pustules), and fever.

What is BEIZRAY Injection? BEIZRAY is a prescription anticancer medicine used to treat certain people with: breast cancer non-small cell lung cancer prostate cancer stomach cancer head and neck cancer It is not known if… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 180 words ▾

Package/Label Display Panel BEIZRAY (docetaxel) Injection 80 mg/4 mL (20 mg/mL) For Intravenous Infusion Only Must be diluted in a prepared solution containing Albumin Human USP and 0.9% Sodium Chloride Injection Do not substitude BEIZRAY for other docetaxel products Discard unused portion Warning: Hazardous Drug BEIZRAY (docetaxel) Injection, 80 mg/4 mL -Vial Label BEIZRAY (docetaxel) Injection, 20 mg/mL -Vial Label BEIZRAY (docetaxel) Injection, 80 mg Kit -Carton Label Each kit Contains: -One 4 mL Single-dose vials of Beizray (docetaxel) Injection -One 50 mL Single-dose vial of IV Solution Stabilizer (25% Albumin Human USP) BEIZRAY (docetaxel) Injection, 160 mg Kit -Carton Label Each kit Contains: -Two 4 mL Single-dose vials of Beizray (docetaxel) Injection -One 50 mL Single-dose vial of IV Solution Stabilizer (25% Albumin Human USP） BEIZRAY (docetaxel) Injection, 80 mg single-dose vial -Carton Label Contains One 4 mL Single-dose vial of Beizray (docetaxel) Injection only BEIZRAY (docetaxel) Injection, 20 mg single-dose vial -Carton Label Contains One 1 mL Single-dose vial of Beizray (docetaxel) Injection only 80mg vial 20mg vial 80mg kit 160mg kit 80mg single dosevial 20mg single dosevial

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

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

Medicare Part D (outpatient prescription) spending for Docetaxel (matched by generic name) — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Docetaxel. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$295.3K
Claims incl. refills
534
Beneficiaries
263
Spend / beneficiary
$1,122.66
Spend / claim
$552.92
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zhuhai Beihai Biotech Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Zhuhai Beihai Biotech Co., Ltd. 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.
← 83513-0008-01 · Zhuhai 83516-0241-01 · Resilience →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.